NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

It is critical that applicants follow the instructions in the Multi-Project Instructions for the SF424 (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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

In 2012, the NIH in partnership with the Wellcome Trust, and with advice from the African Society of Human Genetics, initiated the Human Heredity and Health in Africa Program (H3Africa). At the NIH, H3Africa is a component of the NIH Common Fund’s Global Health Initiative, and several Institutes and Centers have joined the Common Fund to support it. Recognizing that African researchers and populations have been, and still are, substantially underrepresented in genomics and environmental research and disproportionately affected by some environmental exposures, H3Africa is designed to provide new opportunities to African scientists to lead research on the genetic and environmental contributors to health and disease issues of importance to Africa through the use of genomics and other cutting-edge approaches. In this document, the term genomics and other cutting-edge approaches is used broadly and is intended to include approaches such as genetic epidemiology, phenotyping, biomarker development, pre-clinical research including the use of model organisms, and research on clinical utility, among others. The term "environmental contributors" is also used broadly and includes physical, chemical, biological, behavioral, and social environmental factors, among others. For further background on the origin and development of H3Africa, see the article Research Capacity: Enabling the Genomic Revolution in Africa Science (2014) 344: 1346-1348, and the H3Africa web site http://www.h3africa.org.

In order to enhance the capacity for genomics and environmental health research, in Africa by African scientists, and to understand the genetic and environmental factors that determine disease susceptibility, H3Africa has three interrelated, interdependent objectives:

• To support human genomics and genetics research that will not only generate important findings and discoveries relevant to human health, but will also serve as a vehicle to improve the research capacity of African laboratories and provide research opportunities for young scientists at the institutions where the research is carried out.
• To expand expertise and experience in genomics-based biomedical research and environmental epidemiology in Africa through research experience, skills development, and enhanced collaborations with regional, national, and international partners.
• To improve infrastructure including bioinformatics and biorepository capacity needed to support genomics-based and environmental research and associated data and sample sharing.

These objectives have been addressed through a set of awards to African institutions from the two funding partners using several different funding mechanisms, awarded primarily in 2012 and 2013. In its initial five-year phase, the Wellcome Trust has supported collaborative research projects and NIH has supported H3Africa Collaborative Centers (U54), H3Africa individual research projects (U01; including studies in the area of the ethical, legal, and societal issues of genomics in Africa), H3Africa Biorepositories (UH3), and a bioinformatics network, H3ABioNet (U41). This Funding Opportunity Announcement (FOA) is being issued to solicit applications for H3Africa Collaborative Centers (U54). A Collaborative Center should have projects based at three or more African institutions and projects should work collaboratively to investigate 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. Related H3Africa FOAs include announcements for Research Projects (RFA-RM-16-015), a Bioinformatics network (RFA-RM-16-011), research on ethical, legal, and social implications (RFA-RM-16-013 and RFA-RM-16-014), an H3Africa Administrative Coordinating Center (RFA-RM-16-017), and Research Training Grants (RFA-RM-16-012).

The H3Africa program is an initiative of the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. Investigators are invited to develop bold and innovative approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress. Common Fund programs are limited to a maximum of 10 (ten) years in length. The NIH H3Africa program will complete its first five years in 2017; therefore, activities proposed in applications submitted in response to this FOA should (a) be framed in terms of what can realistically be accomplished in the remaining five years of the program (2017 2021) and (b) discuss how activities will be sustained after 2021, when Common Fund support for the program ends.

Investigators funded by the H3Africa program operate as a highly collaborative Research Consortium. The Research Consortium meets regularly in person and by teleconference. The H3Africa Consortium has developed a number of overall policies and guidelines (see http://www.h3africa.org/consortium/documents). These policies will be referred to at appropriate places in this document and all applicants are expected to recognize and adopt these policies (or else provide justification why a particular policy cannot be followed).

A. Scientific scope

An H3Africa Collaborative Center is structured around significant collaborative projects within the PD/PI's home country, with scientists in other African nations, or both. In practice, each H3Africa Collaborative Center must be composed of a minimum of three and a maximum of 5 collaborating projects. In addition to the PD(s)/PI(s) project, at least two of the others need to be carried out in Africa with African investigators outside the home institution of the PD(s)/PI(s). Collaborations with scientists in non-African countries can be included in addition to the minimum three African projects. Together, the collaborations must provide the complete capacity needed to carry out research on a disease or condition important to Africa.

These applications bring together different areas of expertise, different research approaches, and/or different African contexts that provide synergy and allow each project to accomplish more than it would be able to on its own. The scientific scope of applications responsive to this FOA should be broadly focused on understanding how human genetic variation combined with environmental risk factors affect specific disease outcomes, exposures to specific disease, or impact other specific health-related traits in Africa. The following list provides some examples of different types of topics, any of which could be the focus of an H3Africa Collaborative Center. Applicants should understand, 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. Data clearly demonstrate the increasingly important impact of chronic disease in Africa (including but not limited to cancer, chronic kidney disease, diabetes mellitus, cardiovascular disease, mental illness, neurological disorders, and others) as well as increased incidence of disease-related conditions such as obesity and hypertension. A Collaborative Center application may involve collection of new samples and/or the use of existing samples from one or more populations of interest to study the genetic epidemiology of non-communicable diseases that present a significant public health burden. The individuals from whom samples are collected or re-used should be well-phenotyped to ensure that the disease being studied has been properly diagnosed. Samples must 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. If environmental measures or risk factors are being analyzed to explain etiology along with genetic risk factors, the project is expected to include robust validated environmental measures or biomonitoring, as well as a plan for how any environmental samples might be collected and stored.

The genetic/environmental contributors to communicable disease in Africa. Infectious diseases, including HIV/AIDS, malaria, tuberculosis, leishmaniasis, trypanosomiasis, schistosomiasis, ebola, lassa fever, and others, have historically been major health problems in Africa. A variety of genetic and environmental factors contribute to the susceptibility, development, and progression of disease. Genomic technologies have been useful in identifying genetic and environmental factors that impact transmission and pathogenesis of infectious diseases. These studies have the potential to lead to new strategies for treatment and prevention of these diseases; environmental manipulations may also be useful for primary prevention. Examining how behavioral and social factors contribute to the transmission and prevention of different communicable diseases could also substantially contribute to understanding how to prevent and treat these diseases. Studies that combine human genetics with studies of the genetics of the infectious agents and vectors involved and/or combine genomics with studies of other environmental contributors will be considered responsive to this FOA.

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 of particular body sites have been correlated with the onset or progression of several diseases (including but not limited to Crohn’s disease, psoriasis, neurodegenerative diseases, and bacterial vaginosis). Given the expectation that microbiome composition and resulting function are highly dependent on many environmental factors, including geographical location, diet, socio-economic status, in addition to host genetics, the relevance of the results of studies done outside of Africa to understanding health and disease in Africa cannot be assumed. Therefore, studies of the role of microbiome composition and/or function in diseases of African interest, along with comparative analyses of microbiomes from healthy cohorts, would be appropriate H3Africa research projects.

Inherited diseases in Africa. An analysis of individuals affected by monogenic diseases (including but not limited to albinism, beta-thalassemia, cystic fibrosis, sickle cell disease, etc.) or complex genetic disorders (including but not limited to neurodegenerative disorders including Alzheimer's and Parkinson's disease, systemic lupus erythematosus and other autoimmune disorders, asthma, cleft palate and other birth defects, etc.) to identify causative mutations, modifier genes, and early development environmental risk factors in African populations would be appropriate research projects for H3Africa.

Pharmacogenomics. Pharmacogenomics research seeks to identify genetic factors that are responsible for individual differences in drug efficacy and susceptibility to adverse drug reactions as well as the role these individual differences may play in the development of antimicrobial resistance. Analysis of pharmacogenomic effects in Africans would be an appropriate H3Africa research project, including projects that explore the genetics of inter-individual variability in the response to chemotherapy drugs, drugs used for the treatment of HIV, malaria, tuberculosis and other infectious diseases, treatments for stroke as well as pain medications.

Bioinformatics. Advances in tools and techniques for data generation are rapidly increasing the amount of data available to researchers, particularly in genomics. This increase requires researchers to rely ever more heavily on computational and data science tools for the storage, management, analysis, and visualization of data. Appropriate H3Africa bioinformatics research projects would involve research and development of transformative approaches and tools that maximize the integration of Big Data (like genomics data, environmental measures, phenotypes, and biomarkers) and data science into biomedical research. Projects that address association of genetic variation with disease in an African context, for example developing or using appropriate admixture models, and innovative bioinformatics approaches to address genetic and environmental contributions to complex disease outcomes are particularly encouraged as are projects that incorporate mobile and wireless technology validation and implementation to assess behavioral, social and environmental determinants of health.

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. Specifically:

• NHGRI is interested in applications from individuals who are developing genomics methods and research resources that support, or are conducting basic and translational research in: genomic sciences, informatics, implementation of genomics in clinical care (genomic medicine), and cost-effectiveness of genomic interventions. The specific research topic proposed should apply across a broad spectrum of diseases and health conditions and should not be specific to just one disease, except to the extent that a particular disease may serve as a model with broader applicability. Projects that capitalize on unique opportunities to use, as models, diseases and conditions that are more difficult to study in the U.S. because of prevalence or other factors will be considered.
• NHLBI is interested in applications that address the genetic and environmental contributors to heart, lung, and blood disorders. Examples would include, but not be limited to, the impact of these contributors on hypertension, heart failure, coronary artery disease, rheumatic heart disease, asthma, chronic obstructive pulmonary disease, hemoglobinopathies, nutritional anemias, and peri-partum hemorrhage.
• NIAID is interested in studies of infectious diseases found in Africa including, HIV/AIDS, malaria, tuberculosis, leishmaniasis, trypanosomiasis, schistosomiasis, ebola, lassa fever, pneumonia, Group B streptococcus and other emerging and re-emerging pathogens (e.g. pertussis).
• NIAMS is interested in applications that include mechanistic studies dealing with keloids, albinism, and lupus.
• NIDDK is interested in studies that address the genetic and environmental contributors to Chronic Kidney disease occurrence and progression.
• NIEHS is interested in supporting research that addresses the understanding of how exposures to toxic environmental insults alter biologic processes, are linked to disease initiation, progression or morbidity, and activities that lead to the development of prevention and intervention strategies to reduce environmentally induced diseases. Examples of environmental exposures relevant to the mission of the NIEHS include industrial chemicals or manufacturing byproducts, e-waste, metals, pesticides, herbicides, toxins in food, and inhaled toxicants including indoor air pollutants from cooking and other sources, as well as social stressors and microbiome determinants when combined with more traditional toxicants. Topics and disease outcomes of particular interest include airway diseases, CVD and neurological disorders or cognitive outcomes, and children’s environmental health. NIEHS is also interested in the unique vulnerability of developing children to harmful environmental exposures including outcomes such as low birth weight, premature birth, or reproductive outcomes, climate change and human health, and research exploring exposures during early life stages or critical windows of susceptibility that may directly or indirectly affect the risk of developing disease.
• NIMH is interested in genomic studies of mental health disorders in well-phenotyped cohorts to further our understanding of the genetic basis of mental disorders in African populations.
• NIMHD is interested in studies that focus on populations of the African Diaspora, and in particular, those populations that have significant immigration to the United States. Comparing genetics and health outcomes of Africans and African-descended populations in the United States is consistent with that interest. The specific research might examine how the prevalence of chronic diseases (e.g. diabetes) differ in these two populations that share the same/similar genetic heritage.
• NINDS is interested in neurological projects that address the H3 goals including, for example, in the areas of stroke and stroke risk factors, neurodegenerative disorders, epilepsy, and other neurological diseases and disorders.
• NIDA is interested in studies that 1) examine the epigenetic consequences of famine on brain development, behavior, and drug metabolism; 2) identify the role of nutrition and diet in brain development and 4) study the pharmacogenomics of HIV treatment.
• NIDCR is interested in applications that focus on genetic and environmental contributors to development of dental, oral, or craniofacial conditions, including the human oral microbiome; areas of interest include but are not limited to craniofacial birth defects, dental caries, periodontitis, oral cancer, Sj gren’s syndrome, and temporomandibular joint disorder and related orofacial pain conditions.
• ORWH is interested in funding applications that address issues associated with women's health and/or sex/gender influences in health and disease. Information about the ORWH mission and strategic plan can be found at: http://orwh.od.nih.gov/research/strategicplan/ORWH_StrategicPlan2020_Vol1.pdf.

All applications proposing research to improve the understanding of HIV/AIDS prevention, diagnosis, treatment, cure and related complications will also be considered in accordance with the NIH AIDS Research Priorities document found at the following link (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html).

B. Additional objectives of H3Africa.

As noted in the Purpose section, there are several specific objectives that the H3Africa Program is trying to achieve. Successful applicants will become members of the H3Africa Consortium, and will be expected to adhere to these policies, unless adequate justification can be provided.

H3Africa Consortium Participation: H3Africa is organized as a research consortium that brings participants together in a highly collaborative and synergistic effort. The H3Africa Consortium includes all participants of research and infrastructure projects funded through H3Africa, as well as responsible Wellcome Trust and NIH staff. Groups funded under this initiative will be expected to participate in the H3Africa Research Consortium and to collaborate effectively with each other to maximize the chances of overall success of the program. Each funded applicant is expected to participate directly or via proxy in consortium Working Groups that establish rules, guidelines, and resources for the Consortium (a list of H3Africa Working Groups can be found at www.h3africa.org). Each project is expected to comply with applicable consortium policies and procedures (found at www.h3africa.org). In addition the PD/PI(s) will be active members of the H3Africa Steering Committee, which meets regularly by teleconference. The H3Africa Consortium generally holds two meetings per year, usually in Africa.

H3Africa Data Sharing Policies: Data sharing is an increasingly important aspect of contemporary biomedical research, and the Consortium has developed a Data Sharing, Access, and Release Policy (www.h3africa.org/consortium/documents). One of the roles of the H3Africa Informatics Network (currently: http://h3abionet.org) is to facilitate data sharing, by providing a data repository in Africa for all genetic and genomic data, as well as selected associated phenotypes. Members of the H3Africa Consortium submit data to the Informatics Network according to that policy, and thereby facilitate transfer of those data to the European Genome-Phenome Archive (EGA). An H3Africa Collaborative Center is expected to share data in the agreed-upon format with the H3Africa Bioinformatics Network

The NIH Big Data to Knowledge (BD2K, https://datascience.nih.gov) program is a trans-NIH data science program that is addressing data sharing by working to make biomedical data Findable, Accessible, Interoperable, and Reusable (FAIR; see https://www.force11.org/group/joint-declaration-data-citation-principles-final). Data and analytical resources generated by an H3Africa Collaborative Center are expected to conform to the FAIR principles.

H3Africa Sample Sharing Policies: H3Africa funds a Biorepository Program consisting of three Biorepositories, located in Eastern, Western, and Southern Africa, respectively. All DNA samples must be deposited in one of the H3Africa Biorepositories according to H3Africa policies (www.h3africa.org/consortium/documents) so that they can be distributed and shared for further research consistent with achieving the goals of this funding initiative. Other biological samples may also be banked for future use. Samples generated by an H3Africa Collaborative Center are expected to be deposited in an H3Africa Biorepository, even if that involves sending the samples out of the country.

Community Engagement: H3Africa recognizes ongoing community engagement and the building of trust relationships with research participants as an essential feature of ethical biomedical and population-based genomics research involving human subjects (www.h3africa.org/consortium/documents). Community engagement can include a variety of activities, such as broad consent for sharing of samples and data, recontact of research participants, return of results to individual participants, or other relevant topics.

Collaborations. One of the major goals of the H3Africa Initiative is to facilitate opportunities for collaboration between and among investigators within Africa, in order to help build a larger African scientific community, which will in turn lead to more research opportunities and cutting-edge science on the continent. Intra-continental collaborations will also contribute to sustainability of African genomics programs. Therefore, each H3Africa Collaborative Center must include at least three collaborating projects based in African institutions that will interact to provide the complete capacity needed to carry out the proposed research effort. At least two collaborators, in addition to the PI/PD(s) should be based in African institutions outside of the applicant institution. International collaborations within Africa are encouraged, but not required. In addition to collaborations within each U54 Collaborative Center, collaboration and cooperation across the H3Africa Consortium are important. Harmonization of phenotypes across studies will facilitate cross-consortium analyses.

Providing the next generation of African researchers with opportunities in genomics. Establishing the next generation of African researchers to take advantage of genomic approaches to health research is a primary objective of the H3Africa program. Research in an H3Africa Collaborative Center provides a variety of career enhancement opportunities to students, postdoctoral researchers, and young investigators, such as attending seminars and scientific meetings, writing papers, and giving talks. Long-term sustainability and institutional/governmental commitments to research education programs and independent career opportunities are objectives of the H3Africa program.

All applicants are strongly encouraged to contact NIH Staff early in the application process to discuss the alignment of their proposed work with the goals of this FOA, and with the H3Africa Project. Technical Assistance Sessions and teleconferences will be held for potential applicants to this FOA and companion FOAs. NIH staff will be available to answer questions related to this FOA. Location, time, date, and dial in information will be announced in an NIH Guide Notice and will be posted on the H3Africa website: http://www.h3africa.org. During the Information Sessions, NIH staff will present an overview of these FOAs and answer questions from prospective applicants. The Information Sessions are open to all prospective applicants, but participation is not a prerequisite to applying.

See Section VIII. Other Information for award authorities and regulations.

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 Public/State Controlled Institutions of Higher Education
• African 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 not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD/PI should be an established investigator in their field and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI should have research experience in Africa, particularly in the country where the proposed research program will be established. The PD/PI will be responsible for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the program and appointing members of an Advisory Committee, as appropriate, and using their recommendations to modify the overall direction, management, administration, and evaluation of the program.

The contact PD/PI must be affiliated with the low and middle income (LMIC) African institution submitting the application where the proposed research program will be established and must have citizenship in an LMIC African country. Other Multiple PDs/PIs with relevant expertise from partner institutions in Africa, U.S. or other high income country (HIC) institutions may be proposed. Multiple PDs/PIs should have a documented history of collaboration relevant to the proposed program.

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the Multi-Project Instructions for the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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 activity
Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
Names of other key personnel
Participating institution(s)
Number and title of this funding opportunity

The letter of intent should be sent to:

Jennifer Troyer, Ph.D.
Telephone: 301-402-2852
Fax: 301-435-1580
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	6
Admin Core	6
Core (use for Shared Cores)	6
Project (use for Research Projects)	12

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required, maximum of 1
• Shared Cores: optional
• Research Projects: required, minimum of three, maximum of 5

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover. Note that more than 50% of the total funds for an H3Africa Collaborative Center must be spent in Africa.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Specific Aims: A concise set of specific aims that explain the overall goals and expected outcomes of the research is required. .

Research Strategy: Describe the H3Africa Collaborative Center's overall research strategy. The discussion should address:

• scientific vision and goal(s) of the H3Africa Collaborative Center, and its organization;
• research strategy from the perspective of the center itself and how the specific research to be carried out by each project will contribute to the success of the center;
• community engagement activities, especially as they pertain to the topic of broad consent for sharing samples and data;
• center-level analyses of genetic and (if appropriate) environmental data
• phenotype harmonization;
• bioinformatics capabilities of the H3Africa Collaborative Center, the challenges and problems that the project may encounter and suggestions as to how they will be solved or overcome;
• any optional cores that the applicant wishes to include in the H3Africa Collaborative Center;
• research education and career enhancement activities that will be included in the center; and
• management of the overall center, particularly with respect to collaborations that are not located at the PI/PD(s) home institution
• plans to move toward sustainability, during and beyond the period of funding requested.

The methods and technologies that will be used should be briefly presented; more detailed descriptions can be provided in the individual project sections. Innovative approaches that will be employed by the H3Africa Collaborative Center should be identified and the impact of those methods/technologies on the future of African science and/or medicine should be described.

The approaches to meeting the H3Africa Collaborative Center's bioinformatics needs should also be outlined in this section, and then described more fully in the individual project sections. Issues of data acquisition, data management, data storage, and analytical capability that the H3Africa Collaborative Center will confront should be concisely discussed. The bioinformatics activities may be embedded within the individual research components or may appear as a separate bioinformatics core in the Center, as one of the optional Cores. Additionally, a bioinformatics research component, for example new computational tool development, may be included within the research application as one of the collaborative projects.

Unless otherwise justified, the proposed H3Africa Collaborative Center will be expected to adopt current H3Africa policies with respect to community engagement, informed consent, data and biospecimen access, data sharing and release, and publications; the current policies can be found at www.h3africa.org/consortium/documents.

Letters of Support: Applications should include a letter of support from the appropriate institutional official (University or Medical School President, Dean or Director, or the head research administrator or equivalent) from each collaborating institution to substantiate the institution's commitment to the proposed H3Africa Collaborative Center. Each institution should state its commitment to overcoming any administrative obstacles to the implementation of the proposal, such as accommodation for participation by multiple schools at the university or collaboration with other institutions within or outside of the applicant s country. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and resources needed for the success of the planned program. In particular, the letter should address institutional commitment to any new faculty whose labs are established within the H3Africa Collaborative Center. It should also address commitment to collaborating and sharing data with the H3Africa Bioinformatics Network and sharing samples and relevant data with the H3Africa Biorepositories. 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 in FY2021.

Resource Sharing Plan: A plan for data and resource sharing and release is expected for all NIH applications (https://grants.nih.gov/grants/policy/data_sharing/). Applicants are, therefore, expected to provide a well thought-out plan for widely sharing data and resources generated by the H3Africa Collaborative Center, which should be consistent with the H3Africa Consortium's Data Release Policy (http://h3africa.org/consortium/documents).

Data Sharing Plan: All applications, regardless of the amount of direct costs requested for any one year, should include a Data Sharing Plan. The data sharing plan must be consistent with H3Africa Consortium policies (found at www.h3africa.org), and the application must include a statement that the investigators and applicant institutions will abide by the Consortium’s data sharing policies.

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.

All instructions in the SF424 (R&R) Application Guide must be followed.

An H3Africa Collaborative Center must comprise at least three collaborating research projects in Africa that together address one or more research areas of interest to the applicant. Each Project should be described as a distinct component.

When preparing your application in ASSIST, use Component Type Project.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Project Lead investigators' experiences with conducting research and employing the proposed methods and technologies should be documented.

Budget forms appropriate for the specific component will be included in the application package. The budget should include costs for shipping samples to the H3Africa Biorepository.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: A set of specific aims to be accomplished by the collaborating project is required.

Research Strategy: The significance of the project should be described, including the specific contribution that the project will make to the overall success of the H3Africa Collaborative Center. The research strategy that will be pursued in the project should be described in this section. .

The experimental plan that will be employed should be discussed in detail, including methods and technologies. The samples to be analyzed should be identified and the research strategy must include a plan for sample acquisition (where applicable), storage, preparation of material needed, etc. If environmental measures or risk factors are being analyzed to explain etiology along with genetic risk factors, robust validated environmental measures or biomonitoring should be demonstrated as well as an explanation of how any environmental samples might be collected and stored.

Human subjects issues associated with the samples to be used should be identified. In particular, when collecting new samples, investigators are required to obtain consent for the broad sharing of samples and data, while detailed justification must be provided if archived samples and data cannot be shared or only shared in a limited manner. A document entitled "H3Africa Guidelines for Informed Consent" may be helpful to applicants in writing their informed consent documents; this can be found at http://h3africa.org/consortium/documents. A timeline for developing and implementing an informed consent process, including obtaining IRB/REC approval, must be included in the application.

If the data are to be generated by the research project itself, the costs of generating the data should be addressed. The availability of supplies should be discussed, as should any issues of long-term maintenance and servicing of the necessary equipment.

If, instead, the applicant chooses to send samples elsewhere for data generation, for example to a research center or to service providers, 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, and the timeline for obtaining the data. In yet another approach, the applicant may choose to use previously generated or publicly available data, in which case the plans for obtaining and storing the data should be described.

Whether the data are new, previously generated, or publicly available, and whether new data are produced in-house or obtained externally, the applicant should describe how they will be analyzed, as well as the applicant’s experience with the relevant analytical technologies and methods. Applicants should state their willingness to work with the H3Africa Informatics Network and other grantees to harmonization phenotypes, where appropriate for the population being studied. Ideally this will occur when questionnaires and Case Report Forms are being developed, using standardized collection protocols, so phenotypes are harmonized from the beginning (see current H3Africa core phenotype recommendations and collection protocols here: www.h3africa.org/consortium/documents). Phenotype harmonization will also involve close collaboration after data is collected and submitted to the H3Africa Informatics Network so that phenotypes can be mapped to appropriate ontologies.

The bioinformatics needs of the project should be clearly described, including issues of data acquisition, data management, data storage, and analytical capability; the bioinformatics tools that will be used, and the relevant investigators' bioinformatics experience. The bioinformatics activities may be embedded within the individual research components or may appear as a separate bioinformatics core in the Center (see Shared Core section, below). Additionally, a bioinformatics research component, for example new computational tool development, may be included within the research application as one of the collaborative projects. Applicants are encouraged to describe their approaches to ensure that the data and analytical resources supported through this FOA will conform to the FAIR principles (Findable, Accessible, Interoperable, and Reusable; see https://www.force11.org/group/joint-declaration-data-citation-principles-final).

Applicants should be aware of the H3Africa Informatics Network (see companion FOA, RFA-RM-16-011 and website: www.h3abionet.org), which provides connectivity among the H3Africa participants, supports the bioinformatics skills development and analysis needs of genomics projects, and develops bioinformatics tools for genomics research in Africa. Applicants are strongly encouraged to take advantage of this resource. All H3Africa-funded projects are required to interact with H3Africa Informatics Network for data QC, standardization, and sharing. Therefore, applicants for a research project funded under this FOA must include a statement from the applicant institution committing it to collaborating and sharing data with the H3Africa Informatics Network, consistent with achieving the goals of H3Africa.

The applicant should identify potential major challenges or problems that might be encountered in conducting the proposed research, and discuss how these would be addressed should they arise. Innovative approaches that will be developed or employed by the project should be identified and the impact of those methods/technologies on the future of African science and/or medicine should be briefly discussed.

Engagement of Research Participants. The research plan must include a detailed plan for sample acquisition (where applicable), storage, preparation of material needed etc. In particular, when collecting new samples, investigators are required to obtain consent for the broad sharing of samples and data; detailed justification must be provided if archived samples and data cannot be shared or only shared in a limited manner. A document entitled "H3Africa Guidelines for Informed Consent" may be helpful to applicants in writing their informed consent documents; this can be found at http://h3africa.org/consortium/documents. A timeline for developing and implementing an informed consent process, including obtaining IRB/REC approval, must be included in the application. Applicants should also include a community engagement plan which includes ongoing and future community engagement activities and specifically addresses the benefit to the community.

Sustainability: A primary goal 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 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. 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 research activity will contribute to success in continuing the research efforts of its participants. 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.

Letters of Support: 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) from all collaborating institutions to substantiate the institutions commitment to the proposed plan. Each institution should also 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. Where applicable, the letter should address institutional commitment to any faculty who participate in associated skill-building programs. It should also address commitment to collaborating and sharing data as appropriate. The letter should also briefly discuss the institution's plans for sustaining an active program of genomics related research subsequent to the end of the funding period.

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 should be provided with the application if possible; if letters are not provided with the application, they may be requested from the applicant at a later date. 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).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

The resource and data sharing plan for the Collaborative Center should be described in the Administrative Core.

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.

PHS Inclusion Enrollment Report (Research Project)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type 'Admin Core.'

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used
• The H3Africa Collaborative Center PD/PI (contact PD/PI for applications with multiple PDs/PIs) must serve as the Administrative Core Lead.
• If the multi-PD/PI model is not used, applicants must designate an appropriate senior investigator as an overall scientific research lead.
• The Administrative Core is expected to have a qualified Center Administrator to manage the day-to-day operations with responsibility for the administrative, budgetary, and operational aspects of the Center. For the Center Administrator, in the additional Senior/Key Profiles section, use Project Role of 'Other (Specify)' and provide the role under 'Other Project Role Category' as 'Center Administrator'.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

• Leadership Effort Commitment: The Research Center contact PD/PI must commit and maintain through the life of the award a minimum of 2.4 person-month of effort. The required levels of effort may reflect an aggregate of the effort for the entire H3Africa Collaborative Center (listed here under Administrative Core) and the efforts for other components, as applicable.
• Center Administrator: Applicants are expected to propose and budget for a full-time or part-time Center Administrator to manage day-to-day operations, based on the complexity of the H3Africa Collaborative Center.
• Travel Funds: The budget should include funds to support travel for Center and Consortium activities, including but not limited to supporting the participation of PD(s)/PI(s) and additional staff members at the Consortium meetings. It is expected that each Collaborative Center will bring at least 4 people to each H3Africa Consortium meeting.
• Other: Funds (including travel if appropriate) may be allocated for expenses related to the formation of a Scientific Advisory Board.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims. Outline Specific Aims for the Administrative Core.

Research Strategy. The Administrative Core is expected to have appropriate and effective administrative and organizational capabilities to provide administrative support for genomics and environmental research, and research opportunities and career enhancement for early stage scientists. It is also expected to foster synergy and integration of the H3Africa Collaborative Center; and support any planning and evaluation activities that the Applicant chooses to include. Applications must describe the structure of the Administrative Core utilizing the following subsections (instead of the standard sub-sections):

Sub-section A. Administration and Management. The organizational structure of the Collaborating Center, and the plans for administering, managing, tracking, and coordinating the activities of the Center and its individual components should be described.

Sub-section B. Scientific Advisory Board (optional): Each awarded H3Africa Collaborative Center will, at the discretion of the PD/PI(s) be able to recruit external experts (i.e., from outside of the Center) to serve as scientific advisors to the H3Africa Collaborative Center leadership. If a Scientific Advisory Board (SAB) is included in the H3Africa Collaborative Center application, describe its general composition, the range of expertise to be sought, and how the panel will be expected to contribute to the Center's activities. However, to facilitate the review process, DO NOT name specific individuals in the application and DO NOT contact any potential candidates.

Sub-section C. Travel: A plan and budget for travel of Center members to H3Africa Consortium meeting, internal Center meetings, and other scientific meetings should be included.

Sub-section D. Research and Career Enhancement opportunities for early stage scientists including students, post-docs, and early stage investigators. Opportunities for involvement of scientists at all stages of the career pipeline should be described. Applicants should describe how their research will provide opportunities for students, postdoctoral researchers, and young investigators. They should also consider what career enhancement opportunities such as attending seminars and scientific meetings, writing papers, and giving talks will be provided. Long-term sustainability and institutional/governmental commitments to research education programs and independent career opportunities should also be discussed

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Applicants are expected to provide a well thought-out plan for widely sharing data and resources generated by the H3Africa Collaborative Center, which should be consistent with the H3Africa Consortium's Data Release Policy (http://h3africa.org/consortium/documents).The resource sharing plan must be consistent with H3Africa Consortium policies (found at www.h3africa.org), and the application must include a statement that the investigators will abide by the Consortium’s sample sharing policies.

Data Sharing Plan: All applications, regardless of the amount of direct costs requested for any one year, should include a Data Sharing Plan. The data sharing plan must be consistent with H3Africa Consortium policies (found at www.h3africa.org), and the application must include a statement that the investigators will abide by the Consortium’s data sharing policies

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.

PHS Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Shared Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Shared Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Shared Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components

Project /Performance Site Location(s) (Shared Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Shared Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Shared Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Shared Core)

Specific Aims: Succinctly describe the role of the Core in the H3Africa Collaborative Center, and how the Core will meet the needs of two or more of the research projects.

Research Strategy: Explain how the Core is justified by the scientific and translational needs of the H3Africa Collaborative Center. Describe how the expected contributions of the Core will accelerate progress and promote more effective approaches that will enhance the likelihood of success of the research project(s) in achieving the overall objectives of the H3Africa Collaborative Center. Explain why support for the indicated functionality in the form of a Core of the H3Africa Collaborative Center will be more efficient than if the research projects themselves were to provide the functionality or how the Core provides added value beyond that which would be provided by acquisition through fee for service or commercial access. For a Core that by its nature is not innovative, describe why it is essential to achieve the goals or objectives of the H3Africa Collaborative Center.

Describe plans and procedures for establishing and managing the Core. Describe the role of the Core Leader and each of the key participants. Present a clear picture of the facilities, techniques, and skills that the core will provide. Describe plans and procedures for quality control and cost-effectiveness of the services and resources provided by the Core to the H3Africa Collaborative Center investigators. Where applicable, include sections on plans for data management and data analysis.

Since the Core will necessarily be geographically separate from at least one of the supported research projects, describe the process(es) that will be in place to facilitate coordination, distribution and accessibility to the services, facilities or resources that the Core proposes to provide.

Resource Sharing Plans: Generally, Resource Sharing Plans are expected, but they are not applicable for this component of the FOA.

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.

PHS Inclusion Enrollment Report (Shared Core)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date 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 SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: https://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(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 System for Award Management (SAM). 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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant 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.

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects. H3Africa projects are also encouraged to consult the H3Africa Phenotype Harmonization documents (found at http://h3africa.org/consortium/documents) and describe efforts to ensure CDEs with other H3Africa projects.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 score to reflect their assessment of the likelihood for the H3Africa Collaborative Center 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 H3Africa Collaborative Center 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 H3Africa Collaborative Center that by its nature is not innovative may be essential to advance a field.

Does the H3Africa Collaborative Center address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the H3Africa Collaborative Center 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 proposed Center address the goals of H3Africa?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the H3Africa Collaborative Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI , do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are the proposed collaborators likely to work together synergistically?

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 Center promote and support innovation that will strengthen and sustain genomic and environmental research in Africa?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the H3Africa Collaborative Center? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the H3Africa Collaborative Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Will the program proposed be effective in addressing the H3Africa goal of enhancing the competitiveness of African genomics investigators? Will the Center support the capacity building objectives of H3Africa? Are the evaluation plans, milestones and timelines proposed appropriate and adequate for the program? Has the issue of future sustainability been adequately addressed? Does the Center describe a strategy for community engagement with clear objectives of what they expect to achieve? Are there adequate plans to evaluate whether the strategies to engage the community are successful and the objectives achieved?

Are the proposed timelines appropriate and adequate for the program? How will the activities initiated under this award be sustained at the conclusion of the five-year award period?

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 Center take advantage of resources available at the collaborating institutions? Does the application identify and plan to take advantage of other resources at the participants' institutions, countries or other countries where necessary? Do the letters of collaboration and institutional support show strong commitment to the project and to the PD(s)/PI(s)? Is there a commitment at the institution to providing quality research education and career development for early stage scientists?

As applicable for the H3Africa Collaborative Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Center-Specific Review Criteria

Is the proposed collaborative nature of the Center conducive to achieving the Center's goals?

Does the application provide adequate evidence of the advantages of conducting the proposed research as a collaborative program rather than through separate research efforts?

Will the research efforts taken together have more impact on the field than each separate project conducted in isolation?

Are adequate mechanisms proposed for regular communication and coordination among investigators in the Collaborative Center?

Are adequate administrative structures in place for the day-to-day management of the center, including arrangements for internal quality control of ongoing research?

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

Does the Center include adequate plans to ensure future sustainability? What additional collaborations will be pursued to further its research program?

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 Guidelines for the Review of Human Subjects.

When the proposed H3Africa Collaborative Center involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

For Renewals, the committee will consider the progress made in the last funding period.

Not Applicable

As applicable for the H3Africa Collaborative Center 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 score.

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.

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).

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) Genomic Data Sharing Plan.

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

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 Research 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? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How do the goals of the project contribute to the Collaborative Center overall? How will the research proposed be enhanced by being part of the Collaborative Center?

Investigator(s)

Are the Lead(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 there is more than one Lead, do the investigators have complementary and integrated expertise? Do the investigators have a track record of success in carrying out human genomic research programs? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical research? Do the investigators have the experience and ability to handle diverse data types and to present an integrated view of these data?

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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Does the project describe a strategy for community engagement with clear objectives of what they expect to achieve? Are there adequate plans to evaluate whether the strategies to engage the community are successful and the objectives achieved? Are the evaluation plans, milestones and timelines proposed appropriate and adequate for the project?

Are the proposed timelines appropriate and adequate for the project? Has the issue of future sustainability been adequately addressed? 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?

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 score, but will not give separate scores for these items.

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed research project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

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, an Admin Core that by its nature is not innovative may be essential to advance a field.

Significance

Does the Admin Core address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the program? If the aims of the Admin Core 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 Lead(s), collaborators, and other researchers well suited to the Admin Core? 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 there is more than one Lead, do the investigators have complementary and integrated expertise? Do the investigators have a track record of success in carrying out human genomic research programs? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical research? Do the investigators have the experience and ability to handle diverse data types and to present an integrated view of these data?

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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Admin Core? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the Admin Core involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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?

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

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed Admin Core involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

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 Shared Core that by its nature is not innovative may be essential to advance a field.

Significance

Does the Shared Core address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the Shared Core 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 Lead(s), collaborators, and other researchers well suited to the Shared Core? 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 there is more than one Lead, do the investigators have complementary and integrated expertise? Do the investigators have a track record of success in carrying out human genomic research programs? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical research? Do the investigators have the experience and ability to handle diverse data types and to present an integrated view of these data?

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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Shared Core? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the Shared Core involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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?

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

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed Shared Core involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the National Human Genome Research Institute (NHGRI) in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group 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 score.
• 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 National Advisory Council for Human Genome Research. 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.
• Overall program balance in the H3Africa program.
• Relevance of the proposed project to the goals of H3Africa.
• Commitment to compliance with H3Africa policies and procedures.
• Potential for establishing a sustainable research program.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this 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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 Part 75, 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.

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.
• 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 H3Africa Consortium.
• Awardee(s) will ensure that the data are submitted to the H3Africa Bioinformatics Network, that samples are deposited in the H3Africa Biorepositories, 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 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."
• Awardees agree to the governance of the Consortium through the Steering Committee
• PD(s)/PI(s) will serve as active members of the H3Africa Steering Committee and will participate directly or by proxy on relevant H3Africa Working Groups.
• Awardees 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:

• The Project Scientists will negotiate goals with the awardees as needed, serve as a liaison between the awardees and 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.
• The Project Scientists will participate (with H3Africa investigators) in the group process of deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted.
• Project Scientists will attend Steering Committee meetings as non-voting members, serve on H3Africa Working Groups, and assist in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

Participation on the H3Africa Steering Committee. On voting matters, each funded project will have one vote and each funding agency will have a single vote. The Steering Committee will: (1) discuss progress in meeting the goals of various H3Africa projects and of H3Africa as a whole; (2) 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; (3) endorse and oversee progress and products of Working Groups within the Consortium; (4) meet twice a year in person in conjunction with network meetings and conduct intermittent conference calls.

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. It will have three members: 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 Research Performance Progress Report (RPPR) 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Jennifer Troyer, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-2852
Email: [email protected]

Rudy Pozzatti, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-8739
Email: [email protected]

Deanna Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
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 Part 75.