It is critical that applicants follow the instructions in the Training 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). 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

Global health research is increasingly utilizing genomic approaches (e.g. GWAS, whole genome sequencing, epigenomic mapping, transcriptomics, proteomics and metabolomics), computational structure determination of proteins and other biochemical entities and digital image, phenotype and clinical record analysis that generate enormous amounts of data. Bioinformatics expertise is essential to develop new methods to manage large datasets, databases and pipelines for analysis as well as apply computational methodologies to visualize data and solve biological questions related to disease pathogenesis, transmission, prevention, diagnosis or treatment.

While the Human Heredity and Health in Africa Informatics Network (H3IN) will continue to provide short term user training as well as develop and implement cutting-edge, reliable, and cost-effective approaches to address the informatics needs of the H3Africa Consortium, more advanced bioinformatics research leadership and sustainable training capacity in additional African institutions are needed to meet the larger overall objectives of H3Africa.

The purpose of this FOA is to invite applications to support bioinformatics research training programs at African institutions in low or middle income countries (LMICs) that will address the need for advanced bioinformatics and data science research expertise in the H3Africa Consortium. African LMIC applicant institutions with significant genomics research capacity (documented by genomics research funding and publications) may propose bioinformatics research training programs. The program proposed should aim to coalesce and create the leadership, interdisciplinary approaches and mentorship necessary to create a sustainable bioinformatics research training program relevant to global health research for the African continent. Each award will support interdisciplinary training to develop bioinformatics scientists capable of leading or participating in integrative, team approaches to significant global health problems. Programs may involve faculty and trainees with backgrounds in informatics, biology, medicine, computer science, statistics, engineering and mathematics. The training program should provide:

• A strong foundation in research design, methods, and analytic techniques appropriate for bioinformatics research related to genomic approaches to global health issues;
• The enhancement of the trainees ability to conceptualize and think through research problems with increasing independence;
• Experience conducting research using state-of-the-art methods as well as presenting and publishing research findings;
• The opportunity to interact with members of the scientific community at appropriate scientific conferences and workshops; and
• The enhancement of the trainees understanding of the health-related sciences and the relationship of their bioinformatics research training to global health.

The proposed institutional research training program may complement other ongoing research training and career development programs at the applicant institution, but the proposed program must be clearly distinct from related programs currently receiving U.S. government support.

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 community engagement, data and sample sharing, and other policies and procedures (found at www.h3africa.org). 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. 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. It is expected that H3Africa trainees will have opportunities to participate in consortium-wide research collaborations and training opportunities as appropriate, as well as forging new collaborative partnerships within and outside of the H3Africa consortium.

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. H3Africa projects provide a variety of career enhancement opportunities for students, 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 H3Africa.

Biomedical research is increasingly complex and multidisciplinary in nature. PDs/PIs are encouraged to develop research training programs that will expose trainees to a diversity of scientific approaches, systems for study, research methodologies, and tools and technologies appropriate to address global health issues in African LMIC institutions. Consideration of innovative team-based bioinformatics research training approaches to address the goals of the H3Africa Consortium is encouraged.

Awards will support the development of new bioinformatics research training capacity at African LMIC institutions. Where justified, applicants may propose some training of individuals in existing master’s or doctoral degree training programs at the applicant institution or at collaborating African, U.S., or other high income country (HIC) institutions. However, awards may not exclusively support these training slots in existing programs since new bioinformatics training capacity should be established.

Trainees emerging from proposed masters, doctoral and postdoctoral programs should be able to conduct original basic or applied research at the intersection of computer, statistical and information sciences with one or more biomedical applications. Successful trainees from these programs should be prepared for research roles in African institutions. This initiative is not intended to prepare trainees for careers primarily focused on the planning, deployment, maintenance, or administration of computer systems in health care, public health, medical education or research. The emphasis in this program is on the development of trainee capabilities to pursue new knowledge that advances biomedical research, bioinformatics and data science.

Proposed training in a core curriculum for research masters' and doctoral degrees should include bioinformatics and data science principles and concepts, quantitative methods, such as biostatistics and applied mathematics, concepts of computer science, engineering, information sciences and/or other relevant fields. Special emphasis should be given to instruction in the design of rigorous, reproducible research studies in bioinformatics and data science related to genomics research. This core curriculum may be supplemented by other relevant courses and research experience in one or more biomedical applications so that trainees acquire an appropriate depth of knowledge to pursue meaningful global health research in areas such as mining of large scale genome-phenome datasets, intelligent tools for curation, visualization and analysis of biomedical big data, precision medicine, biomedical big data analytics, biostatistics, in-silico trials, merging and mining large disparate data sets that mix images, text and data.

Practicum experiences may be specifically designed as part of the curriculum to promote the integration of basic informatics/data science methods and biomedical applications relevant to H3Africa research. Beyond the proposed core curriculum, trainees may be offered opportunities for advanced training in those fields basic to informatics (computer, statistical, information, social/behavioral sciences and other fields) that prepares them for their research projects, thesis or dissertation work.

It is expected that trainees will disseminate the results of their research at scientific conferences and in peer-reviewed publications during and after the training period. Trainees from these programs are expected to be capable of carrying out independent research at a level of sophistication compatible with publication of results and competition for fellowships, research grants and contracts.

Applicants may propose to provide training through a partnership structure. Partnerships should be well justified to enhance the specific objectives of the training program. A partnership structure including African, U.S. or other high income country (HIC) institutions may be proposed to:

1) Involve faculty with the specific technical bioinformatics expertise needed initially to offer curriculum and relevant mentored research training across the range of bioinformatics subfields or;

2) Involve faculty with expertise in a specific global health focus needed initially to offer curriculum and relevant mentored research training relevant to create interdisciplinary bioinformatics researchers able to contribute to broad global health areas such as environmental health, non-communicable or infectious disease.

However, if a partnership structure is proposed, the African applicant should also propose how additional faculty from their institution will be trained to fill these existing gaps in expertise to eventually establish a sustainable bioinformatics research training program. In a partnership structure involving U.S. or other HIC institutions, trainees should be matched to both African and U.S. or HIC mentors, conduct mentored research related to H3Africa priorities (using H3Africa research data, if possible) and obtain advanced degrees from African institutions, as much as feasible.

Research training grants must be used to support a program of full-time research training. The duration of training, the transition of trainees to individual support mechanisms, and their transition to the next career stage are important considerations in the evaluation of the success of institutional research training programs. The proposed program should make appropriate skills training available so that trainees are prepared to apply for subsequent independent support for their training or research program (e.g., an individual fellowship award, mentored career development award, or research project grant), as appropriate for their career stage. Training programs should provide career development advising and skills development opportunities (e.g. workshops, discussions, Individual Development Plans). Through such opportunities, trainees should be expected to obtain a working knowledge of various potential career directions that make strong use of the knowledge and skills gained during research training and the steps required to transition successfully to the next stage of their chosen career.

Short-term training will not be supported by these awards. Awards made in response to RFA-RM-16-011, Human Heredity and Health in Africa (H3Africa): Informatics Network (U24) will support short term training for bioinformatics capacity building and implementation for informatics research and tool development; user support; preparation and guidance; and outreach and communication for H3Africa’s collaborative centers, research projects, bio-repositories, and coordinating center.

Attention should be given to recruiting and retaining trainees from racial or ethnic groups underrepresented in the biomedical, behavioral and clinical sciences in the LMIC context, women, individuals with disabilities, and individuals from disadvantaged backgrounds.

All applicants are strongly encouraged to contact NIH Staff early in the application process to discuss the alignment of their proposed training program 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.

Other

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Only public or private institutions of higher education in African low or middle income countries (LMICs) are eligible to apply. LMICs are defined by the World Bank classification system (according to Gross National Income (GNI) per capita as low-income, lower-middle-income, and upper-middle-income (http://data.worldbank.org/about/country-classifications/country-and-lending-groups). See Notice of Change in Country Eligibility for Fogarty International Training Grants and Country Eligibility for definition of "eligible LMIC" used in this FOA.

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

The applicant institution (and partner institutions, if relevant) must have a strong and high quality research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, potential trainees and facilities to conduct the proposed research training program. The proposed program may complement (but not duplicate) other ongoing research training programs occurring at the applicant institution (and collaborating institutions, if relevant). It is anticipated that a substantial number of program faculty will have active research projects in which participating trainees may gain relevant experiences consistent with their research interests and goals.

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 training program as the Training Program Director/Principal Investigator (Training PD/PI) 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 SF 424 (R&R) Application Guide.

The PD/PI should be an established investigator in bioinformatics and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI should have bioinformatics research training experience in African LMICs, particularly in the country where the proposed research training 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 day to day administration of the program and appointing members of the Training Advisory Committee 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 training program will be established and must have citizenship in an LMIC African country. Other Multiple PDs/PIs with bioinformatics or relevant genomic 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 research training program.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number is allowed.

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).

Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

Program faculty should have experience providing bioinformatics research training in African LMICs including successful former trainees from African LMICs who have established productive bioinformatics careers.

Trainees must be citizens of African low or middle income countries and affiliated with the applicant institution or another institution in the H3Africa Consortium. Trainees should be prepared to enter the training level proposed by the program, which can include master's, pre-doctoral, or post-doctoral level training.

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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

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

Letter of Intent

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

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

• Descriptive title of proposed 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:

Laura Povlich
Telephone: 301-827-2227
Fax: 301-402-0779
Email: [email protected]

All page limitations described in the SF424 (R&R) 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 an application to this FOA.

Follow all instructions provided in the SF424 (R&R) Application Guide.

Follow all instructions provided in the SF424 (R&R) Application. Include the applicant institution and all the collaborating institutions where research training will be supported.

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

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research training program, as well as key activities in the training plan. Indicate the planned duration of training, the projected number of trainees including their levels (i.e., master's, predoctoral, postdoctoral, and intended trainee outcomes. Identify all collaborating institutions. Describe the relevance of the proposed research training to the goals of H3Africa.

Other Attachments. A Training Advisory Committee is a required element of a training program to monitor program progress. This committee should include relevant experts who are not affiliated with the program and the majority of members should be affiliated with African institutions. The composition, roles, responsibilities, and expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Please name your file Advisory_Committee.pdf .

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

Follow all instructions provided in the SF424 (R&R) Application.

• If applicable, include the name of one person at each collaborating institution who will serve as the primary collaborator for that training site.
• List all members of the Training Advisory Committee (TAC)

Follow all instructions provided in the SF424 (R&R) Application.

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

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

• Use the Other Personnel section to submit costs for salary support for administrative staff.
• Use the Travel section to submit costs for key personnel and faculty travel.
• Use the Participant/Trainee Support Costs section to submit costs for 1) Tuition and fees 2) Trainee stipends 3) Trainee travel. Include health insurance under Training Related Expenses (not in Tuition/Fees/Health Insurance). Do not use the Subsistence category. Provide details of trainees and training related expenses in the budget justification.
• Use the Other Direct Costs section to submit costs for other direct costs related to training activities. Describe fully in the budget justification.

The PHS 398 Research Training Program Plan Form is comprised of the following sections:

• Training Program
• Faculty, Trainees, and Training Record
• Other Training Program Sections
• Appendix

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

Training Data Tables are not required for these applications.

Training Program

Program Plan

Background - In addition to the instructions in the SF424 (R&R) Application Guide:

Applications must describe overall technical or interdisciplinary global health bioinformatics focus of the proposed research training program and how it is relevant to the H3Africa goals.

Applicants should state the specific objectives of the proposed bioinformatics research training plan. Descriptions of the various proposed components of the research training program should be linked to these objectives.

Applications should document the existing bioinformatics research capacity at the African LMIC institution where a new bioinformatics research training capacity will be established. Measurable parameters of increased bioinformatics research capacity expected as a result of the proposed research training activities at the end of the grant period should be defined.

If a partnership structure is proposed, applications should describe how each collaborating institution will contribute to the specific objectives of the research training plan including how the applicant institution will gain the bioinformatics training capacities initially provided by partners to eventually establish a sustainable bioinformatics training program.

Institutions with existing related research training programs must explain what distinguishes the proposed program from the others, how their proposed program will synergize with the others, if applicable, and demonstrate that the pool of faculty, potential trainees, and resources are robust enough to support an additional program.

Program Plan

a. Program Administration - In addition to the instructions in the SF424 (R&R) Application Guide:

Applicants should describe how decisions regarding the components of the proposed research training program will be made in consultation with the proposed faculty and Training Advisory Committee.

Applicants should describe plans for how all mentored research projects under this award will receive independent scientific review through procedures established by the applicant institution and Training Advisory Committee. In addition, applicants should describe how trainees who conduct mentored research involving human subjects will receive education in the protection of human subjects. Trainee research must receive annual approval from an institutional (or ethical) review board or committee at the applicant institution and, if different, at the institution in which the research is being conducted.

b. Program Faculty- In addition to the instructions in the SF424 (R&R) Application Guide:

Describe the specific role of each proposed faculty mentor in the proposed research training program. Briefly describe any relevant research, including any current research collaborations with the PD(s)/PI(s) or other faculty, H3Africa Consortium involvement, if any and research training record, in particular, for trainees from African LMICs. Applicants should explain how the relevant research grant support and activities of the PD(s)/PI(s) and proposed faculty mentors may contribute to the proposed bioinformatics research training plan.

c. Proposed Training- In addition to the instructions in the SF424 (R&R) Application Guide:

The research training proposed should instill advanced bioinformatics expertise and research leadership capabilities through rigorous and innovative didactic, practicum and mentored research activities designed to address the H3Africa goals and the global health needs of African LMICs. Applicants should describe in detail the research masters, doctoral and/or postdoctoral research training proposed including the scientific focus, faculty, institutional location and duration for curriculum components, practicum experiences and mentored trainee research. The numbers of trainees expected to participate in each training component should be stated.

Applicants are encouraged to include plans for strengthening the associated skills and knowledge necessary for long-term research career sustainability, such as scientific writing and presentation, grant writing, and expertise in research administration and management of intellectual property. Training in English as a second language may be supported, if needed.

Research training by interactive distance learning technology may be proposed, if appropriate and sustainable for the African LMIC trainees and institutions involved. Applicants should describe the availability of distance learning facilities, equipment, internet connectivity, and technical support.

Applicants should provide specific implementation plans during the requested grant period to meet the proposed research training objectives. A time line may be included.

e. Trainee Candidates- In addition to the instructions in the SF424 (R&R) Application Guide:

Applicants should describe plans for how the most qualified African LMIC trainees will be recruited for the proposed research training programs. The specific criteria and decision-making process for selecting trainees should be delineated. Strategies that will be used to retain trainees in master's and doctoral degree programs and postdoctoral mentored research projects as well as facilitate sustainable bioinformatics research and training careers in African institutions should be characterized.

f. Institutional Environment and Commitment to the Program- In addition to the instructions in the SF424 (R&R) Application Guide:

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 training program 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 training program beyond the H3Africa program and how the research training program will contribute to success in continuing the research efforts of its participants.

Faculty, Trainees, and Training Record

Letters of Support: The application should include letters of institutional commitment of resources from the appropriate official at all proposed research training site institutions. If partner training sites are proposed, partner institution faculty who agree to serve as faculty/mentors should provide letters indicating their willingness to participate and specific contribution to the training proposed.

Plan for Instruction in the Responsible Conduct of Research

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

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.

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). 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.

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) 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.

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 training 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 that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of the merit of the training program, 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.

Training Program and Environment

• Are the research facilities and research environment in all proposed training sites conducive to preparing trainees for successful careers as bioinformatics research scientists in Africa?
• Are the objectives, design and direction of the proposed research training program likely to ensure effective training?
• Do the proposed research training program objectives address the goals of H3Africa?
• Do the courses and practicum experiences, where relevant, and research experiences provide opportunities for trainees to acquire state-of-the-art scientific knowledge, methods, and tools that are relevant to the goals of the training program?
• Does the program provide appropriate inter- or multidisciplinary research training opportunities?
• Is the level of institutional commitment to the training program at all proposed training sites, including administrative and research training support, sufficient to ensure the success of the program?
• Is it clear how the proposed training program is new and distinguished from other externally funded research training programs at the institution?
• If multiple training sites are proposed, is there a history of successful research and/or research training collaboration between the sites?
• If distance learning approaches are proposed, are sufficient facilities, equipment, internet connectivity and technical support available at the African institutions involved to insure success?
• Are the Training Advisory Committee membership and proposed roles likely to strengthen the research training program?
• Are plans for independent scientific review (and ethical review if human subjects involved) of mentored trainee research adequate?

Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

• Does the PD/PI have the scientific background, expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program?
• Does the PD/PI plan to commit sufficient effort to ensure the program s success?
• Is the PD/PI currently engaged in bioinformatics research relevant to the goals of H3Africa?

For applications designating multiple PDs/PIs:

• Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainees?
• Is there evidence of previous collaboration between the multiple PDs/PIs identified?
• Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and the complementary expertise of the PDs/PIs

Preceptors/Mentors

• Are sufficient numbers of experienced preceptors/mentors with appropriate expertise and research funding to support the number and level of trainees proposed in the application?
• Are the preceptors/mentors currently engaged in research relevant to the goals of H3Africa?
• Do the preceptors/mentors have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training program?
• Do the preceptors/mentors have strong records of training individuals from African LMICs at the level of trainees proposed in the program?
• Is there a history of successful research and/or research training collaboration between the proposed faculty?
• Are appropriate plans in place to ensure that any gaps in faculty expertise at the applicant institution are addressed by additional training during the grant period?

Trainees

• Is a recruitment plan proposed with strategies likely to attract well-qualified African LMIC trainees from the applicant and H3Africa consortium institutions for the training program?
• Is there a qualified applicant pool of sufficient size and quality, at each of the proposed levels (master's, pre-doctoral, postdoctoral), to ensure a successful training program?
• Are there well-defined and justified selection criteria as well as retention strategies?

Training Record

• Does the program propose a rigorous evaluation plan to assess the quality and effectiveness of the training? Are effective mechanisms in place for obtaining feedback from current and former trainees?

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, pre-doctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Select Agent Research

Not Applicable

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by 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 response to this FOA.

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Relevance of the proposed project to the goals of H3Africa.
• Commitment to compliance with H3Africa policies and Procedures.
• Consideration of programmatic and geographic distribution.

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

Awards made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required, as described in the NIH Grants Policy Statement.

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 research training program, including any modification of its design, management, evaluation, preparation of publications, and collaboration with other faculty, unless otherwise provided for in these terms.
• Awardee(s) will provide goals and progress toward those goals at regular intervals as requested by FIC staff and ensure that the research training provided meets the quality standards agreed to at the beginning of the project by the H3Africa Consortium.
• Awardee(s) will ensure that trainee research data are submitted to the H3Africa Bioinformatics Network, that trainee research samples are deposited in the H3Africa Biorepositories, that resources developed as part of this program 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 FIC 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 H3Africa 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 finalizing optimal research training approaches and program component design, and contributing to the adjustment of research training program components 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, evaluation 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 H3Africa Consortium; (3) endorse and oversee progress and products of Working Groups within the H3Africa 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. Continuation support will not be provided until the required forms are submitted and accepted.

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

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

Recipients are requested to annually update and maintain data on trainees in NIH's CareerTrac (https://careertrac.niehs.nih.gov/).

A final Progress Report 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.

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.

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

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

eRA Commons Help Desk (Questions regarding 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

Laura Povlich, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-827-2227
Email: [email protected]

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

Bruce Butrum
Fogarty International Center (FIC)
Telephone: 301-496-1670
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 Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66.

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