It is critical that applicants follow the instructions in the Research 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. 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 an H3Africa Informatics Network. Research awards will support research on the genetic/environmental contributors to health and disease in Africa that fall within the mission of the NIH, which is to seek fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability. Related H3Africa FOAs include announcements for biomedical research projects (RFA-RM-16-015 and RFA-RM-16-016), research focused 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 Awards (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 provide justification as to why a particular policy cannot be followed.

The purpose of this FOA is to provide support for a Human Heredity and Health in Africa Informatics Network to develop and implement cutting-edge, reliable, and cost-effective approaches to address the informatics needs of the H3Africa Consortium.

H3Africa promotes the development of collaborative genetics and genomics research by African investigators in order to contribute to the improvement of health in African populations. To enable the H3Africa Consortium to fulfill its goals, it is anticipated that an H3Africa Informatics Network will have the expertise and capability to:

• Enhance information processing and information systems across Africa by supporting capacity building for informatics research and by implementing innovative, cost-effective means of providing an overall informatics infrastructure for the H3Africa Consortium, taking advantage wherever possible of existing capability and infrastructure.
• Function as a Data Coordinating Center for the H3Africa Consortium. This includes, but is not limited to: establishing secure, reliable transmission and archiving of H3Africa Consortium generated data; working with the consortium to establish and implement standardized data QC, phenotype harmonization, ontology mapping, and analysis pipelines; serving a key role in oversight and implementation of H3Africa data sharing policies (http://www.h3africa.org/consortium/documents); and assisting in cross-consortium projects and meta analyses.
• Foster connectivity and interactivity among the H3Africa research groups to enhance translational research and informatics across the continent by establishing the necessary links at the level of research groups and, where possible, research institutions.
• Provide collaborative analysis support for H3Africa research projects and other Consortium resources including, but not limited to, standard operating procedures related to next generation sequencing analysis, Genome Wide AssociationStudies, RNA-seq, and biorepository submission and requests.
• Conduct outreach activities that will help make the informatics network resources as widely accessible and highly utilized as possible (e.g., tutorial sessions, community workshops, online resources, help desk services, etc.).
• Develop new computational tools customized to address the specific issues of genomic research in African populations.

Currently, the informatics network consists of approximately 32 Bioinformatics research groups distributed among 15 African countries, with 2 partner institutions outside of Africa. Together, these groups support H3Africa researchers and their projects, while also developing informatics capacity within Africa. In addition, the informatics network has established several workgroups that provide guidelines and support for infrastructure, user support, accreditation, data archiving, systems administration, ontology and standardized vocabulary. A full list of activities of the current H3Africa informatics network can be found at http://www.h3abionet.org/. The new network will be expected to maintain backwards compatibility with previous services.

The H3Africa Consortium is involved in substantial data generation. Therefore, it is expected that the H3Africa Informatics Network will have the expertise, resources, and capability to develop and implement cost-effective methods for data storage, QC (including phenotype harmonization and ontology mapping), analysis, and transmission, as well as facilitate and consult on data submission by H3Africa sites to international repositories. This includes development of methods to support genetics and genomics research in geographic locations that have a range of capability, from robust and stable infrastructure as well as for those with less stable infrastructure. Applicants should have demonstrable expertise in creating or taking advantage of forward-looking solutions to obstacles posed by the large amounts of data being generated in genomics-based research. Examples of potential solutions include, but are not limited to, the use of combinatorics, mathematical and statistical modeling, and cognitive computing techniques for genetics and genomics research, and cloud computing for storage, analysis, and data transfer.

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 H3Africa are expected to conform to the FAIR principles.

Members of the H3Africa Consortium are diverse both in their background and in their geographic locations on the African continent. In order to address their coordinated informatics needs, outreach and communication must be structured and implemented in a manner that is trans-continental and considers a diverse range of needs. Therefore, it is expected that the H3Africa Informatics Network will build the capability to provide informatics support in appropriate user languages as well as be proficient in the utilization of multiple platforms for disseminating information to the public, i.e., website development and management, mobile technology platforms, and developing standard operating procedures related to genomic research. The Informatics Network should track user activity for continual monitoring and evaluation of community interest, and conduct usability testing to ensure the Informatics Network is providing optimal service to the broad user communities.

While H3Africa projects and Collaborative Centers should have their own informatics capacity, the H3Africa Informatics Network should be prepared to provide trans-Consortium informatics needs and may also offer analysis and other informatics services to individual projects on a collaborative or fee-for-service basis. Current H3Africa projects can be found at http://www.h3africa.org/consortium/projects. While the research areas of future projects have not yet been determined, the application should discuss how provisions will be made for the addition of new research projects in the H3Africa Consortium.

It is expected that the H3Africa Informatics Network awardee will function as a single entity covering a variety of informatics needs for the H3Africa Consortium. Therefore, an efficient management style is required to address the needs of the H3Africa Consortium. Currently, the H3Africa Bioinformatics Network is organized as a central administrative site and associated bioinformatics nodes, in a hub and spokes model. However, other types of organization that will meet the scientific objectives of H3Africa may be considered.

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.

Participating in H3Africa Consortium: 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 data and sample sharing and other 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.

Collaborating with H3Africa projects and infrastructure: The H3Africa Informatics Network will serve as a hub connecting to all of the other elements of the consortium. The H3Africa informatics Network will need to work closely with the H3Africa Administrative Coordinating Center to develop and maintain tools to measure and track Consortium activities including, but not limited to, recruitment, deposition of data and samples in publically accessible venues, and publications. These two entities will also work together to provide Consortium-wide tools and resources and to serve as the interface between H3Africa and the public. The H3Africa informatics Network will work with the H3Africa Biorepositories to provide catalogs of available data and biospecimens and to handle coordinated requests for data and biospecimens. Finally, the Network will work directly with research projects to assist in the transfer and archiving of their data.

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 and Collaborative Centers provide a variety of career enhancement opportunities for 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 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).

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 Research 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.

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:

Ken Wiley, Jr., Ph.D.
National Human Genome Research Institute (NHGRI)
5635 Fishers Lane, Suite 4117, MSC 9305
Rockville, MD 20852
Telephone: 301-435-5540
Email: [email protected]

All page limitations 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 an application to this FOA.

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

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

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

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

• Include a description of the applicant’s experience in providing a bioinformatics resource for a scientific community

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

• Travel Funds: The budget should include funds to support travel for the PD/PI and an additional staff members to Consortium meetings.

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

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

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

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

Research Strategy: Provide an overview that concisely describes a vision for the proposed H3Africa Informatics Network; its role in the H3Africa project; the units and organization of the proposed network and how it will be managed; outreach to and beyond the participants in the H3Africa Consortium; and the anticipated overall impact of the network beyond the H3Africa project to the research community in Africa. The overview should describe the role of the Informatics Network within the larger range of bioinformatics activities that the H3Africa Consortium and its participants will need to carry out their research efforts successfully.

Describe plans for an H3Africa Informatics Network that is capable of working with data, metadata, and analyses from all members of the H3Africa Consortium. The Research Strategy should include any necessary preliminary data that support the technological approach planned to establish the network. The Research Strategy should include, but not be limited to, a detailed descriptions of:

1) Plans to implement an innovative, cost-effective means of providing an overall bioinformatics infrastructure for H3Africa, wherever possible building upon existing bioinformatics capability and infrastructure, including:

• a description of the role(s) that various participants/sites will play in the H3Africa Informatics Network and a management plan for the Network
• plans to improve the bioinformatics capability of members of the Informatics Network and one or more ways to assess improvement in their abilities over time
• plans to develop new computational tools, particularly ones that are customized to address the specific issues of research in Africa
• plans to interact with one or more major international data repository and/or other international bioinformatics entities as one way of maintaining awareness of cutting-edge technologies and systems for data storage, transmission, and management
• a description of which current activities of the H3Africa Informatics Network will continue, which will sunset, and what new activities are being proposed

2) Plans to function as a data coordinating center for the H3Africa Consortium, including:

• establishing secure, reliable transmission and archiving of H3Africa Consortium-generated data
• standardizing data QC and analysis pipelines
• providing personnel and tools to support and facilitate phenotype harmonization across consortium studies whenever possible, both before and after data collection
• facilitating the ability of H3Africa participants to implement the H3Africa data sharing policies (http://www.h3africa.org/consortium/documents)
• working to make biomedical data Findable, Accessible, Interoperable, and Reusable (FAIR principles)
• creating systems for tracking deposition and release of data from H3Africa projects
• assisting in cross-Consortium projects and meta-analyses
• working with other participants in the H3Africa Consortium to help them address their bioinformatics needs; these groups include the research projects and collaborative centers, biorepositories, the H3Africa Administrative Coordinating Center, and the various working groups of the H3Africa Consortium
• providing assistance to individual H3Africa projects with any unique, high-level analyses that exceed their own bioinformatics capabilities

3) Plans to work across Africa, beyond the H3Africa Consortium, to enhance the bioinformatics capabilities of African researchers more generally, including:

• conducting outreach activities that will help make the informatics network resources as widely accessible and highly utilized as possible (e.g., tutorial sessions, community workshops, online training resources, help desk services, etc.)
• enhancing translational research and bioinformatics across the African continent by fostering connectivity and facilitating interactivity among the H3Africa research groups through establishment of necessary links at the level of research groups and, as possible, research institutions
• tracking user activity for continual monitoring and evaluation of community interest; and conducting usability testing to ensure the Informatics Network is providing optimal service to the broad user communities
• working across Africa, beyond the H3Africa project, to enhance the bioinformatics capabilities of African researchers more generally
• addressing the issue of the long-term sustainability of a H3Africa or pan-African Bioinformatics Network

Sustainability: One of the primary goals of the H3Africa program is to enable African scientists to demonstrate their world-class skills through the establishment of cutting-edge research programs that will lead to more publications and other evidence of productivity, thereby increasing their opportunities for future funding through normal competitive grant processes, as well as through increased investment in research by national governments and private sources. Dedicated funds for H3Africa by the NIH Common Fund will provide 5 years of support. 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 should discuss the issue of future sustainability of informatics capacity beyond the H3Africa program and how the Informatics Network activity will contribute to success in continuing the research efforts of all of the participants in the network. 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 effort by the network.

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:

A plan for data and resource sharing and release is expected for all NIH applications (https://grants.nih.gov/grants/policy/data_sharing/). In addition, applicants are expected to adhere to the NIH's Genomic Data Sharing Policy (https://gds.nih.gov/03policy2.html), as well as the NIH Position Statement on Use of Cloud Computing Services for Storage and Analysis of Controlled-Access Data (https://gds.nih.gov/pdf/NIH_Position_Statement_on_Cloud_Computing.pdf). Applicants are expected to provide a well thought-out plan for widely sharing data, tools and other resources generated by the Informatics Network to further the H3Africa goal of encouraging more genomics-based research on health and disease by African scientists. The H3Africa Consortium has developed a unified plan for data and resource release, and the application must include a statement that the investigators in the Informatics Network will abide by the Consortium's data and resource policy. Examples of current data release guidelines for H3Africa can be found at http://www.h3africa.org/consortium/documents.

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.

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

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

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). 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. See Section III of this FOA for information on registration requirements.

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. 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.

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 project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

Significance

Does the proposed Center address the needs of the H3Africa Consortium that it will serve? Is the scope of activities proposed for the Bioinformatics Network appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the H3Africa program?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Bioinformatics Network? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing genomics research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Bioinformatics Network is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Network? Does the applicant have experience overseeing selection and management of subawards, if needed?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research program the Network will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed? How does the program promote and support innovation that will strengthen and sustain genomic and environmental research in Africa?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium the Network will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium?

Are an appropriate plan for work-flow and a well-established timeline proposed? How will the activities initiated under this award be sustained at the conclusion of the five-year award period?

Do the development plans for the Informatics Network include obtaining input from potential end users and usability testing? Will the Informatics Network be flexible to respond to the changing needs of the scientific community in a timely manner?

Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

How does the Network plan to ensure future sustainability? What additional collaborations will be pursued to further its research program?

Environment

Will the institutional environment in which the Network will operate contribute to the probability of success in facilitating the research conducted? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Network proposed? Will the Network benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling? Do the letters of collaboration and institutional support show strong commitment to the project and to the PD(s)/PI(s)?

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

Sustainability

Is the plan for sustainability feasible? Will the project be well-positioned to apply for other sources of funding at the end of the project period? Do the letters of Institutional and National commitment suggest that the environment is conducive to a sustained enterprise? Do collaborations suggest viable long-term partnerships?

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 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.

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 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.

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 (GDS).

For Networks 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.

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 the National Human Genome Research Institute. 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.
• Potential for establishing a sustainable 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

Ken Wiley, Jr., Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-5540
Email: [email protected]

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

Chris Darby
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-0738
Email: [email protected]

Diane Patterson
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7861
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.