It is critical that applicants follow the Multi-Project (M) Instructions in 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

Recent technological advances in Africa and around the world have enabled researchers to collect enormous volumes of data. From rural clinics to the most sophisticated genomics laboratories data are central to our ability to improve health, from delivering care to conducting biomedical research. The ability to fully extract useful knowledge from these data will lead to accelerated discoveries and innovations that can impact health in Africa and globally.

In the next decade, rapid advances in data science, including new approaches to the description, collection, storage, integration, and analysis of large, heterogeneous, structured and unstructured data sets, and new computational methods such as advanced deep learning, digital phenotypes, machine learning and artificial intelligence, and 3D imaging are expected to transform biomedical and behavioral research and lead to improved health for individuals and populations. Traditional datasets (e.g. national health systems, surveillance, surveys) are becoming deeper and richer while new sources of data based on new technologies and sensors (e.g. social media, geospatial data, mobile phones, wearables, electronic medical records, bioimaging, and genomics) are emerging that may be of greatest value when linked to data science. Progress in development of new large data sets and advanced methods for mining them underpin advances in diagnostics, technology development, and the potential for precision public health. The Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa) program is designed to spur discoveries and innovations through application of data science in the African context that will ultimately promote significant improvements in health for African individuals, communities, and populations. We define data science as the interdisciplinary field of inquiry in which quantitative and analytical approaches, processes, and systems are developed and used to extract knowledge and insights from increasingly large and/or complex sets of data (NIH Strategic Plan for Data Science).

Decades of infrastructure building and training in Africa have provided compelling opportunities for research to address the disproportionate share of the global burden of disease that Africa bears. Data science has the potential to significantly impact both quantitative and qualitative research and health on the continent. By leveraging existing digital infrastructure, new solutions can be developed that are relevant, affordable, acceptable, and scalable. For example, extensive mobile phone coverage in Africa has led to major innovations in banking and agriculture and similarly has the potential to rapidly advance health care delivery systems, bringing the clinic to the patient through point of care technologies and self-management systems, with applications to rural and underserved populations worldwide. Additionally, this initiative is synergistic with and leverages the substantial investments NIH, the President's Emergency Plan for AIDS Relief (PEPFAR), and other US government entities have already made in research and research training in Africa. NIH funds more than 1,600 active grants working in Africa and has catalyzed well-developed clinical and academic research networks through prior investments by the NIH Common Fund and its partners in the Medical Education Partnership Initiatives (MEPI) and the Human Health and Heredity in Africa (H3Africa) consortium.

The DS-I Africa Open Data Science Platform and Coordinating Center will serve as a core component within the larger DS-I Africa program, which will also consist of 1) data science and innovation research hubs, 2) data science training programs, and 3) research on the ethical, legal, and social implications (ELSI) central to data science health research and innovation in Africa. As a group, awardees will constitute a collaborative consortium, made up of all programs funded through the broader DS-I Africa program, and will work collectively toward strategic objectives designated by the consortium, beyond the individual research objectives of the awards.

The DS-I Africa Open Data Science Platform and Coordinating Center FOA will consist of two components the DS-I Africa Open Data Science Platform (ODSP) and Coordinating Center (CC) funded via one U2C award.

The ODSP will be a scalable data-sharing gateway available to the research community with access to disparate types of open and controlled-access data, generated from the DS-I Africa Research Hubs (see Companion Funding Opportunities) as well as other existing sources. The ODSP will enable discovery and harness the collective data into actionable insights that individual researchers and health care professionals would not easily be able to develop with only the data generated from their own studies democratizing access to and use of data through the use of FAIR (Findable, Accessible, Interoperable, Reusable) principles. The ODSP will also provide a core set of tools that enable cross-network projects and have the ability to deploy computational pipelines, workflows, and analyses developed by the Research Hub investigators and other users to analyze their own data in conjunction with other data accessible via the ODSP. The awardee will serve as a technical resource for the DS-I Africa Consortium to support relevant use cases including system capabilities to comply with international data protection and anonymization requirements. The awardee is also expected to foster collaborations with industry to leverage existing technologies and solutions that are cost-effective and sustainable.

The ODSP is expected to include (but is not limited to) the following capabilities:

• Enable discovery (find and access) of data generated by the DS-I Africa research hubs and related resources.
• Provide tools, workspaces, and other value-added services to enable data analyses.
• Scalable and extensible to support data volume, diversity, and computing needs.
• Measure and share metrics for performance and usage.
• Provide a sustainable and transparent cost model for above services.
• Serve diverse users - biologists, informaticists/data scientists and engineers/tool developers - and provide training and helpdesk services.
• Adhere to international authentication policy and services.
• Comply with international data protection and anonymization requirements.
• At a minimum, be interoperable with other components of the Common Fund Programs Ecosystem.

The ODSP is expected to deliver a software solution that will improve discoverability and use of DS-I Africa and other related digital assets data, tools and standards. The goal is not to serve as a data coordination / management center(s) but instead to serve as gateway to the assets and outcomes of the DS-I Africa Research Hubs and other related data science research resources.

The CC will be responsible for managing cross-consortium administrative functions, including engagement and communications across the consortium and among participants in all DS-I Africa elements (Working Groups, Steering Committee, DS-I Africa staff and external advisory groups/stakeholders and the public). The CC will also disseminate information about the consortium and facilitate working groups and semi-annual consortium meetings. In addition, the CC will work in close partnership with the ODSP to coordinate data science or related short-courses (online and in-person) and other training activities and establish a web presence for the consortium.

Additional Objectives of DS-I Africa Program

As noted above and in the companion FOA's, there are several specific objectives that the DS-I Africa Program is trying to achieve. Successful applicants will become members of the DS-I Africa Consortium, and will be expected to adhere to these policies.

DS-I Africa Consortium Participation: DS-I Africa will be organized as a research consortium that brings participants together in a highly collaborative and synergistic effort. The DS-I Africa Consortium will include all participants of research, training, ELSI, and open data science platform/coordinating center programs funded through DS-I Africa, as well as responsible NIH staff. Groups funded under this initiative will be expected to participate in the DS-I Africa 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 or that develop cross-network research projects. Each project is expected to comply with applicable consortium policies and procedures. In addition, the PD/PI(s) will be active members of the DS-I Africa Steering Committee, which will meet regularly via virtual or teleconference meetings. The DS-I Africa Consortium will generally hold two in-person meetings per year, usually in Africa at Consortium member sites.

DS-I Africa Data Sharing Policies: Data sharing is an increasingly important aspect of contemporary biomedical research, and the Consortium will develop a Data Sharing and Access Policy within year 1 of the award that applies to data and resources funded with NIH support. The policy will address the data sharing needs of the Consortium while safeguarding the privacy of research participants and protecting confidential and proprietary data and resources. One of the roles of the associated DS-I Africa Open Data Science Platform is to facilitate data and resource access and sharing, and all DS-I Africa awardees will be expected to work closely with the Open Data Science Platform team to facilitate appropriate alignment of activities. The NIH Office of Data Science Strategy (ODSS), guided by the NIH Strategic Plan for Data Science, is committed to ensuring that data-science activities and products supported by the NIH are FAIR. Data, analytical, educational, and other resources generated by a DS-I Africa awardee are expected to conform to the FAIR Principles, where possible. Additionally, guidance may be developed by the Consortium to inform data acquisition, collection and curation, including appropriate consent for data sharing, as appropriate for the Consortium member projects and their relevant standards or schemas.

Partnerships and Collaborations: One of the major goals of the DS-I Africa program is to enhance the impact of data science on health in Africa and spur innovation through support of new African and global partnerships. These partnerships are expected to contribute to the sustainability of African data science programs and the advancement of product development. Awardees are expected to maintain and strengthen existing partnerships that are proposed in applications and engage new partners throughout the duration of the award funding. Collaboration within the DS-I Africa consortium will also be facilitated through the DS-I Africa Coordinating Center. The DS-I Africa Research Hubs will have the opportunity to develop cross-consortium research projects enabled by the DS-I Africa Open Data Science Platform. DS-I Africa Research Training Programs will have the opportunity to collaborate with the DS-I Africa Research Hubs through mentored training experiences for trainees. Finally, DS-I Africa ELSI awardees will collaborate with the Research Hubs to explore and address issues that are specifically relevant to the data science projects within the consortium.

Community Engagement: NIH recognizes ongoing community engagement and the building of trust relationships with research participants as an essential feature of effective and ethical biomedical and population-based data science research involving human subjects. DS-I Africa awardees are expected to incorporate relevant community engagement activities into data science research and research training activities. Community engagement can include a variety of activities, including those that empower communities to contribute to and become partners in data science research and activities that engage diverse stakeholders to learn about and contribute to DS-I Africa efforts in data science.

Data Science Capacity in Africa: Another major objective for the DS-I Africa program is to increase capacity at African institutions to use and develop data science approaches in health research and innovation. The DS-I Africa Research Training Programs will build individual and institutional data science capacity through development of new data science curriculum and training of data science research leaders in master s, PhD, post-doctoral, and faculty development programs. Research in DS-I Africa Research Hubs and DS-I Africa ELSI awards provide a variety of training and career enhancement opportunities to students, postdoctoral researchers, and young investigators in diverse disciplines through mentored research experiences. Additionally, Research Hub pilot projects provide opportunities for early career data scientists to initiate small research projects that could launch their careers. The DS-I Africa Open Data Science Platform and Coordinating Center will enhance activities conducted by the other awardees by developing short courses relevant to data science and innovation that fill training gaps in the consortium and have potential to reach the broader African research community. Long-term sustainability and institutional/governmental commitments to research education programs and independent career opportunities are objectives of the DS-I Africa program.

Technical Assistance and DS-I Africa Virtual Symposium

All applicants are strongly encouraged to contact NIH Staff early in the application process to discuss the alignment of their application with the goals of this FOA, and with the DS-I Africa program. 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 connection information will be announced in an NIH Guide Notice and will be posted on the DS-I Africa website: https://commonfund.nih.gov/AfricaData. During the Technical Assistance Sessions, NIH staff will present an overview of these FOAs and answer questions from prospective applicants. Additionally, these technical assistance sessions will be part of a larger DS-I Africa Virtual Symposium, which will examine the state of data science in Africa and facilitate networking across disciplines, sectors, and geographies to promote data science for health in Africa. Registration and other details will be posted on the Virtual Symposium website: https://commonfund.nih.gov/africadatasymposium. All virtual events are free and open to all prospective applicants, but participation is not a prerequisite to applying.

Open Data Science Platform (ODSP) Core

The scope of the ODSP core is to provide a software solution to serve as a data science gateway, empower the network of data scientists in DS-I Africa, and democratize access to data resources in Africa. While the ODSP should initially focus on developing a resource for DS-I Africa Consortium members, users of the ODSP could eventually expand to scientists outside the Consortium.

Open Architecture: The architecture of the proposed ODSP must be open, modular, and enable access to a variety of digital assets. The data model must be extensible to allow access to new data/metadata types, with architecture scalable to support federated discovery of petabyte scale primary and secondary data/metadata. The applicant must leverage existing software solutions as far as possible. The ODSP must be available for use by the other companion awards within the first 12 months of award.

The architecture could use commoditized cloud providers, private cloud providers, or other specialized configurations of commoditized hardware. If cloud providers are used, proposed solutions must be cloud agnostic. The applicant is encouraged to leverage the NIH STRIDES initiative as appropriate. To the extent that an applicant intends to use or include commercial products in its designs, the products must be available both to the U.S. Government and the public through standard commercial terms. Any software developed under this award must be released under an Open Source Initiative-approved, non-viral, open source license. See http://opensource.org/licenses.

Data Access and Discovery: The ODSP must have the ability to search and browse data within and across scientifically relevant studies to support common use cases. ODSP must work with the Research Hubs generating and managing the data to support adopted/commonly used data standards, formats, and vocabularies, including supporting emerging technologies such as artificial intelligence, machine learning, and natural language processing.

Analysis and Computing Workspace: The ODSP must provide a user-workspace to store, manage, compute on and share user’s own data and analysis results with collaborators or the larger research community. It must allow data to be combined across users in conjunction with other data openly accessible via the ODSP.

The ODSP must enable portable tools to be deployed for one's own use, shared with collaborators or openly with the broader research community.

ODSP must serve the diverse user personas including novices and computationally savvy users by providing a web interface as well as Application Programming Interface (API) access to data, tools, and computation as well as to support interoperability with other Systems.

Sustainable Cost Model: The ODSP must provide plans for a sustainable cost model for storage and computes by users. ODSP must have the ability to invoice users for charges incurred and users should be given tools to estimate usage costs. The ODSP must monitor overall costs and continually consider approaches to optimize operational costs. ODSP is encouraged to leverage the NIH STRIDES program to optimize costs.

Open Metrics: The ODSP must develop and implement a performance metrics plan to benchmark query and compute performance and a usage metrics plan to measure the use of data and tools to inform sunsetting of unused data/tools.

Access & Security: The ODSP must address data security and privacy.

The ODSP is expected to address security requirements and support an existing, open authentication capability and/or provide resources to do remote identity proofing and credential distribution as per NIST Special Publication 800-63B for any community researcher that desires access to the data. Additionally, the ODSP must implement contingency procedures for incidents and breaches related to data loss or compromise.

Privacy includes complying with data protection and anonymization requirements and adhering to data use limitations/agreements. The ODSP must comply with and implement NIH research authentication policy and services respectively to enable use of controlled-access data for approved users. These requirements should be implemented in consultation with NIH program staff to ensure fit within the Common Fund data ecosystem.

The ODSP must provide for and govern data access guidelines, data use agreements and data sharing policies that are consistent with the NIH Data Sharing Policy and Implementation Guidance as well as with the NIH Genomics Data Sharing Policy (NOT-OD-14-124) and the NIH Notice for Use of Cloud Computing Services for Storage and Analysis of Controlled-Access Data Subject to the NIH Genomic Data Sharing Policy (NOT-OD-15-086), as applicable. The ODSP should also implement the NIH security best practices and provisions to protect the privacy and confidentiality of research participants and prevent unauthorized access to data.

Consortium Collaborations: In addition to the partnerships and collaborations mentioned under the objectives, the ODSP awardee will support the Research Hubs, who will maintain a single, shared copy of the relevant data; ODSP will work with the Research Training Programs to host training content developed by other consortium members; and with ELSI Research Studies to comply with and implement international data policy requirements in the software stack. ODSP will develop a help desk that will serve the Consortium and potentially other users of the platform.

Coordinating Center (CC) Core

The DS-I Africa Coordinating Center will provide the organizational framework for the management, direction, and overall coordination of all common DS-I Africa activities. In doing so, it will be guided by the DS-I Africa Steering Committee, with the participation of NIH staff. Coordinating Center activities will include, but are not limited to, the tasks listed below. Applicants may propose other administrative and coordinating tasks for the DS-I Africa Coordinating Center that will contribute to the achievement of the objectives of this FOA.

The CC will:

Coordinate all functions of the DS-I Africa Steering Committee and Working Groups, the DS-I Africa Independent Expert Committee, and interactions between the DS-I Africa program and outside parties. This will include arrangements for all teleconferences and web conferences, coordination of call schedules, maintaining email lists and ensuring that minutes for all meetings are recorded and archived appropriately.

Plan and manage DS-I Africa Consortium biannual meetings and collaborate with the ODSP and other Consortium awardees to implement in-person and online short courses, workshops, and hackathons. Topics should be driven by needs assessment and can expand beyond data science to include innovation, team science, ELSI, and other areas.

Assist in the development and implementation of DS-I Africa operating policies and procedures under the guidance of the DS-I Africa Steering Committee.

Develop and maintain effective communications among participants in all DS-I Africa elements (Working Groups, Steering Committee, External Advisory Committee, DS-I Africa staff and external stakeholders).

Develop and maintain the DS-I Africa Website, jointly with the ODSP core to function both as an internal resource for the storage and exchange of all DS-I Africa documents and as the interface between DS-I Africa and the broader scientific community and between DS-I Africa and the public.

Manage and track cross-consortium collaborations and encourage and enable opportunities for team science and trainee exchanges.

Work with Consortium members to develop a DS-I Africa Consortium-wide sustainability plan.

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 from this FOA.

Non-domestic (non-U.S.) Entities (Foreign Institutions) in Africa, specifically:

• African Public/State Controlled Institutions of Higher Education
• African Private Institutions of Higher Education
• African Nonprofits Other Than Institutions of Higher Education

African applicants may propose partners from all types of organizations in Africa, the U.S., or other countries, including for-profit and government entities.

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) 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.
• o 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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.

Individuals with interdisciplinary skills and expertise are encouraged.

Given the two distinct functions required, it is expected that meritorious applications will contain partnerships with the roles of the participating PD(s)/PI(s) clearly defined in the multi-PD/PI plan. Partnership with US and other high-income country institutions is allowed, and applicants are strongly encouraged to leverage expertise and experience of investigators with interdisciplinary skills and expertise developing similar infrastructure solutions.

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).

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

Tiffani Bailey Lash, Ph.D.
Telephone: 301-451-4778
Fax: 301-496-8859
Email: [email protected]

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	6
Open Data Science Platform Core	12
Coordinating Center Core	12

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

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

The application should consist of the following components:

• Overall: required
• Open Data Science Platform Core: required, maximum of 1
• Coordinating Center Core: required, maximum of 1

When preparing your application, use Component Type Overall .

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

Complete entire form.

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

Follow standard instructions.

Project Summary/Abstract: Applicants should briefly describe the broad, long-term objectives of the proposed Open Data Science Platform and Coordinating Center and the methods for achieving the stated goals for each core. The summary should identify the main collaborating partners in the proposed application.

Enter primary site only.

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

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

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

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

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

Specific Aims: Outline the overarching, high-level vision and goals for the proposed Open Data Science Platform and Coordinating Center for the funding period that is distinct from the aims of the individual functional units.

Research Strategy: The Open Data Science Platform and Coordinating Center will serve as resources for the DS-I Africa Consortium that work synergistically to reduce barriers for coordinating research teams, participants and related activities; making datasets, tools and related services accessible in a scalable and sustainable manner as well as meeting the objectives of the DS-I Africa Program.

To ensure the performance of these activities, both the Open Data Science Platform and Coordinating Center will allow for both continuance and expansion of DS-I Africa related research that includes an overview of the software, security, backup, analytical and administrative capabilities. As part of this section, describe the following elements:

Background and Progress: Briefly summarize previous experience with research databases and interfaces and with the web-based platforms needed to deliver a system for researchers and participants that works on an international scale;

Overall goals for both the Open Data Science Platform and Coordinating Center as resources. Summarize how both the Open Data Science Platform and Coordinating Center intend to work both independently and synergistically to meet the objectives of this FOA and the DS-I Africa Program and identify the selected areas of focus and strategic goals related to creating a rapid and reliable and scalable research system, including:

• Overview of all components;
• Plans for strategic oversight and coordination of effort among components; and
• Plans for collaboration and coordination with the broader DS-I Africa Consortium.

Letters of Support: Applications should include a letter of support from the appropriate institutional or organizational official (University or Medical School President, Dean or Director, or the head research administrator, company leader, government representative, or equivalent) from the applicant and all collaborating organizations to substantiate the organizations' commitment to the proposed DS-I Africa Open Data Science Platform and Coordinating Center. Each organization should state its commitment to overcoming any administrative obstacles to the implementation of the application, such as accommodation for participation by multiple schools at a university or collaboration with other institutions within or outside of the applicant’s country. Appropriate organizational commitment to the program includes the provision of adequate staff, facilities, and resources needed for the success of the planned program. It should also address commitment to DS-I Africa policies and procedures, including collaborating and sharing data, as appropriate. Where applicable, the letter should address corporate interests and commitment to the proposed project and applicable in-kind support.

The programmatic activities of this initiative will support national and international collaborations. Where relevant and attainable, 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 are strongly encouraged. The letter should briefly describe the national policy concerning scientific research and health funding priorities.

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:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

When preparing your application, use Component Type Open Data Science Platform Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

List all performance sites that apply to the specific component.

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

In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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

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

The budget should include funds to support PD/PI(s) travel to the biannual DS-I Africa Consortium meetings in rotating locations in Africa. Funds may be budgeted to support attendance of additional key personnel, as applicable.

Specific Aims: Identify general objectives planned for the open data science platform core along with the main benchmarks that would indicate the accomplishment of these objectives

Research Strategy: The Open Data Science Platform Core will provide a reliable and scalable resource for investigators to extract useful knowledge from data that will lead to discoveries that can impact health in Africa and globally. The following elements should be included:

1. Define the open data science platform that will be proposed for the DS-I African Consortium, that includes an overview of software, security and backup, user interfaces, analytic and administrative as well as other capabilities outlined in the Scope of this FOA.

2. Summarize how the proposed open data science platform intends to meet the objectives of this FOA and identify the selected areas of focus and strategic goals related to creating a scalable and reliable platform for the DS-I Africa Consortium.

3. A description of anticipated key issues and challenges.

4. Proposed timelines and milestones for the whole project period.

5. Governance structure: Applicants should clearly describe the division of responsibilities for the whole project. The Governance structure should also describe how the PD(s)/PI(s) will manage the proposed resource, coordinate the day-to-day activities and support achievement of the proposed goals and milestones, plans for conflicts resolutions, as well as the provisioning of data for research use.

6. Data/software transition plan: Applicants should provide a transition plan for transferring the associated data, software and related resources generated or otherwise made available during the award period in the event the award will need to be transferred to another grantee or to the U.S. Government.

7. Summarize plans for evaluating the usability, performance, and usage of the proposed open data science platform, including performance tests that progressively assess the functioning of the platform and its tools before it is available to the broader research community.

8. Describe basic technical support for users that will utilize the proposed open data science platform.

9. Sustainability: Dedicated funds for DS-I Africa by the NIH Common Fund will provide 5 to 10 years of support. Beyond that, any support for continuation of DS-I Africa programs and established infrastructure will be dependent on other funding. Therefore, applicants need to discuss the issue of future sustainability of the Open Data Science Platform beyond the DS-I Africa program, including a sustainable cost model and any potential support from the private sector, government, or other entities.

10. Other elements: Applicants are encouraged to include in the application additional topics or features that may improve the quality, usefulness, and effectiveness of the Open Data Science Platform.

Letters of Support: Applicants may include letters of support specific to the Open Data Science Platform core. These letters should not repeat the letters of support included with the Overall or CC components. Letters could be included from research collaborators, stakeholders, potential end-users, and/or entities whose resources may be utilized as part of the core. Letters from appropriate stakeholders vital to the success of the proposed core or those highlighting the unique capabilities of the collaborative team and environment for addressing the associated goals are also encouraged.

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 modifications. Applicants to this FOA should provide plans regarding the sharing needed to achieve the Open Data Science Platform's objectives that are not otherwise described in the Research Strategy, as appropriate and consistent with achieving the goals of the program. Plans should also be included for documenting and openly sharing any software or methods developed under this award in a source-code management system such as GitHub with an approved non-viral, open-source license, as appropriate and consistent with achieving the goals of the program.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).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.

When preparing your application, use Component Type Coordinating Center Core'

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

List all performance sites that apply to the specific component.

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

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

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

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

Specific Aims: Identify general objectives planned for the DS-I Africa Coordinating Center core along with the main benchmarks that would indicate the accomplishment of the objectives. Include the administrative and outreach requirements of the Coordinating Center and how the work proposed supports these activities.

Research Strategy:

The Coordinating Center Core will provide the organizational framework for the management, direction, and overall coordination of all common DS-I Africa Consortium activities. The following elements should be included:

1. Overview of the Coordinating Center

Provide an overview of how the Coordinating Center will be structured to facilitate the Center’s objectives and enhance data science, innovation, training, and ELSI efforts supported by the DS-I Africa Program. Describe how the Coordinating Center meets the objectives of the DS-I Africa Program.

This section should include a description of previous experience in facilitating collaborations and coordination of large, complex research efforts, appropriate expertise in data science, team science, and other relevant fields, as well as a description of the staffing and management structure for each objective without duplicating information in biosketches.

Applicants should also include their plans for collaborating with the DS-I Africa Consortium and NIH staff in the development of approaches and strategies relevant to meeting the Coordinating Center’s objectives.

If there are any additional responsibilities that are not detailed in the FOA but are considered necessary for operation of the Coordinating Center, applicants should note them in this section and describe potential approaches.

2. Plans and Approaches to Facilitate Collaborations

Describe plans for organizing biannual investigator meetings for the DS-I Africa program. This should include descriptions of needed logistical and operational management.

Provide plans to facilitate coordination of cross-consortium activities, including, but not limited to, research projects, working groups, trainee exchanges, steering committee meetings, and development of a Consortium sustainability plan.

Provide strategies and approaches for enabling communication and coordination of program activities such as establishment of virtual meeting or teleconferencing platforms and any other needed communication platforms.

Applicants are encouraged to propose and justify any other activities relevant to facilitating collaborations and coordinating scientifically focused discussion groups.

A description of anticipated key issues and challenges with facilitating collaborations in a pan-African, multidisciplinary, and multisectoral consortium should be included, along with potential solutions or mitigation strategies.

For all activities proposed, appropriate evaluation plans, milestones, and metrics should be incorporated.

3. Plans and Approaches to Disseminate Advances, Develop Educational Resources, and Develop Outreach and Community Engagement Approaches

Provide a strategy for development and maintenance of the DS-I Africa website in partnership with the ODSP. Within this strategy, applicants should detail a plan for the design of the web resource that is synergistic with the ODSP and plans for transferring this resource and any other Coordinating Center generated resources to the U.S. government (or another Center) at the completion of the Center’s project period.

Propose and describe strategies for developing and hosting educational and training resources and activities needed by the DS-I Africa consortium, as described in the FOA, including relevant needs assessment plans. Resources and activities may include webinars, web-based tutorials, in-person and online short courses, hackathons, and specialized sessions at the biannual meetings.

Propose and describe strategies that include approaches for developing and promoting educational materials and other informational resources.

Provide plans for outreach and community engagement. This should include an overview of target audience(s) and methods.

Where applicable, propose and justify any other activities relevant to disseminating advances and developing outreach and community engagement approaches.

For all activities proposed, appropriate evaluation plans, milestones, and metrics should be incorporated.

Letters of Support: Applicants may include letters of support specific to the Coordinating Center core. These letters should not repeat the letters of support included in the with the Overall or ODSP components. Letters could be included from research collaborators, stakeholders, potential end-users, and/or entities whose resources may be utilized as part of the core. Letters from appropriate stakeholders vital to the success of the proposed core or those highlighting the unique capabilities of the collaborative team and environment for addressing the associated goals are also encouraged.

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

Applicants to this FOA should provide plans regarding the sharing needed to achieve the Coordinating Center's objectives that are not otherwise described in the Research Strategy, as appropriate and consistent with achieving the goals of the program. If not documented elsewhere, these should include plans for managing the intellectual property concerns of investigators during annual meetings, and any other opportunities in which investigators share information with the Coordinating Center. Plans should also be included for documenting and freely sharing any software or methods developed under this award, as appropriate and consistent with achieving the goals of the program.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).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) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

This initiative is not subject to intergovernmental review.

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

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

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission 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 Open Data Science Platform and Coordinating Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the 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, an application l that by its nature is not innovative may be essential to advance a field.

Does the application address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the application are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific for this FOA: Does the application address the needs of the Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa) participants that it will serve? Is the scope of activities proposed for both the Open Data Science Platform and Coordinating Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the DS-I Africa Consortium?

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

Specific for this FOA: Do the investigators have experience overseeing the selection and management of subawards, if needed? Is the proposed governance structure, including its timelines and milestones well thought out and appropriate for the efforts proposed in the application? Is the leadership structure appropriate for this application, including the level of effort of key personnel? Do the investigators demonstrate significant experience with coordinating collaborative international research projects as well as developing computationally-based platforms?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific for this FOA: Does the application sufficiently promote and support innovation that will strengthen and sustain research in Africa? Does the application propose innovative strategies, such as team-science approaches, to foster community building?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the research consortium they will serve? ? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the applicationinvolves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific for this FOA: Will the environment(s) in which the resources will operate contribute to the probability of success in serving the broader research community? Do the letters of collaboration and institutional support show strong commitment to the project and to the PD(s)/PI(s)?

Reviewers will provide only one overall score for the Open Data Science Platform (criterion scoring is not used for this component), which will influence the overall impact score of the application. Reviewers will consider the following aspects while determining scientific and technical merit of this component:

• Are the proposed interfaces/tools to be developed likely to provide value to the DS-I Africa Consortium?
• Are the proposed metrics to assess the utilization of the Open Data Science Platform and its impact on the DS-I Africa consortium adequate?
• Does the applicant propose innovative technical approaches, features, or solutions to support the needs of a diverse research community?
• Is a well-established timeline proposed?
• Are proposed cost control and tracking methods adequate?
• Are the plans for safe-guarding sensitive data adequate?
• Are the plans for ensuring and maintaining data access, data security, including audits of the data security processes, adequate?
• Are the proposed plans for user authentication and authorization appropriate?
• Will the ODSP and associated tools and features conform to FAIR principles?
• Are the plans for incorporating new scientific and technology advances to support efficient and cost-effective data sharing, access and computing adequate?
• Do the development plans for the ODSP include obtaining input from potential end users and usability testing?
• 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 support suggest that the environment is conducive to a sustained enterprise?
• Do collaborations suggest viable long-term partnerships?

Reviewers will provide only one overall score for the Coordinating Center (criterion scoring is not used for this component), which will influence the overall impact score of the application. Reviewers will consider the following aspects while determining scientific and technical merit of this component:

• If the aims of the project are achieved, will the proposed Coordinating Center contribute to the successful operation of the DS-I Africa Consortium? Will it bring unique advantages or capabilities to the Consortium?
• Do the applicants show evidence of being able to manage and coordinate a complex consortium on an international scale?
• Does the applicant propose innovative coordinating plans and administrative solutions?
• Are the plans and approaches proposed for facilitating collaboration within the DS-I Africa Consortium well-reasoned and appropriate?
• Are the plans and approaches well-reasoned and appropriate for disseminating advances, developing and disseminating educational resources, and developing outreach and community engagement strategies for the DS- I Africa Consortium?
• Are the proposed metrics to assess the utilization of the Coordinating Center and its impact on the DS-I Africa Consortium adequate?
• Are the institutional support, equipment and other physical resources available to the investigators adequate for the Coordinating Center proposed?
• Do collaborations suggest viable long-term partnerships?
• Will the project be well-positioned to apply for other sources of funding at the end of the project period?

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.

For research that involves human subjects but does not involve one of the 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 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 individuals of all ages (including children and older adults) 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.

Not Applicable

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 .

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

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review 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 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 Institute of Biomedical Imaging and Bioengineering. 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 DS-I Africa.
• Relevance of proposed project to co-funding component priorities.
• Commitment to compliance with DS-I Africa 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.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Awardee-selected projects that involve studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

• The awardee institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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. 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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides 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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• 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.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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.

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.

Awardee and Principal Investigator Primary Responsibilities:

• Planning, directing, and executing all aspects of the proposed activities, including any modification of design, implementation, quality control, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators, unless otherwise provided for in these terms;
• Providing effective leadership and management of all activities under the award;
• Developing programmatic goals, timelines, and milestones, reporting of progress to NIH biannually, and ensuring that the outputs produced meets the quality standards agreed to at the beginning of the project by the DS-I Africa Consortium;
• Assuring compliance with all applicable DHHS/NIH policies for conduct of research and clinical trials as well as host country regulations for protection of human subjects and conduct of clinical research;
• Ensuring collaborations/interactions with the other DS-I Africa awards, that data resources developed are shared/made accessible according to DS-I Africa policies, and done so in a timely manner;
• Working in close coordination, cooperation, and participation with NIH staff for scientific and technical management of the project, described further under NIH Responsibilities;
• Agreeing to the governance of the Consortium through the Steering Committee, including adherence to DS-I Africa policies and procedures; and
• Serving as active members of the DS-I Africa Steering Committee, attending Steering Committee meetings, and participating directly or by proxy on relevant DS-I Africa Working Groups, both remotely through regular teleconferences and in-person at biannual DS-I Africa Consortium Meetings.

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 Responsibilities

NIH staff (including, but not limited to, Project Scientists, Program Officers, Intramural Scientists, and Program Analysts) have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.

NIH Project Scientists roles include:

• Participating (with DS-I Africa 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;
• Attending Steering Committee meetings, serving on DS-I Africa Working Groups, and assisting in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action;

NIH Program Officer roles include:

• Negotiating goals and milestones with the awardees as needed;
• Serving as liaisons between the awardees and the appropriate NIH Institute and Center National Advisory Councils and the NIH DS-I Africa Working Group made up of program staff that collectively manage the program;
• Attending Steering Committee meetings, serving on DS-I Africa Working Groups, and assisting in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action;
• Convening external consultants to support NIH oversight of the DS-I Africa consortium?;
• Interacting with the PD(s)/PI(s) on a regular basis to monitor progress, which may include regular communication with the study leadership and staff, periodic site visits for discussion with the awardee research team, observation of data collection and management techniques, fiscal reviews, and other relevant stewardship matters; and
• Making recommendations for continued funding based on (a) overall research progress; (b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or (c) maintenance of high-quality research.
• Normal scientific and programmatic stewardship of the award and assignment in the award notice. The assigned NIH Program Official may not also serve as an NIH Project Scientist.
  

The government, via NIH Program Scientists, will have access to all data generated under this Cooperative Agreement and may periodically review and analyze the data for the preparation of internal reports related to the Cooperative Agreement.

An NIH intramural scientist may not serve as the PD/PI of a project awarded under this FOA but may participate as a collaborator or consultant. For applications that include NIH intramural components, the involvement of intramural scientists needs to be consistent with NIH policy ?-? https://oir.nih.gov/sourcebook/ethical-conduct/research-ethics/nih-policies/intramural-extramural-collaborations.

The NIH reserves the right to withhold funding or curtail studies in an individual award in the event of (a) substantive changes in the agreed-upon work scope with which NIH cannot concur, (b) human subject ethical issues that may dictate a premature termination; (c) or insufficient project progress.

Collaborative Responsibilities

A Steering Committee (SC) will serve as the governing board for awardees. All participants in the program are bound by the policies and procedures developed by the SC and adoption of such policies and procedures requires a majority vote. Membership on the SC will include the PI(s) of each award and associated NIH program officers and projects scientists. On voting matters, each funded project will have one vote for determining appropriate collaborative activities, with NIH providing final approval for consortium activities. The chair will be chosen by a majority vote of the SC, with years of service as chair determined by the committee. The chair, in collaboration with the associated program Coordinating Center staff, is responsible for preparing meeting agendas, for chairing meetings, and for approving minutes in a timely manner. NIH staff may not serve as Chair of the SC.

Steering Committee responsibilities include:

• Discussing progress in meeting the broad goals of various DS-I Africa projects (while maintaining appropriate project-specific protection of intellectual property) and of DS-I Africa as a whole;
• Developing recommendations for uniform procedures and policies necessary to meet the goals of the Consortium, for example for data quality measures and assessment as well as conventions for data sharing;
• Cooperating to ensure the timely and broad dissemination of lessons learned to inform researchers and health care systems engaged in data science for health discovery and innovation in Africa;
• Endorsing and overseeing progress and products of Working Groups within the Consortium; and
• Meeting twice a year in-person in conjunction with Consortium meetings and conducting regularly scheduled 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 and a Dispute Resolution Panel will be convened. The Panel 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 RPPR, 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, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Tiffani Bailey Lash, Ph.D.
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-4778
Email: [email protected]

Seetha Bhagavan, Ph.D.

Center for Scientific Review (CSR)
Telephone: 301-237-9838
Email: [email protected]

Katie Ellis
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4791
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.