It is critical that applicants follow the Research (R) 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

The National Institutes of Health (NIH) of the United States (U.S.) Department of Health and Human Services (DHHS) supports international collaborative biomedical research to advance science and expand biomedical knowledge. Scientific cooperation between the U.S. and the Republic of South Africa was initiated in 1995 and has grown in recent years. Recognizing that enhanced cooperative biomedical research would be of mutual benefit to the U.S. and South Africa, the NIH Director and the President of the South African Medical Research Council (MRC) signed a Memorandum of Understanding (MOU) in January 2013 to develop the U.S.-South Africa Program for Collaborative Biomedical Research. The first phase of this program included awards made in response to RFA-AI-14-009, RFA-AI-14-010, RFA-AI-14-018, RFA-AI-16-039, RFA-AI-16-040, RFA-AI-16-082, and RFA-AI-16-083. A working group, made up of members from both the NIH and MRC, developed strategic plans for continued collaboration. Both the NIH and MRC have allocated resources to support the second phase of this program. Phase 2 will solicit applications for research under four separate funding opportunity announcements which are outlined in further detail below.

The purpose of this Funding Opportunity Announcement (FOA) is to establish Phase 2 of the U.S.-South Africa Program for Collaborative Biomedical Research. Research areas supported under this program include HIV/AIDS and HIV/AIDS-associated malignancies. This opportunity is specifically designed to promote partnerships between eligible NIH Intramural Research Program (IRP) investigators (e.g., those conducting research within the laboratories and clinics of the NIH) and eligible South African investigators (e.g., those conducting research in eligible laboratories in South Africa). In order to be eligible for this program, in addition to the South African PDs/PIs, the application must include at least one NIH IRP investigator serving as a Project Scientist with an equal role in the conceptualization, design and execution of the research.

The intent of this FOA is to foster, stimulate, and/or expand basic, translational, behavioral and applied research that will advance scientific discovery and engage U.S. and South African researchers working collaboratively in the areas of HIV/AIDS and HIV/AIDS-associated malignancies. Proposed research should reflect the highest possible scientific standards, as well as shared interests, international and local public health needs and priorities, and involve mutually advantageous collaborations among institutions, including participating communities and other partners. U.S. and South African investigators working in partnership will prepare and submit a single joint application. Applications must include at least one U.S. investigator from the NIH IRP serving as Project Scientist and one South African investigator from an eligible institution from South Africa serving as the PDs/PIs.

An overarching goal of this bilateral program is to engage underrepresented groups of scientists in South Africa and historically disadvantaged institutions. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all in South Africa. NIH and MRC encourage South African institutions to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences.

Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital (NOT-OD-18-210). NIH's ability to help ensure that it remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds, particularly those from underrepresented groups, who will help to further NIH's mission.

This FOA encourages collaboration with underrepresented scientists within South Africa. Underrepresented scientists are defined as individuals from African, Coloured and Indian population groups in South Africa. The MRC and the South Africa Department of Higher Education and Training have a long history of prioritizing support for underrepresented scientists in the South African research community (http://www.mrc.ac.za/funding/grants-and-scholarships). One of the major tenets of these groups is the development of research capacity. The MRC is addressing transformation, bringing in medical scientists and early stage investigators who reflect the diversity of the country, both by race, gender and geography, by specifying funding for Historically Disadvantaged Institutions (HDIs) as well as crafting a new model for funding early stage investigators with Self-Initiated Research (SIR) grants. More information can be found in the MRC’s Strategic Plan (http://www.mrc.ac.za/publications/MRCStrategicPlan.pdf) and Annual Performance Plan (http://www.mrc.ac.za/publications/MRCAnnualPerformancePlan.pdf).

Finally, to stimulate regional excellence in scientific research, Phase 2 of the U.S.-South Africa Program for Collaborative Biomedical Research encourages applicants to engage investigators from Kenya, Lesotho, Uganda, and Zimbabwe as collaborators in the research project developed by the U.S. Project Scientist and South African PDs/PIs (please see FAQs below for additional information).

This FOA encourages New Investigators and Early Stage Investigators (https://grants.nih.gov/policy/early-investigators/index.htm) from the U.S. and South Africa to participate in this research program.

Basic, translational, behavioral, clinical, preventive, or epidemiological research may be proposed under this program. HIV-related research is encouraged in accordance with the NIH Director's statement describing the NIH's overarching HIV research priorities, at the following link: http://www.nih.gov/about/director/08122015_statement_aids_pandemic.htm, and the accompanying NOT accessible at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html.

Specific Research Areas of interest include:

Reduce Incidence of HIV (Prevention)

• Understanding HIV transmission dynamics among different populations and age groups, and the geographic distribution of HIV prevalence and incidence.
• Informing development of new biomedical prevention strategies through understanding host/virus interactions associated with HIV acquisition, establishment of infection and disease progression.
• Prevention of mother-to-child HIV-transmission (MTCT) in era of South Africa Option B policy.
• Voluntary medical male circumcision (VMMC) programs and impact in different populations.
• Effects of maternal HIV infection and antiretroviral treatment on HIV-exposed uninfected children.
• HIV prevention particularly in men and young/adolescent women.
• Combination prevention strategies.
• The role of food insecurity and nutrition in prevention, care and treatment of HIV/AIDS.
• Novel strategies to enhance uptake of HIV testing and sustained linkage to care by men aged 25-40 years to assist South Africa achieve the three 90s in the UNAIDS 90-90-90 strategy.
• Strategies to achieve high uptake and adherence to daily oral pre-exposure prophylaxis (PrEP) in young women in South Africa.
• Risk factors, causes and sequelae of genital inflammation and its role in HIV acquisition in women.
• The potential role of broadly neutralizing antibodies in HIV prevention and treatment.
• The potential role of long-acting injectable technologies in HIV prevention and treatment.
• What interventions can reduce HIV risk for key populations.
• New HIV testing technologies, such as self-testing, and innovative testing strategies, such as index testing.
• Examination of pathophysiology and direction of effects between mental disorders and HIV acquisition as well as broader HIV outcomes.
• Motivations and reasons for age-disparate sexual partnering (>10 years age difference) and its role in HIV acquisition.
• Studies related to use and/or disposal of condoms taken or received from government clinics and hospitals.
• Strategies that can reduce the impact of stigma, gender bias, prejudice and homophobia on HIV prevention, care, and treatment.
• Strategies that can strengthen demand for HIV services among different populations.

Develop Next-Generation HIV Therapies (Treatment and Care Continuum)

• Best approaches to optimizing durability of ART regimens beyond the first line regimen. For example; how can adherence and retention best be supported to prevent regimen failure? Can resuming second line regimens be successful with adherence support when there is loss of virologic control, rather than switching to third line regimens?
• Research on testing, linkage, adherence to HIV treatment, and retention in care, including use of mobile technologies.
• Approaches to monitoring antiretroviral therapy (ART) treatment.
• Strategies to improve annual viral load testing rates for patients on ART so that South Africa can improve this shortcoming in the current ART scale-up activities. Strategies that lead to patients demanding to know their annual viral loads and/or that lead to health care providers increasing their annual viral load testing rates would be considered responsive.
• Optimal programmatic combinations of HIV treatment and contraception.
• Differentiated care, including adherence clubs and alternate drug delivery.
• Strategies to standardize use of unique patient identifiers for all patient records, tests, and health care engagement.

Research Toward HIV Cure

• Research toward "functional cure" for pediatric HIV.

Address HIV-Associated Comorbidities, Coinfections, and Complications

• Interplay or impact of TB with HIV infection and its management.
• Chronic inflammation in treated HIV disease.
• Approaches to integrate chronic disease and mental health care into AIDS care services.
• Approaches to enhance and support integration of HIV and TB care.
• Discovery, development and/or testing of diagnostic and/or prognostic biomarkers, host directed therapies, and vaccines (both preventive and therapeutic) for people living with HIV/AIDS (PLWH).

Cancer

• Epidemiology of cancer in persons with HIV (PWH) in the era of antiretroviral therapy.
• Studies that identify biological differences between AIDS-defining and non-AIDS defining cancers.
• Understanding interactions of HIV with human papilloma virus (HPV), human herpes viruses (EBV and HHV-8), hepatitis B and C viruses, herpes simplex virus (HSV) and other oncogenic viral co-infections that lead to increased cancer risks.
• Studies on pathogenesis and pathobiology of virally associated cancers in PWH.
• Strategies for optimizing diagnosis, prevention and treatment of cancer in PWH.
• Studies on complications and outcomes of treating cancers in HIV infected vs. HIV uninfected populations.
• Studies that enhance our understanding of the role stigma plays in accessing cancer screening and care as well as its impact on survivorship.

Behavior and HIV Risk

• Integrative approaches to treating and preventing mental health and substance abuse co-morbidities in HIV, especially in women exposed to violence or abuse, and youth.
• Studies to test novel approaches to integrate screening for mental symptoms or disorders into HIV prevention or care, with referral and linkages to appropriate levels of mental health care in South Africa.
• Studies on biomarkers to assess the status of mental disorders, HIV, and other comorbidities.
• Cost-effectiveness studies to assess economic benefits of the integration of HIV and mental health system approaches.
• Mechanisms (e.g. neurotoxic, epigenetic) underlying genetic, physiological, environmental, social, cultural and economic factors and interactions that affect brain function or development and result in neurobehavioral outcomes (e.g., expression of cognitive impairment, coping, adaptation, response to intervention).
• Evaluation of the interaction among neuropsychiatric co-morbidities in HIV and age-related cognitive, physical, and functional decline; and how this is affected by socio-environmental factors.
• Neurobehavioral sequelae of perinatal and in-utero exposure to HIV, other infections, and antiretroviral and related treatments.
• Studies on the relationship between stress and HIV (e.g. 1. investigation of stress-induced immune changes and implications for HIV; 2. impact of stress and HIV on cognitive impairment; 3. psychosocial dynamics impacted by HIV and stress; and 4. implications of stress on HIV reservoirs).
• Longitudinal outcomes of the co-occurrence of HIV, alcohol and/or drug use, and other mental health comorbidities (e.g. depression), and associated genetic, epigenetic, neurobiological and environmental mechanisms.
• The role of alcohol and drug use in gender-based violence and rape.

In addition, and complementary to the proposed research project, applicants are highly encouraged to include in their applications an optional career enhancement partnership for fostering and enhancing research skills and experience of underrepresented scientists in biomedical research. These partnerships are intended to target under-resourced institutions and individuals with a demonstrated commitment to biomedical research. The goal is to include scientists from South African HDIs and other South African Universities of Technology and/or scientists from the African, Coloured or Indian population groups with limited resources or experience and develop a collaboration to further expose underrepresented scientists to rigorous research experiences.

Applications proposing the topics below will be considered non-responsive and will not be reviewed:

• Stage III or IV clinical trials.
• Research using select agents.
• Applications without the appropriate PD/PI requirements.

U01 support for Phase 2 of the U.S.-South Africa Program for Collaborative Biomedical Research is available under two FOAs that are being published concurrently. This FOA is soliciting for research on HIV/AIDS and HIV/AIDS-associated malignancies. A companion FOA is soliciting for research on other infectious diseases (tuberculosis; sexually transmitted infections; parasitic infections; arboviruses and emerging/re-emerging viral pathogens; and vector biology and control). These two companion FOAS will support research under the U01 activity code.

Companion FOA:

RFA-AI-19-025 - U.S.-South Africa Program for Collaborative Biomedical Research - Phase 2 (Infectious Diseases) (U01 Clinical Trial Optional)

Two additional R01 FOAs under this bilateral program solicit for research on HIV/AIDS and HIV/AIDS-associated malignancies and research on other infectious diseases (tuberculosis; sexually transmitted infections; parasitic infections; arboviruses and emerging/re-emerging viral pathogens; and vector biology and control). These companion FOAs will support research under the R01 activity code and are solicited separately from the U01 FOAs.

For more information please refer to specific Questions and Answers sites for all of the FOAs for the U.S.-South Africa program:

For the R01: https://www.niaid.nih.gov/grants-contracts/questions-answers-us-south-africa-R01

For the U01: https://www.niaid.nih.gov/grants-contracts/questions-answers-us-south-africa-U01

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)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Only non-domestic entities that are National Research Foundations (as defined below) from South Africa 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.

Eligible South African Institutions and Organizations

An eligible National Research Foundation (NRF) South African Institution is defined as a legally constituted public higher education institution or organization wherein research is one of the primary purposes for its existence, including the training of postgraduate students. Eligible South African institutions include, but are not limited to, historically disadvantaged institutions (HDIs) and Universities of Technology.

The following universities have been designated by the MRC as HDIs:

• Mangosuthu University of Technology
• North-West University
• Sefako Makgatho Health Science University
• University of Fort Hare
• University of Limpopo
• University of the Free State
• University of the Western Cape
• University of Venda
• University of Zululand
• Walter Sisulu University

South African Universities of Technology:

• Cape Peninsula University of Technology
• Central University of Technology
• Durban University of Technology
• Sol Plaatje University
• Tshwane University of Technology
• University of Mpumalanga
• Vaal University of Technology

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.

This program requires the collaborative efforts of the South African PDs/PIs of the South African applicant institution and the NIH IRP investigator; the NIH IRP investigator will serve as Project Scientist in this full collaboration.

Required Partnership

• U.S. NIH IRP investigator (serving as NIH Project Scientist) and South African investigator as PD/PI (single) or multi-PDs/PIs (note that only South African investigators may serve as PDs/PIs, and one of the South African PDs/PIs must be the contact PD/PI)

At least one U.S. NIH IRP investigator must serve as Project Scientist and one South African investigator must be listed as the PD/PI on the application. One of the South African PDs/PIs must serve as the contact PD/PI and an eligible South African Institution must be the applicant institution. The South African PDs/PIs must be either permanently employed at an eligible South African research institution or be in a long-term contract (at least for the minimum of the duration of the project). Postgraduate students, full or part-time, are not eligible to serve as PDs/PIs.

The partnership of the U.S. NIH IRP Project Scientist and South African PDs/PIs are strongly encouraged to include scientists at South African HDIs and other South African Universities of Technology and/or scientists from the African, Coloured or Indian population groups as collaborators.

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, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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

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:

Holly Curtis, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-5666
Fax: 301-480-4447
Email: [email protected]

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

Facilities and Other Resources: In a clearly labeled section, applicants should include a description of available resources, naming those resources that are provided by the PDs/PIs, the NIH IRP Project Scientist and other collaborators, and a description of how resources will be shared among the individuals performing specific elements of the research project (e.g., individual contributions of specific reagents, patient samples, compounds, and access to populations for epidemiologic studies).

Other Attachments: Two separate attachments must be submitted for this section: a Collaboration Plan and a Financial Management and Oversight Plan (both required). An optional third attachment is a Short-term Scientific Exchange Plan (optional).

A Collaboration Plan (pdf file named Collaboration Plan) must be included that describes the interactions among the awardees (the South African PDs/PIs, the NIH IRP Project Scientist and other collaborators) in terms of communications, processes for making decisions on scientific direction and planning activities, procedures for resolving conflicts, and fostering collaborations with the community, if applicable. Outline the combined roles and responsibilities of all participating partners in the research, including contingency plans addressing solutions to setbacks or delays. Collaborations with scientists from South African HDIs and other South African Universities of Technology and/or scientists from the African, Coloured or Indian population groups are highly encouraged. Engagement with investigators from Kenya, Lesotho, Uganda and Zimbabwe is also encouraged.

A Financial Management and Oversight Plan (pdf file named Financial Plan) must be included that describes plans for implementing subcontracts and collaborations with research partners. Describe subcontract oversight activities to ensure adequate fiscal management and project timeliness. In this paragraph describe the minimum experience required by organizational representatives of HDIs or Universities of Technology to serve as subcontractors for financial engagement on the research project. Describe the internal institutional plans and procedures to ensure that recipients will comply fully with all applicable U.S. Federal regulations, policies, and Guidelines for research involving vertebrate animals and human subjects, including for human subjects the evaluation of risks and protections in project proposals and appropriate ethical oversight of funded projects.

A Short-term Scientist Exchange Plan (pdf file named Exchange) is optional. If proposed, applicants should describe the plans for short-term scientist exchanges of the NIH IRP Project Scientist or the South African PDs/PIs to the respective physical laboratory as part of the overall research project plan.

Eligibility Factors:

For the NIH IRP Project Scientist: Applicants may propose a one-time visit of a duration not to exceed one month for the NIH IP Project Scientist to engage in the proposed research project work in the host laboratory in South Africa. The host laboratory in South Africa will provide laboratory costs to cover the proposed research activities for the duration of the scientist exchange; however, those costs may not include salary or per diem for the NIH IRP Project Scientist.

For the South African PD/PI: Applicants may propose a one-time visit of a duration no less than one week and no more than six months for the South African PD/PI to engage in the proposed research project work effort within the NIH IRP Project Scientist at the NIH. The NIH IRP Project Scientist host laboratory will cover the costs for the research performed during the exchange; no other costs will be covered by the NIH IRP host laboratory, including support for the South African PD/PI investigator family members or dependents or salary support for the South African PD/PI while at the NIH.

Scientist Exchange Proposal Elements: If proposed, explain how the scientist exchange will advance future research opportunities and contribute to the scientific field of both the NIH IRP Project Scientist and the South African PDs/PIs.

Applicants proposing short-term scientific exchanges must include the following elements in a single pdf document labeled Exchange (not to exceed eight pages total):

• A description of the specific collaborative research activities to be undertaken in the sponsor's laboratory, specifying what is to be accomplished and how it fits in the overall research strategy of the application (three-page limit).
• A short curriculum vitae of the visiting scientist, including full contact information, identification of three scientists willing to serve as references, and no more than five publications (two-page limit).
• A Letter of Support from the host institution that includes a brief description of the visit including a timeline, specific goals, how the visit relates to the proposed research project and how it will promote or enhance collaborations between the NIH IRP laboratory and the South African PD/PI (one-page limit).
• A Letter of Invitation from the chief of the hosting laboratory indicating tentative dates (one-page limit).
• A Letter of Assurance by the eligible South African investigator that he/she will return to home country at the end of the exchange, if applicable (one-page limit).
• All letters required in support of the Short-term Scientist Exchange (Letter of Support, Letter of Invitation and Letter of Assurance) must be included in this section. Do not include these letters in the Letters of Support for the overall application.

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

Note: the NIH IRP Project Scientist role must be filled by a tenured or tenure-track scientist from the NIH Intramural Research Program, with whom the South African PDs/PIs has made prior contact for the collaborative project.

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

The budget request for this FOA must distinguish between extramural costs and the intramural costs. Extramural costs are associated with the work of the South African PDs/PIs and other extramural collaborators and the applicant (South African) organization. These extramural total costs cannot exceed $200,000. Extramural (South African PDs/PIs and other collaborators); if proposed costs may include such items as salary support for the extramural PD/PI and staff at the applicant organization, supplies, laboratory animals, data analysis, and other allowable costs for work performed at the (extramural) applicant organization, as well as travel costs for the extramural investigator(s).

Intramural (NIH IRP Project Scientist) costs may not exceed $50,000 total costs per year. Intramural costs are associated with the work of the NIH IRP Project Scientist at NIH and are those required by the NIH IRP Project Scientist for carrying out the proposed work specifically identified with the project. Although the budget request may not include salary support for such individuals, it should indicate person months for any Federal staff as key personnel. Resources required need to be determined before the research can be approved by the respective NIH Institute/Center. Prospective applicants are strongly encouraged to contact staff at the participating NIH Institute/Center to discuss intramural investigator costs, because individual Institutes/Centers may have different policies regarding support for the intramural portion of the project.

Once the intramural investigator costs are known, the extramural applicant will enter this amount as a "subaward" budget in the application, and attach appropriate justification and documentation, including any spreadsheets as appropriate. Support for intramural participation will be provided by a budget allocation within the NIH.

In the budget justification section, applicants should indicate how the proposed budget will be utilized by the South African PDs/PIs, NIH IRP Project Scientist and collaborators collectively to result in the outcomes related to the proposed research project.

The combined total cost for intramural and extramural components cannot exceed $250,000.

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

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

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

Specific Aims: Applicants should clearly describe the specific aims of the project and indicate how the specific aims will be accomplished by the South African PDs/PIs, NIH IRP Project Scientist and other collaborators.

Research Strategy:

• Describe how the outcomes from the research project support the global health efforts to monitor, understand, treat, or prevent disease.
• Provide the scope of research conducted by each member of the research team and discuss how the PD(s)/PI(s), key personnel and collaborators (if applicable) will be involved in the execution of the research.
• If applicable, provide a description of the research activities or experiences provided through the proposed research project(s) that will engage underrepresented scientists in the biomedical research enterprise leading to the establishment or enhancement of research skills and expertise. Describe the specific role of the underrepresented scientist in the proposed project and how their role contributes to the overall success of the proposed research.
• Provide a plan for monitoring the day-to-day activities of the research and remediating any identified delays or set-backs in the implementation of the research project.
• Describe potential collaborations and involvement of community groups, local organizations or other institutions in the research project.

Letters of Support: Applicants from South Africa, South African HDIs, and South African Universities of Technology must include a Letter of Support signed by the respective institutional official agreeing to provide institutional support for the proposed research project, and confirming eligibility status (as applicable, HDIs, Universities of Technology). NIH IRP Project Scientist (intramural applicants) must include a letter from the respective NIH Institute and Center Scientific Director or their Designee to confirm that the intramural scientist from the respective NIH Institute and Center will be able to engage in the proposed research project.

Letters required for the (optional) Short-term Scientific Exchange should not be included here.

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 Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) 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 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.

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.

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit 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) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as NIH Project Scientist in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.

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.

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

Does the project 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 project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: Will the outcomes from the proposed research support long-term global health efforts to address disease? Does the proposed research add to the understanding of mechanisms or health related outcomes to diagnose, monitor, treat and prevent disease? If proposed, will the experiences gained through participation in the Short-term Scientist Exchange lead to improved global health research efforts?

In addition, for applications involving clinical trials:

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? 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 plans for integrating the proposed work of the U.S. and South African investigators draw on their unique expertise related to the research project? If proposed, is the experience of the combined partnership between the U.S. and South African investigators sufficient to provide a unique research experience for underrepresented scientists in terms of advancing their own research expertise?

In addition, for applications involving clinical trials:

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

In addition, for applications involving clinical trials:

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the 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 project involves human subjects and/or NIH-defined clinical research, are the plans to address

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

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

Specific for this FOA: Is the proposed research well planned and feasible? Is the collaboration plan suitable for the proposed project? Are the plans for monitoring progress of the research adequate? Has the applicant provided remedies or solutions to potential set-backs or delays? If applicable, will the proposed research provide sustainable outcomes for the local community?

In addition, for applications involving clinical trials:

Does the application adequately address the following, if applicable:

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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: Has the applicant described the plan for use and sharing of resources among all investigators working on the research project? Are the objectives for financial management and oversight well-defined, and does the plan describe the process for engaging other institutions in the research funding process?

In addition, for applications involving clinical trials:

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

Study Timeline

Specific to applications involving clinical trials:

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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.

Not Applicable.

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

For 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 (CSR) , in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Geographic distribution of South African institutions.
• Commitment to foster underrepresented scientists.

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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Per NOT-OD-19-055, recipients must provide NIH with a certification that all non-exempt human subjects research has been reviewed and approved by an appropriate IRB. The date of final IRB approval is the date that all protocols in the proposed research application received IRB review and approval (i.e., the date of the last protocol approval). When human subjects research is anticipated within the period of the award but definite plans for involvement of human subjects cannot be described in the application or proposal (referred to as "delayed onset human subjects research"), prior to the involvement of human subjects in non-exempt research, the recipient must submit to the NIH awarding IC for prior approval (1) detailed information as required in the Human Subjects and Clinical Trials Information Form of the application, as well as the certification and date of final IRB approval.

Under no circumstances may NIH-supported non-exempt human subjects research be initiated prior to meeting the requirements for conducting an IRB review of protocols as well as obtaining the date of final IRB approval. NIH will not allow any funds to be used by recipients where a certification and an IRB approval date has not been provided to the funding IC.

Recipients are also reminded that any changes to study protocols that have been subject to peer review, as well as the addition of new study protocols, require the prior approval of the NIH awarding Institute or Center consistent with Section 8.1.2.5 of the NIHGPS. Such requirements are also generally described in the Funding Opportunity Announcement and/or the Notice of Award.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In addition, information on 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 can be found at https://grants.nih.gov/grants/policy/harassment.htm.

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.

The PD(s)/PI(s) will have the primary responsibility for:

• The South African PDs/PIs will have the primary responsibility for defining the research objectives, approaches and details of the project within the guidelines of the Funding Opportunity Announcement and for performing the scientific activity.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• The NIH IRP investigator will serve in the role of Project Scientist and will provide substantial scientific input to the research project without duties associated with programmatic stewardship for the project.
• The NIH IRP Project Scientist will work closely with the PDs/PIs in terms of the research objectives, approaches and details of the project and be responsible for performing the scientific activity.
• The NIH IRP Project Scientist may have primary responsibility for one or more specific aims within the proposed research project.
• The NIH IRP Project Scientist may provide advice and technical assistance to the South African PD/PI, may participate in monitoring the progress of ongoing research, and assist in the analysis, interpretation, and reporting of findings in the scientific literature and to the community at large and the public policy community within the Federal government.
• The NIH IRP Project Scientist will be subject to the same publication/authorship policies as the official NIH publication policy governing extramural NIH staff.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• The PDs/PIs and the NIH IRP Project Scientist will work closely on all aspects of the proposed research project in terms of the research objectives, approaches and details of the project and be responsible for performing the scientific activity.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final 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]

Mark Pineda, M.S.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-7693
Email: [email protected]

Brian Remortel, M.P.H.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-4816
Email: [email protected]

Geraldina Dominguez, Ph.D.
National Cancer Institute (NCI)
Telephone: 301-920-6044
Email: [email protected]

Sonia Lee, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-594-4783
Email: [email protected]

Shiv Prasad, PhD
Center for Scientific Review
Telephone: 301-443-5779
Email: [email protected]

Philip Smith
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2948
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

Bryan Clark, M.B.A.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

Arlene Smith
South Africa Medical Research Council (MRC)
Telephone: 27-21-938-0653
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 .