Required Application Instructions

It is critical that applicants follow the 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 President’s Emergency Plan for AIDS Relief (PEPFAR) is a global health initiative launched in 2003 designed to provide HIV prevention, care, and treatment services in low- and middle-income countries in order to combat the devastation of HIV/AIDS globally. While Phase I of PEPFAR focused on building an emergency response, Phase II, continued under President Obama s Administration, emphasized sustainability. An emphasis was also placed on increasing the impact of PEPFAR’s investments by scaling up evidence-based interventions including access to antiretroviral therapy (ART), preventing mother-to-child transmission of HIV (PMTCT), and voluntary medical male circumcision (VMMC). Now, PEPFAR is heading into Phase III, focusing on continued sustainable control of the epidemic while delivering on the promise of an AIDS-free generation. To accomplish this, PEPFAR is pivoting to a data-driven approach that achieves the most impact on investments by strategically targeting services to geographic regions with greatest disease burden and populations at greatest risk, and then targeting appropriate evidence-based interventions to these sub-groups.

New knowledge and discovery have provided us with tools to combat the HIV/AIDS epidemic, but full use of these tools in low resource settings devastated by HIV/AIDS remains a great challenge. Interventions showing efficacy in controlled research studies, such as VMMC or ART as HIV prevention, may hit obstacles when scaled up or when adapted to delivery in new contexts. Implementation science is an interdisciplinary area of health research focusing on best methods to improve the uptake, implementation, and translation of research findings into routine and common practices (the "know-do" or "evidence-to-program" gap). Implementation science research can generate valuable evidence on delivery, scale-up, and sustainability to inform PEPFAR approaches and optimize the impact of investments applied to reverse the HIV/AIDS epidemic. Examples of types of implementation science research include studies to improve acceptability, coverage, and quality of services; approaches to strengthening service delivery systems; analysis of cost-effectiveness outcomes and the impact of interventions on health systems and/or the larger community. Evidence from rigorously designed implementation science research is crucial to delivering the promise of an AIDS-free generation.

Since the launch of PEPFAR in 2003, substantial investments have been made in human resources for health in low resources settings. The Medical Education Partnership Initiative (MEPI), a collaborative partnership between PEPFAR, the National Institutes of Health/ Fogarty International Center, and African medical schools in twelve African countries, has increased the number of medical professionals trained in sub-Saharan Africa. The Nursing Education Partnership Initiative (NEPI) is a parallel investment made by PEPFAR in partnership with the Health Resources and Services Administration (HRSA) and African nursing schools, and is currently active in six other African countries. Through these partnerships and others, there is a broader base of African health care professionals to design, implement and disseminate implementation science research that will improve PEPFAR programs and local health care delivery systems.

In order to support PEPFAR’s goal of improving human resources for health in African countries where PEPFAR is active, this FOA encourages the use of Multiple Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) for study teams. In particular investigators affiliated with the institutions collaborating with MEPI and/or NEPI are encouraged to apply. Applications must include at least one PD/PI affiliated with an institution from the following countries: Botswana, Ethiopia, Ghana, Kenya, Lesotho, Malawi, Mozambique, Nigeria, South Africa, Tanzania, Uganda, Zambia, Zimbabwe, Swaziland, Rwanda, and/or the Democratic Republic of Congo.

The intent of this FOA is to solicit implementation science research projects that will have a high impact on controlling the HIV epidemic and provide evidence for best programmatic practices in PEPFAR programs. A more complete description of programmatic priorities for PEPFAR, as well as a rationale for the pivot to a data-driven approach that strategically targets resources towards geographic areas and populations where the greatest impact in epidemic control is most likely to occur, can be found at: http://www.pepfar.gov/documents/organization/234744.pdf.

Studies submitted in response to this FOA should address the challenges that PEPFAR encounters in the implementation of HIV/AIDS prevention, treatment, and care programs for antenatal, pediatric, adolescent, and adult populations (including pregnant and breastfeeding women) in eligible African countries. Within the countries of focus for this FOA, the expectation is that research will be conducted in regions most affected by HIV/AIDS (high prevalence, high incidence settings) among neglected and hard-to-reach populations with low service coverage and a potential for high impact, such as pediatric populations, adolescent girls and young women, high-risk men, and sex workers. Priorities should reflect those of the country and also produce results that are generalizable across PEPFAR programs. Studies that use existing clinical, administrative, or programmatic data to study resource allocation and how to maximize impact are particularly important.

Responsive Applications:

The list below provides examples of priority research areas identified in consultations with multiple stakeholders. This FOA for Exploratory/Developmental Research Grant (R21) supports studies that may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research. Implementation science research projects that address the research priorities described below using existing data from health surveys; public health surveillance; HIV prevention, care and treatment services; or administrative/programmatic datasets will be considered under this FOA.

• Identifying and Targeting Hotspots
• Neglected and Hard to Reach Populations
  • Specific Issues for Adolescent Girls and Young Women
• HIV Care Continuum
  • Tuberculosis (TB) Specific Issues for the Care Continuum
  • Maternal Child Health (MCH) Specific Issues for the Care Continuum

Identifying and Targeting Hotspots :

From basic epidemiology to effective place- or venue-driven sentinel surveillance programs, careful epidemiology has enabled substantial advances in HIV control. However, to date efforts in sub-Saharan African countries with generalized HIV epidemics have largely focused on equitable distribution of resources with uniform care standards applied across a country. This approach may have lowered overall community risk but does not address hotspots of transmission. In fact, although the broad implementation of HIV prevention and treatment programs has made substantial progress in controlling HIV transmission, the epidemic continues unabated in certain geographical locations and risk groups. Effective prevention and treatment efforts must focus on these groups who are at greatest risk of acquiring HIV, transmitting HIV or progressing to illness. Such hotspots of infection may be defined geographically within sub-national units, or by demographic characteristics, such as highly mobile workers (fishermen, miners, truckers, etc.), or adolescent girls and young women in Eastern and Southern Africa. Fortunately, as PEPFAR has evolved, more site-level data are available, allowing for better identification of such hotspots through better characterization of local HIV epidemics and local patterns of HIV service delivery. Targeted approaches must be further developed and tested in order to reach recalcitrant hotspots of infection and make further progress to end HIV/AIDS. Applications submitted in response to this FOA should propose approaches to characterize local epidemics and target HIV prevention and treatment resources to obtain the greatest impact. Developing methods to use routinely collected administrative programmatic data and clinical data are encouraged. Research on the following questions is encouraged:

• What evidence-based models of program delivery most effectively and efficiently target those at highest risk of infection and transmission within urban versus rural communities, as well as mobile versus fixed populations, while supporting the pivot in PEPFAR program prioritization?
• What are the best approaches to implement and evaluate the effectiveness and efficiencies of the current programmatic pivot from broadly distributed services to more geographically targeted services?
• What are methods for assessing coverage of multiple interventions across a hotspot? How can estimates of coverage be developed quickly to achieve epidemiological goals for HIV prevention?
• How can research and program data be combined in an effort to assess the accuracy of programmatic data? How can these data sources be used to drive decision-making in the design and implementation of effective HIV prevention and treatment programs?
• What models of HIV transmission based on granular epidemiologic data best inform allocation of public health resources?
• How can the accuracy and timeliness of HIV epidemiologic data be enhanced? Can diverse datasets from disparate sources (e.g., big data ) produce more rapid assessment of local HIV epidemiology?
• What robust analytic and visualization approaches maximize the knowledge gained from these data and improve public health targeting of hotspots? How can these methods translate knowledge into cost effective allocation of resources?
• How can the ability of health information systems to collect longitudinal data on a variety of populations be improved, including HIV-exposed and HIV-infected infants, children, and adolescents?

Neglected and Hard to Reach Populations:
Specific issues related to adolescent girls and young women as neglected and hard to reach populations include:

• What are the most successful approaches for implementing and monitoring complex, multi-component interventions for females age 15-24? Can inputs that address more distal outcomes like social capital, personal agency and norms be tied to concrete health outcomes?
• How can different combinations of interventions for females age 15-24 be evaluated for effectiveness in a way that is rigorous, fast and cost-efficient?
• HIV prevalence tends to rise most sharply in females age 20-24, yet the most effective known interventions are for females age 15-19. What are the most effective packages for young women age 20-24?
• Under the DREAMS initiative, PEPFAR will support limited demonstration projects of pre-exposure prophylaxis (PrEP) for sub-populations of females age 18-24 at very high risk. What are the most effective ways to identify appropriate sub-populations for PrEP? What are the most effective and appropriate delivery models? NIH Implementation Science research is limited to evidence based interventions, and all interventions to be implemented must have appropriate regulatory approval and be indicated for the study population. Therefore, the following special requirements must be met by applicants wishing to address questions on PrEP in young women:

• Research addressing PrEP is limited to study populations of young women between the ages of 18 and 24 years. Adolescent girls less than 18 years of age may not be included
• The research is restricted to countries where PrEP has been approved for use in HIV prevention by the MOH and/or national drug regulatory board
• If special approval is being provided for PrEP demonstration projects, the PD/PI must submit a letter from the PEPFAR Coordinator in the country where the research will be done, verifying that government approval is anticipated prior to the date of these grant awards (Winter/Spring 2016). This letter must be submitted with the grant application. Applicants seeking information on the current PEPFAR Coordinator may contact the Scientific/Research Contact for this FOA (Melanie Bacon: [email protected])
• Applications including the required letter (indicating anticipated approval by local authorities) will be reviewed, but awards will not be made for any PrEP research which does not have written approval from the local government by December 31, 2015, regardless of how meritorious it is rated by reviewers. Applications for research in countries where PrEP is not approved, or applications from countries involved in the PEPFAR DREAMS initiative that do not have a letter from the PEPFAR Coordinator, will be considered incomplete and will not proceed to review.
  
  
• Male sexual partners of girls and young women are often reluctant to be tested for HIV, and then to seek appropriate services, e.g. VMMC for those test negative and ART for those who test positive. What are the most effective approaches for identifying these male partners, and increasing uptake of HTC, VMMC and ART in this population?
• What are the most effective approaches for increasing access to, and uptake of, appropriate clinical services among females age 15-24? Is there a model that is both effective and sustainable to make services youth friendly ?
• In some countries, young females in the higher wealth quintiles have higher rates of HIV, yet most prevention programs target those in lower income quintiles. What are effective HIV prevention strategies for reaching those higher wealth young females?
• What are the most effective approaches for reaching vulnerable subsets of females age 15-24 such as young, married girls and women, young sex workers and those living in urban areas?
• Girls who stay in school have a reduced risk of HIV acquisition. What are the key factors in parents decisions to enroll female children in school and support continued attendance? What are the most effective approaches for increasing parental support for school attendance in this population?

HIV Care Continuum:

Early identification and treatment for people living with HIV (PLHIV) have established health benefits: health outcomes for the individual improve and transmission to others is prevented. Yet many PLHIV in many countries are not successfully engaged in care and treatment. The Joint United Nations Programme on HIV/AIDS (UNAIDS) has set an ambitious 90-90-90 treatment target by 2020 meaning: by 2020, 90% of all people living with HIV will know their HIV status; 90% of all people with diagnosed HIV infection will receive sustained ART; and 90% of all people receiving ART will have sustained viral suppression. Achieving these goals would more than double the percentage of HIV infected persons who reach and maintain viral suppression, significantly reducing the incidence of new infections, and potentially ending transmission of HIV by 2030.

The HIV Care Continuum has become the common way of framing programmatic success and failure of HIV diagnosis and treatment goals by depicting community coverage for discrete steps along the progression from initial HIV test to viral suppression. Points of loss along the continuum suggest which steps need to be specifically targeted to improve public health outcomes. Recent WHO guidelines have set goals for earlier care and treatment initiation, aiming to start ART in all HIV-infected children under age five (5) years, all pregnant women, all HIV/TB co-infected individuals and all HIV-infected adults with a CD4 count below 500. While there has been significant progress, there are also significant points of patient or client loss along the HIV Care Continuum which correspond to opportunities for targeted programmatic improvement. These points of loss may differ significantly by age, gender, and behavioral risk, illustrating the need for testing varied approaches and allocating resources depending upon local characteristics of the HIV epidemic. For example, considerable progress needs to be made to better integrate TB services with HIV services, and vice versa, and to integrate HIV care with Maternal Child Health (MCH) programs. Implementation science is needed to answer the following:

• How can services for testing, care and treatment of HIV be made accessible, affordable, and appealing to those populations most at-risk for acquiring HIV, particularly in those areas where the burden of HIV is high but service coverage is low?
• Can we use crowd sourcing from the community to improve accountability of HIV service delivery and also improve community engagement and problem solving around service delivery?
• What service delivery models improve uptake of HIV testing, including but not limited to, outside health facility approaches, such as multi-disease prevention campaigns, home-based testing and using HIV tests that can be self-administered and/or administered with minimal support?
• Can supply-side health workforce strategies, such as quality management systems, performance-based financing, or task shifting, improve the availability, quality and efficiencies of HIV services? What will be the impact of these strategies on care and treatment outcomes if brought to scale?
• What are best methods (in terms of effectiveness and efficiency) to link mobile HIV-infected individuals to care and to support services between locations to maintain their engagement over time? What are the best methods for tracking those linkages?
• Can we predict and prevent loss-to-follow up, and track and re-engage those who have dropped from treatment?
• What are the most cost-effective models of task-shifting along the HIV Care Continuum?

TB-specific issues for the care continuum:

• What is the best scalable approach to integrating HIV and TB services to improve the cascade and to reach 90-90-90 targets?
  • What are the barriers to providing ART to TB/HIV co-infected individuals who present for care at TB clinics and who are not currently on ART? What are effective models to link and/or integrate TB care within HIV care?
• How can HIV clinics best offer combination TB prevention, including early HIV testing, earlier ART before TB, TB screening, Isoniazid Preventive Therapy (IPT), ART after TB diagnosis, as well as infection control? What is the modelled and measured impact and cost effectiveness of such integrated programs?
• How can TB or other non HIV specific services best offer HIV related prevention and care, including HIV testing of clients and early ART, both before and after TB diagnosis?
• How can HIV and TB services be best integrated into non-facility based strategies (e.g., home-based, multi-disease community campaigns)? Can these integration strategies reach people earlier after they acquire HIV or develop TB disease? Do these non-facility locations improve access to HIV/TB care and treatment?

MCH-specific issues for the care continuum:

Special circumstances, such as pregnancy and entry into antenatal care for women, lead to increased opportunities to test for HIV infection and, for those women found to be HIV-infected, initiation of lifelong ART (WHO Option B+ for prevention of maternal to child transmission). However, the continuum of care for these women may show significant drop off in ART adherence in the period following delivery. More implementation research is needed to support adherence to lifelong ART for women whose HIV is diagnosed during pregnancy.

Similarly, infants who become infected with HIV need to be identified and engaged in HIV care as soon as possible due to high rates of mortality in HIV-infected infants and children. Maternal infection acquired late in pregnancy or during the breastfeeding period may go undetected, even with high quality antenatal services. Without systematic HIV testing approaches for pregnant women and infants, HIV infection in infants may go undetected until HIV-related illness occurs. Strengthening systems for follow-up and HIV testing of HIV-exposed infants as well as detecting HIV in older children and engaging and retaining them in lifelong HIV care is important to the success of PEPFAR programs. Examples of relevant implementation science questions for these populations include the following:

• What are the characteristics of health delivery systems or specific strategies that will improve long term outcomes of therapy in women who start lifelong ART because of pregnancy?
• Does treatment literacy regarding the benefits of early and sustained treatment to prevent illness, death and transmission among pregnant women and providers impact on ART uptake and adherence?
• What models are most effective for improved follow-up of infants exposed to HIV during pregnancy and breastfeeding?
• What are demand and supply factors that can increase routine uptake of early infant diagnosis?
• Can strategies using point-of-care diagnostics improve early infant diagnosis?
• Can service delivery models of task-shifting improve the HIV Care Continuum for special populations, including HIV-infected children and adolescents? What are the effects of those models on health worker retention?

Non Responsive Applications:

Applications proposing basic laboratory based research or clinical trials testing unlicensed drugs/products or unproven interventions will be considered not responsive and will not be reviewed.

Applications proposing PrEP research in countries where PrEP is not approved, or applications from countries involved in the PEPFAR DREAMS initiative that do not have a letter from the PEPFAR Coordinator, will be considered incomplete and will not proceed to review.

Support for the NIH-PEPFAR collaboration Implementation Science for HIV: Towards an AIDS-free Generation is available under two separate companion FOAs that are being published concurrently. This FOA is soliciting for R21 applications that will support shorter term (up to two years) developmental/exploratory research activities, whereas the companion R01 FOA will support more developed (up to 5 years) applications.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

This FOA must list at least one Investigator affiliated with an African institution as a PD(s)/PI(s). African PD(s)/PI(s) must be either permanently employed at an eligible 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 PD(s)/PI(s). Eligible African Institutions must be located in one of the following countries: Botswana, Ethiopia, Ghana, Kenya, Malawi, Mozambique, Nigeria, South Africa, Tanzania, Uganda, Zambia, Zimbabwe, Swaziland, Rwanda, and/or the Democratic Republic of Congo.

Applications not including at least one Investigator affiliated with one of the African institutions listed above will be considered ineligible and will not be reviewed.

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).

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

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

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

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

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

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

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

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

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

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

A minimum of 80% of the direct cost budget should be apportioned to activities that will be conducted at the eligible African site over the entire project period.

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:

Research Strategy: As part of the research strategy, applicants should clearly describe how implementation of the project will increase local scientific capacity to conduct implementation research in order to support sustainability of PEPFAR programs. Applicants must include a realistic management plan with milestones and timelines. This plan should also outline the responsibilities of key members of the research team and how responsibilities will be divided among the investigators.

Multiple PD/PI Leadership Plan: If applicable, a multiple PD/PI leadership plan must be included. Each multi-PD/PI application must address priority implementation science research questions carried out by creative, multi-disciplinary teams configured to increase the likelihood for success of the project, while simultaneously supporting the development of in-country scientists at early stages in their career to gain skills and develop greater independence.

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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Letters of Support: If special approval is being provided for PrEP demonstration projects, the PD/PI must submit a letter from the PEPFAR Coordinator in the country where the research will be done, verifying that government approval is anticipated prior to the date of these grant awards (Winter/Spring 2016).  This letter must be submitted with the grant application.  Applicants seeking information on the current PEPFAR Coordinator may contact the Scientific/Research Contact for this FOA (Melanie Bacon: [email protected])

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

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

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

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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.

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, please note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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? 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?

Will implementation of the project increase local scientific capacity to conduct implementation research in order to support sustainability of PEPFAR programs?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If 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?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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?

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

Is the research management plan realistic? Does the management plan include project milestones and timelines? Does the management plan clearly outline key responsibilities of the members of the research team? Do investigators from within the country have meaningful leadership roles on the project team? If a multiple PD/PI application is proposed, is the project's leadership structure designed to support further development of in-country investigators to become independent scientists?

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

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

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

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

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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 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.

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.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

The following term applies for agreements between the US Government and foreign governments:

PROSTITUTION AND SEX TRAFFICKING

• The U.S. Government is opposed to prostitution and related activities, which are inherently harmful and dehumanizing, and contribute to the phenomenon of trafficking in persons. None of the funds made available under this agreement may be used to promote or advocate the legalization or practice of prostitution or sex trafficking. Nothing in the preceding sentence must be construed to preclude the provision to individuals of palliative care, treatment, or post-exposure pharmaceutical prophylaxis, and necessary pharmaceuticals and commodities, including test kits, condoms, and, when proven effective, microbicides.
• The following definitions apply for purposes of this provision:
  • Commercial sex act means any sex act on account of which anything of value is given to or received by any person.
  • Prostitution means procuring or providing any commercial sex act and the practice of prostitution has the same meaning.
  • Sex trafficking means the recruitment, harboring, transportation, provision, or obtaining of a person for the purpose of a commercial sex act.
• The Grantee must insert this provision, which is a standard provision, in all subawards or subcontracts.
• This provision includes express terms and conditions of the award and any violation of it is grounds for unilateral termination of the award by USAID prior to the end of its term.

The following term applies for agreements between the US Government and recipients other than foreign governments:

PROSTITUTION AND SEX TRAFFICKING

• The U.S. Government is opposed to prostitution and related activities, which are inherently
• harmful and dehumanizing, and contribute to the phenomenon of trafficking in persons. None of the funds made available under this agreement may be used to promote or advocate the legalization or practice of prostitution or sex trafficking. Nothing in the preceding sentence shall be construed to preclude the provision to individuals of palliative care, treatment, or post-exposure pharmaceutical prophylaxis, and necessary pharmaceuticals and commodities, including test kits, condoms, and, when proven effective, microbicides.
• (1) Except as provided in (b)(2) and (b)(3), by accepting this award or any subaward, a non-governmental organization or public international organization awardee/subawardee agrees that it is opposed to the practices of prostitution and sex trafficking because of the psychological and physical risks they pose for women, men, and children. Any enforcement of this clause is subject to Alliance for Open Society International v. USAID, 05 Civ. 8209 (S.D.N.Y., orders filed on June 29, 2006 and August 8, 2008) (orders granting preliminary injunction) for the term of the Orders.

The lists of members of GHC and InterAction can be found at: http:/transition.usaid.gov/business/business_opportunities/cib/pdf/GlobalHealthMemberlist.pdf

(2) The following organizations are exempt from (b)(1): the Global Fund to Fight AIDS, Tuberculosis and Malaria; the World Health Organization; the International AIDS Vaccine Initiative; and any United Nations agency. (3) Contractors and subcontractors are exempt from (b)(1) if the contract or subcontract is for commercial items and services as defined in FAR 2.101, such as pharmaceuticals, medical supplies, logistics support, data management, and freight forwarding.

(4) Notwithstanding section (b)(3), not exempt from (b)(1) are recipients, subrecipients, contractors, and subcontractors that implement HIV/AIDS programs under this assistance award, any subaward, or procurement contract or subcontract by:

(i) Providing supplies or services directly to the final populations receiving such supplies or services in host countries;

(ii) Providing technical assistance and training directly to host country individuals or entities on the provision of supplies or services to the final populations receiving such supplies and services; or

(iii) Providing the types of services listed in FAR 37.203(b)(1)-(6) that involve giving advice about substantive policies of a recipient, giving advice regarding the activities referenced in (i) and (ii), or making decisions or functioning in a recipient’s chain of command (e.g., providing managerial or supervisory services approving financial transactions, personnel actions).

• The following definitions apply for purposes of this provision:

Commercial sex act means any sex act on account of which anything of value is given to or received by any person.

Prostitution means procuring or providing any commercial sex act and the practice of prostitution has the same meaning.

Sex trafficking means the recruitment, harboring, transportation, provision, or obtaining of a person for the purpose of a commercial sex act. 22 U.S.C. 7102(9).

• The recipient shall insert this provision, which is a standard provision, in all subawards, procurement contracts or subcontracts.

This provision includes express terms and conditions of the award and any violation of it shall be grounds for unilateral termination of the award by USAID prior to the end of its term.

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

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Kendall Bryant, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-0332
Email: [email protected]

Melanie C. Bacon, R.N., M.P.H.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3215
Email: [email protected]

George Siberry, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-7350
Email: [email protected]

Shoshana Y. Kahana, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-2261
Email: [email protected]

Christopher Gordon, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 240-627-3867
Email: [email protected]

Lyn Hardy, Ph.D., R.N.
National Institute of Nursing Research (NINR)
Telephone: 301-594-5976
Email: [email protected]

Robert Freund, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1050
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Jenny Greer
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2949
Email: [email protected]

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

Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-253-8729
Email: [email protected]

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: [email protected]

Judy Sint
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
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.