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.

Purpose

The National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Neurological Disorders and Stroke (NINDS), in collaboration with the Global Alliance for Chronic Diseases (GACD), invites grant applications to address late-stage implementation research questions focused on optimally and sustainably scaling up evidence-based interventions at the population level for prevention and management of hypertension in low- and middle-income countries (LMICs) and small island developing states (SIDS). For the purposes of this Funding Opportunity Announcement (FOA), late-stage implementation research is defined as research to identify strategies to achieve sustainable uptake of proven-effective interventions in routine clinical and public health and community-based settings and maximize the positive impact on population health. Implementation science examines what works, for whom, and under what contexts, and how interventions can be adapted and scaled up in ways that are accessible and equitable (additional information and resources on implementation science can be found on the GACD website). Each awarded project will conduct late-stage implementation research in LMICs and/or SIDS in one of six geographical regions (e.g., East Asia and the Pacific; Europe and Central Asia; Latin America and the Caribbean; Middle East and North Africa; South Asia; Sub-Saharan Africa). As a group, awardees will constitute a research alliance for hypertension implementation science research in low-resource settings with capabilities for addressing scale-up of evidence-based interventions at the population level for the prevention and management of hypertension. This program is not intended to support research that will be conducted primarily in and/or by the United States or other high-income institutions that do not meet eligibility criteria.

This FOA utilizes the bi-phasic, milestone driven UG3/UH3 cooperative agreement mechanism. Awards made under this FOA will initially support a two-year milestone-driven needs assessment and planning phase, with possible transition to an implementation (UH3) phase of up to 4 additional years. Only UG3 projects that meet the scientific milestones and award requirements of the UG3 phase will transition to the UH3 phase. Applications submitted in response to this FOA must address both the UG3 and UH3 phases and are expected to include plans for project management and performance milestones for each phase.

The GACD is a partnership among research funding agencies in twelve countries and the European Commission focused on tackling the world’s most pressing global health challenges, especially the emerging tide of chronic, non-communicable diseases. GACD funding agencies, including the U.S. National Institutes of Health (NIH), work together in selecting research focus areas, issuing calls for research applications, organizing peer review of applications, and facilitating collaboration and joint learning across awardees globally. This FOA is part of the fifth joint GACD call for applications, which focuses on scaling up evidence-based interventions at the population level for the prevention and/or management of hypertension and/or diabetes. As a group, awardees funded by all GACD partners under this joint GACD initiative will constitute a network for implementation research with capabilities for answering research questions about the delivery of evidence-based prevention, early intervention, treatment, and care for hypertension, stroke, and diabetes and sustaining high-quality care in resource-limited settings. Awardees funded by all GACD partners will exchange research findings and information by means of cross-project working groups and annual joint meetings that will be organized by the GACD, and which all awardees are expected to attend.

The GACD aims to coordinate research on chronic diseases at a global level in order to enhance knowledge exchange across individual projects, and to better understand the impact of socioeconomics, culture, geopolitics and policy on research findings, so as to appropriately adapt interventions and foster scale up to different geographical, economic and cultural settings. Research under GACD involves regular exchange of research findings and information across participating projects by means of cross-project working groups and annual joint meetings. The NHLBI, NINDS, GACD, and/or other funding agencies will work together wherever feasible to harmonize and standardize data collection and exchange data across awards. Applicants are encouraged to use data dictionaries developed by GACD programs.

Background

Hypertension affects one billion people worldwide and is a major risk factor for cardiovascular disease and stroke. Currently, it is estimated that raised blood pressure indirectly kills more than 10 million people every year. By 2025, however, the number of adults living with high blood pressure is estimated to increase to approximately 1.56 billion, with more than two-thirds living in LMICs. Not only is hypertension more prevalent in LMICs, but there are also more people affected in total because a larger proportion of the population live in LMICs than in high-income countries (HICs).

To avoid a significant and growing burden on future populations, it is critically important to implement strategies that will prevent the development of hypertension as well as improve the identification, management, and control of hypertension after onset. Proven, evidence-based interventions exist for hypertension prevention and control, and previous research investments from the NIH and other organizations (i.e., NHLBI United Health Centers of Excellence, Global Alliance for Chronic Disease, etc.) provided evidence for addressing hypertension at the local (i.e., city or suburban) level via innovative mechanisms (e.g., salt substitution, task shifting/sharing, adaptation of the DASH diet, etc.) Identifying and evaluating interventions to assess efficacy is not always enough to ensure interventions wide uptake in the real world. Even when information, tools, and interventions have been tested within real-world effectiveness studies, the development of knowledge to support their broader uptake often has remained outside the sphere of research. Effectively implementing and scaling up interventions, programs, and policies at the regional and national levels remains a persistent challenge.

It is essential that policymakers, communities, families, caregivers, patients, as well as healthcare practice and other settings are equipped with tailored, evidence-based strategies to integrate scientific knowledge and effective interventions into everyday use. Researchers have found it challenging to ensure that tools and interventions deemed efficacious within clinical and/or community-based studies are readily adopted and implemented. Scaling-up interventions to large populations is not a straightforward task. In practice, translation from a pragmatic trial to the real-life commissioning and continuous delivery of an intervention across a health system is a major system level challenge that can also include political, economic, and societal elements. Without intentional efforts to guide scale up, new evidence-based interventions might not be broadly implemented.

Research Scope and Objectives

The objective of this FOA is to support applications for multidisciplinary and cross-sectoral research projects that propose to test late-stage implementation research strategies for optimally and sustainably scaling up evidence-based hypertension interventions in LMICs, and/or in SIDS, and thereby maximize the positive impact on population health. Applications are expected to propose projects that: (1) identify the barriers that impede population-level adoption of evidence-based interventions; (2) scale up optimal and sustainable strategies that, when fully scaled up, will have lasting population-level impact; (3) develop effective teams that can identify and address implementation barriers for hypertension in LMICs by studying those barriers at the population-level; and (4) develop effective partnerships that will drive intervention uptake and long-term sustainability of model approaches. Applications addressing the concurrence of hypertension, stroke, and co-occurring diseases such as diabetes, are encouraged as well as those addressing the underlying risk factors of both conditions. Applications may build on previous hypertension and diabetes research projects supported under the GACD that have demonstrated their potential for impact, however this is not a requirement of this FOA.

Partnerships:

Research partnerships are key to enhancing resources and improving capacity for global health research in LMICs. A partnership model of research in which LMIC PIs lead research projects with any needed technical support from colleagues in HICs can lead to ownership, sustainability, and the development of local and national research capacity. Cultural and national influences play a large role in the interpretation and application of research findings. Similarly, local and national researchers in LMICs have critical knowledge of the cultural and national influences regarding health problems and health systems. Thus, in global health research conducted in LMICs, local and national researchers should engage in partnerships as needed, to provide technical assistance, enhance resources, and build capacity.

The NIH expects research supported by this FOA to be designed and planned in collaboration with in-country government agencies, non-governmental organizations (NGOs), and health care institutions and organizations so as to be responsive to local needs, interests, and capacities; embrace cultural and health system factors; and to increase likelihood of long-term sustainability. The NIH expects research supported by this FOA to align with commitments or planned commitments at a regional or national level to implement evidence-based interventions (including evidence of cost-effectiveness and affordability) across health or other sectors (e.g., education, information technology). In addition to a broad geographic scope, applications are expected to ensure scale up covers diverse populations with consideration given to geography (e.g., remote, rural, urban); demographic mix (e.g., gender, age, ethnicity); community readiness for interventions; and/or other relevant criteria. As such, this FOA is intended to support applications that propose partnerships with representatives from: (1) one or more LMIC research organizations; (2) one or more LMIC government agencies with a health-related function (e.g., Ministry of Health; Ministry of Social Welfare; Department of Health; Ministry of Public Health, etc.) and that has a policy-making, evaluation, or research role within the agency; and (3) one or more LMIC NGOs and/or health care institutions or systems that provide access to provider and service user viewpoints, so as to be responsive to local needs, interests, and capacities. In addition, the NIH expects the proposed research to provide participating countries, regions, and/or local jurisdictions with the knowledge, tools, and strategies needed to maximize the positive effects of hypertension interventions, to scale up services to a wider population, to sustain delivery of evidence-based care for hypertension broadly as well as secondary hypertension prevention in stroke survivors, and/or to foster evidence-based policy and program development for meeting the needs of hypertension and/or stroke patients.

Policymakers, intervention payers (excluding research funding agencies), local in-country researchers, implementers, and beneficiaries are expected to be involved at all stages of the interventions selection, adaptation, and implementation design to identify the challenges to the delivery of the interventions in real world settings. Such partners will be integral to the success and sustainability of the program and it is essential that they are engaged early, and participate equitably and meaningfully in the design and conduct of the proposed research. Researchers should be integrated closely with the authorities responsible for the program’s delivery. The GACD expects that those authorities will commit to pay for and provide the interventions, possibly through loans contracted from development banks or other financial providers. Applications will support the conduct of research associated with the scale up of the interventions.

Regions:

The NIH expects the proposed research to take place in World Bank-designated LMICs, Small Island Developing States (SIDS), and previously designated LMICs re-categorized by the World Bank as high-income (from LMIC) on or after January 1, 2011. This program is not intended to support research that will be conducted primarily in and/or by the United States or other high-income institutions that do not meet eligibility criteria. The NIH recognizes that countries reclassified as high-income (from LMIC) in the past seven years may continue to have low-resource regions and population sub-groups like those in LMICs. Consequently, the NIH also encourages countries from these re-classified countries. Throughout this FOA, the term LMIC is used broadly to denote countries currently designated as LMICs, those countries designated as LMICs prior to January 1, 2011 that have since been re-categorized as high-income by the World Bank, and SIDS. Research is expected to take place in the following World Bank regions:

• East Asia and the Pacific
• Europe and Central Asia
• Latin America and the Caribbean
• Middle East and North Africa
• South Asia
• Sub-Saharan Africa

Implementation Research Elements

The NIH expects that applications will propose an implementation research study focused on an aspect of delivering, scaling up, or sustaining proven-effective, evidence-based interventions at the population level for prevention and management of hypertension. Applications are expected to build on evidence-based interventions (including evidence of cost-effectiveness and affordability) for the respective population groups under defined contextual circumstances and to replicate and scale-up comprehensive interventions. Interventions can focus at the individual, community, and/or system level and may combine interventions from different levels. They may target strategies for the sustainable scale up of proven-effective interventions for the prevention, treatment, and control of hypertension. Applications are expected to provide strong evidential support that the selected interventions are equitable, safe, effective, and efficient, and include assessments of accessibility, reach, and health economic assessments as an integral part of the proposed research.

This FOA is intended to support applications that propose to: (1) employ validated theoretical or conceptual implementation research frameworks (e.g., Consolidated Framework for Implementation Research (CFIR); Promoting Action on Research Implementation in Health services (PARiHS); Pragmatic-Explanatory Continuum Indicator summary (PRECIS); Reach Effectiveness Adoption Implementation Maintenance (RE-AIM); PRECEDE-PROCEED, K2A, etc.); (2) include implementation research study designs (e.g., experimental, quasi-experimental, observational, modeling, cluster randomization, stepped-wedge, Type III hybrid effectiveness, etc.); (3) include implementation measures as primary research outcomes (e.g., acceptability, adoption, appropriateness, affordability, costs, feasibility, fidelity, penetrance, sustainability, etc.); and (4) inform understanding of key mediators and mechanisms of action of the implementation.

Applicants proposing to conduct a clinical trial under this FOA must adhere to NIH requirements for clinical trials research.

Structure

Phases of Award

The UG3 phase will support the following planning activities focused on sustainable uptake of proven-effective interventions throughout the community of interest:

• Identification of the population in which the strategies to deliver and scale up proven-effective interventions will be tested;
• Establishment of collaborative relationships;
• Identification of the strategies to be tested during the UH3 implementation phase;
• Conduct of a health needs assessment

Milestones and Transition to UH3 Phase

Delineation of milestones is a key characteristic of this FOA. The application is expected to propose a well-defined set of milestones for the UG3 phase as well as the UH3 phase. A milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Milestones must

be performance-based to enhance the likelihood that the project will be completed on-time and on-budget. It is understood that the proposed milestones for the UH3 phase may be revised as activities in the UG3 phase progress. In the event of an award, the PD/PI and NIH staff will negotiate the final list of milestones for each year of support. At the completion of the UG3 planning phase, the applicant will be required to submit a detailed transition request for the UH3 phase. Satisfactory completion of UG3 milestones will be assessed administratively to determine eligibility to transition to the UH3 implementation phase. The quality of the planning, design, and documentation products for the UH3 phase will be given key consideration when the NIH considers the transition to the UH3 implementation phase. If at any time the project fails to make progress toward meeting milestones (e.g., developing a final protocol and/or manual of procedures including a detailed description of study procedures and process details; completing training of study staff, etc.), the NIH may consider ending support and negotiating an orderly close-out of the award.

Relevant research topics might include, but are not limited to, implementation research that tests:

• Delivery of national hypertension prevention and control programs that target multiple levels, including patients and the community; health care providers and alternate providers (e.g., use of mid-level providers such as community health workers, nurses, pharmacists); and the health care delivery system level within LMICs;
• Optimal use of nurse case managers across low-income countries to deliver evidence-based guidelines for prevention, treatment, and control of hypertension across urban, rural, and low-resource areas aligned with national non-communicable disease programs;
• Implementation of optimal, acceptable, and sustainable strategies for task-shifting and task-sharing of various health care workers, especially within human resource shortage areas (e.g., rural areas) to deliver national policy for clinical and public health interventions within national health care systems across countries within a region;
• Delivery of national hypertension prevention and control policies that identify optimal strategies using mobile health technologies and other informatics-enabled devices (e.g., electronic sliding scales, smartphone apps, etc.) to improve adherence at the level of the patient, provider, and/or health system;
• Implementation of the WHO Best Buys interventions across all levels, and which tests optimal, affordable, and sustainable strategies for delivery of national policy recommendations for hypertension prevention and control;
• The best evidence-based interventions and their potential for adaptation to the communities and contexts in which they will be implemented;
• Known strategies to scale up evidence-based interventions into public health, clinical practice, and/or community settings at a regional or country level. They may include pilots in multiple settings (using a defined scalable unit), in order to identify optimal scale-up approaches;
• Strategies for overcoming barriers to the adoption, adaptation, integration, scale up, and sustainability of evidence-based interventions across different communities and contexts, specifically to address scale up challenges, including complex processes, inefficient use of resources, inequitable allocation of resources, poor uptake of the intervention, and supply and demand barriers to scale up and sustainability;
• Strategies for measuring the unintended consequences of intervening at a system level;
• Relevant and measurable outcomes, including health outcomes, of the implemented interventions, and their success in scale up and sustainability, including measures of health equity and an understanding of how interventions impact populations differentially.

Applications that are not responsive to this FOA and will be returned without review include those that:

• Propose research to be conducted primarily in and/or by the U.S. or other HICs that do not meet eligibility criteria;
• Do not conduct research focused on an aspect of delivering, scaling up, or sustaining proven-effective, evidence-based interventions at the population level for prevention and management of hypertension;
• Propose research on the scale up of hypertension prevention, treatment, or services exclusively for HIV/AIDS populations;
• Do not propose or provide evidence of collaboration among one or more research organizations, one or more LMIC government agencies with a health-related function; and one or more LMIC NGOs and/or health care institutions or systems that provide access to provider and service user viewpoints;
• Propose outdated evidence-based guidelines and/or develop or test new intervention(s) that have not yet been proven to be effective;
• Conduct pre-clinical studies with animals.

1. Eligible Applicants

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)

• U.S. Territory or Possession

• 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)

Eligible organizations must be in a World Bank defined LMIC; those countries designated LMIC prior to January 1, 2011 that have since been re-categorized as high-income by the World Bank; and SIDS.

Given that the GACD expects applicants to apply to research calls from the funding agencies within their own countries, applications from the following GACD member countries are not eligible for this FOA: Canada, United Kingdom, Argentina, Japan, India, Brazil, Australia, Mexico, China, New Zealand, South Africa, Thailand.

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.
  • 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.

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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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)

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

Letter of Intent

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

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

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
Telephone: 301-435-0270
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

The application must contain the following information, according to the instructions below. The information provided here will be considered by reviewers and is meant to supplement, not duplicate, information provided in the Research Plan. The following documents must be uploaded as separate pdf files with the names indicated below.

1. Schedule of Events. The filename "Schedule of Events" should be used to name this attachment.

Provide a schematic, table, or text description of the schedule of events for the execution of the proposed implementation research project, including associated activities expected each quarter of each grant year of the UG3 and UH3 phases of the award.

2. Milestone Plan. The filename "Milestone Plan" should be used to name this attachment. A milestone is defined as: a scheduled event in the project timeline that signifies the completion of a major project stage or activity. The Milestone Plan must describe objective, measurable milestones with separate milestones for the UG3 and UH3 phases. The milestone plan must include clearly stated annual milestones that will be reached at the end of the UG3 planning phase and annual milestones that will be completed during the UH3 implementation phase. The milestone plan should address anticipated challenges to meeting milestones and propose potential mitigation or corrective action strategies.

Milestones may be refined and finalized in consultation with NIH Program Staff at the time of the UG3 phase award and the UH3 phase award, if granted.

• Milestones that may be completed during the UG3 phase include, but are not limited to:
  • Demonstration that the necessary study population is available for appropriate testing of implementation research strategy
  • Collection of any data to determine feasibility of study procedures and establish a timeline for accrual of study participants
  • Finalization of the health needs assessment
  • Finalization of study protocol
  • Acceptance of the protocol by NIH
  • Finalization of study-related documents, including consent/assent documents, that are ready for submission to IRB and/or applicable oversight committees (such as a Data and Safety Monitoring Board)
  • Finalization of the statistical analysis plan
  • Near-final drafts of all documents necessary to implement the study (e.g., Manual of Procedures, study procedure documents for practitioners, study-specific data management plan)
• Milestones that may be completed during the UH3 phase include, but are not limited to:
  • Practitioner skills development
  • Study activation
  • Enrollment of the first patient participant
  • Enrollment and randomization, if applicable, of 25%, 50%, 75% and 100% of the projected study population
  • Retention target for the study population
• Completion of data collection time period
• Completion of primary outcome data analyses
• Reporting of results in ClinicalTrials.gov, if applicable

Provide evidence that the PD(s)/PI(s) and key personnel have:

• The necessary implementation research expertise for the proposed project;
• The expertise and capacity to form a multidisciplinary team that can facilitate collective efforts to determine best ideas or approaches;
• The capacity to foster and coordinate successful collaborations and manage complex projects, which will contribute to the coordinated completion of the milestones, and therefore, the scientific objectives of the program.

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

As a group, awardees will constitute a research alliance for hypertension implementation science research in low-resource settings with capabilities for addressing scale-up of evidence-based interventions at the population level for the prevention and management of hypertension. The GACD will organize and lead the network, arranging cross-project working groups and annual joint meetings that all awardees are expected to attend. Accordingly, applicants must budget for annual costs of having two team members participate in one annual three-day face-to-face meeting of the GACD network for implementation research (international meeting location to vary annually). Attendance at this meeting is required for the PI and another key person from each awardee team, with participants from the LMIC preferred. Teams are also encouraged to include a junior team member in each annual meeting.

Applicants should also budget for the annual costs of the PI and another key person to attend a 3-day workshop held by the NHLBI each year (location to vary annually). For planning purposes, applicants should budget to attend a start-up meeting in the Washington, DC area during year 1 of the grant and an annual meeting (international location to vary annually) in all subsequent years of the award.

If applicable, budgets should include all costs associated with Data Safety and Monitoring Board (DSMB) activities, including preparing reports for the DSMB, meeting reimbursement for DSMB members, and support for at least two DSMB meetings per year, and Clinical Study and Site monitoring. Applicants should assess the need for liability insurance for DSMB members and provide a plan commensurate with the risk of the trial. The budget should include provision for executing the plan proposed. Include a plan for assessing DSMB member conflict of interest, and include associated costs in the budget.

Research Strategy

Applications must address the following:

• Provide a concise description of the aims of the implementation research study to be conducted. Explain how the study addresses a particular aspect of delivering, scaling up, or sustaining one or more evidence-based interventions for prevention and management of hypertension in low- and middle-income countries and small island developing states at the population level. Provide evidence that the proposed research is responsive to local needs, sociocultural and economic contexts, interests, and capacities.
• Propose the use of indicators and measures of project context, reach, outcomes, and scale up potential. The study should also include assessment of implementation costs as an integral part of the proposed research.
• Describe how the study is designed to inform understanding of key mediators/mechanisms of action of the implementation, scale up, or sustainment effort. Note that applicants proposing to conduct a clinical trial under this FOA must adhere to NIH’s requirements for clinical trials research.
• Describe how the study is designed to take into consideration relevant gender and cultural aspects, as well as vulnerable populations.
• Provide a description of how the project is designed to promote a culture of evidence-informed learning and effective uptake of results by embedding real time monitoring/evaluation throughout the intervention selection and scale up process.
• Incorporate considerations for capacity building for implementation science and knowledge translation, particularly within the countries and across the regions where the research will be conducted.
• Describe how suitable management and government structures will be established to ensure relevant stakeholders are appropriately engaged throughout the research.
• Describe how the proposed research will fully consider ethical issues (e.g., related to research with populations in vulnerable circumstances; potential harmful or inequitable impacts of research outcomes; and appropriate mechanisms for protection of sensitive data while enabling data sharing for research purposes).
• Ensure conflicts of interest are appropriately minimized or managed to protect the scientific integrity and credibility of the research and fulfill ethical obligations to research participants, particularly in situations where interventions are supported by the private sector and/or there is the potential for commercial gains.

UG3 Planning Phase

• Describe activities to take place during the planning period, including a local needs assessment.
• Describe the process of protocol development, including developing collaborations and refining the protocol based on results of the planning period activities.
• Outline the proposed implementation framework that will be employed in the research and its potential to improve hypertension scale up.
• Describe establishment of successful partnerships with various stakeholders.
• Document the ability to recruit and engage a sufficient pool of eligible participants

Implementation Strategies

• Identify the implementation strategies that will be tested during the UH3 phase. Discuss how the proposed implementation strategy represents an improvement over currently used strategies and/or standards of care.
• Describe the conceptual framework of the proposed implementation strategy.
• Specify how the proposed implementation strategy will be adaptable and responsive to the context and account for cultural and organizational factors.
• Identify key implementation facilitators and barriers that could affect the adoption, adaptation, integration, scale up and future sustainability of the implementation strategy.
• Describe plans to consider contextually-relevant implementation elements such as workflow impact, process adjustments, and mitigation strategies
• Clearly describe the expected primary outcomes of the implementation strategy. Describe plans for data collection, sources of data values, addressing missing data, data analysis, and evaluating and documenting outcomes. Validated outcomes are expected to include process-focused measures such as acceptability, uptake and adoption, affordability, appropriateness and feasibility, costs, fidelity, penetrance, and sustainability.
• Describe plans to document and evaluate the quality and delivery of the implementation strategy
• Discuss the potential challenges in preparing and implementing the research protocol and how these will be addressed

UH3 Implementation Phase

• Describe plans to test the implementation strategies for the identified evidence-based intervention(s).
• Provide a detailed plan to assess the consistency and quality of targeted adoption and scale up of the interventions, organizational characteristics most likely to impact fidelity, and contextual factors likely to impact intervention sustainability (positively or adversely).
• Describe plans for assessment of project implementation costs.
• Describe plans for optimizing sustainability of the implementation beyond the funded project period.
• Describe plans for maximizing external validity such as generalizability, feasibility, and sustainability of findings across health care settings, patient populations, and community settings.

Investigators

Without repeating information from the individual biosketches, describe how the expertise and experience of the investigator team will be leveraged, organized, and managed to meet the objectives of the proposed project. Address the management and coordination of efforts. Identify the collaborative process for engagement and involvement of stakeholders to participate fully in all phases of the implementation strategy, including design, deployment, testing, and reporting of results.

Letters of Support

To be considered complete, applications must include letter(s) of support from collaborating partners, and/or other organization(s) indicating their relevant expertise and commitment to participate. Applications without the required letter(s) of support will returned without review.

If partial funding is to be provided by sources other than NIH, provide letter(s) of support from the source(s) signed by an authorized representative.

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Where applicable, the awardee will work with GACD, the NHLBI, and/or other suitable NIH ICOs on efforts to harmonize data and use common data standards and elements across funded research sites. For instance, NHLBI can partner with the PD(s)/PI(s) to prepare a dataset and documentation for submission to the Biological Specimen and Data Repository Information Coordinating Center (BioLINCC) as described in the NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies and the Guidelines for NHLBI Data Set Preparation. BioLINCC or another mutually agreed upon NIH-based data repository may be used for the wide sharing of study data to enable public access to data.

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.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

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

Applications from foreign organizations must:

• Request budgets in U.S. dollars.
• Contain detailed budgets. See NOT-OD-06-096.

In addition, for applications from foreign organizations:

• Charge back of customs and import fees is not allowed.
• Funds for up to 8% Facilities and Administrative (F&A) costs (excluding equipment and subawards in excess of $25K) may be requested. See https://grants.nih.gov/grants/policy/nihgps/HTML5/section_16/16.6_allowable_and_unallowable_costs.htm
• Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards.
• Organizations must comply with Federal/NIH biosafety and biosecurity regulations.

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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.

7. Other Submission Requirements and Information

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.

1. Criteria

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 interventions 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.

For this particular announcement, note the following:

The UG3/UH3 phased innovation cooperative agreement supports investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research. A UG3/UH3 grant application need not have preliminary data, extensive background material or preliminary information; however, they may be included if available. Reviewers will assign a single impact score for the entire application, which includes both the UG3 and UH3 phases.

Significance

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?

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?

Specific to this FOA:

• Is the proposed research scientifically compelling, and does it leverage existing programs and platforms, if relevant?
• How fitting is the conceptual framework underlying the proposed implementation research?
• What is the likelihood that successful project implementation will lead to a significantly new understanding that is relevant for scientists and knowledge users?
• How will successful completion of project aims impact potential scientific, technical, and/or organizational challenges and system barriers (health care and other sectors) to implementation of the interventions which drive this field?
• How do the proposed intervention strategies demonstrate relevance to the socio-political, cultural, policy, and economic contexts of the study settings and understanding of the contextual factors affecting implementation?
• Is the proposed research aligned with international, regional, and/or national commitments?
• What is the potential for sustaining the proposed intervention at scale and for translating findings into different settings?

Investigator(s)

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?

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?

Specific to this FOA:

• How strong are the implementation research expertise and capacity of the PD(s)/PI(s) and Key Personnel to foster and coordinate collaborations to test implementation strategies?
• Does the research team demonstrate a high-quality track record in evaluative science as well as fields relevant for the effective implementation of the proposed research?
• How effectively does the application demonstrate that key stakeholders have been actively involved in informing the proposed research, including in the selection and adaptation of the intervention and the research design?

Innovation

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?

Approach

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?

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?

Specific to this FOA:

• To what extent will the proposed plans have the potential to optimize sustainability of the implementation delivery strategy beyond the funded project period?
• What is the quality of the capacity-building skills development plan?
• Is the design of the UG3 phase likely to enable the intervention delivery strategy to appropriately move forward to the larger UH3 phase?
• How appropriate is the plan for dissemination of findings to regional partners?

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?

Environment

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?

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?

Specific to this FOA

• How well does the environment support timely completion of both the UG3 and UH3 phases?
• To what extent will the plans for developing partnerships with stakeholders contribute to adequately testing the implementation strategy?

Study Timelines

In addition, for applications involving clinical trial:?

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)?

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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.

Vertebrate Animals

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.

Biohazards

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.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Applications from Foreign Organizations

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.

Select Agent Research

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).

Resource Sharing Plans

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).

Authentication of Key Biological and/or Chemical Resources:

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.

Budget and Period of Support

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

2. Review and Selection Process

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.

• 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.

• 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.

3. Anticipated Announcement and Award Dates

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

1. Award Notices

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.

Specific to applications proposing clinical trials

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/

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

2. Administrative and National Policy Requirements

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see 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.htmlhttps://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.

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 HHS grant administration regulations at 45 CFR Part 75 and other HHS 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.

2.A.1. Awardee and Principal Investigator Rights and Responsibilities

The PD(s)/PI(s) will have the primary responsibility for defining the research objectives, approaches, and details of the research within the guidelines of the FOA and retain primary responsibility for the performance of all UG3/UH3 supported research activities. The PD/PI will be responsible for:

• Planning, directing, and executing the proposed research activities, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators;
• Assuring compliance with applicable federal, state, and local regulations;
• Assuring compliance with all applicable DHHS/NIH policies for conduct of research and clinical trials.

PD(s)/PI(s) agree to participate in the cooperative research program, including serving on the Steering Committee, participating in Steering Committee meetings and teleconferences, adhering to Steering Committee policies and decisions, attending an annual GACD-organized meeting or workshop, attending an annual NHLBI-organized research consortium meeting, and accepting the close coordination, cooperation, participation and assistance of NIH staff in accordance with the guidelines described in Section VI.2.A. Cooperative Agreement Terms and Conditions of Award: NIH Responsibilities.

All awardees proposing clinical research must comply with federal, state, and local regulations regarding clinical research and monitoring of clinical trials and oversee that all training requirements for the protection of human subject are in compliance.

The PD/PI will ensure that on-site administrative structure, scientific capacity, and training are available to enable the research team, including local research investigators and partners, to perform the research activities proposed in this grant application.

The PD/PI will ensure that research and research capacity-building activities conducted under this cooperative agreement employ an approach that identifies optimal and sustainable strategies to deliver proven-effective interventions into routine clinical and public health practice and community-based settings to achieve maximal population health impact. The PDs/PIs will provide a process for assessing ongoing research and research capacity building projects and modifying, redirecting, and/or curtailing ongoing research activities to reflect local changes/shifts based on emerging needs or changing epidemiological conditions.

The PD/PI will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this cooperative agreement. Manuscripts shall be submitted to the NIH Program Official within two weeks of acceptance for publication and must comply with the NIH Public Access Policy. Publications or oral presentations of work performed under this cooperative agreement will require appropriate acknowledgement of NIH support. Timely publication of major findings is encouraged.

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.

2.A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. The role of the NIH Project Scientist will be to facilitate and not to direct the activities. It is anticipated that the NIH Project Scientist will offer advisory input. The NIH Project Scientist will facilitate liaison activities for partnerships and aid with access to NIH-supported resources and services. Other appropriate NIH program staff assistance will be coordinated by the NIH Project Scientist, which may include Medical Officer(s), clinical operations and regulatory specialists, biostatisticians, and other expertise as required. The NIH Project Scientist, with support of the appropriate staff and expertise, may provide coordination and assistance to the awardees to meet the requirements for clinical protocol content and conduct. The NIH Project Scientist with substantial programmatic involvement may:

• Provide guidance and support in the design of the research activities
• Serve as a resource for protocol design and development
• Provide programmatic support during the accomplishment of the research
• Advise in the selection of sources or resources
• Advise in management and technical performance
• Participate in scheduled meetings and teleconferences to discuss program coordination and/or progress
• Coordinate and facilitate the interactions among the awardees
• Participate as a voting member in Steering Committee meetings
• Facilitate collaboration with other NIH-supported research resources
• Serve as a resource for all major transitional changes that the awardees might propose (e.g., a change in partnership organization) and advise on their appropriateness prior to implementation to assure consistency with the goals of this FOA
• Assist in avoiding unwarranted duplication of effort with other NIH efforts
• Provide technical assistance and advice to the awardees as appropriate
• Interact with the PDs/PIs on a regular basis to monitor progress. Monitoring may include regular communication with the PDs/PIs and study staff, periodic site visits for discussion with the awardee research team, observation of field data collection and management techniques, fiscal reviews, and other relevant stewardship matters.
• Make recommendations for continued funding based on (a) overall research progress; (b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or (c) maintenance of high quality research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements.

A network Scientific Advisory Group (NSAG) may be appointed and supported by NIH to review the progress and provide scientific advice for the intersecting and joint activities of all grants that receive funding under this FOA. The NSAG will be comprised of no more than seven federal and non-federal experts selected by the NIH to participate in NSAG activities in an advisory capacity, when appropriate. When convened, the NSAG will meet at the annual meeting of awardees.

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. The agency Program Official or IC Program Director will conduct at least two administrative reviews to determine progress toward achievement of milestones included in the mutually-agreed upon milestone plan, one toward the end of the UG3 phase, and one within the first two years of the UH3 phase. If the milestones have not been satisfactorily met, subsequent funding years may not be approved. NIH reserves the right to phase-out or curtail the study (or an individual award) in the event of (a) failure to develop or implement a mutually agreeable protocol, (b) substantial shortfall in subject recruitment milestones, core milestones mutually agreed upon by the recipient organization and PD/PI and the NIH, consortium participation and collaboration with other awardees, (c) substantive changes in the agreed-upon methodologies and tools with which NIH cannot concur, (d) human subject ethical issues that may dictate a premature termination, or (e) results that substantially diminish the scientific value of study continuation.

2.A.3. Collaborative Responsibilities

A Steering Committee (SC) will serve as the governing board for awardees. All participants in the program are bound by the policies and procedures developed by the SC; adoption of such policies and procedures requires a majority vote. Awardees under this FOA will be required to accept and implement policies approved by the SC. Membership on the SC will include the PI of each award, or a designated representative in the case of a Multiple PI award. Each member will have one vote. The NIH Project Scientist will be a voting member of the SC. The chair will be chosen by a majority vote of the SC, with years of service as chair determined by the committee. The chair is responsible for preparing meeting agendas, for scheduling and chairing meetings, and for preparing concise minutes which will be delivered to SC members within 21 days of the meeting. Virtual meetings are appropriate. The NIH Project Scientist may not serve as Chair of the SC.

Steering Committee responsibilities will include:

• Evaluating, reviewing, and recommending new collaborations and resource allocations for projects across awardees
• Coordinating research sharing among awardees (e.g., measures, consultations with staff across awardees)
• Developing and conducting shared protocols, when appropriate
• Jointly developing appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data
• Cooperating to ensure the timely and broad dissemination of lessons learned to inform researchers and health care systems engaged in scaling up evidence-based interventions at the population level for prevention and management of hypertension in low- and middle-income countries and small island developing states.

2.A.4. Dispute Resolution Process

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: 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.

3. Reporting

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.

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LeShawndra N. Price, Ph.D.
National Heart, Lung, and Blood Institute
Telephone: 301-496-1051
Email: lprice@mail.nih.gov

Claudia Moy, Ph.D.
National Institute of Neurological Disease and Stroke
Phone: 301-496-9135
Email:moyc@ninds.nih.gov? ?

Seetha Bhagavan, Ph.D.
Center for Scientific Review
Telephone: 301-237-9838
Email:bhagavas@csr.nih.gov

Nina Hall
National Heart, Lung, and Blood Institute
Telephone: 301-827-2393
Email:hallnn@mail.nih.gov?

Tijuanna Decoster, Ph.D.
Chief, Grants Management Branch
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-9231
Email: decostert@mail.nih.gov