Part 1. Overview Information

Key Dates

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 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) seeks applications for a Research Coordinating Center (RCC) that will support the associated FOA, "Heart, Lung, and Blood Co-morbiditieS Implementation Models in People Living with HIV (HLB SIMPLe)" UG3/UH3 phased cooperative agreements (see RFA-HL-20-025) that propose to optimally and sustainably address late-stage implementation research questions to address the delivery of proven-effective prevention and treatment interventions for heart, lung, blood, and sleep (HLBS) comorbid diseases and disorders in people living with HIV (PLHIV) in World Bank designated low- and middle-income countries (LMICs) and Small Island Developing States (SIDS). Throughout the remainder of 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. For the purposes of this FOA, late-stage (T4) implementation research is defined as research to identify strategies to achieve sustainable uptake of proven-effective interventions in routine clinical, public health, and community-based settings and maximize the positive impact on population health. The RCC will coordinate the collaborative efforts of the global alliance of funded UG3/UH3 phased cooperative agreements conducting late-stage implementation research within the following geographical regions: East Asia and the Pacific, Europe and Central Asia, Latin America and the Caribbean, Middle East and North Africa, South Asia, and Sub-Saharan Africa. The HLB SIMPLe RCC will serve as the central hub for coordination and management of all HLB SIMPLe alliance activities.

Background

Globally, an estimated 36.9 million people were living with HIV in 2017. New infections are decreasing worldwide and deaths due to AIDS have also decreased. HIV/AIDS, however, will remain among the top five leading causes of death in low- and middle-income countries (LMICs) for the foreseeable future. With a call to end the global AIDS epidemic by the year 2030, WHO, UNAIDS, PEPFAR and others have called for an increase in the number of persons on antiretroviral therapy (ART) to combat the disease. There is now a push for rapid scale-up of ART utilization in LMICs, and over 70% of the adult population with known HIV status in these countries could be on ART as early as 2020. While this treatment is vital for proper management of HIV symptoms and complications, transmission ability, and viral progression, ART has been shown to increase the risk of heart failure and other cardiopulmonary conditions in high-income countries (HICs). The early appearance of chronic heart, lung, blood, and sleep (HLBS) comorbid disorders in PLHIV in HICs suggests similar HLBS comorbid complications will occur in LMICs and low-resource settings as ART uptake increases, especially as ART-related viral suppression continues to drive a significant increase in the average lifespan of PLHIV around the world. In comparison to those without HIV, PLHIV have a higher prevalence of smoking, and thus the occurrence of pulmonary complications such as COPD and other pulmonary conditions are also increased. Sleep disturbances are also prevalent in PLHIV, along with the increased risk for other comorbid disorders such as stroke, and diabetes. There is a need to strengthen the evidence base on implementation of scalable interventions that have proven effectiveness to promote HLBS health management in PLHIV in LMICs, identify individuals in need of care early in the disease process, intervene early to preempt disease progression, and treat and manage illness and care in these individuals while considering the varying needs of different population groups across the life course. As global health paradigms continue to transition from acute to chronic treatment, integration of care and person-centered care is of increasing interest for creating sustainable health systems, especially with regard to HLBS comorbid care in PLHIV in LMICs. Further opportunities for decreasing siloes between the non-communicable disease (NCD) and infectious disease communities are vital as the burden of NCDs rises disproportionately in LMICs. This requires diverse scientific communities to work closely together and learn new skills across platforms, disciplines, countries, and regions to address integrated health needs.

Additionally, implementation research is a vital component of the evolving healthcare paradigm in LMICs for effective, sustainable, contextualized treatment of comorbid diseases. Implementation research evaluates salient research outcomes for evidence-based interventions including acceptability, affordability, and appropriateness of interventions, including feasibility, fidelity, penetration, and sustainability of the intervention in specific contexts. Proven-effective interventions and guidelines exist for HLBS diseases and disorders for PLHIV, (e.g., using chronic care models to manage patients, treating and controlling hypertension, smoking cessation). However, globally these interventions have not been fully implemented and/or scaled up due to a multitude of factors. Because of the earlier and more pronounced onset of non-communicable diseases (NCDs) increasingly being seen in PLHIV, the HIV population presents an ideal opportunity to gain an understanding of how to promote sustainable uptake of proven interventions and integrated care programs that could then be translated to broader populations, including non-HIV populations with NCDs. In addition, the ongoing, highly visible, and widely supported international efforts (e.g., PEPFAR, UNAIDS, WHO’s HIV program, etc.) to rapidly scale-up adequate treatment for PLHIV present a unique opportunity for large-scale, multi-site, multidisciplinary collaborations and integrated care networks to more sustainably address management of HLBS and comorbid chronic illnesses in PLHIV.

Description of Activities

The HLB SIMPLe RCC will provide crucial leadership for the HLB SIMPLe global research alliance and coordinate activities including, but not limited to, in-person and virtual Network Steering Committee meetings, subcommittee meetings, and working groups; promote collaboration and communication among investigators and the broader research community; coordinate alliance outreach activities; coordinate joint research and capacity building efforts conducted across the HLB SIMPLe alliance; and organize, implement, and manage a global implementation research data safety and monitoring board (DSMB). These alliance leadership efforts are also meant to drive a concerted approach to global information sharing, assessment of contextualized needs associated with HLBS/HIV integrated care in LMICs, and facilitation of strategic thinking and action across the alliance for overcoming barriers to implementation and sustainability. As such, NHLBI expects that applications will describe the organization and management of the RCC and infrastructure for overall HLB SIMPLe coordination, research project and data coordination, and joint alliance efforts regarding late-stage (T4) implementation research and research capacity building efforts, especially with regard to integrated HIV/HLBS prevention, care, and treatment.

Specific activities of the HLB SIMPLe RCC will include, but are not limited to:

Organization and Management

• Coordination and project management for the administrative, research and data coordinating, and research capacity building functions
• Providing organizational and administrative structure conducive to ensuring collaboration and interaction among all HLB SIMPLe projects and awardees
• Providing administrative support for all HLB SIMPLe alliance activities such as scheduling and hosting teleconferences, web meetings, face-to-face meetings, and monthly conference calls of the Steering Committee
• Coordinating Steering Committee (SC), ad hoc and advisory committees, subcommittees, and working groups as needed, including, but not limited to, organizing teleconferences and face-to-face meetings, and maintaining documentation such as meeting minutes
• Preparing reports including, but not limited to, an annual consortium report for NIH and other funding or regulatory agencies, and other materials as requested by NHLBI staff
• Coordinating and enhancing communication, marketing, and outreach of the HLB SIMPLe activities and disseminating research findings. Such activities may include organizing sessions at scientific meetings, public lectures, and managing the Network's social media presence
• Developing and maintaining a secure, 508-compliant website that will be the main entry point for resource and information sharing related to HLB SIMPLe activities. The website will include public-facing content and the newsletter, as well as a portal reserved for awardees, NIH staff, and authorized users, designed to promote sharing of information, expertise, technology development, or other areas of common interest
• Working with NHLBI staff to organize and coordinate the alliance start-up meeting in the first year of the award in the Washington, DC, USA area at a location determined by NHLBI staff
• Working with NHLBI staff and alliance planning committees to plan and execute 3-day in-person annual meetings with HLB SIMPLe network investigators, held in HLB SIMPLe awardee countries; these meetings are intended to identify areas of collaboration amongst awardees and will include a focus on determining how the expertise, facilities, and other resources of the awardees and their collaborators can contribute to ongoing or new projects, data sharing, and identifying opportunities for joint research involving awardees. Investigators will also be expected to present their scientific progress and future plans. Payment for facilities and logistical costs of annual meetings will be the responsibility of the RCC
• Broadening communications among HLB SIMPLe investigators and other NIH implementation science- and global health-related researchers to enhance cross-disciplinary collaborations relevant to the HLB SIMPLe goals, including expanding the scope of the annual alliance meetings, developing and supporting new meetings on specific cross-disciplinary research topics, enhancing virtual communications and information sharing, sharing lessons learned about research facilitators and barriers, leveraging capacity building resources, and spurring interdisciplinary/cross-disciplinary research

Research and Data Coordination

• Facilitating collaboration and resource sharing within the HLB SIMPLe alliance and disseminating research resources (e.g., measurement instruments and procedures, protocols, statistical analysis tools, algorithms, study design resources, recruitment techniques, and study forms and templates) to the broader scientific community
• Working closely with HLB SIMPLe investigators and NHLBI staff to ensure that all data, publications, or products generated by HLB SIMPLe investigators are deposited in a timely manner and made accessible through the HLB SIMPLe web portal and/or through other portals such as the NIH Data Commons, consistent with NIH and NHLBI data sharing policies and policies of the HLB SIMPLe Network
• Developing common data elements, data and metadata standards, and data collection processes for research across HLB SIMPLe awardees
• Conducting statistical analyses and assisting with the development and harmonization/standardization of data across research sites in support of consortium-wide data analysis
• Providing oversight, coordination, and support (including robust biostatistical support) to HLB SIMPLe awardees and other NHLBI global efforts, as appropriate, through administration of a Data and Safety Monitoring Board (DSMB). The RCC will coordinate with NHLBI for the selection of DSMB board members that represent technical experts in HLBS diseases and disorders, HIV/AIDS, T4 implementation research, global health, biostatistics, etc.; protocol and consent review; oversight of regulatory reviews and approval processes; monitoring adherence to good clinical practice standards, study protocols, and adverse events reporting; and monitoring enrollment and data integrity
• Conducting clinical site and study monitoring for HLB SIMPLe awardees to ensure compliance with U.S. and country-specific regulatory requirements and guidelines (i.e., monitoring visits, development and implementation of QA/QC plan, providing regular GCP training to awardees, implementing training activities for all staff)
• Assisting the development of IRB applications and/or coordinating IRB approvals
• Developing and providing additional personnel and resources to enhance the conduct of research of individual HLB SIMPLe awardees and/or support of novel cross-awardee collaborations through multisite studies. The RCC may provide limited funds to sites to support pilot studies or other research projects. The responsibility for conduct and oversight of such projects remains with the recipient awardee(s) consistent with NHLBI and NIH policies

Research Skills Development and Capacity Building

• Assisting research sites with implementing skills development and capacity-building programs to prepare early-stage and more established researchers to transition to T4 implementation research, assisting with the development of appropriate mathematical modeling skills and integrated care skills, and bridging research and practice in real-world settings, with a focus on HLBS diseases and conditions
• Assisting research sites with leveraging currently available resources to expedite and standardize capacity building efforts
• Coordinating efforts among HLB SIMPLe awardees and partners to develop sustainable research capacity by establishing and maintaining diverse opportunities for researchers at different career stages and professions (e.g., academia, community health workers, Ministries of Health staff, etc.)
• In collaboration with NHLBI staff and HLB SIMPLe awardee investigators, organizing and conducting a yearly conference (in conjunction with the annual alliance meeting) to address timely challenges and opportunities for advancing implementation research in LMICs
• Serving as a clearinghouse for educational opportunities, online resources for global implementation science and interdisciplinary research, the exchange of experiences among developing investigators at all awardee sites, and developing an online mentoring network

It is anticipated that an HLB SIMPLe alliance meeting in an HLB SIMPLe awardee country will be held annually (country to be determined) and will include representatives from all awardees, scientific experts, appropriate NHLBI staff, and awardees from other NIH implementation science and global health research programs, as applicable. These meetings are intended to identify areas of collaboration amongst awardees. The focus of the meetings will include, but will not be limited to determining how the expertise, facilities, and other resources of the awardees and their collaborators can contribute to ongoing or new projects; sharing of data; and identifying opportunities for research involving awardees. Investigators will also be expected to present their scientific progress and future plans.

Section II. Award Information

Section III. Eligibility Information

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

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.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

Section IV. Application and Submission Information

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
National Heart, Lung, and Blood Institute
Email: [email protected]

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

These additional instructions must also be followed:

Facilities and Other Resources:

Applicants are strongly encouraged to name an experienced, collaborative team with the capabilities needed to carry out all functions of the RCC. The RCC requires a multidisciplinary team and the application should reflect the team's hands-on involvement in RCC functions, including coordination, tracking, logistics and administration, communications, data management (including quality control), data security and IT infrastructure (including development of public and secure project websites), regulatory support, and biostatistical/analytical support, especially regarding facilitation of activities within low-resource settings. Applicants are encouraged to describe any special expertise or unique strengths offered by the team members to the collaborative effort (e.g., experience in clinical trial management, collaborations with industry partners, patient groups, NGOs, or Ministries of Health).

Applications must provide evidence that Senior/Key Personnel have:

• Experience and expertise in relevant areas including T4 implementation research, global health, HLBS-related diseases and disorders, HIV/AIDs, and other expertise in low-resource settings, as well as research planning, project administration, biostatistical oversight, research coordination, implementation, and monitoring;
• Documented experience in project management of consortia related to a recent research project and/or multisite program, with a description of the collaborative leadership structure used.

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

These additional instructions must also be followed:

A detailed budget for the HLB SIMPLe RCC should be presented for activities related to coordinating the HLB SIMPLe program's administration and research site supervision. The budget must reflect all activities delineated in the list of responsibilities included in this FOA. The operational budget must include, but is not limited to the following items:

• Costs for PD(s)/PI(s) supervision of day-to-day operations and oversight of the professional activities of the proposed administrative, data and research coordination, and skills development program;
• Costs of developing and maintaining consortium publicfacing and secure websites;
• Costs for planning and hosting one HLB SIMPLe alliance meeting per year in awardee host countries (for budgeting purposes, assume Zurich, Switzerland, with approximate meeting attendance of 50 delegates);
• In the first year of the award, requested budgets must include funds for travel by the PD/PI and at least two additional key personnel to attend and participate in a start-up meeting in the Washington, DC, USA area at a location determined by NHLBI staff.
• Travel costs for at least three individuals from the RCC (including PD(s)/PI(s) and two additional representatives) to attend the annual alliance meeting in an HLB SIMPLe awardee country to be determined (for budgeting purposes, assume Zurich, Switzerland);
• Costs associated with administering the Data and Safety Monitoring Board (DSMB) and clinical site and study monitoring;
• Associated planning activities; start-up activities; implementation activities; close-out phase activities; participation in investigator meetings, the steering committee or appropriate subcommittees, and other leadership committee functions; and communication, documentation and reporting;
• Costs for monthly consortium-wide teleconferences or webinars;
• Costs associated with securely housing consortium data;
• Subcontracts as necessary.

Specific Aims

Present a clear statement of the ways in which the RCC will contribute to the goals of the HLB SIMPLe program.

Research Strategy

The following instructions differ from the Application Guide and should be followed for this section of the FOA.

A typical research strategy description is not expected as part of this CC application HLB SIMPLe RCC applicants should not propose a research program, because research programs will be proposed through RFA-HL-20-025. Instead, the following items should be addressed by the applicant:

Significance

Explain the purpose and functions of the RCC. Present a clear statement of the way in which the RCC relates to the goals of the HLB SIMPLe program.

Approach, Innovation, and Environment

Applications must describe the following:

• The administration and operation of the RCC
• The types of activities that the RCC will conduct to achieve its goals
• How the proposed activities of the RCC will be evaluated
• Detailed plans for coordinating an alliance of research sites in LMICs that will develop and conduct T4 implementation research to scale up evidence-based interventions for HLBS comorbid diseases and disorders in PLHIV
• SOPs currently in place and planned, including how tasks will be delegated and supervised; how the management team will be directed
• How the management team will communicate among themselves, with the research awardees, and with the steering committee and subcommittees (e.g., clearly describe how interactions and communications between the RCC and the awardees will be managed)
• How the RCC will coordinate broad communication and collaboration across the HLB SIMPLe alliance and with NHLBI
• Plans to organize, implement, and manage a global implementation research DSMB, with all necessary biostatistical support required for properly assessing clinical trials that involve late-stage implementation research
• Plans for ensuring that the RCC personnel possess and/or acquire required skills, as needed
• How the RCC will develop and maintain the public-facing and private website
• Plans for developing and conducting future skills development and research capacity-building activities, including sustainability plans
• Potential problems, alternative strategies, and benchmarks for success
• How the risks associated with the activities of the alliance will be managed
• How the RCC will promote strategies to ensure a robust and unbiased scientific approach across the alliance, as appropriate for the work proposed
• Sufficient infrastructure to implement the proposed research coordinating center within the proposed setting
• The available technical resources and information technology capabilities for housing and securely sharing network resources and/or data, as well as to build and manage the consortium public facing and secure websites
• The timeline of proposed events along with a work-flow plan for management and execution of proposed activities

Letters of Support

Include letters of resource support specific to the RCC, including support provided by the applicant institution and partner organizations that will enhance the potential for success. Examples of such support would include, but are not limited to, institution-funded staff time and effort, donated equipment and space, providing free and open access to tools, web space, databases, workflow processes, logistical resources or other resource investments. Specific and detailed descriptions of these contributions, as well as the assurances that partner organizations are committed to providing these resources to the RCC should be included in this section. Also include individual letters of commitment to the partnership specific to the RCC by all other partners and/or consultants.

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. Applications should address plans to make available within one year of the end of the NHLBI period of support for the project, data not previously released and other materials or products not previously distributed to individuals who are not project investigators in accordance with the NHLBI Data Sharing Policy available at http://www.nhlbi.nih.gov/funding/datasharing.htm.

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.

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.

Section V. Application Review Information

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.

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?

Specific to this FOA:

What unique advantages or capabilities will the proposed RCC bring to the research network? In what ways will the RCC contribute to and enhance the goals of the HLB SIMPLe program? Has the application adequately described how the RCC will serve the community of investigators within and outside of the HLB SIMPLe alliance and the public? What unique advantages or capabilities to the research network will the proposed RCC bring upon successful completion of the aims?

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?

Specific to this FOA:

How well-suited are the PD(s)/PI(s) and other personnel to their roles in the RCC? How appropriate are their experience and training for fulfilling this role? How have the PD(s)/PI(s) demonstrated experience and an ongoing record of accomplishments in managing multidisciplinary, HLBS, T4 implementation, and HIV/AIDS research? Do the investigators demonstrate significant experience with coordinating collaborative, multi-site research networks? If the RCC is multi-PD/PI, how complementary and integrated are the investigators' expertise and skills? How appropriate is the leadership approach of the proposed PD(s)/PI(s), their plans for conflict resolution, and the proposed organizational structure for effective multi-PI management for the RCC? How experienced is/are the applicant(s) in overseeing selection and management of sub-awards, if needed? Is there evidence, or a track record, for successful collaborations or partnerships with the organizations and/or systems proposed in the application? To what extent are the investigators closely partnered with the relevant systems and organizations to develop the necessary support to carry out the proposed activities of the RCC? How well does the application demonstrate that the PD(s)/PI(s) possess experience working productively in collaborative environments and in large, distributed scientific projects?

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?

Specific to this FOA:

How does the applicant propose to utilize novel organizational concepts and management strategies in coordinating the research network that the RCC will serve? How are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? What refinement, improvement, or new application of organizational concepts or management strategies are proposed? How will the RCC employ novel strategies to enhance the work of individual HLB SIMPLe awardees, foster new collaborations within and outside the HLB SIMPLe alliance, and advance the goals of the HLB SIMPLe program?

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?

Specific to this FOA:

How well-reasoned and appropriate are the overall strategy, operational plan, and organizational structure to accomplish the goals of the HLB SIMPLe alliance that the RCC will lead and serve? How will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network as appropriate for the work proposed? How effectively and appropriately are potential problems, alternative strategies, and benchmarks for success presented? Does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network? How appropriate are the proposed timeline and work-flow plan? How well-developed is the proposed plan to develop and sustain a public and internal website? How strong is the plan for communication and collaboration across the HLB SIMPLe program and NHLBI?

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?

Specific to this FOA:

To what extent does the application demonstrate sufficient infrastructure to implement the proposed coordinating center within the proposed setting? How sufficient are the described technical and information technology resources to house and securely share network resources and/or data, as well as build and manage the consortium public facing and secure websites?

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

Not Applicable

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 NHLBI, 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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Heart, Lung, and Blood Advisory Committee (NHLBAC). 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.
• Compliance with resource sharing policies

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information

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.

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 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

• Determining the overall function, scientific and administrative leadership, and objectives of the RCC;
• Developing and implementing a governance structure for the RCC;
• Meeting goals, timelines, and milestones;
• Collaborating with the NIH Program Officer (PO) and Project Scientist (PS) in all aspects of scientific and technical research needed for the management of the RCC;
• Developing and maintaining the HLB SIMPLe website;
• Administering a DSMB and providing overall biostatistical support and clinical study and site monitoring for HLB SIMPLe awardees;
• Assuring compliance with applicable Federal, State, and Local regulations;
• Assuring compliance with all applicable DHHS/NIH/NHLBI policies for conduct of research and clinical trials;
• Participating in all annual meetings, teleconferences, workshops, and working groups. The PD(s)/PI(s) of this award will be required to participate in periodic meetings and conference calls with NIH programmatic staff. Payment for facilities and logistical costs of annual meetings will be the responsibility of the RCC.
• Ensuring that research capacity-building activities conducted under this cooperative agreement employ an approach that supports the translation and uptake of proven-effective interventions to prevent and/or mitigate the impact of HLBS comorbid conditions in HIV/AIDS affected populations in LMICs. The PD/PI will provide a process for assessing ongoing research projects and modifying, redirecting, and/or curtailing ongoing research activities to reflect local changes/shifts based on emerging needs or changing epidemiological conditions within the geographic regions.
• The PD(s)/PI(s) are expected to publish and release publicly and disseminate results, tools, protocols, resources and other products, in accordance with established protocols and governance of the SC. It is expected that all methods, analyses, and data (e.g., software, and algorithms) will be made available in a timely manner to the scientific community.

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 HHS, PHS, and NIH policies. It is expected that all methods, analyses, and data (e.g., software, and algorithms) will be made available in a timely manner to the associated consortium members as well as the scientific community.

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

The NIH Program Scientist (PS) will:

• Provide substantial scientific and programmatic involvement in conduct of the RCC through technical assistance, advice, and coordination;
• Participate in the development and prioritization of activities;
• Provide assistance in coordinating activities with other NIH-supported resources;
• Serve as a voting member of the HLB SIMPLe steering committee;
• Assist in the selection and convening of an NHLBI Data and Safety Monitoring Board, with coordination and management by the HLB SIMPLe RCC;
• skills development and capacity-building resources
• Facilitate interactions with other US Federal resources to expand research and capacity-building, as applicable.

The NIH Program Officer (PO) will:

• Be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice;
• Periodically report progress about HLB SIMPLe to NHLBI and FIC leadership, including the Directors of NHLBI and FIC;
• Provide timely assistance in providing relevant updates, documents, and other materials for the annual progress reports to the NHLBI.

The assigned NIH PO may not also serve as an NIH PS.

The NHLBI reserves the right to withhold funding or curtail CC activity in the event of a substantive change in, or failure to make sufficient progress toward, the agreed-upon work scope with which the NIH cannot concur or when there are ethical issues that may dictate a premature close-out.

Areas of Joint Responsibility include:

• Organizing and coordinating the alliance start-up meeting in the first year of the award in the Washington, DC, USA area at a location determined by NHLBI staff.
• Planning and execution of 3-day in-person annual meetings with HLB SIMPLe alliance investigators, held in HLB SIMPLe awardee countries each year.

2.A.2 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. The three members will be: 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.

Section VII. Agency Contacts

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

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

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

Brad Newsome, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8170
Email: [email protected]

Geetha P. Bansal, PhD
Fogarty International Center (FIC)
Telephone: 301-496-1492
Email: [email protected]

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: [email protected]

Lynn Rundhaugen
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-480-4546
Email: [email protected]

Bruce Butrum
Fogarty International Center (FIC)
Telephone: 301-496-1670
Email:[email protected]

Section VIII. Other Information