Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Recent studies have consistently found a rising burden of chronic non-communicable diseases (NCDs) in low-income countries (LICs) (as defined by the 2016 Country and Lending Groups categories from The World Bank (http://data.worldbank.org/about/country-and-lending-groups)). Although numerous evidence-based effective interventions for NCD prevention and control exist, implementation is challenging leading to underutilization within LICs. This underutilization of evidence-based interventions presents a distinctive opportunity to invest in late-stage translation phase 4 research (T4TR) . T4TR is defined as research to identify implementation strategies to enhance sustainable uptake of proven-effective interventions into routine clinical practice and community-based settings in order to maximize population health impact.

Given the complexities of T4TR, fostering skills development for scientific communities involved in local research in LICs, and providing opportunities to utilize those skills to identify chronic non-communicable heart, lung, blood, and sleep (HLBS) diseases and disorders that will benefit from T4TR efforts are critical.

The purpose of this FOA is to support 1) the creation of robust trans-disciplinary collaborative teams that will undertake the design of plans for skills development for T4TR, 2) systematic local assessments of needs, infrastructure, and capacity for T4TR, 3) local needs assessments for chronic non-communicable HLBS diseases and disorders in LICs, and 4) use of this data to create an actionable and context-specific T4TR research plan for HLBS diseases and disorders. Applications for infectious diseases (e.g., HIV, tuberculosis and malaria) will be considered non-responsive to this FOA.

This FOA encourages applications that provide plans for T4TR skills development for a trans-disciplinary collaborative team. Applications that propose teams that will also complete systematic national or regional (subnational) needs assessments for high-priority HLBS diseases and disorders, including assessment of local infrastructure and systems that can be utilized to facilitate T4TR are strongly encouraged. For this FOA, LICs are defined by 2016 Country and Lending Groups categories from The World Bank. This FOA intends to support applicants from LICs who propose to collaborate with institution(s) in the US or other high income economies on T4TR skills development programs; collaborating institutions will have demonstrated knowledge and expertise in T4TR and will assist LIC institutions in developing the relevant skills for T4TR. Furthermore, this FOA is intended to support applications that propose to form a trans-disciplinary collaborative research team with broad membership from in-country institutions to conduct local needs assessments and create an actionable, context specific T4TR research plan for HLBS diseases and disorders based on the country’s identified disease priorities. Applications that demonstrate the capacity to obtain pertinent T4TR skills development planning from high income country collaborators, undertake local needs assessments, and create a T4TR research plan are of high programmatic interest. Only applications from LIC institutions with collaborations in either/or high income countries and/or other low or middle income countries are encouraged to apply. Applications from high income or middle income countries are not eligbile for the FOA.

The key objectives of this T4TR Capacity Building Initiative in Low Income Countries (TREIN) will include:

• Participation in a collaborative network of LIC grantee teams engaged in a T4TR skills development program, needs assessment, and research plan development;
• Development of formal collaborations with high income country institutions to achieve needed design of plans for a skills development program in T4TR;
• Formation of in-country strategic T4TR collaborations among major in-country academic health centers, public health agencies, Ministry of Health and other local, regional, and national governmental organizations, non-governmental organizations, and community organizations;
• Formation of country- and region-based cadres of skilled T4TR researchers capable of conducting quantitative and qualitative research of local needs and capacity assessments that directly address country-identified HLBS health priorities;
• Identification and prioritization of at least three evidence-based interventions for HLBS diseases and disorders identified as country priorities;
• Creation of an actionable and context specific T4TR research plan for high-priority HLBS diseases and disorders;
• Dissemination of the results of the skills development program and needs assessments.

It is the intention of this FOA that, at the conclusion of the funding period, the grantees will be well-positioned with a comprehensive T4TR plan to deploy and evaluate multifaceted implementation strategies to improve local delivery of evidence-based interventions for high-priority HLBS diseases and disorders.

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

Non-domestic (non-U.S.) Entities (Foreign Institutions)

Only applications from LIC institutions with collaborations in either/or high income countries and/or other low or middle income countries are encouraged to apply. Applications from high income or middle income countries are not eligbile for the FOA.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

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

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

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

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

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

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

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

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 NHLBI 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
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (Express Mail Zip: 20817
Telephone: 301-435-0270
Fax: 301-480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

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

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

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

All instructions in the SF424 (R&R) Application Guide must be followed. The following additional guidance should also be followed.

Low income country institutions where the proposed skills development programming, needs assessment, and dissemination and context specific T4TR research plan will be developed, should have a well-established record of research and skills development activities and faculty qualified in areas such as biomedical, behavioral, clinical, and public health research..

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

Facilities and Other Resources: Applicants must include a brief description of the features of the institutional environment as they are related to T4TR. Describe capacity to design a T4TR skills development program that will maximize the use of both high and low income country research institutional environments, including available facilities and resources. If the research institution has limited capacity for T4TR (e.g., space, equipment, personnel, etc.), applicants must address how the deficiencies in capacity will be mitigated to achieve the goals of this initiative.

All instructions in the SF424 (R&R) Application Guide must be followed. The following additional guidance should also be followed.

Applicants are expected to assemble a collaborative research team whose members have demonstrated experience and expertise in relevant areas including T4TR, global health, HLBS diseases and disorders in low resources settings, as well as research planning, project administration, implementation, and monitoring. Describe commitment to collaborating with other researcher(s) within country, and across low and high income countries. Provide evidence of a track record of strong scientific collaborations.

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

The operational budget including 8% Facilities and Administrative (F&A) costs should include, but not be limited to the following items:

• PD(s)/PI(s) supervision of day to day operations and oversight of the professional activities related to the design of plans for a T4TR skills development program
• Staff training and certification in core T4TR methodology
• Reasonable administrative costs
• Necessary project management costs
• Costs of developing an infrastructure needs assessment document for dissemination purposes
• Costs of developing a disease specific needs assessment document for dissemination purposes
• Subcontracts as necessary
• Awardees of this FOA are required to attend semi-annual meetings to present progress of the implementation of their T4TR skills development program, the needs assessment, and the T4TR study design activities. To maximize the impact and utility of T4TR skills developed under TREIN, awardees are encouraged to interact and collaborate with each other. Periodically, TREIN may organize special workshops as part of or in lieu of a semi-annual project meeting to discuss emerging topics and issues for HLBS in low resource settings that require community engagement and input. Awardees will be expected to participate in these activities. In the application, include travel costs for two persons (including PD(s)/PI(s) or their delegate) to attend program meetings to be held two times a year, in a location to be determined (for budgeting purposes, assume Johannesburg, Republic of South Africa).

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

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

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

Specific Aims: Describe a concise set of specific aims that explain the overall goals and expected outcomes and describe how successful completion of the aims support creation of a trans-disciplinary collaborative team that will undertake skills development, HLBS diseases and disorders needs assessment and infrastructure needs assessment for HLBS T4TR in LICs.

Research Strategy: The Research Strategy should include detailed plans for the design of skills development programming, needs assessments, and generation of a context specific T4 research plan. The research strategy should include plans for the four years described below. After an administrative review by NHLBI staff, awardees that have met the finalized milestones in years 1 and 2 may transition to years 3-4.

1. Design of T4TR Skills Development Program (Year 1)

1A. Planned Skills Development Activities for proposed T4TR Training Program.

Applicants should describe a T4TR skills development program design aimed at enhancing in-country national or regional T4TR capabilities that can address HLBS diseases and disorders. Present well-conceived skills development program plans and include the following information:

• The rationale for designed program activities, identification of specific skill sets needed, and their long-term contribution to T4TR for high priority HLBS diseases and disorders;
• Plans to engage domain experts from high income countries and if applicable, from other low or middle income countries, with T4TR expertise and establish the trans-disciplinary research team;
• Plans to engage external partners (e.g., health care workers, in-country academis health centers staff, members of public health agencies, representatives from the Ministry of Health, and community organizations, etc.);
• Describe the proposed structure, curriculum, operations, and meeting schedule for the targeted trans-disciplinary team; Describe plans to promote knowledge retention and to provide for continuing eduction.
• Long-term sustainability and institutional/governmental commitments to the planned T4TR skills development program;
• Administrative and grants management infrastructure and administrative support personnel.

1B. Planned Participation in Existing Training Programs.

Applicants are encouraged to take advantage of including current programs that are supported by other NIH entities, as well as other agencies and societies, in their design plans for T4TR skills development.

Some examples are below. Applicants should briefly describe any intent in this regard and identify which programs will be pursued.

• Medical Education Partnership Initiative (MEPI): http://www.fic.nih.gov/programs/pages/medical-education-africa.aspx. Where possible, applicants are encouraged to collaborate with MEPI grantees in order to take advantage of the training infrastructure and opportunities available through MEPI.
• Fogarty Emerging Global Leader Award: http://www.fic.nih.gov/Programs/Pages/emerging-global-leader.aspx. This program provides supportive mentorship, research opportunities, and a collaborative research environment for early stage investigators from low- and middle-income countries to enhance their global health research expertise and careers. When possible, applicant(s) are encouraged to collaborate with this program.
• H3Africa: http://h3africa.org/. The objective of the H3Africa Initiative is to enhance the capability of African scientists and research institutions to use genomics and other powerful new approaches to address problems of African health and disease. When possible, applicant(s) are encouraged to collaborate with this program.

2. Needs Assessment (Years 2-3)
2A. Needs Assessment Phase I (Year 2). Discuss how a needs assessment for infrastructure will be conducted with in-country partners including Ministry of Health (or equivalent) and local governmental and non-governmental entities. Describe plans for how the following information will be identifed, obtained, assessed, and/or utilized:

• How the applicant(s) would propose to identify the current infrastructure needs for T4TR;
• How the applicant(s) could address deficiencies in infrastructure needed to conduct T4TR;
• Foster partnerships with other external partners;
• Describe the long-term sustainability and institutional/governmental commitments to improving the infrastructure for HLBS-related T4TR;
• Engage in knowledge dissemination efforts for other researchers in low or lower middle income countries

2B. Needs Assessment Phase II (Year 3) for chronic, non-communicable HLBS diseases and disorders. Discuss how a needs assessment for HLBS diseases and disorders will be conducted with in-country partners including Ministry of Health and local or regional governmental and non-governmental entities. Describe plans for how the following information will be identified, obtained, assessed, and/or utilized:

• Current national and regional disease burden and needs for T4TR for HLBS diseases and disorders;
• Existing infrastructure and resources (including health care workers, in-country academic health centers staff, members of public health agencies, collaborations with the Ministry of Health, and community organizations, etc.) to address the local HLBS priorities;
• Identify three intervention strategies for HLBS diseases and disorders and develop context-specific T4TR plans;
• How the applicant(s) will address the deficiencies in infrastructure needed to conduct T4TR for the three evidence-based interventions in a context specific manner;
• Engage in knowledge dissemination efforts for other researchers in low or lower middle income countries

3. Create comprehensive, actionable, and context specific T4TR research plan for HLBS diseases and disorders (Year 4). Discuss how the proposed skills development program and needs assessment activities will be used to facilitate T4TR at the country or regional level. Because the actual research plan will be dependent upon the findings of the to-be-conducted needs assessment, the applicant should submit a research strategy that describes the ways in which the needs assessments and skills development will be utilized. Present an example case that demonstrates how T4TR methodology could be applied to a potential local HLBS priority. The example should describe how a particular evidence-based intervention could be utilized in a T4TR framework to address the HLBS disease burden by incorporating local partners (sites, health care workers, agency representatives) and infrastructure. Applicants should also discuss planned dissemination activities to share the T4TR research plan.

4. Milestones and Metrics:

Applications should include a well-defined set of yearly milestones for the activities proposed in numbers 1, 2 and 3 of the Research Strategy. The milestones from years 1 and 2 will be used as the the metrics to determine the transition to years 3-4. Milestones should conform to the timeline described below and the proposed Research Strategy.

Year 1: Development Phase: Establish T4TR Skills Development Program Plan and establish Trans-disciplinary Collaborations

Years 2: Needs Assessment Phase I - Initiate planned needs assessment for infrastructure and begin planned needs assessment for HLBS diseases and disorders

Year 3: Needs Assessment Phase II - Fully initiate needs assessment for HLBS diseases and disorders

Year 4: Dissemination and context-specific T4TR research plan

Milestones will be finalized prior to award and subsequently incorporated into the Notice of Award.

Letters of Support: Applicants must include letters of support that cite past collaborations and working relationships from collaborators including those from major in-country academic health centers, public health agencies, Ministry of Health and/or governmental and non-governmental entities, and community organizations in LICs. Applicants must also obtain letters from collaborators from institutions in high income countries that will lead and facilitate the T4TR skills development and delivery of research methods needed to conduct T4TR. Letters should clearly demonstrate commitment to the proposed interaction/collaboration and describe how the proposed collaboration will benefit the applicant(s)' T4TR research program.

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

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Applicants are expected to include a brief description (no more than 2 pages) of planned dissemination activities to share the T4TR research plan and the results of research once conducted. Describe how collaborations with stakeholders will be utilized for dissemination activities.
• Describe plans to to allow stakeholders to access the data collected, it is expected that appropriate preparation must be made to disseminate this information via internet, academic publications, publications from Ministry of Health, and other national, international and/or local partners. A website will be established based on guidelines from the SC. This website will be updated twice per year or as needed.
• One of the goals of TREIN is to establish a repository of T4TR needs assessments in LIC, T4TR study data, and dissemination plans for T4TR in low resource settings. Furthermore, the results of the needs assessment and dissemination plan will produce knowledge helpful to other entities that might want to undertake T4TR within their local context. Funded individual projects are expected to deposit their outputs including source data, tools, materials, and documents into the T4TR repository, allowing centralized access and dissemination, consistent with achieving the goals of this program.

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

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

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

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

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

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

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

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

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

Specific to this FOA: How will successful completion of the aims support creation of a trans-disciplinary collaborative team that will undertake skills development, HLBS diseases and disorders needs assessment and infrastructure needs assessment for HLBS T4TR in LICs?

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

Specific to this FOA: How strongly have the applicant(s) demonstrated a commitment to collaborating with other researcher(s) within country, and across low and high income countries? Have the applicant(s) demonstrated a track record of strong scientific collaborations?

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

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

Specific to this FOA: How well have the applicant(s) described their plans for developing skills in T4TR? Are the overall strategy and methodology well-reasoned and appropriate to ensure a feasible program for T4TR skills development with linkages to high income countries and also when appropriate with other LICs?

To what extent have the applicant(s) developed a timeline for skills development that allows for knowledge retention? How well are the applicant(s) prepared to engage/involve other collaborators including but not limited to health care workers, in-country academic health centers staff, members of public health agencies, representatives from the Ministry of Health, and/or other governmental and non-governmental entities and community organizations, etc. in skills development for T4TR?

How well have the applicant(s) described the proposed structure, curriculum, operations, and meeting schedule for the targeted trans-disciplinary team?

How well have the applicant(s) described how the needs assessment for infrastructure will be conducted with in-country partners including the Ministry of Health and local or regional governmental and non-governmental entities? Have the applicants adequately addressed deficiencies in infrastructure needed to conduct T4TR?

How well have the applicant(s) described the needs assessment for HLBS diseases and disorders? How strong is the focus on leveraging collaborations with in-country partners including the Ministry of Health and local or regional governmental and non-governmental entities to conduct the needs assessment?

How well have the applicant(s) described how they will identify the current in-country or regional high-priority HLBS diseases and disorders and needs for T4TR?

To what extent have the applicant(s) described how they will create a comprehensive, actionable, and context specific T4TR research plan for HLBS diseases and disorders? Have the applicant(s) discussed how the skills development activities and needs assessment activities will be used to facilitate T4TR at the country or regional level?

How feasible are the applicant(s)' proposed achievable milestones?

How well have the applicant(s) described their dissemination plans for the infrastructure and chronic HLBS diseases and disorders needs assessments? Are the overall strategies well-reasoned with appropriate timelines to ensure timely execution of dissemination activities in LICs? How strong is the focus on leveraging collaborations with stakeholders for dissemination activities?

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

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

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

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

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

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not Applicable

Not Applicable

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

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

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Heart, Lung, and Blood Institute, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Heart, Lung, and Blood Advisory Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

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 2 CFR 200, and other HHS, PHS, and NIH grant administration policies.

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

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

The PD(s)/PI(s) will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted under this program. The PD(s)/PI(s) assume responsibility and accountability to the applicant organization officials and to the NHLBI for the performance and proper conduct of the research supported by the U24 award. Specific responsibilities include:

• The PD(s)/PI(s) will implement procedures for T4TR skills development, needs assessment for both disease control and infrastructure, and creation of comprehensive, actionable, and context specific T4TR research plan for HLBS conditions from identified priorities via the needs assessment.
• The PD(s)/PI(s) will be actively engaged in skills development for T4TR by collaborating with institutions in high income countries to develop the necessary domain expertise. Furthermore, the PI will also provide outreach activities targeting the larger in-country and regional partners to develop skills for T4TR. These partners will include but will not be limited to major in-country academic, health centers, public health agencies, Ministry of Health, and community organizations in LICs and other regional collaborators without the necessary T4TR skill sets.
• The PD(s)/PI(s) or their delegates will participate in all annual meetings, workshops, andworking groups.
• The PD(s)/PI(s) will agree to accept close coordination, cooperation, and participation of NIHstaff in those aspects of scientific and technical management of the project as described under NIH Program Staff Responsibilities
• The PD(s)/PI(s) will agree to the governance of the program through the Steering Committee(SC).
• The PD(s)/PI(s) will be expected to work closely and deposit publications, findings and otherdocuments into a Repository or central location to facilitate knowledge dissemination activities across other low resource settings.
• The awardee will retain custody of and have primary rights to the documents, publicationsand other items developed under the award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

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

• The NIH Project Scientist will coordinate and facilitate interactions and collaborations among the awardees of the TREIN and provide technical assistance and advice to the awardees as appropriate.
• The NIH Project Scientist will serve as the liaison between individual projects and other components of the TREIN including its Steering Committee.
• The NIH Project Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned Project Officer may also serve as an NIH Project Scientist.
• The NIH Project Officer will periodically report progress about the TREIN to NHLBI leadership including the Director of the NHLBI; PD(s)/PI(s) will provide timely assistance in providing relevant updates, documents, and other materials for these periodic progress reports to the NHLBI.

The NHLBI reserves the right to withhold funding or curtail the pilot study or needs assessment for an individual award in the event of a substantive changing 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.

Steering Committee (SC)

A SC will serve as the main governing board and monitor progress; facilitate coordination and synergy across the entire program; and develop recommendations for uniform procedures and policies. The Steering Committee membership will include the NIH Project Scientist(s) and the PD/PI of each award. The Steering Committee Chair will not be an NIH staff member but will be appointed by NIH staff. Additional members may be added by action of the Steering Committee. Other government staff may attend the Steering Committee meetings, if their expertise is required for specific discussions. As necessary, NIH staff will create appropriate subcommittees to handle interests that may be specific to a set of awardees funded by this FOA.

SC Responsibilities:

• Discuss progress in meeting the goals of various TREIN projects;
• Facilitate coordination and synergy across the entire TREIN program;
• Develop recommendations for uniform procedures and policies necessary to meet the goals of the TREIN, for example for uniform measures and assessment;
• Schedule the time for, and prepare concise (3 to 4 pages) summaries of the Steering Committee meetings, which will be delivered to members of the group within 30 days after each meeting. The SC will meet twice a year with intermittent conference calls.
• The SC will seek to operate by consensus, but in the event that a vote is needed, the PD/PI of each award, and the NIH Project Scientist will each have one vote. In the case of multiple PD/PI awards, the awardee will identify one PD/PI who will vote on behalf of the awardee's team.

Areas of Joint Responsibility include:

The awardee will retain custody of and have primary rights to data development under this award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

The PD(s)/PI(s) of this award will be required to participate in periodic meetings and telephone conference calls with the NHLBI Project Officer and Scientist.

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.

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.

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

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

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

After an administrative review by NHLBI staff, awardees that have met the program milestones in years 1 and 2 may transition to years 3-4. PD(s)/PI(s) will be permitted to present adjusted milestones for consideration; however, adjusted milestones will be considered a Prior Approval action and must be submitted in writing from the grantee's Authorized Organizational Representative (AOR) to the NHLBI Grants Office. Agreement shall be evidenced by a revised Notice of Award including adjusted milestones.

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

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Emmanuel Peprah, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-451-7691
Email: peprahek@nhlbi.nih.gov

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Kimberly Stanton
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0159
Email: standtonk@nhlbi.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.