Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)
National Institutes of Health (NIH)
Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)

Funding Opportunity Title
BLOODSAFE: Research to enhance availability of safe blood for patients with severe anemia and hemorrhagic conditions in low or lower-middle income countries (LLMICs) in Sub-Saharan Africa (UG3/UH3 Clinical Trial Optional)
Activity Code
UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement
Announcement Type
New
Related Notices
    RFA-HL-20-009
  • April 12, 2019 - Notice of Change to Key Dates in RFA-HL-20-010. See Notice NOT-HL-19-694.
Funding Opportunity Announcement (FOA) Number
RFA-HL-20-009
Companion Funding Opportunity

RFA-HL-20-010, U24 Resource-Related Research Projects

Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.839, 93.840
Funding Opportunity Purpose

This funding opportunity announcement will support projects to enhance the availability and delivery of safe blood to be used for transfusion in patients from low or lower-middle income countries (LLMICs) in Sub-Saharan Africa (SSA). For example, ensuring that children with malaria or sickle cell disease and pregnant women who suffer from obstetric hemorrhage have access to safe transfusion therapies is of high programmatic interest. BLOODSAFE will support projects that develop and test feasible, effective and sustainable strategies to increase the number of safe blood donors, to improve quality and safety of blood supplies, and to enhance blood delivery to patients in need, especially in remote settings. 

Key Dates

Posted Date

March 11, 2019

Open Date (Earliest Submission Date)
April 19, 2019
Letter of Intent Due Date(s)

April 19, 2019

Application Due Date(s)
New Date June 11, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review
New Date December 2019
Advisory Council Review

January 2020

Earliest Start Date
April 2020
Expiration Date

New Date June 12, 2019 per issuance of NOT-HL-19-691. (Original Expiration Date: May 21, 2019)

Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This funding opportunity announcement will support projects to enhance the availability and delivery of safe blood to be used for transfusion in patients from low or lower-middle income countries (LLMICs) in Sub-Saharan Africa (SSA). For example, ensuring that children with malaria or sickle cell disease and pregnant women who suffer from obstetric hemorrhage have access to safe transfusion therapies is of high programmatic interest. BLOODSAFE will support projects that develop and test feasible, effective and sustainable strategies to increase the number of safe blood donors, to improve quality and safety of blood supplies, and to enhance blood delivery to patients in need, especially in remote settings.

Background and Objectives

Inadequate blood collection and donation screening are associated with significantly reduced blood transfusion availability and safety in many LLMICs. Key vulnerable populations, particularly women and children, are most impacted by transfusion inadequacies. Inadequacies in blood supply have significant impact on population health in LLMIC contexts across much of SSA. Malaria-associated anemia is a common indication for transfusion therapy in the region. Malaria is the most common cause of severe anemia in childhood and many affected children are known to die of otherwise preventable death due to blood shortage. Obstetric hemorrhage, one of the most significant causes of maternal mortality worldwide, constitutes another important indication for transfusion in SSA. Countries in SSA that are designated by the World Bank as low income or lower-middle income countries include those that have extremely high maternal mortality rates (i.e., 100 deaths or more per 100,000 live births in 2015, as shown in the report: Estimates by WHO, UNICEF, UNFPA, World Bank Group and the United Nations Population Division on Maternal Mortality 2010-2015). A reduction in maternal mortality is one of the United Nations Millennium Development Goals. Many of these women are not transfused due to a limited blood supply, a situation that likely exacerbates the already high maternal death rates seen in SSA. Patients with sickle cell disease(SCD) and other hemoglobinopathies also often require transfusion. The majority of the world's SCD occurs in SSA. Many SCD patients require acute transfusion therapies for complications such as stroke, and severe anemia secondary to splenic sequestration and aplastic crises. Lack or delay of such therapies is associated with high morbidity and mortality. Improvement in blood supply availability and quality as well as access to transfusion could significantly impact SCD clinical outcomes and quality of life.

The objective of this FOA is to identify and address current challenges to the availability and delivery of safe blood for transfusion in LLMICs in SSA, including:

1) to assess core problems associated with poor transfusion services in an SSA LLMIC local area or region using specific descriptive epidemiologic approaches

2) to develop and test effective strategies that will enhance the availability and delivery of safe blood for transfusion in SSA LLMICs using regional effectiveness, implementation science and/or hybrid approaches

Program Structure

The BLOODSAFE program will consist of two functional units including 1) UG3/UH3 Research Teams and 2) a Data Coordinating Center (DCC), RFA-HL-20-010).

BLOODSAFE will consist of up to three Research Teams, a Data Coordinating Center (DCC), and will be governed by a Steering Committee (SC). Each SSA LLMIC country may be represented only once among the teams selected. No more than one research team will be led by investigators from any one country.

The DCC will coordinate the activities of the research program, support the Steering Committee, and provide study design and statistical support to the research teams. For details, please refer to the companion FOA: RFA-HL-20-010.

The NHLBI will be responsible for providing program oversight through an NHLBI Observational Study Monitoring Board (OSMB) or Data and Safety Monitoring Board (DSMB); overall monitoring of interim data and safety issues; providing representation on the Steering Committee; and collaborating with the DCC and all investigators in the development and implementation of the research program.

The Steering Committee (SC) for the program will be composed of the PD/PI from each Research Team and one additional investigator, the PD/PI of the DCC and one additional team member, NHLBI scientific staff, and an independent chairperson appointed by the NHLBI. Each Research Team will have one vote on the SC. The SC will identify issues that have broad applicability across the program. Initial recommendations regarding program level organization (overall program procedures), and an evaluation of where studies can achieve consistencies (e.g., common data elements) will be made by the SC. It is expected that the SC will review the protocols developed by the Research Teams and provide comments to optimize the protocol designs. Such recommendations might involve areas such as study design, standardized aspects of informed consent, sharing of expertise in implementation science research, optimizing stakeholder involvement, data collection, data sharing, data quality control plans and data analysis. Protocols that have been reviewed and approved by the SC will then undergo review by the NHLBI Protocol Review Committee before they can be implemented.

A Protocol Review Committee (PRC) will be appointed by NHLBI. The membership of this committee will consist of members with expertise in transfusion medicine, epidemiology, implementation science research, biostatistics, and ethics. The PRC will review protocols after they have been reviewed by the SC. Recommendations from the PRC will be given to NHLBI for approval, before a study can be launched by a Research Team.

An independent program-wide Observational Study Monitoring Board (OSMB) or Data and Safety Monitoring Board (DSMB) will be appointed by the Director of NHLBI. Members of the OSMB or DSMB will advise the Institute regarding study feasibility, participant safety and burden, data monitoring, and successful achievement of milestones for each project. The OSMB/DSMB will consist of five members with expertise in blood supply availability and safety, implementation science, statistics and ethics. Meetings will be held via conference calls and will use web-based systems. The DCC will budget honoraria for the OSMB or DSMB. The DSMB or OSMB may also serve as the Protocol Review Committee (PRC) for this program.

A sub-Committee of the SC will serve as the Publications Committee. The Publications Committee will follow a publications policy approved by the SC at the beginning of the program period and will be responsible for review of all abstracts, presentations, and manuscript submissions by all BLOODSAFE investigators.

Phases of Award

The UG3 phase will support the assessment of core problems associated with poor transfusion services in an SSA LLMIC local area or region using descriptive epidemiologic approaches, and the development of strategies to enhance the availability and delivery of safe blood for transfusion based on assessment results.. The UH3 phase will support implementation science or hybrid approaches (i.e., mixed effectiveness and implementation science) to test the strategies developed during the UG3 phase. Specific projects to be conducted in UH3 phase need to cover both an urban center and at least one remote area where access to safe blood for transfusion is limited. A research team could propose two specific projects with one targeting an urban center(s) and another targeting a remote area(s). A research team could also propose a specific project that covers a whole country or multiple countries including a remote area(s).

Examples of Research Projects

The following types of projects are examples of research topics supported by this FOA. Applicants should not feel limited to the subjects mentioned and are encouraged to submit other topics pertinent to the objectives of this FOA.

Projects that propose to:

  • Compare various outreach modalities to recruit and educate potential blood donors and/or convert new donors to repeat donors
  • Develop and test strategies to cultivate future blood donors such as interventions in schools, faith-based or community settings
  • Evaluate the effectiveness of social media or mobile technologies in recruiting and retaining safe blood donors
  • Develop and test strategies to encourage local institutions including corporations to support donor recruitment and retention
  • Evaluate evidence-based interventions for donor care such as iron supplementation to avoid iron deficiency among blood donors
  • Develop optimal and sustainable strategies to convert family or replacement donors to become voluntary, repeat donors and to increase repeat voluntary donations by existing donors
  • Evaluate the effectiveness of a training or education program for staff working on donor recruitment and retention
  • Evaluate the effectiveness of different health history questionnaires (DHQ) for donor selection in reducing the risk of transfusion-transmissible infections
  • Evaluate the cost-effectiveness and sustainability of approaches for blood inventory management and delivery of blood products to remote settings
  • Develop simulation modeling and system science approaches to understand determinants for success within a comprehensive blood transfusion delivery system in low resource settings

Applications that do not address blood availability or blood delivery during the award period will be considered non-responsive to this FOA and will be withdrawn without review.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?
Optional: Accepting applications that either propose or do not propose clinical trial(s)

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications

NHLBI intends to commit total costs of up to $1,300,000 in fiscal year (FY)2020 and in FY2021, $ 1,900,000 per year in FY2022 through FY2024, and $1,300,000 in FY 2025 to fund up to 3 awards.
Award Budget

Application budgets are limited to direct costs of up to $415,000 in FY2020 and in FY2021 (UG3 Phase), $580,000 per year in FY2022 through FY2024 (UH3 Phase), and $415,000 in FY2025 (UH3 Phase).

Award Project Period

Applicants may request up to 2 years for the UG3 phase and up to 4 years for the UH3 phase.

The maximum project period is six years.   

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 
Required Registrations

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.
  • 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.

Eligible Individuals (Program Director/Principal Investigator)
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.

The primary PD/PI must have a academic appointment at an institution in a low income or lower-middle income country (by the World Bank criteria ) in Sub-Saharan Africa. This academic affiliation must constitute at least 50% of the PD/PI full time professional effort in the past 2 years.

2. Cost Sharing

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

3. Additional Information on Eligibility

 

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)

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

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

 

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

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

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

The letter of intent should be sent to:

Director, Office of Scientific Review

National Heart, Lung, and Blood Institute (NHLBI)

Telephone: 301-435-0270

Email: NHLBIChiefReviewBranch@nhlbi.nih.gov

Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
Instructions for Application Submission
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.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.

Investigators will be expected to have research experience and expertise in transfusion medicine and implementation science. The PD/PI must have a substantial academic appointment at a LLMIC institution in Sub Saharan Africa (SSA). This academic affiliation must constitute at least 50% of the effort of the PD/PI in the past 2 years. One or more members of the Research Team should have expertise in epidemiology and implementation science as well as experience participating and collaborating in large multicenter programs. T he Research Team includes all personnel whose efforts will be supported by the award. Any consultants must have prior experience working in LLMICs and may be from LLMICs or other countries.

 

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

Include costs for travel to two Steering Committee meetings, each lasting two days, to be held in Bethesda, Maryland in each year of the program.

R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

   Research Strategy

UG3 (years 1-2)

  • Describe plans for descriptive epidemiological studies, with attention to both urban and rural settings, as appropriate, to identify major barriers to availability and delivery of safe blood for transfusion in each of these settings.
  • Delineate plans for evaluation and characterization of the blood donor populations in the selected areas including motivations and deterrents to donation, donor selection, prevalence of anemia and iron deficiency in the local population or among people who present to donate blood, donation/component characteristics including donation screening for HIV and other transfusion-transmissible infections, patient populations and needs, as well as an understanding of blood delivery, utilization and discard rates.
  • Describe planned research methods, which may include focus groups as well as survey methodologies, that are expected to result in the recognition of major barriers to availability and delivery of safe blood for transfusion in that region as well as various factors such as social and cultural factors that may be associated with such barriers.
  • Identify strategies that could address barriers to the provision and delivery of safe blood in their settings, and among them, identify strategies that will be evaluated in phase 2 (years 3-6). The strategies to be evaluated in Phase 2 can address any of the various elements of the blood supply continuum, from recruiting and retaining low-risk blood donors, implementation of laboratory screening tests, establishment of donor/donation/component inventory systems, to delivery approaches.
  • Prioritize the identified strategies based on their likely feasibility, effectiveness and sustainability and select the top one or two strategies that are most likely to advance the availability and delivery of safe blood for transfusion in their local settings depending on the most pressing needs identified. Research teams will be strongly encouraged to test a combination of strategies affecting various steps of the entire blood collection, processing and delivery process; this would have the advantage of evaluating an overall strategy to improve the availability and delivery of safe blood.
  • Propose a plan to evaluate these selected strategies for feasibility, acceptability, effectiveness and sustainability during the UH3 phase. Identify the validated theoretical or conceptual research framework(s) (e.g., Consolidated Framework for Implementation Research (CFIR); Promoting Action on Research Implementation in Health Services (PARiHS); Pragmatic-explanatory continuum indicator summary (PRECIS); Reach Effectiveness Adoption Implementation Maintenance (RE-AIM); PRECEDE-PROCEED, K2A, etc.) and the implementation research study design(s) (e.g., experimental, quasi-experimental, observational, modeling, cluster randomization, Type III hybrid effectiveness, etc.) that will be employed. Include implementation measures as primary research outcomes (e.g., acceptability, adoption, appropriateness, affordability, costs, feasibility, fidelity, penetrance, and sustainability, etc.).
  • Provide a plan for obtaining all appropriate regulatory and ethical approvals.
  • Detail the plan for communicating with and outreach to authorities and community organizations
  • Propose milestones to be achieved by the end of the UG3 phase. Milestones used to determine the transition to the UH3 include:
    • Evidence of the research team's commitment and ability to collaborate with other awardees and within the program
    • Active participation in the Steering Committee and its subcommittees
    • Cooperation with the DCC in developing the manual of operation(s) and in submitting ethics review board (e.g., an institutional review board or IRB) applications in a timely manner
    • Provision and entry of high-quality data from the UG3 activities into a comprehensive database, in adherence with program procedures and description of methodologies used to conduct the project
    • Completion of descriptive epidemiological studies, with attention to both urban and rural settings, as appropriate, to identify major barriers to availability and delivery of safe blood for transfusion in each of these settings
    • Identification of strategies that can be evaluated for feasibility, effectiveness and sustainability in providing adequate and safe blood supply for transfusion in the local settings, especially remote settings, including conceptual framework(s) or model(s) used to develop the implementation science research studies and what will constitute their successful conduct
    • Development of research protocols to evaluate the identified strategies and approval of these protocols by the Steering Committee
    • Documentation of key partnerships such as the Ministry of Health, health care system providers and local health agencies

UH3 (years 3-6)

In years 3-6, the research team must evaluate the selected strategies to address the identified barriers to improving blood collection, processing, and delivery of safe blood for transfusion. Research teams are strongly encouraged to test a combination of strategies affecting various steps of the entire blood collection, processing and delivery process.

  • Develop the plan for evaluating the strategies identified in the UG3 phase for feasibility, acceptability, effectiveness Describe the target area(s) and population(s), including blood donors, blood establishments and their blood collections and distributions, health and regulatory authorities governing blood supplies, healthcare providers and transfusion recipient populations.
    • Include in the plan: 1) description of access to infrastructure that has the capability to collect and transmit research data, establish datasets, and perform quality control checks; 2) details for obtaining necessary governmental, administrative and regulatory approvals and for adherence to pertinent regulations, policies, and legal, ethical and social obligations; 3) plans for collaboration with NHLBI, the DCC, and the other funded Research Teams within the program.
  • Describe the quality assurance and quality control procedures that will be established to ensure research data quality and validity.
  • Describe how the feasibility, acceptability, effectiveness and sustainability of the selected implementation strategies will be evaluated.
  • Provide a detailed description of how project data will be analyzed in conjunction with the DCC. Provide a detailed plan for disseminating results
  • List the milestones relevant to data collection, data QC, data analysis, and dissemination of their results.

For clinical trials during the UG3, if applicable, milestones of particular interest include but are not limited to:

  • Timely registration of the trial on clinical trials.gov as required by regulations at 42 CFR part 11
  • Enrollment of 25%, 50%, 75% and 100% of the projected recruitment for all study participants, including women, minorities and children (as appropriate)
  • Assessment of study protocol implementation performance
  • Collection of data related to primary and secondary endpoints and database lock
  • Submission of primary manuscript to peer-reviewed scientific journal(s) and dissemination of results
  • Submission of study results to ClinicalTrials.gov within 12 months of the completion date of data collection for primary outcomes

Please note the new, broadened NIH definition of clinical trials (https://grants.nih.gov/ct-decision/index.htm).

Although applications for the UG3 and UH3 activities must be submitted and will be reviewed simultaneously, funding for the UH3 component is contingent on achieving the pre-specified milestones during the UG3 component. These milestones will ensure sufficient progress during the UG3 to provide feasibility and scientific rationale for the conduct of research proposed in the UH3. Milestones may be negotiated based on comments of the peer review panel. Applicants should consult with their institution's legal authorities to plan for how intellectual property resulting from the research will be protected.

Letters of Support:

Each applicant must provide a statement that addresses how institutional commitment will be established and sustained, and how the research team efforts will be given a high priority within the institution. The institutional commitment may be in the form of support for recruitment of scientific talent, provision of discretionary resources to the research team Director, assignment of space, and/or other ways proposed by the applicant institution. Letters from a high-level institution official(s) (e.g., Dean of the School of Medicine, President, or Vice President for Research) must be attached confirming this commitment.

Applications should also include letters of support from the Ministries of Health and/or Education and any other national entities that can further endorse the project.

Letters of support from collaborators, including blood services and healthcare providers, whose supports are necessary to the successful conduct of the research should be provided.

If additional funding is to be provided by sources other than NHLBI, provide Letter(s) of Support signed by an authorized organization representative (AOR).

Applications that do not include letter(s) of institutional support or commitment for the proposed research in response to this FOA will be considered incomplete and will not be peer reviewed

 

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.

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.
  • In addition to publication of findings, applications are expected to include a plan to share data with the Data Coordination Center for preparation of datasets for public access.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
 

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

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 NHLBI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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.

In addition, for applications involving clinical trials: 

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

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

 

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

 

In addition, for applications involving clinical trials

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

 

Specific to this FOA:

 

Does the application address blood availability and blood delivery? What is the likelihood that the proposed project will improve the availability and delivery of safe blood for transfusion in the local setting or region? Will the proposed project identify strategies that can potentially work across LLMIC settings?

 

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

In addition, for applications involving clinical trials

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

Specific to this FOA:

Do investigators have research experience as well as expertise in transfusion medicine and implementation science? Do the key personnel have experience working in or collaborating with investigators in low or lower-middle income countries and knowledge of local regulatory requirements? Does one or more of the investigators have expertise in participating and collaborating in large multicenter programs? How strong is the leadership to coordinate the multicenter research activities?

 

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

In addition, for applications involving clinical trials

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

Specific to this FOA:

?Does the application propose innovative strategies or new methods that can overcome the challenges in LLMIC settings in SSA to improve data collection, needs assessment, as well as the availability and delivery of safe blood for transfusion for patients in need, especially in remote settings?

 

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project ? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

Specific to this FOA:

How feasible are? the proposed epidemiologic methods for effectively identifying barriers to improving availability and delivery of safe blood for transfusion for patients in SSA LLMICs, especially in remote settings?

How likely are the epidemiologic studies and needs assessment proposed for the UG3 phase to enable appropriate identification of strategies for improving the availability and delivery of safe blood for transfusion for patients in the local settings?

?How will the identified strategies be prioritized for evaluation in the UH3 phase? Are the criteria used for prioritization of strategies supported by data? Has the proposed prioritization algorithm taken into account the most pressing local needs as well as feasibility, acceptability, effectiveness and sustainability?

?Has the research proposed for the UH3 phase that evaluates the identified and prioritized strategies employed theoretical or conceptual implementation research frameworks, detailed implementation research study designs, described implementation measures as primary research outcomes, and included plan to inform understanding of key mediators and mechanisms of action of the implementation research?

How appropriate and adequate is the plan for obtaining the necessary regulatory and ethical approvals?

Has the application included appropriate plans to engage health authorities as well as relevant community organizations, blood establishments, health care systems, providers, patients, and key cultural stakeholders?

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?

 

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

In addition, for applications involving clinical trials

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

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

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

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

Specific to this FOA:

How convincing and adequate is the institutional commitment?

?Are the letters of support from authorities, collaborators and others adequate?

How adequately and effectively will the infrastructure to be accessed by investigators as described in the application support the research activities in both the UG3 phase and the UH3 phase, including data collection, management, transmission to the DCC, and data analysis?

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

Study Timeline

Specific to applications involving clinical trials

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

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

Specific to this FOA

Are the listed milestones for each phase appropriate for the goals of the project? To what extent are the milestones relevant, measurable, achievable, result-focused and time-bound?

 

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

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

 

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

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

 

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

 

Not Applicable

 

 

Not Applicable

 

Not Applicable

Additional Review Considerations
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.

 

Only institutions in low or lower-middle income countries in Sub-Saharan Africa can apply. This program will target countries in Sub-Saharan Africa that belong to low income or lower-middle income countries by the World Bank Classification (http://documents.worldbank.org/curated/en/408581467988942234/pdf/WPS7528.pdf).  

 

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 Data Sharing Plan (GDS). Reviewers will comment on the appropriateness of the plan to share data with the Data Coordinating Center.

 

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

 

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NHLBI. 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 NHLBI. 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 NHLBI 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.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

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

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

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

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

2. Administrative and National Policy Requirements

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

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

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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

 

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

 

Awardee and PI(s)/PD(s) Rights and Responsibilities

 

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

 

The PI(s)/PD(s) or their delegates will participate in all annual meetings, workshops, and working groups. The PI(s)/PD(s) will agree to accept close coordination, cooperation, and participation of NIH staff in those aspects of scientific and technical management of the project as described under the NIH Program Staff: Program Official (PO) and Project Scientist (PS) Roles. The PI(s)/PD(s) will agree to the governance of the program through the Steering Committee (SC).

 

The PI(s)/PD(s) will be responsible for the timely submission to the Publication Committee for review and approval of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this cooperative agreement before submission for presentation or publication.  Manuscripts shall be submitted to the NIH Program Official within two weeks of acceptance for publication and must comply with the NIH Public Access Policy.  Publications or oral presentations of work performed under this cooperative agreement will require appropriate acknowledgement of NHLBI support.  Timely publication of major findings is encouraged.  The awardee will retain custody of and have primary rights to the documents, publications and other items developed under the award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

 

NIH Responsibilities

 

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

 

The NIH Project Scientists will coordinate and facilitate interactions and collaborations among the awardees of this research consortium and provide technical assistance and advice to the awardees as appropriate. The NIH Project Scientists will serve as the liaison between individual projects and NHLBI. The NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned NIH Program Official may also serve as an NIH Project Scientist. The NIH Program Official will periodically report progress about the program to NHLBI leadership including the Director of the NHLBI; PI(s)/PD(s) will provide timely assistance in providing relevant updates, documents, and other materials for the annual progress reports to the NHLBI.

 

Collaborative Responsibilities

 

A Steering Committee (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 PI(s)/PD(s) of each award. The Steering Committee Chair will not be an NIH staff member but will be appointed by NHLBI 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, the Steering Committee will create appropriate subcommittees to handle interests that may be specific to a set of awardees funded by this FOA.

 

SC Responsibilities:

 

SC will discuss progress in meeting the goals of various research projects; facilitate coordination and synergy across the entire program; and develop recommendations for uniform procedures and policies necessary to meet the goals of the program. For example, SC will determine research collaborations such as methodology, data, and core measures and assessment available.

   

SC will lead organizational management including the schedule and concise summaries of the Steering Committee meetings. The SC will meet at least once a year in person and hold regular conference call meetings. The SC will seek to operate by consensus, but in the event that a vote is needed, the PI(s)/PD(s) of each award and NIH will 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.

   

Dispute Resolution:

   

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. 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

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (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: support@grants.gov

Scientific/Research Contact(s)

Shimian Zou, PhD

Division of Blood Diseases and Resources

National Heart, Lung, and Blood Institute (NHLBI)

Telephone: 301-435-0065
Email: shimian.zou@nih.gov

 

LeShawndra Price, PhD

Center for Translation Research and Implementation Science
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8166
Email:leshawndra.price@nih.gov
Peer Review Contact(s)

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

Financial/Grants Management Contact(s)
Laurel Kennedy

Division of Extramural Research Activities

The National Heart, Lung, and Blood Institute

Telephone: 301-827-4777

Email: laurel.kennedy@nih.gov

Section VIII. Other Information

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.
Authority and Regulations
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.


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