Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Health Resources and Services Administration (HRSA)
Administration for Children and Families (ACF)

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Minority Health and Health Disparities (NIMHD)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

Office of Research on Women's Health (ORWH)

Funding Opportunity Title
Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) Multisite Resource and Coordinating Center (U24 Clinical Trial Required)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-HL-22-008
Companion Funding Opportunity
RFA-HL-22-007 , UG3/ UH3 Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II
Assistance Listing Number(s)
93.837, 93.840, 93.307, 93.313
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications for a Resource and Coordinating Center (RCC) for the Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) program, a new NIH multi-center group- or cluster- randomized trial with clinical or community sites to be supported under the companion RFA-HL-22-007. The RCC will coordinate and provide support for the clinical or community sites that propose to test the effectiveness of an implementation-ready intervention designed to promote cardiovascular health (CVH) and address CVH disparities in both mothers and children (0-5 years of age) who are of low socio-economic status (SES), live in low-resource rural or urban communities, or are in diverse geographic regions of the U.S. with a high burden of cardiovascular disease (CVD) risk factors.

Applicants should propose activities that include the following:

  1. Plan and support study coordinating structure and functions, including efforts to promote communication and collaborations among study investigators, training of staff on study protocols, convening of meetings, evaluating the data collected from the ENRICH clinical/community sites , and coordinating ancillary studies that leverage the ENRICH research platform
  2. Facilitate the development of a common intervention protocol for the UH3 phase, including the study design, analytic plan, sample size, and use of common elements and measures across studies, to be reviewed by the NHLBI-appointed DSMB and approved by the NHLBI prior to UH3 phase for the clinical or community sites
  3. Develop and implement data collection procedures, facilitate the collection of biomedical data, establish a central database, provide additional biostatistical expertise, conduct data analysis of data across study sites, and facilitate reporting of trial results, including process, impact, and outcomes measures.
  4. Involve and develop the skills of Early Stage Investigators (ESIs) and home-visiting staff professionals in early CVH promotion and implementation strategies to foster the next generation of researchers in promoting maternal and child CVH.
  5. Coordinate the development of public access data files to be made available in a data repository as designated by the NHLBI.

This U24 cooperative agreement initiative is administered by the NHLBI but includes extensive participation and funding contributions from a coalition of Institutes, Centers, and Offices (ICOs) at the National Institutes of Health (NIH) as well as the Health Resources and Services Administration (HRSA) and the Administration for Children and Families (ACF). HRSA and ACF will provide the infrastructure and in-kind support to awardee investigators to gain access to evidence-based home visiting programs already being supported by HHS. HRSA and ACF staff, along with NIH staff will provide staff-level scientific and technical input for ENRICH. HRSA and ACF staff along with NIH staff may serve as project scientists on the Steering Committee and various subcommittees (e.g., intervention, measurement, publications, ancillary studies subcommittees). .

Key Dates

Posted Date
February 22, 2021
Open Date (Earliest Submission Date)
May 11, 2021
Letter of Intent Due Date(s)

May 11, 2021

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
June 11, 2021 Not Applicable Not Applicable November 2021 January 2022 April 2022

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

Expiration Date
June 12, 2021
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

This Funding Opportunity Announcement (FOA) invites applications for a research Resource and Coordinating Center (RCC) under the NIH Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) program. ENRICH will aim to test the effectiveness of an implementation-ready intervention designed to promote cardiovascular health (CVH) and address CVH disparities in both mothers and children (0-5 years old) who are of low socio-economic status (SES), live in low-resource rural or urban communities, or who are in diverse geographic regions of the U.S. with high burden of cardiovascular disease (CVD) risk factors. Specifically, this initiative will support multi-site interventions designed to determine if a CVH module delivered within the context of a home visiting program can enhance maternal and early childhood CVH. The overall estimated number of mother-child dyads needed for the trial is about 3,000. The RCC will coordinate and provide support for the ENRICH clinical/community sites, to be funded under a parallel, companion FOA, RFA-HL-22-007.

This U24 cooperative agreement initiative is administered by the NHLBI but includes extensive participation and funding contributions from a coalition of Institutes, Centers, and Offices (ICOs) at the National Institutes of Health (NIH) as well as the Health Resources and Services Administration (HRSA) and the Administration for Children and Families (ACF). HRSA and ACF will provide the infrastructure and in-kind support to awardee investigators to gain access to evidence-based home visiting programs already being supported by HHS. HRSA and ACF staff, along with NIH staff will provide staff-level scientific and technical input for ENRICH. HRSA and ACF staff along with NIH staff may serve as project scientists on the Steering Committee and various subcommittees (e.g., intervention, measurement, publications, ancillary studies subcommittees).

Background

Maternal morbidity and mortality rates in the U.S. have risen in recent years. Racial disparities in maternal mortality are particularly alarming, with African Americans having more than 3-fold and American Indians/Alaskan Natives more than 2-fold higher rates compared with non-Hispanic Whites. More women at older ages, or with chronic conditions, such as diabetes, hypertension, or obesity are becoming pregnant -- all risk factors for maternal morbidity and mortality. In addition to adverse pregnancy outcomes and poor peri-partum health, maternal obesity, preeclampsia and gestational diabetes are also associated with long-term risk of CVD in the mother. Many research reports have noted that women who had preeclampsia had significantly higher risk of adverse cardiovascular health (CVH) outcomes 15 years later compared to controls who did not have preeclampsia, and maternal preeclampsia, gestational diabetes, or hypertension, are associated with risk of high blood pressure in mothers post pregnancy and in children as early as 3 years of age.

Evidence from epidemiologic studies in children supports the conclusion that the development of cardiometabolic risk factors begins in utero and early childhood, progresses from childhood through adolescence and into adulthood, and results in adverse clinical CVH outcomes. Beginning prenatally and in childhood, unhealthy behaviors such as poor diet and nutrition, sedentary behavior and lack of physical activity, sleep timing and disruptions, and smoking exposures (e.g., second-hand smoke exposures); health factors such as obesity, elevated blood pressure, glucose and lipids in the mother; and social determinants of health (e.g., poor access to health care) all contribute to the loss of ideal CVH. The associated loss of CVH prenatally and postpartum is accelerated by poor lifestyle behaviors. The loss of CVH is also exacerbated by adverse social determinants of health indicators, including poverty, poor access to or utilization of health services, and contextual factors within the home and in social and community environments. These adverse exposures have direct effects on CVH and constrain behavioral options leading to further deterioration in CVH. Strategies that optimize and promote CVH and reduce adverse effects of social determinants of health indicators have the potential to reduce health disparities, reduce maternal morbidity, and improve the health and well-being of infants and children in a way that could be sustained across the lifespan.

ENRICH Research and Resource Coordinating Center Specific Responsibilities

This FOA invites applications for a Resource and Coordinating Center (RCC) for the NIH Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH), a new multi-center group- or cluster-randomized trial with clinical/community sites to be supported under the companion RFA-HL-22-007.

Applicants should propose activities that include the following:

  1. Plan and support study coordinating structure and functions of ENRICH, to include:
    • Developing a coordinating structure to include Steering Committee and subcommittees, composed of personnel from the clinical/community and RCC sites and NIH project office scientists. Examples of subcommittees include: Design Committee, Recruitment Committee, Quality Control Committee, Publications and Presentations Committee, Ancillary Study Committee, and possibly others.
    • Promoting communication and collaborations among study investigators, including coordinating and providing support for the clinical/community sites
    • Training staff on study protocols
    • Planning and supporting meetings with ENRICH investigators, project office scientists, and others as appropriate
    • Tracking manuscript proposals and publications that stem from the ENRICH program
    • Convening meetings of NHLBI-appointed Data and Safety Monitoring Board (DSMB)
    • Collecting and evaluating the data collected from the ENRICH clinical/community sites
    • Coordinating the review of ancillary study proposals that leverage the ENRICH research platform, as well as facilitate the integration of any approved and funded ancillary studies into ENRICH [Note: although not funded under this FOA, it is anticipated that future opportunities will permit investigators to propose ancillary studies using other funding mechanisms (such as investigator-initiated grants) to collect genetics and biological markers aside from serum glucose and lipids, as well as potentially other measures, on ENRICH study participants.]
  2. Facilitate the development of a common intervention protocol for the UH3 phase, including the study design, analytic plan, sample size, and use of common elements and measures across the ENRICH clinical/community sites, to be reviewed by the NHLBI-appointed DSMB and approved by the NHLBI prior to UH3 phase for the clinical/ community sites [Note: the RCC will work together with the ENRICH clinical/community sites and NIH staff to develop the one protocol (including study design, analytic plan, same size, etc.) to be adapted across multiple sites in the UH3 phase].
  3. Develop and implement data collection procedures, facilitate the collection of biomedical data, establish a central database, conduct data analysis of data across study sites, provide additional statistical expertise to the program as needed, and facilitate reporting of trial results, including process, impact, and outcomes measures.
  4. Involve and develop the skills of Early Stage Investigators (ESIs) and home-visiting staff professionals in early CVH promotion and implementation strategies to foster the next generation of researchers in promoting maternal and child CVH. Training on preserving or promoting CVH will need a broad understanding and skills in clinical trials, data analytic procedures, behavioral interventions, and implementation science. Creating this kind of knowledge base will require a cross-disciplinary team approach to facilitate the ability of the next generation of investigators to create new knowledge and a more rapid approach to translation of evidence to the clinical and community settings.
  5. Coordinate the development of public access data files to be made available on a data repository as designated by the NHLBI.

Please refer to the Frequently Asked Questions (FAQ) page for additional guidance.

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. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Required: Only accepting applications that propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NHLBI intends to fund one award, corresponding to total costs of up to $1.5 million in FY 2022, $1.2 million per year in FY 2023 through FY 2027, and $1.5 million in FY 2028 for up to a total cost of $9 million for 7 years.

Award Budget

Application budgets are not limited but must reflect the actual needs of the proposed project.

Award Project Period

 The period of award is expected to be 7 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)

Local 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)

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not 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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung and Blood Institute (NHLBI)
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.

All Key Personnel who are major contributors to the project must provide an NIH Biosketch, whether or not they are budgeted.

The experience of each PD/PI and all Key Personnel must be carefully documented and roles and responsibilities must be well-defined. Applications must provide evidence that Senior/Key Personnel have:

  • Experience working with and/or leading multidisciplinary research team including level of expertise in coordination, tracking, logistics and administration, communications, data management (including quality control), data security and IT infrastructure (including development of public and secure study websites), regulatory support, and biostatistical/analytical support, including expertise in group- and cluster-randomized trial designs.
  • Any special expertise or unique strengths that will be brought to the RCC (e.g., experience in clinical trial management, home visiting organizations, or non-government organizations, data analytic skills, etc.).
  • Experience in the planning, implementation, project coordination and administration/management and monitoring of multi-center research or clinical trials including success in meeting milestones and timelines.
  • Experience and expertise in clinical trial design, implementation and monitoring, and cardiovascular disease prevention research.
  • Experience in maternal and early child health.
  • Expertise in coordinating collaborative, multi-site research in low-resource and/or diverse settings (e.g., rural, urban, suburban, other geographically or otherwise diverse settings across the U.S.) or among research that include underrepresented populations and with vulnerable and diverse populations.
  • Documented experience and expertise in project management of recent research project and/or multisite consortia, with a description of the collaborative leadership structure used.
  • Experience in data analysis across multiple sites.

R&R Budget

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

A detailed budget for the ENRICH RCC should be presented for activities related to coordinating functions for the ENRICH clinical or community sites. The operational budget should include, but not be limited to the following items:

  • Management of day-to-day operations and oversight of the professional activities including proposed administrative activities, data and research coordination, and skills development program;
  • Development and maintenance of ENRICH public-facing and secure websites;
  • Planning, coordinating, and facilitating in-person and virtual ENRICH meetings including the start-up meeting, monthly steering committee meetings, webinars, conference calls, the meetings with the DSMB and other PD/PI meetings including NHLBI/NIH staff, as needed,
  • Plan for in-person two-day meetings in the Washington DC area for the Senior Key persons from the RCC and each of the Clinical/Community sites who are members of the study’s Steering Committee (SC) and other subcommittees, such as the Design Committee, Recruitment Committee, Quality Control Committee, Publications and Presentations Committee, Ancillary Study Committee, and others. Include travel costs for at least two individuals from the RCC including PIs or their delegates to the in-person SC meetings. In Years 1 and 2, plan for three of these meetings to occur annually. In subsequent years, plan for two of these meetings annually.
  • Suggest a plan for an independent overall study chair to lead the SC including honorarium and travel cost. The overall study chair would be selected with input from the PI’s of the clinical sites and NIH.
  • Coordination and delivery of skills development and training in the common protocol among ENRICH awardees, including ESIs and home delivery health professionals.
  • Costs associated with data transfer to the RCC, statistical analysis of common data, and publication of primary outcome and other papers (e.g., Open Access);
  • Development of public access data files, and close-out phase activities;
  • Participation in awardee meetings, the steering committee or appropriate subcommittees, and other leadership committee functions; and communication, documentation, and reporting;
  • Costs for data transfer from clinical sites to RCC and other monthly teleconferences and/or webinars;
  • Sub-awards as needed. The application must include only its own budget, including any subcontract budgets associated with it. Separate itemized budgets must be prepared for each subcontract. The application must provide detailed annual budgets that will enable the RCC to meet its milestones.

Start-up and Annual Meetings

Budgets must include funds for the PD/PI and two additional key personnel for start-up and future meetings.

DSMB

  • Include all costs associated with up to a seven-member NHLBI-appointed DSMB activities which will consist annually of a one-day in-person meeting in the Washington, DC area and one or more conference call meetings. The study leadership is required to attend this meeting. A DSMB meeting could be held in conjunction with one of the in-person Steering Committee meetings. Travel cost and honorarium for the DSMB should also be include as should the costs for preparing reports for the DSMB and meeting requirements for the DSMB members.
  • The RCC should include in their budget coordination of support for at least two DSMB meeting per year (by teleconference or videoconference) and any site visits at the RCC and clinical sites as needed.
  • Include budget support for publication, data sharing, and broad dissemination of results
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:

Specific Aims

Describe how the RCC will contribute to the goals of the ENRICH program to foster improvement in maternal and child health in populations with high burden of cardiovascular morbidity and mortality.

Research Strategy

A typical research strategy description is not expected. ENRICH RCC applicants should not propose a research project since projects will be proposed through RFA HL 22-007. However, the RCC should demonstrate expertise in group-based randomized trials and be able to advise the ENRICH Program team on development of the common protocol, calculate sample size and power estimations, and oversee data management and analyses. To that end, the following items should be addressed by the applicant:

Significance

Present a clear statement of the way in which the RCC relates to the goals of the overall ENRICH program. Explain why the chosen coordinating center framework is optimal.

Approach and Innovation

Applicants must describe the following:

  • The management, administration, and operational needs of the RCC; Discuss how the overall administration and coordination strategies, and operational plan are appropriate for maternal and child health research and home visiting within the context of ENRICH.
  • The proposed timeline and work-flow plan.
  • The proposed leadership structure including plans for communication and decision making, conflict resolution and organizational structure.
  • How the proposed activities of the RCC will be evaluated and include plans for addressing potential challenges; Describe metrics for evaluation.
  • Present plans to identify and solve problems, determine alternative strategies and milestones to be accomplished as well as benchmarks for success.
  • Plans to utilize novel organizational concepts and management strategies in coordinating the overall ENRICH program. Include any plans to employ unique or novel methodologies, design and statistical analytic processes. With regard to statistical designs, expertise in group-based randomized trials must be demonstrated.
  • Discuss processes to be used to facilitate and foster recruitment and retention of study subjects, train study staff including home delivery professionals.
  • Detailed plans for coordinating the functions of the clinical research sites across the United States.
  • Describe processes to be used to maintain the integrity of the study, including blinding of study staff, training of measurement staff and facilitating the intervention.
  • Communication among the management team, the research awardees, and any proposed working groups and subcommittees (e.g., clearly describe how interactions and communications between the RCC and the awardees will be managed), and with the broader research community.
  • Describe how data will be transmitted in an accurate and timely fashion from clinical sites to the RCC, and how the RCC will establish accessible and secure methods of communication and data transfer.
  • Plans for data analysis across sites, as well as plans to track and review manuscript proposals and publications (e.g., establishment of an ENRICH program publications and presentations committee).
  • Plans for research site and study monitoring.

Letters of Support

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

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.
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 human subjects research, clinical research, and/or NIH-defined 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.

Section 5 - Other Clinical-Trial Related Attachments

5.1 Other Clinical Trial-related Attachments

Applicants must provide a detailed table listing the characteristics of trials they have been involved in that demonstrate experience in trial coordination in the last 5 years. The table must be provided as an attachment called "Clinical Trial Research Experience.pdf" and may not exceed 3 pages. The table columns should include:

  • Column A: clinical study title
  • Column B: applicant's role in the study
  • Column C: a brief description of the study design
  • Column D: planned enrollment
  • Column E: actual enrollment
  • Column F: whether the studies completed on schedule or not
  • Column G: publication reference(s)
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.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

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

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.

For this particular announcement, note the following:

Reviewers will consider the overall coordinating functions and whether the coordinating center would be able to support coordinating functions for the clinical trials being supported in the companion announcement RFA HL-22-007 to answer key scientific questions, and whether novel approaches would be used.

This FOA along with the RFA HL-22-007 (UG3/UH3) are cooperative agreements. The clinical site will support investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research.

A 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.

Significance

Does the proposed Resource and Coordinating Center address the needs of the research program that it will serve? Is the scope of activities proposed for the Resource and Coordinating Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research program?

Specific to this FOA:
How likely will successful completion of the aims promote the reduction in maternal morbidity and improve maternal and child cardiovascular health?

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?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Resource and Coordinating Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing clinical research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the Resource and Coordinating Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Resource and Coordinating Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this FOA:

  • How strong are the investigators in having the necessary qualifications and experience in conducting coordinating functions and in facilitating and leading multidisciplinary teams?
  • How strong is the application regarding past and/or ongoing experience with coordinating collaborative, multi-site research in diverse settings as demonstrated in the Clinical Trial Research Experience Table?
  • How strong is the evidence that the applicant(s) have experience in clinical trial management, and/or home visiting experience in working with diverse populations in rural, urban, suburban, other geographically or otherwise diverse settings across the U.S.?
  • If the RCC is multi-PD/PI, how complementary and integrated are the investigators' expertise and skills?
  • To what extent does the applicant’s experience support the ability to build partnerships and collaborative research and support clinical centers?
  • How strong is the organizational structure of the RCC and project management expertise represented among the key personnel?
  • To what extent does the documented experience of the Key Personnel support the proposed coordinating functions including coordination and administration, logistics, communications, data management (including quality control), data capture and transfer from clinical sites to coordinating center, data security and IT infrastructure (including development of public and secure study websites), regulatory support, clinical study and site monitoring, and biostatistical/analytical support, especially in group-based randomized trials?
  • Does the personnel have the ability to analyze data across multiple sites? Do they have sufficient expertise and experience in coordinating the conduct of group-based randomized 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?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research program the Resource Coordinating Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

Specific to this FOA:
How strong are the proposed plans to utilize novel organizational concepts and management strategies in coordinating the functions across sites for ENRICH?

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?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research program the Resource Coordinating Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the program, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
 

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?

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?

Environment

Will the institutional environment in which the Resource and Coordinating Center will operate contribute to the probability of success in facilitating the research program it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Resource and Coordinating Center proposed? Will the Resource and Coordinating Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Specific to this FOA:

  • To what extent does the application demonstrate sufficient infrastructure to implement the proposed coordinating center functions?
  •  Are technical and information technology resources sufficient to house and securely share resources and/or data, as well as build and manage the ENRICH Program's public-facing and secure websites?

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?

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

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications will receive a written critique.

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.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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

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 recipient'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: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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

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

2. Administrative and National Policy Requirements

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, Recipients, 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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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. 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.

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.

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.

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 recipient 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 recipient for the project as a whole, although specific tasks and activities may be shared among the recipient and the NIH as defined below.

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

All aspects of their study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators. The recipient  agrees to accept close coordination, cooperation, and participation of NHLBI and other NIH staff in those aspects of scientific and technical management of the study. Upon implementation of the protocol, each clinical/community site, whether a single institution or a consortium of institutions, will follow the procedures required by the protocol regarding study conduct and monitoring, patient management, and data collection. Support or other involvement of industry or any other third party in the study--e.g., participation by the third party; involvement of project resources or citing the name of the project or the NHLBI support; or special access to project results, data, findings, or resources--may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur with the concurrence by NHLBI Program Officer to ensure objectivity of research.

Obtaining prior written approval of the NHLBI Grants Management Specialist in consultation with the NHLBI Program Officer for a change in any of the key personnel identified in the Notice of Award.

Recipient will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

Have access to data generated under this Cooperative Agreement and will periodically review the data and progress reports. NHLBI staff may use information obtained from the data for the preparation of internal reports on the activities of the study.

Serve as a resource to provide scientific/programmatic support during the accomplishment of the ENRICH program by participating in the design of the activities, advising in the selection of sources or resources, advising in management and technical performance, or participating in the preparation of publications.

Participate in the monitoring of issues relating to recruitment, retention and follow-up of study participants, and monitoring of data integrity and quality control through consideration of the annual reports, site visits, patient logs, etc. This review may include, but is not limited to, compliance with the study protocol, meeting patient enrollment targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting. Assist in the development and modification of study protocols.

Additionally, an agency program official or IC Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

A Steering Committee, composed of the principal investigator of the coordinating center , as well as the principal investigators of the various field clinical centers, and NHLBI and other NIH Scientific Officers from co-funding Institutes or offices. The NHLBI and NIH Scientific Officers will have voting membership on the SC and, as appropriate, on its subcommittees. The PIs will have the majority of the voting members on the SC. The SC will have primary responsibility for facilitating the conduct and monitoring of studies and reporting study results. As the components of the SC may be geographically dispersed, the SC should meet with at least monthly conference calls, supplemented as deemed necessary by face to face meetings. Each full member will have one vote. Recipient members of the Steering Committee will be required to accept and implement all policies governing the study conduct approved by the Steering Committee.

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. It will have three members: 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 recipient. This special dispute resolution procedure does not alter the recipient'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)

Charlotte A. Pratt, MS, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0382
Email: prattc@mail.nih.gov

Elizabeth Neilson, PhD, MPH, MSN
Office of Disease Prevention (ODP)
Telephone: 301-827-5578
Email: neilsone@mail.nih.gov

Jamie White
Office Of Research On Women's Health (ORWH)
Phone: 301-402-1770
E-mail: jamie.white@nih.gov

Priscah Mujuru, DR.PH, MPH, RN
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-9765
E-mail:mujurup@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Allison Moyal
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8036
Email: moyala@mail.nih.gov

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail:pg38h@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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NIH... Turning Discovery Into Health®


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