Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

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.

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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) seeks applications for an Implementation Science Hub/Resource Center as part of the Maternal Health Research Centers of Excellence initiative. This FOA runs in parallel with companion FOAs that seek applications for Research Centers of Excellence (RFA-HD-23-035) and a Data Innovation and Coordinating Hub/Resource Center (RFA-HD-23-036). The Implementation Science Hub will serve as a resource to awarded Maternal Health Research Centers of Excellence Research Centers and collaborate with the Data Innovation and Coordinating hub/resource center.

This FOA seeks applications from investigators with expertise in implementation science research models, including but not limited to implementation science conceptual frameworks, including those emphasizing health equity, and hybrid-effectiveness implementation design, expertise in disseminating information to diverse audiences/ interested parties, integrating implementation related data elements, including needs assessments, process evaluations, and aiding in the design of implementation-focused sub-studies. The Implementation Science Hub will develop and implement a consultation and technical assistance program tailored to the needs of the Maternal Health Research Centers and facilitate in bridging the evidence-to-practice gap to inform integrated efforts involving policy and practice changes to improve pregnancy, perinatal, and postpartum care and advance maternal health and maternal health equity. Expertise in the promotion and equitable dissemination and implementation of evidence-based interventions among underrepresented communities is strongly encouraged.

Background

The collaborative Maternal Health Research Centers of Excellence FOAs represent one part of the multipronged initiative, Implementing a Maternal Health and Pregnancy Outcomes Vision for Everyone (IMPROVE), launched by the NIH in response to the rising rates of MM in the U.S. Over the past 25 years, the MM rate has more than doubled in the U.S. and is now higher than any high-income country in the world. Approximately 700 women die each year from conditions related to or associated with pregnancy or childbirth. In addition, severe maternal morbidities affect more than 65,000 women in the U.S. per year. Women experiencing SMM are at increased risk for future adverse health (e.g., hypertension, diabetes, chronic stress inclusive of historical trauma, mental health conditions, strokes, and heart disease). High rates of maternal deaths disproportionately affect Black/African American and American Indian/Alaskan Native women. There are also disparities by age, education, socioeconomic status, and geographic region.

One-third of pregnancy-related deaths occur during pregnancy, one-third occur during or in the week after delivery, and one third occur between one week to one year postpartum. Causes of SMM and MM are multifaceted. In the U.S., the leading causes are cardiovascular disease, cerebrovascular disease, hemorrhage, infection, hypertensive disorders, and thromboembolism. Significant contributing factors include comorbid conditions (e.g., hypertension, diabetes, immune-mediated diseases, organ-specific diseases, mental illness, and substance use disorders) and social determinants of health, which include structural racism and health care system factors. It is estimated that 60 to 70 percent of maternal deaths in the U.S. are preventable.

The Implementation Science Hub/Resource Center, as part of the Maternal Health Research Centers of Excellence initiative, will facilitate in bridging the evidence-to-practice gap to support the development and implementation of strategies to inform integrated efforts involving policy and practice changes to improve pregnancy, perinatal, and postpartum care and advance maternal health and maternal health equity.

Maternal Health Centers of Excellence Structure

As described above, the Maternal Health Research Centers of Excellence structure will consist of one Data Innovation and Coordinating Hub/Resource Center, one Implementation Science Hub/Resource Center, and up to seven Research Centers. The Innovation and Coordinating Hub, The Implementation Science Hub, and the Research Centers are each integral components of the Centers of Excellence. Success will require close, active cooperation and collaboration to assimilate these elements into a highly effective research structure. Annual Centers of Excellence meetings will be held. The annual meeting will foster the initiation and maintenance of collaborative efforts and resource sharing among the Centers. PD/PIs should budget funds for the PD/PI and one to -two designees to attend an annual meeting in the Bethesda, Maryland / Washington DC area or virtually, if necessary.

Specific Objectives and Scope of this FOA

This FOA seeks applications from investigators with demonstrated expertise in maternal health related implementation science, including but not limited to implementation science conceptual frameworks and hybrid-effectiveness implementation design, expertise in disseminating information to diverse audiences/interested parties, serving as an implementation science consultant, integrating data elements, including needs assessments, leading process evaluations, and aiding in the design of implementation-focused sub-studies.

Specific activities of the Implementation Science Hub include, but are not limited to:

Implementation Research Elements:

• Serve as a key resource to awarded Maternal Health Research Centers and other IMPROVE researchers in planning projects focused on delivering, scaling up, or sustaining proven-effective, evidence-based interventions to address preventable maternal mortality, decrease severe maternal morbidity, and promote maternal health equity in partnership with communities that are most affected (i.e., Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, sexual and gender minorities, socioeconomically disadvantaged populations, and underserved rural populations). Persons with disabilities are also a priority population.
• Conduct a needs assessment with awarded Research Centers and other IMPROVE researchers, as needed, to identify potential challenges to implementation, clarify implementation strategies that are still in process, and provide technical assistance that will support implementation planning and execution. Research Centers and other IMPROVE researchers will be required to implement the intervention for which they are funded (under a separate Funding Opportunity Announcement or Research Opportunity Announcement) within the awarded project period.
• Provide expertise to employ validated, theoretical, or conceptual implementation research frameworks, including but not limited to, 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); and PRECEDE-PROCEED
• To include in Research Center projects implementation outcome measures as appropriate (e.g., acceptability, adoption, appropriateness, affordability, costs, feasibility, fidelity, penetrance, scale-up, sustainability, etc.)
• If needed, suggest appropriate implementation research study designs (e.g., experimental, quasi-experimental, observational, modeling, cluster randomization, stepped-wedge; Type III hybrid effectiveness, etc.)
• Inform understanding of key mediators and mechanisms of action of the implementation, scale-up, or sustainment effort.

Research Skills Development:

• Develop plans/strategies/models for future skills/career development designed to increase research capacity to conduct implementation research in one or more populations that experience maternal health disparities, including but not limited to, Blacks/African American, Hispanics/Latino, American Indian/Alaska Native, Asian American, Native Hawaiian and other Pacific Islander, socioeconomically disadvantaged populations, underserved rural populations (e.g., living in obstetrical deserts), sexual and gender minority (SGM) populations. Persons with disabilities are also a priority population.
• Skills development activities may focus on the development of independent researchers by providing mentorship and support to develop research projects for graduate students, advanced post-doctoral candidates, early career faculty, and investigators who may wish to refocus their careers on implementation research.

Key Definitions

The following key definitions apply:

Implementation Science: The study of methods to promote the integration of research findings and evidence into public health, clinical practice, and community settings. It seeks to understand the behavior of healthcare professionals and other stakeholders as a key variable in the sustainable uptake, adoption, and implementation of evidence-based interventions.

Translation Research: For the purpose of this solicitation, translation research is defined as research that seeks to study, in a scientifically rigorous way, the best methods to reach clinicians, patients, healthcare systems, and populations to ensure that evidence-based preventive interventions and treatments are delivered effectively and sustained.

Common Data Elements:Common data elements (CDEs) are a type of health data standard that is commonly used and reused in both clinical and research settings. CDEs provide a way to standardize data collection ensuring that data are collected consistently, and otherwise-avoidable variability is minimized.

Populations that experience health disparities: Populations defined in section 464z-3(d)(1) of the Public Health Service Act, 42 U.S.C. 285t(d)(1) as health disparity populations based on higher overall rates of disease incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general population. Populations that experience maternal health disparities, include but are not limited to, Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations (e.g., living in maternity care deserts), or sexual and gender minority (SGM) populations. Persons with disabilities are also a priority population.

Community organization: A non-Federal, non-academic organization that provides goods, services, support, resources, or advocacy to members of a defined community. Examples include community or faith-based organizations, local businesses, neighborhood associations, labor unions, patient or consumer advocacy groups, public health departments, healthcare systems, school systems, law enforcement or criminal justice agencies, social service agencies, or departments of commerce, labor, transportation, housing, recreation. Governmental organizations at the local, regional, tribal, or state level fall within this definition.

Rural: For the purposes of this FOA, the follow areas are defined as rural: non-metro counties; all metro census tracts with RUCA codes 4-10; large area Metro census tracts of at least 400 sq. miles in area with population density of 35 or less per sq. mile with RUCA codes 2-3; and all outlying metro counties without an Urbanized Area (UA).

Pregnancy-associated mortality:Death while pregnant or within one year of the end of the pregnancy, irrespective of cause. This is the starting point for analyses of maternal deaths.

Pregnancy-related mortality:Death during pregnancy or within one year of the end of pregnancy from a pregnancy complication; a chain of events initiated by pregnancy; or the aggravation of an unrelated condition by the physiologic effects of pregnancy. Used by the Centers for Disease Control and Prevention (CDC) to report U.S. trends, this measure is typically reported as a ratio per 100,000 live births.

Maternity care desert: Maternity care deserts are counties in which access to maternity health care services is limited or absent, either through lack of services or barriers to a woman's ability to access that care within counties. A maternity care desert is any county in the United States without a hospital or birth center offering obstetric care and without any obstetric providers. Low access to appropriate preventive, prenatal and postpartum care is defined as counties with one or fewer hospitals or birth centers that provide obstetric care, few obstetric providers (fewer than 60 per 10,000 births) or a high proportion of women without health insurance (10 percent or more). Moderate access to care is defined as living in a county with access to few hospitals/birth centers or obstetrical providers and adequate health insurance coverage (less than 10 percent of women of reproductive age uninsured). Full access to maternity care can be defined by availability of hospitals or birth centers providing obstetric care and availability of providers offering obstetric care.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

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

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 Government

• 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

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.

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.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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 SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women 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 PD/PI should be an established investigator with expertise in implementation science conceptual frameworks and hybrid-effectiveness implementation design, expertise in disseminating information to diverse audiences/interested parties, serving as an implementation science consultant, integrating data elements, including needs assessments, leading process evaluations, and aiding in the design of implementation-focused sub-studies.

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, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

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:

Nahida Chakhtoura, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6872
Email: nahida.chakhtoura@nih.gov

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

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

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

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

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

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

R&R Budget

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

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

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

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

Research Strategy: A typical research strategy description is not expected as part of the Implementation Science Hub application.

Applicants must:

• Describe plans for how the Implementation Science Hub will serve as a key resource to awarded Research Centers and other IMPROVE researchers in planning projects focused on an implementation aspect of delivering, scaling up, or sustaining proven-effective, evidence-based interventions to address preventable maternal mortality, decrease severe maternal morbidity, and promote maternal health equity in partnership with communities that are most affected (i.e., Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, sexual and gender minorities, socioeconomically disadvantaged populations, and underserved rural populations). Persons with disabilities are also a priority population.
• Propose an operational structure for providing and coordinating implementation science functions for multiple research studies simultaneously, including lines of responsibility for staff. Describe plans to meet timelines efficiently when managing multiple priorities for awarded Research Centers and other IMPROVE researchers.
• Describe experience in promoting collaborations such as those proposed across maternal health Research Centers and the Coordinating Hub/Resource Center.
• Describe experience with recommending implementation measures as outcome measures (e.g., acceptability, adoption, appropriateness, affordability, costs, feasibility, fidelity, penetrance, scale-up, sustainability, etc.)
• Include a description of prior projects applicable to the aims of this FOA including but not limited to implementation research study designs (e.g., experimental, quasi-experimental, observational, modeling, cluster randomization, stepped-wedge; , etc.)
• Propose plans to ensure that personnel possess and/or acquire required skills, as needed.
• Include a description of plans/strategies/models for future skills/career development designed to increase research capacity to conduct implementation research in one or more populations that experience maternal health disparities, including but not limited to, Blacks/African American, Hispanics/Latino, American Indian/Alaska Native, Asian American, Native Hawaiian and other Pacific Islander, socioeconomically disadvantaged populations, underserved rural populations (e.g., living in obstetrical deserts), sexual and gender minority (SGM) populations. Persons with disabilities are also a priority population.
• Skills development activities may focus on the development of independent researchers by providing mentorship and supporting research development projects for graduate students, advanced post-doctoral candidates, early career faculty, and investigators who may wish to refocus their careers on implementation research.

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:

NICHD Plans for Sharing Human and Non-Human Data and/or BiospecimensNICHD expects that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner, per NIH Policy, as amended.

NIH Data Management and Sharing Policyexpects the timely release and sharing of data to be no later than the time of an associated publication, or the end of the award/support period, whichever comes first. Per the Policy, all applications, regardless of the amount of direct costs requested for any one year, are required to include a Data Management and Sharing Plan ( the Plan ) in the Overall component of the application outlining how scientific data and any accompanying metadata will be managed and shared, regardless of whether the data are used to support scholarly publication.

Specific Plan for Data Sharing: Consistent with achieving the goals of this program, the NICHD expects that information such as collected data, technical protocols, and any other metadata collected under this FOA is to be deposited as appropriate into existing, publicly available data repositories that are easily accessible, and in machine readable format.

For human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. Where appropriate, applicants should identify such repositories and plans for deposition. If applicants are proposing research within Indian Country or tribal communities, they must must propose a data sharing plan that respects and enforces principles and practices of Tribal data sovereignty. The applicant is required to propose a data sharing plan that includes a description of how the Maternal Health Centers of Excellence will work with PD s/PI’s and respect sovereignty-based data management and sharing requirements.

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.

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.

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

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.

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit 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 fieldof the Senior/Key Person Profile form. 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 unique entity identifier provided on the application is the same identifier 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.

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.

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 [Center] address the needs of the research [programs/projects/network/consortium/resource] that it will [coordinate/administer/serve]? Is the scope of activities proposed for the [Center] appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research [program/projects/network/consortium/resource]?

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:

To achieve the purpose and objectives of the Centers of Excellence, how well does the application meet the needs of the Implementation Science Hub in terms of:

• Demonstrating an understanding of dissemination and implementation research principles?
• Delivering, scaling up, or sustaining effective implementation science interventions to the COE Research Centers and their research communities and to other IMPROVE researchers to address the maternal mortality and morbidities issues outlines in this FOA?
• Assisting CoE Research Centers and IMPROVE researchers to partner with the communities most affected by these issues (i.e., Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, sexual and gender minorities, socioeconomically disadvantaged populations, underserved rural populations, and persons with disabilities)?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Implementation Science Hub? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing implementation science research? Do the investigators demonstrate significant experience with coordinating collaborative implementation science research? If the 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 Implementation Science Hub? Does the applicant have experience overseeing selection and management of subawards, if needed?

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:

To achieve the purpose and objectives of the Centers of Excellence, how well does the applicant’s team meet the needs of the Implementation Science Hub in terms of:

• Clear evidence of dissemination and implementation research expertise?
• Ability of the PD(s)/PI(s) to serve as an implementation science consultant to the Research Centers integrating data elements, developing needs assessments, leading process evaluations, aiding in the design of studies, and developing implementation measures as outcome measures (e.g., acceptability, adoption, appropriateness, affordability, costs, feasibility, fidelity, penetrance, scale-up, sustainability, etc.)?
• Demonstrating experience in fostering collaborative environments, such as those proposed across the maternal health Research Centers and Data Innovation Hub?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research projects the Implementation Science Hub 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?

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:

To achieve the purpose and objectives of the Centers of Excellence, how significant are the applicant’s innovations for:

• Special strengths that will enhance the success of the Centers of Excellence?
• Innovative methods for increasing research capacity to conduct implementation science, particularly in one or more of the populations that experience maternal health disparities?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research projects the Implementation Science Hub will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the projects, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the overall program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the project activities? 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?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

Specific to this FOA:

To achieve the purpose and objectives of the Centers of Excellence, how adequately does the applicant meet the following requirements:

• A track record in implementation research study design, as well as other areas relevant to the aims of this FOA?
• Capability to develop the skills and research capabilities and support the projects of researchers across the education/career spectrum from graduate students to established investigators refocusing on implementation research?
• A willingness to work and cooperate with the Centers of Excellence Research Centers, the Data Innovation Hub, study investigators, and NICHD staff in a manner summarized in this FOA?
• Procedures ready to meet the NIH Data Sharing requirements, including de-identification and documentation of datasets? Procedures to ensure rapid release of data, including metadata, in a way that will be useful to the community? A commitment to work within the Centers of Excellence to develop and adopt policies relating to data quality?

Environment

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

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:

To further the Centers of Excellence’s purpose and objectives, how well does the application demonstrate:

• Adequate resources to conduct the proposed activities?
• How it will foster a culture of transdisciplinary collaboration and inclusiveness, both within the center's team and with the research community?

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)?

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

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) Sharing Model Organisms; and (2) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

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.

• 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.

Recipients 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 recipient 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, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, 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 (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of the 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, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's 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 reside with the recipient for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

• The planning, direction, and execution of the proposed research, including definition of objectives and approaches; implementation; data management and analysis, interpretations and publication of results;
• Participating in the planning for meetings of the Maternal Health Centers of Exellence award recipients, to focus on infrastructure building, community participation, study initiation, and study results;
• Making drafts of manuscripts available for review (electronically) to the NIH Project Scientists and other NIH staff at the time they are circulated to coauthors and when the final manuscripts are submitted for publication. This ensures the program can maintain an up-to-date summary of program accomplishments and can prepare for press releases of findings if warranted;
• Recipients 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:

During the performance of the award, the NIH Project Scientists, with assistance from other NIH scientific staff will provide appropriate assistance, advice and guidance in the design of the activities; the analysis of data; management and technical performance, and the preparation of publications. The Project Scientists will serve as liaison/facilitators between the recipient, the pharmaceutical and biotechnology industries, and other government agencies (e.g., FDA, USDA, and CDC) and will serve as a resource for scientific and policy information related to the goals of the awardee's research.

The NIH Project Scientist will additionally:

• Monitor study results and quality assurance across all research sites to ensure the production of high-quality, unbiased results;
• Monitor progress towards study goals and achievement of study timelines
• Facilitate access to technical resources to increase harmonization and interoperability of study datasets

The NICHD Program Official will additionally:

• Take responsibility for the normal scientific and programmatic stewardship of the award and will be named in the award notice; these responsibilities include:
• Enforcement of general statutory, regulatory, or policy requirements;
• Approval of recipient plans prior to award and review of performance after completion;
• Evaluation of progress by reviews of technical or fiscal reports, site visits, or external consultants, to determine that performance is consistent with the terms and conditions of the award;
• Technical assistance requested by recipients or unanticipated procedures to correct programmatic or financial deficiencies in recipients' performance;
• Scientific/technical discussions with recipients, or actions to facilitate or expedite interactions between recipients, e.g., organizing and holding meetings of investigators;
• The option to halt a project if technical performance and/or objectives are not met;

Areas of Joint PD/PI and NIH staff Responsibility include:

• Develop a data structure that results in a findable, accessible, interoperable, and reliable dataset to be made available for controlled access public use at the end of the program;
• Coordinate and facilitate access to datasets for all approved internal and external research collaborators;
• Provide input and generate research presentations and publications of data (PD/PI and NIH Project Scientist).

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, recipients 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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.

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: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Nahida Chakhtoura, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6872
Email: nahida.chakhtoura@nih.gov

Jennifer Alvidrez, PhD
Office of Disease Prevention (ODP)
Telephone: 301-827-0071
Email: Jennifer.alvidrez@nih.gov

Afrouz Azari Anderson
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone: 301-496-4558
E-mail: afrouz.anderson@nih.gov

Deidra Roach, M.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-443-5820
E-mail: droach@mail.nih.gov

Leslie Jean Marshall Ph.D.

Office of AIDS Research

Phone: 301-402-1839

Email: leslie.marshall@nih.gov

Keisher’s Highsmith
National Institute on Drug Abuse (NIDA)
Phone: 301-402-1984
E-mail: keisher.highsmith@nih.gov

Mercy PrabhuDas, Ph.D., M.B.A.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3534
Email: mprabhudas@niaid.nih.gov

Gina Wei
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-435-0416
E-mail: weig@nhlbi.nih.gov

Elena K Gorodetsky, M.D., Ph.D.
Office of Research on Women's Health (ORWH)
Phone: (301) 594-9004
E-mail: egorod@mail.nih.gov

Beda Jean-Francois
National Center for Complementary & Integrative Health (NCCIH)
Phone: 202-313-2144
Email: beda.jean-francois@nih.gov

Lillian Shum
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: 301-594-0618
E-mail: shuml@mail.nih.gov

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: christopher.barnhart@nih.gov

Tamara Lewis Johnson, MPH, MBA
National Institute of Mental Health (NIMH)
Telephone: (301) 594-7963
Email: tamara.lewisjohnson@nih.gov

Rada K Dagher
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-451-2187
E-mail: rada.dagher@nih.gov

Yewande A Oladeinde
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-402-1366
E-mail: yewande.oladeinde@nih.gov

Abee Boyles, PhD
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984-287-3241
E-mail: boylesa@mail.nih.gov

Jyoti Dayal
National Human Genome Research Institute (NHGRI)
Phone: 301.480.2307
E-mail: jyotig@nhgri.nih.gov

Jean Marie Lawrence, Sc.D., M.P.H., M.S.S.A.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: (301) 435-6243
E-mail: jean.lawrence@nih.gov

Soju Chang
National Center for Advancing Translational Sciences (NCATS)
Phone: (301) 827-9206
E-mail: changsoju@mail.nih.gov

Patricia A. Haggerty, Ph.D.

Office of Dietary Supplements (ODS)

Tel: 301-529-4884

Email: patricia.haggerty@nih.gov

Sung Sug (Sarah) Yoon, RN, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: sungsug.yoon@nih.gov

Argenia Doss, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
301-827-1373
argenia.doss@nih.gov

Center for Scientific Review (CSR)
Email: FOAReviewContact@csr.nih.gov

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov

Katie Ellis
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone: 301-451-4791
E-mail: kellis@mail.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: (301) 443-4704
E-mail: jfox@mail.nih.gov

Pamela G Fleming
National Institute on Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Annmarie Brasilemejac
National Heart, Lung, and Blood Institute (NHLBI)
Phone: (301) 827-8016
E-mail: brasilea@nhlbi.nih.gov

Diana Rutberg
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: dr258t@nih.gov

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: tjarosik@mail.nih.gov

Priscilla Grant
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: pg38h@nih.gov

Jenny L Greer
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984.287.3332
E-mail: jenny.greer@nih.gov

Natasha Loveless
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-594-8853
E-mail: lovelessnd@mail.nih.gov

Randi Freundlich
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
Email: freundlichr@mail.nih.gov

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.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.

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.