Part 1. Overview Information

Key Dates

No late applications will be accepted for this Notice of Funding Opportunity.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) 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. Notice of Funding Opportunity Description

Purpose

The purpose of this initiative is to support the Specialized Centers for Research on Health Disparities in Uterine Leiomyoma (SCHDULs; hereafter referred to as Centers ; uterine leiomyomas, fibroids or UF are terms used interchangeably here). These multidisciplinary consortia will incorporate basic, translational, and/or clinical studies (excluding clinical trials, see Does Your Human Subjects Research Study Meet the NIH Definition of a Clinical Trial?) in a collaborative center to accelerate research advances in health disparities in uterine fibroids through sharing of knowledge and resources. Increased research is urgently required to improve our understanding of the biologic, behavioral, environmental, and structural differences in risk, diagnosis, disease progression, and treatment (including treatment choice, awareness of treatment options, and treatment outcome) [the entirety of these differences are collectively referred to as health disparities in uterine leiomyomas in this NOFO] that lead to the demonstrated health disparity in fibroids; this research will forge a path towards greater health equity in diagnostics, treatments, and ultimately cures. For the purpose of this NOFO, the focus of the fibroid disparity research MUST include disparities experienced by Black/African American women as compared to White women.

Initiative Background

By age 50, most women will have had uterine leiomyomas with a lifetime cumulative incidence of ~70% for white women and 80-90% for Black women. UF symptoms include heavy menstrual bleeding and gushing that can lead to anemia; pelvic pain and pressure; urinary and bowel problems as the growing tumors press on the bladder and bowels; infertility; and adverse pregnancy outcomes as the birth canal becomes obstructed and the uterus becomes highly distorted. Additionally, fibroid burden can extend beyond physical symptoms; some women with the condition experience significant distress that negatively affects quality of life, including depression, anxiety, and body image concerns. UFs are the most common reason for hysterectomy.

UFs also represent arguably the largest health disparity in gynecologic health. African ancestry is one of the most consistent risk factors for UF.

Black/African American women in the US:

• Are diagnosed with fibroids at about 3x the rate of White women.
• Present with UF at younger ages (and are more likely to develop fibroids before they get pregnant/attempt pregnancy) than White women: nearly a quarter of Black women between 18 and 30 have fibroids compared to about 6% of White women, according to some national estimates.
• Present with more severe disease than White women: Black women on average have faster growing fibroids, develop a greater number of fibroids, and are 2-3x more likely to have recurring fibroids.
• Present with more severe symptoms than White women: Black women on average are more likely to experience heavy menstrual bleeding, 3x more likely to develop anemia secondary to heavy menstrual bleeding, more likely to require blood transfusions due to their fibroids, more likely to be hospitalized due to their fibroids, twice as likely to struggle with infertility, suffer from severe symptoms more often, and report menstrual pain and cramping and mental health detriments more often than White women.

Many of these disparities are impacted or exacerbated by health disparities in access to care, decision-making regarding treatment regimens, and experience in the healthcare system. While treatments are usually equally effective in Black and White women, Black women are:

• 2-3x as likely as White women to remove their uterus through a hysterectomy. A third of hysterectomies are done during peak childbearing years between ages 18 and 44. Despite minimally invasive options, Black women continue to dominate the percentages of women having hysterectomies for benign disease.
• 7x more likely to have a myomectomy (a surgical procedure to remove the fibroid but retain the uterus).
• 2x more likely to experience post-surgical complications.
• More likely to experience delayed diagnoses.
• More likely to have complaints of symptoms (bleeding, pain, etc.) not taken seriously.
• Less likely to self-treat for fibroid symptoms, potentially implicating a greater misconception about what is considered normal levels of uterine bleeding.

Despite the enormity of this proven health disparity across every aspect of the experience of uterine fibroids, the reasons for the disparity are still unclear. Fibroids have been associated with potential risk factors, including starting periods at younger ages, obesity, stress, and lower vitamin D levels. There are several of these possible risk factors that may be more prevalent among Black women that could contribute to the growth and substance of tumors, but none of these factors have been proven to cause fibroids. More data is needed to better understand why Black women get fibroids more frequently and with more severity and why their treatment choices, options, and outcomes differ.

Research Scope

The scope of this NOFO includes basic, translational, clinical, behavioral, and social science projects that will: 1) enhance our understanding of the etiology, pathophysiology, and progression of fibroids and how these differ in NIH-designated populations that experience health disparities (especially racial/ethnic groups, see definition of health disparity populations in Key Definitions section below) and/or 2) enable the development of more effective strategies for the diagnosis, management, and prevention of this disorder that directly impact demonstrated disparities. New treatment modalities are of great interest but are expected to be unlikely to be ready for clinical trial during the period of this NOFO; clinical trials are therefore not allowed in response to this NOFO.

To stimulate novel approaches, it is anticipated that key personnel in complementary disciplines (e.g., biology, medicine, nursing, environmental science, public health, behavioral and social science, biostatistics/statistics, mathematics; computer science, engineering) and community partners will jointly design projects to investigate health disparities in uterine fibroids and identify preventable contributors to these disparities. In addition to demonstrating disciplinary diversity of the team, applications submitted in response to this NOFO must submit a Plan for Enhancing Diverse Perspectives (PEDP). The PEDP will demonstrate how diverse perspectives will be obtained throughout the course of the project and will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

Overall Organization of Each Center

Organization

Each Center must consist of a multidisciplinary research team of investigators, led by one or more Center Directors. Applicants are required to propose at least three research projects. All projects must be thematically integrated.

Centers three or more projects may be:

• Entirely behavioral and/or social research projects (BSSR; projects in which one or more of its specific aims include understanding and/or modifying behavioral or social phenomena relevant to health, see full definition of BSSR under Definitions heading below).
• A mix of basic and/or clinical projects (excluding clinical trials). In such a setup, one of the projects must be basic and one entirely or predominantly translational/clinical.
• A mix of social and/or behavioral, basic, and/or clinical projects (excluding clinical trials).

Centers MAY NOT have projects that are all basic research or all clinical/translational research. Consistent with the NIH definition, clinical research must be conducted with human subjects or on material of human origin such as tissues and other biological specimens; clinical trials are NOT allowed in this NOFO. Basic research projects should be consistent with the following definition: A systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts that does not involve direct observation of or intervention in human subjects.

Each Center will maintain, in addition to the three research projects, an administrative core and an education/outreach core.

Center Director [Program Director/Principal Investigator (PD/PI)] and Leadership

The Center Director [Program Director/Principal Investigator (PD/PI)] will be responsible for scientific and administrative oversight of projects and cores of the Center. The PD/PI (the PD/PIs at the prime institution if a multi-PI application) must devote at least 2.4 person months (20%) of full-time professional effort to the program.

Although multiple PD/PI applications are not required, multi-investigator, collaborative, interdisciplinary applications are highly encouraged to ensure that the most effective and comprehensive computational and experimental approaches are applied to address the biological problem. Research partnerships with investigators with expertise outside the field of gynecologic health are highly encouraged to expand the potential scientific insight and investigational toolkit available to the field. Research teams should be designed as follows:

• Each team member brings specific expertise to address the research problem.
• The team meets regularly (virtually or in person at least monthly or in greater frequency, as needed) to discuss team goals, objectives, next steps, and/or protocols.
• The team shares leadership responsibility, decision-making authority, and data.

Administrative Core

The Administrative Core will manage and coordinate the Center’s research activities between projects, other components, and NIH program staff. It will also be responsible for providing and conducting all oversight for integrating all sets of data generated by each of the cores and projects with consistency.

Community Partnership, Education, and Outreach Core

Centers are required to partner with community collaborators, which may include but are not limited to health systems, state and local public health agencies, prison bureaus, community-based organizations (see definition of community organizations in key definitions section below), community health centers, and faith-based organizations. The proposed research team may include senior and junior faculty, pre- and post-doctoral and other trainees, and community members, all with appropriate justification.

Community partnership is expected from the Center's inception. Community partnership projects may be full-scale projects or more exploratory/developmental projects, but all projects must be fully developed with detailed research plans at the time of application. There should be synergy between the research projects such that there is added value to conducting them as interrelated rather than independent projects. Therefore, planning-phase studies, in which the topic or study design is determined after award because of community and collaborator input, will not be supported.

A cooperative partnership between the proposed Center and the community partner(s) in each stage of the research process (concept, implementation, evaluation, and dissemination) must be clearly demonstrated.

This Core must also support a community education outreach effort to increase awareness about uterine fibroids as a disorder, as well as the implications of their research activities to the general public and health-care professionals, especially among demonstrated health disparity populations and their providers. This may take a range of forms as desired and appropriate for the goals of the Center. As examples, activities could include development of local educational forums, student research internships, or participation in national advocacy efforts. Funds of at least $50,000/year should be allocated to this effort.

Pilot Awards

Centers should serve as national resources for the career development of young scientists electing to pursue careers in this field. The inclusion of junior investigators in the proposed research projects and/or cores is strongly encouraged. The inclusion of small pilot funds of $50,000/yr is required. These pilot projects must be awarded to PIs that are Early Stage Investigators (ESI) as defined by NIH. These pilot awards should be included as part of the administrative core budget with a clear plan for the choice of project(s) and recipients.

Collaboration with NIH and between Centers

Close interactions among the awardees and NIH will be required to ensure successful execution of the projects proposed with each Center. In addition to the evaluation of yearly progress reports detailing program accomplishments, Center project investigators should plan to meet (virtually is acceptable) AT LEAST quarterly with NIH staff and personnel from all awarded Centers to share results and discuss potential areas of collaboration across Centers. These meetings will be attended by NICHD staff to gauge progress and evaluate developing research directions and will be arranged by the award recipients (including providing slides at least 48 hours prior to the meeting).

Projects of high priority for this NOFO include but are not limited to:

• Innovative multi-disciplinary approaches including bioinformatic expertise in artificial intelligence (machine learning, computer-based modeling, and simulation) leading to an integrated model of fibroid risk stratification and development of decision aid tools for shared decision making, with an emphasis on approaches/models that balance ethical concerns as there is a potential for AI/ML tools to exacerbate existing health disparities.
• Research to identify and address the complex biological, genetic, behavioral, nutritional, environmental, sociocultural, structural and health system determinants of fibroid health disparities, as well as identifying factors that contribute to optimal outcomes in high-risk communities.
• Communication science research to develop and evaluate culturally appropriate messaging regarding symptoms, risk factors, and treatments for uterine fibroids through engagement with community partners.
• Projects to identify and validate molecular targets for the development of fibroid treatments, especially those designed to address known racial or ethnic differences or study cultural aspects to maximize treatment impact or uptake.
• Development and utilization of innovative in vitro, in vivo, and ex vivo model systems that recapitulate aspects of the condition, including organoid and tissue-on-a-chip approaches. All models should balance ethical concerns such as cost, access, and source materials, as there is a potential for this technology to exacerbate existing health disparities.

Projects of lower priority for this NOFO include but are not limited to:

• Studies with a primary focus on co-morbid conditions (e.g., anemia, depression).
• Descriptive epidemiologic studies to estimate the incidence/prevalence of fibroids (Exploratory epidemiologic research to identify potential causal mechanisms for further research IS allowed.)

Specific Areas of Research Interest for ORWH: The Office of Research on Women's Health (ORWH) works in partnership with the 27 NIH Institutes and Centers to advance women's health research.

For this NOFO, ORWH encourages interdisciplinary research on the etiology, symptoms, and treatment of uterine leiomyoma. Studies focused on populations of women historically understudied, underrepresented and underreported in biomedical research are of particular interest. ORWH encourages the incorporation of intersectionality into research design, methods, and analysis by applying the NIMHD Minority Health and Health Disparities Research Framework.

Topics of interest include, but are not limited to:

• Research focused on the etiology of uterine leiomyoma; and the risk factors associated with the development of symptoms.
• Research exploring the role of social determinants of health and structural factors in perpetuating health inequities in prevention, diagnosis, and treatment of uterine leiomyoma.
• Research exploring the causes of differences in entry, utilization, and retention of health care services and treatment adherence among understudied, underrepresented, and underserved populations of women (e.g., intersectional stigma) with uterine leiomyoma.

Projects must align with at least one of the strategic goals and objectives outlined in the 2019-2023 Trans-NIH Strategic Plan for Women's Health Research.

ORWH does not award grants but co-funds women’s health-related applications and research projects that have received an award from one of the participating NIH Institutes and Centers (ICs) listed in the announcement.

Non-responsive Projects:

Projects that will be considered non-responsive to this NOFO include but are not limited to:

• Clinical trials, as defined by NIH.
• Studies that examine any aspect of fibroids primarily (a majority of aims) in the context of their impact on fertility or infertility. For example, projects with a majority of aims related to racial differences in IVF or pregnancy outcomes in the presence of fibroids would be considered nonresponsive.
• Studies that focus on any of these conditions primarily (a majority of aims) as they relate to a malignant condition. For example, projects with a majority of aims related to racial differences in the comorbidity of leiomyosarcoma in the presence of fibroids would be considered nonresponsive.
• Projects that focus on fibroid health disparities, but do not include disparities experienced by Black/African American women as compared to White women.

Leveraging Existing Research Resources:

Applicants are strongly encouraged to leverage existing research resources for their studies whenever possible, understanding that many existing resources may lack adequate racial and/or ethnic representation and therefore may not be appropriate for the goals of this NOFO. Resources may include, but are not limited to, access to tissue/biospecimen banks to source healthy and diseased tissues/biospecimens with validated and reliable clinical and genotype information and/or existing ongoing large and/or longitudinal cohorts. Collaborations among academic researchers, clinicians and/or patient advocacy groups and industry are expected and encouraged.

Pre-Application Consultation:

Applicants are strongly encouraged to consult with NIH Scientific and Program Staff indicated in Section VII. Agency Contacts early in the planning of an application, i.e., more than two months before the application due date. This early contact will provide an opportunity to discuss and clarify NIH policies and guidelines, including the scope and goals of the project, and intent of this NOFO.

NICHD Data and Resource Sharing Expectations and Requirements

NICHD 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. The NIH Policy for Data Management and Sharing (Policy) expects scientific data to be made accessible as soon as possible and no later than the time of an associated publication or the end of the award period, whichever comes first. NIH requires all applications submitted in response to this NOFO to include a Data Management and Sharing Plan (Plan). The Plan is expected to address the Elements as described in Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan (NOT-OD-21-014). The Plan will be reviewed and approved by NIH Program Staff prior to award. Awardees will be required to comply with their approved Plan and any approved updates.

For human data, 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. Information about DASH may be obtained at https://dash.nichd.nih.gov/. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP and the Sequence Read Archive, in line with the NIH Genomic Data Sharing Policy. If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories. Researchers can submit information about the location and availability of data in other repositories and biospecimens to the DASH Catalog, if applicable.

For applications that aim to co-analyze already shared data with data that have not yet been shared with the broader research community, applicants must describe in their DMS Plans how such primary data will be shared with the broad research community.

Additional information on the Data Management and Sharing Policy is available on the NICHD Office of Data Science and Sharing website.

Key Definitions

The following key definitions apply:

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. For the purpose of this NOFO, the focus of the fibroid disparity research MUST include disparities experienced by Black/African American women as compared to White women. Intersectionality of other demographic characteristics, such as ethnicity, geographic location, socioeconomic status, sexual and/or gender identity, disability status, etc. may be included, as long as the racial disparity above is also examined.

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, community health centers, 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.

Behavioral and social sciences research (BSSR): The NIH definition of BSSR involves the systematic study of behavioral^I and social^II phenomena relevant to health^III. ^I Behavioral phenomena refers to the observable actions of individuals or groups and to mental phenomena such as knowledge, attitudes, beliefs, motivations, perceptions, cognitions, and emotions. ^II Social phenomena refers to the interactions between and among individuals, and to the characteristics, structures, and functions of social groups and institutions, such as families, communities, schools, and workplaces, as well as the physical, economic, cultural, and policy environments in which social and behavioral phenomena occur. ^III Health refers to state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity (as per WHO).Definition from https://obssr.od.nih.gov/about/bssr-definition.

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

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 NOFO.

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 Governments

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

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

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

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

Applicant organizations

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

• 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 Grants.gov registration; 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. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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 NOFO 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 or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this notice of funding opportunity to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:

Candace Tingen, PhD
Telephone: 301-435-6971
Email: candace,[email protected]

Page Limitations

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing a multi-component application.

Overall Component

When preparing the application, use Component Type Overall .

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Please include additional information for the fields described below:

Other Attachments:

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: Not Applicable

Specific Aims: Describe the broad objectives and goals of the proposed Center. Include the objectives for each of the Components.

Research Strategy: This section will address the objectives and identify the focus or theme of research addressed in the proposed projects and how the projects will interrogate, address and/or reduce health disparities in uterine fibroids. This Research Strategy also provides a sense of the overall significance of the Center, i.e., any unique resources it provides that will impact communities affected by uterine fibroids and the research to be addressed. For the purposes of this NOFO, the research community includes the investigators and their community partners who will establish the Center. Members of the Center may work in the same field or related fields and interact through common meetings, collaborations and shared activities and resources. This section should describe the research community, as well as the significance, approach, and innovation of the Center proposed projects as well as the planned interactions among the Center investigators and their community partners. It should also include a summary of how the efforts of this Center will avoid duplicating institutional, local, or national efforts.

The Research Strategy section of the Overall Component should be organized in the following fashion.

Orientation to the Overall Center
Describe the goals of the Center and the proposed projects. Describe the scientific, organizational and management structure. Include the leadership structure and the individual components, including meaningful and equal community partnership throughout the research development process and training. Include the theme or focus, the research field(s) and the Research Center, any needs assessments that were conducted that led to the selection of project(s) to be developed, and unique aspects of the resources and services being offered by the components. Applications must describe coordination, interrelationships, cohesiveness, and synergy among the research projects and cores as they relate to the common theme of the Center. Provide a brief summary of prior experience pertinent to this application. Applications must address the Center's potential to have a lasting and important impact on its affected community and the topic of focus. Applications must describe an adequate approach or strategy to engage communities (i.e., an effective plan for outreach/training activities that addresses the biological, behavioral, environmental, sociocultural, and/or structural factors that affect health disparities in uterine fibroids).

Research Community
Present an overview of ongoing research on the topic/projects of focus of the Center in sufficient detail such that its extent and the interrelationships of ongoing research are clear. A strong multi-disciplinary research community is a fundamental requirement for establishing a Center. Describe the multidisciplinary research team of investigators, led by one or more Center Directors and how different disciplines will be incorporated in the research, as required. The research community should be composed of funded investigators and community partners with well-defined connections to the focus or theme of the Center and the communities they serve. Applications must demonstrate a strong/collaborative community health partner of sufficient size that the Center can make a major impact on research in the field. Begin with a brief summary of the investigators in the research community and their strengths and continue with a descriptive narrative of how the components can enhance these projects. This narrative presentation should be organized to address the focus and interrelationships of research conducted by the Center investigators (including the research community investigators and researchers leading and staffing the components) and how the research interests of the investigators in the research community are related to the focus or theme of the Center. Criteria for designating an investigator as a Center investigator should be defined in terms of the responsibilities and privileges. Applications must describe effective mechanisms proposed for regular communication and coordination among investigators in the Center, especially for those who may not be at the primary site of the Center. Applications must also describe a coordinated Center-wide plan to encourage and support early-stage investigators in pursuing a career in fibroid research. It is required to describe timelines and milestones in place that will allow an evaluation of progress to be made.
The investigators from the research community of the proposed Center may be documented in greater detail in the Biographical Sketches and Letters of Support. If the Letters of Support and/or Biographical Sketches are used in this way, they should be explicitly referenced within this section. It may also be useful to highlight ongoing and past successful collaborations between investigators in the research community and the Center personnel and to document the outcomes (e.g., publications, grants, major scientific advances, etc.) of these collaborations.

Innovation
Address how the Center will not only evolve with the science, but also challenge and seek to advance or change current research or clinical practice paradigms by using novel theoretical concepts, approaches or methodologies, instrumentation, or interventions. If applicable, describe plans to develop or adapt new and/or unique state-of-the-art services through technology development and/or adaptation of technologies to meet the needs of the communities served by the Center. Explain how the synergy of the Center with the research community will lead to novel services and resources in the components and their application to important questions on the topic of focus. Describe the potential for interdisciplinary collaborations among the Center investigators as well as the Innovative Data and Implementation Science Hub. If the proposed research by its nature is not innovative, describe how it is essential to advance the field. Applications must describe advantages of conducting the proposed research as a program rather than through separate research efforts and how research efforts taken together will have more impact on the field than each separate project conducted in isolation.
Approach
This section should expand on the goals of the Center and should describe the proposed projects/topics of focus of research and their effects on the communities served (i.e., describe how the Center will address the scientific needs of the community). Explain the degree to which the Center is expected to accelerate progress on the aims of the research community grants and projects, improve efficiency and enhance productivity of the research community investigators. If applicable, describe how the proposed Center will make existing resources broadly available to the research community, leverage existing resources, and fill gaps in the services available.

Environment
Describe the importance of the resources being shared and the expected effect of providing access to those resources. Describe how the Center aims to expand and enhance the capabilities of the pool of investigators engaged in research related to the research topic(s). For a Center that provides access to a unique highly specialized resource, provide examples of research projects that would be enabled and/or significantly enhanced by access to that resource. Leveraging of existing resources is encouraged, particularly when this provides a range of services or efficiency or access to resources that would not otherwise be readily available. Applicants from institutions that have a Clinical Translational Science Award (CTSA) funded by the NIH may wish to identify the CTSA as a resource for conducting the proposed research, if appropriate. Provide details of any interactions between Center staff and CTSA staff and/or research personnel describing collaborative linkages being developed. Applications must describe administrative structures in place for the day-to-day management of the Center, including arrangements for internal quality control of ongoing research, identification and evaluation of pilot projects, and conflict resolution.

Letters of Support: Include any letters of support for the proposed Center by appropriate institutional officials of each performance site. These letters should include commitments of space and other resources required by the Center. A letter of agreement from existing resources should be included here if collaborative linkages are being developed between the Center and existing resources. Letters from the investigators of the research community may be provided to document their research interests, current or planned interactions with other Center investigators, the need for and impact of shared resources proposed by the Center, and likely use of Center resources. A table listing the individuals providing the letter of support and their institution is requested.

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.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form (Overall)

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

Administrative Core

When preparing your application, use Component Type Administrative Core.

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Pilot projects - $50,000 direct costs per year must be requested to support pilot projects.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims: Include a brief list of Specific Aims outlining the objectives and functions of the Administrative Core.

Research Strategy: The Administrative Core will provide oversight for the Cores and Research Projects and will promote coordination and collaboration within the program and with investigators and organizations outside the program. The Research Strategy should describe the planning and coordination of research activities, the integration of cross-disciplinary research, allocation of funds, management of resources and quality control, the maintenance of ongoing communication, and plans for evaluation of the Center by internal or external advisory committees. Indicate who will be responsible for each of these activities.

Provide the following information:

1) Objectives of the Administrative Core

2) Staffing: Description of administrative, scientific, technical, and support staff who are not designated as Key Personnel. Describe the experience of the Administrative Core Lead in research administration without duplicating information in the biosketches.

3) Resources: Description of how Administrative Core resources will contribute to the objectives of the Research Projects.

4) Services provided: Description of the services provided to other Cores and Research Projects including method of determining Core access and space assignments.

5) Administration: Description of the strategies and processes that will be used to manage the Center and achieve the overall goals.

6) Describe structures for day-to-day management of the Center, including arrangements for internal quality control of ongoing research. Applications must describe a mechanism for resolving conflicts among investigators.

7) Explain the procedures the Center uses to ensure that early stage scientists and investigators who are not already supported by the Center have access to Administrative Core services

8) Internal and External Advisory Committees: The Administrative Core should establish an Internal Advisory Committee, composed of members of the Center and other institutional faculty, as well as an External Advisory Committee (EAC) composed of members outside the institution. Do not contact or name specific individuals in the application unless the EAC has already been constituted. Describe the general composition of the EAC, the areas of expertise of the proposed members and their role in advising Senior Key Personnel of the Center. Describe how the EAC will contribute to the oversight and evaluation of the Core facilities and specific research projects. Applications must describe a plan for Center evaluation, including the use of internal and external advisory groups in the process. Describe a plan for assessing research productivity of the Center components. Applications must describe a decision-making process within the proposed Center for the evaluation of research productivity, for allocation of funds and for management of the resources.

9) Describe the required inclusion of small pilot funds of $50,000/yr and how these pilot projects must be awarded to PIs that are Early Stage Investigators (ESI) as defined by NIH, as required. Applications must d escribe how the proposed pilot projects will be solicited, evaluated and selected. For example, will advisory panels be used in the selection process?

10) Describe how the Center will fulfill the requirement that the PD(s)/PI(s) and Project Investigators from all of the participating Centers MUST organize and participate in teleconferences with Program staff at least on a quarterly basis or at NICHD's discretion. Core Leads and research fellows participating in the projects should also attend the meeting. The meetings must be attended by all funded centers in order to foster collaborations between centers.

Letters of Support: Include Letters of Support specific to the Administrative Core.

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

Do not include a Resource Sharing Plan for this component. Any resources to be developed under this component should be included with the Resource Sharing Plan for the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Research Project

When preparing your application, use Component Type Research Project.

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific component.Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Project)

Budget forms appropriate for the specific component will be included in the application package.

There should be at least 1.8 person months effort on the part of the Project Lead and at least a total of 2.4 person months effort for the PD/PI of the center.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Project)

Specific Aims: State the specific aims of the Research Project(s).

Research Strategy: Following the instructions in the SF424 (R&R) Application Guide, start each section with the appropriate section heading Significance, Innovation, Approach. Cite published experimental details and provide the full reference in the Bibliography and References Cited section of the Other Project Information form. Clearly describe the project's objectives and explain its relevance to the overall program's theme. Specify the underlying scientific premise and biomedical significance of the work proposed. As part of the Research Strategy, include information on preliminary studies, data, and/or prior experience pertinent to this application without duplicating information in the biosketches. Describe the Research Project's use of Core services, including why the services are needed and the advantages and cost effectiveness of Core usage for the Project. Described any proposed subcontracted resources. If appropriate for the research project, describe how new investigators in uterine fibroid research will be involved in research activities. Provide timelines, milestones, and metrics for success. Describe how progress will be evaluated during the funding period. If a particular approach proves to not be feasible, describe how the investigators would proceed in future years.

Letters of Support: Include Letters of Support specific to the Research Project.

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

The Resource Sharing Plan submitted to the Overall component of the application must include elements to address all proposed activities in this component of the application.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Research Project)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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, with the following additional instructions specific to this NOFO.

In Sections 2.4 "Inclusion of Women and Minorities" and 2.5 "Recruitment and Retention Plan" of the PHS Human Subjects and Clinical Trials Information Form, applicants must address the following points in addition to the G.500 instructions.

Section 2 - Study Population Characteristics

2.4 Inclusion of Women and Minorities

Application attachment Inclusion of Women and Minorities additional requirements:

• Provide data if available on the demographics of individuals affected under study in the catchment area(s) proposed in the application.
• Provide annual milestones for enrollment including numbers by sex/gender, race and ethnicity.
• Identify the person/people in the research team that will carry out the proposed outreach and their qualifications or relevant abilities such as fluency in languages other than English.

2.5 Recruitment and Retention Plan

Application attachment Recruitment and Retention Plan additional requirements:

• Describe how the proposed recruitment and retention plan is designed to overcome obstacles to study participation.
• In addition to the primary plan for recruiting sex/gender, racial, and ethnic group members, provide alternative/back-up strategies to be used if enrollment significantly deviates (more than 20% of any category for each annual milestone) from the planned numbers according to sex/gender, race or ethnicity. Back-up plans may, for example, propose to add research sites with access to additional individuals that are underrepresented in the enrollment.
• Describe what other research studies may be competing for recruitment of the same patient population in the catchment area(s) that are proposed in the application. Describe plans for communicating to potential study participants the options available to them.

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.

Community Partnership, Education, and Outreach Core

When preparing your application, use Component Type Community Ed Core.

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

SF424 (R&R) Cover (Community Partnership, Education, and Outreach Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Community Partnership, Education, and Outreach Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Community Partnership, Education, and Outreach Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Community Partnership, Education, and Outreach Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Community Partnership, Education, and Outreach Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Community Partnership, Education, and Outreach Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Community Partnership, Education, and Outreach Core)

Specific Aims: Include a brief list of Specific Aims outlining the objectives and functions of the Community Partnership, Education, and Outreach Core.

Research Strategy: Describe how the Community Partnership, Education, and Outreach Core will contribute to the thematic focus of the Center. Centers are required to partner with community collaborators. Applications must d escribe plans for a cooperative and equitable partnership between the Center and the community partner(s) in each stage of the research process (concept, implementation, evaluation, and dissemination). Describe the leadership plan, and the principles, policies, and practices that will guide day-to-day operation. Describe the types of activities that will be conducted for the timely and appropriate dissemination of information generated, its research projects and other activities for diverse audiences, including lay community audiences, including a description of approaches or strategies to engage communities. Describe the plan to fulfill the requirement that the Core support a community education outreach effort to increase awareness about uterine fibroids as a disorder. Describe the expected outcomes of the proposed dissemination strategies and activities and how the impact of dissemination efforts will be assessed. Describe dissemination activities with community members, partner organizations, and relevant service organizations or policymakers will be coordinated. Describe how stakeholders will share in the decision making on what, when, how, and to whom findings from research projects will be presented. Describe strategic planning processes to translate findings into sustainable community and system-level changes at the local level and beyond.

Letters of Support: Include Letters of Support specific to the Community Partnership, Education, and Outreach Core.

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

Do not include a Resource Sharing Plan for this component. Any resources to be developed under this component should be included with the Resource Sharing Plan for the Overall Component.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Community Partnership, Education, and Outreach Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

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) using ASSIST or other electronic submission systems. 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.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads must include their eRA Commons ID in the Credential field of 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.

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.

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.

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.

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

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

Significance

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

Specific to this NOFO:

To achieve the purpose and objectives of the Centers, how well does the applicant’s Center application:

• Address the communities it will serve?
• Propose a scientifically compelling project(s) and components that closely align with the overarching theme of the Center?
• Potential to have a lasting and important impact on its affected community and the topic of focus?
• Demonstrate a strong/collaborative community health partner of sufficient size that the Center can make a major impact on research in the field?
• Propose a Plan for Enhancing Diverse Perspectives (PEDP) that will further the significance of the Center?
• Incorporate different disciplines in the research.

Investigator(s)

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

Specific to this NOFO:

To achieve the purpose and objectives of the Centers, how well does the applicant’s team demonstrate:

• Sufficient leadership experience and time commitment to develop the Center?
• Research Project(s) and Component Investigators that have trans-disciplinary backgrounds and expertise?
• Prior research experience relevant to the proposed centers, theme, and/or research projects?
• To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?
• A plan to incorporate early stage and junior investigators in the research, mentor them, and give them access to Center resources (Cores etc).

Innovation

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

Specific to this NOFO:

To help further the Centers' purpose and objectives, how important are the application's plans for:

• Individual projects and components that will contribute toward success and reduction of health disparities in uterine fibroids in the affected communities?
• Addressing a long-standing controversy or unresolved question in the field in a way that could settle it?
• To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

Approach

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

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?

Specific to this NOFO:

To further the Centers purpose and objectives, how adequately does the approach demonstrate:

• An adequate approach or strategy to engage communities (i.e., an effective plan for outreach activities that addresses the biological, behavioral, environmental, sociocultural, and/or structural factors that affect health disparities in uterine fibroids)?
• Synergy and coordination among research projects and components to achieve the scientific goals of the Center?
• Meaningful and equal community partnerships throughout the research process?
• A willingness to work and cooperate with the other Centers, study investigators, and NICHD staff in a manner summarized in this NOFO (ie. plans for at least quarterly meetings with all centers and NIH staff arranged by recipients )?
• The manner in which pilot projects are going to be selected and evaluated and be led by early stage investigators?
• Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

Environment

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

Specific to this NOFO:

To further the Centers purpose and objectives, how well does the environment demonstrate:

• Adequate resources to conduct the proposed activities?
• Fostering a culture of trans-disciplinary collaboration and inclusiveness, both within the Center's team and with the research community?
• A cooperative and equitable partnership between the investigators and the community partner(s) in each stage of the research process (concept, implementation, evaluation, and dissemination)?
• To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

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.

Center as an Integrated Effort

The overall Center will be evaluated as an integrated research effort focused on one or more research areas listed under Research Scope. The review will assess the level of merit of the Center as an integrated effort, including the following criteria:

• Will there be coordination, interrelationships, cohesiveness, and synergy among the research projects and cores as they relate to the common theme of the Center?
• Are there advantages of conducting the proposed research as a program rather than through separate research efforts? Will the research efforts taken together have more impact on the field than each separate project conducted in isolation?
• Are effective mechanisms proposed for regular communication and coordination among investigators in the Center, especially for those who may not be at the primary site of the Center?
• Is there a coordinated Center-wide plan to encourage and support early-stage investigators in pursuing a career in fibroid research?
• Are administrative structures in place for the day-to-day management of the Center, including arrangements for internal quality control of ongoing research, identification and evaluation of pilot projects, and conflict resolution?
• Are timelines and milestones in place that will allow an evaluation of progress to be made?

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 Center 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 Animals 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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For Centers 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.

Review Criteria - Cores

In addition to the above criteria, the following components of the Center will be scored independently AND will be considered in the determination of the overall impact score for the whole application:

Administrative Core:

Reviewers will consider the following criteria in the determination of an impact score for the Administrative Core, although scores for the individual criteria will not be provided.

• Does the Administrative Core Lead have appropriate experience in research administration?
• Is there a decision-making process within the proposed Center for the evaluation of research productivity, for allocation of funds and for management of the resources?
• Is there a mechanism for resolving conflicts among investigators?
• Is there an effective process by which pilot projects, if applicable, will be selected and evaluated for potential funding?
• Is there a plan for Center evaluation, including the use of internal and external advisory groups in the process?

Community Partnership, Education, and Outreach Core:

Reviewers will consider the following criteria in the determination of an impact score for the Community Partnership, Education, and Outreach Core although scores for the individual criteria will not be provided.

• Is there evidence of a cooperative and equitable partnership between the Center and the community partner(s) in each stage of the research process (concept, implementation, evaluation, and dissemination)?
• To what extent does the application include a description of approaches or strategies to engage communities?

Review Criteria: Research Projects

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

Investigator(s)

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

Innovation

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

Approach

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Environment

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

Additional Review Criteria - Research Project

As applicable for the research 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.

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.

Additional Review Considerations - Research Project

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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

2. Review and Selection Process

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development Council (NACHHD). 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.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that 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.

Prior Approval of Pilot Projects

Recipient-selected projects that involve studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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:

• Federal wide 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 will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. 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 NOFO.

• 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.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/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 religious nondiscrimination laws and 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.

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. If additional Data Management and Sharing requirements need to be added, please insert what requirements are desired.

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. Awardees will provide updates at least annually on implementation of the PEDP.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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 NOFOs 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 75and 2 CFR Part 200 Award Term and Condition 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: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

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

Candace Tingen, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6971
Email:[email protected]

Elena K Gorodetsky, M.D., Ph.D.
ORWH - Office of Research on Women's Health
Phone: (301) 594-9004
E-mail: [email protected]

Joanna Kubler-Kielb, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6916
Email: [email protected]

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

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 and 2 CFR Part 200.