Part 1. Overview Information

Key Dates

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

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

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose:

The purpose of this FOA is to fund additional research projects that will develop and test prospective interventions at the community or community organization level with the aim of preventing firearm and related violence, injury and mortality. These research projects will become part of the existing Community-Level Interventions for Firearm Violence Prevention Research Network (CLIF-VP), which also includes a Coordinating Center. Funded under a cooperative agreement, members of the CLIF-VP Research Network will collaborate to share approaches, data, and methods, working closely with NIH Institutes, Offices and Centers. Applicants applying to this FOA are encouraged to review the Coordinating Center FOA (PAR-22-120) to fully understand the CLIF-VP Research Network structure and activities.

Background:

Violence is defined by the World Health Organization as: the intentional use of physical force or power, threatened or actual, against oneself, another person, or against a group or community, that either results in or has a high likelihood of resulting in injury, death, psychological harm, maldevelopment, or deprivation. Violence affects people of all ages and its impact is far-reaching. It is a leading cause of death and nonfatal injuries in the United States and constitutes a major public health crisis, especially among young people, and in particular among racial/ethnic minority, sexual and gender minority (SGM) and disability populations. Each day more than 1000 youth are treated in emergency departments for physical assault related injuries. Both direct and indirect (e.g., witnessing) violent victimization events are associated with not only physical injury or mortality, but also a range of acute and chronic physical, mental and behavioral health conditions, such as obesity, cardiovascular disease, asthma, substance use disorders, and sleep disturbance.

CDC identifies a number of priority areas for violence prevention efforts including child maltreatment, elder abuse, intimate partner violence, community violence, firearm violence (including self-directed violence), sexual violence, and youth violence (including bullying). Firearm related injuries and death, in particular, constitute an urgent public health crisis with firearms being involved in almost 80% of homicides and overall half of all suicides. The overall homicide rate increased by 35% from 2019 to 2020 to its highest rate in over 25 years, further widening disparities by race ethnicity, and poverty with Black men showing the largest increase. In addition, firearm related injuries became the leading cause of death for children and youth ages 1-19 in 2020. Homicide is also a significant cause of maternal mortality, as a recent study using national death certificate data found that pregnant women in the United States died by homicide (most often from partners) more often than they died of pregnancy-related causes. In 2020, firearms accounted for the highest proportion of all methods for suicide for males and females. American Indian/Alaska Native individuals experienced the greatest increase in firearm suicide rate between 2019 and 2020 of all racial groups, with the greatest risk concentrated in those aged 10-44 years.

Despite recognition that violence is a public health condition that is linked to social determinants across the lifespan, most violence prevention and intervention programs remain focused on individual risk factors of violence victimization or perpetration. Many current violence prevention strategies tend to be brief, psycho-educational programs that attempt to change individual knowledge, attitudes, and behaviors or are group based, such as bullying or dating violence prevention in schools. There is also a growing body of violence intervention programs aiming to reduce community violence, particularly firearm violence, which often focus on identifying and intervening directly with individuals at high risk of perpetrating violence. While existing violence prevention programs have demonstrated success in changing attitudes and in some cases violence-related behaviors, often such benefits are short-lived. In addition, little is known about the best implementation strategies to optimize the effectiveness, adoption, and scale up of existing evidence-based violence prevention programs, policies, and practices as well as the optimal combination of these individually focused programs with those focused on higher level influences. The limited resources for prevention or early intervention (e.g., funding, staff capacity) make it difficult to reach individuals one by one who might need or benefit from intervention.

Furthermore, recent events including the COVID-19 pandemic and events focused on racial and social justice issues (e.g., police violence, mass shootings) have brought an increased recognition that social determinants of health (SDOH; see https://health.gov/healthypeople/priority-areas/social-determinants-health), namely the often-intersecting burden of poverty and structural racism, are drivers of population-level health disparities. Violence prevention efforts must therefore address these sociocultural forces in order to reduce the disproportionate impact of violence and victimization on women, children, racial/ethnic minorities, sexual and gender minorities, and other socially marginalized groups. Recent HHS efforts have specifically identified the critical need to focus on these determinants in developing and implementing interventions. For example, CDC’s new strategic vision for violence prevention prioritizes community or societal level preventive efforts along with identifying root causes that cut across these types of violence and address racial/ethnic, gender and economic disparities. Similarly, as outlined in a recent NIMHD Science Visioning process, there is a need for more community- and practice- derived, structural, multi-level, and multi-sectoral interventions in order to effectively and sustainably improve minority health and eliminate health disparities.

As such, the current situation calls for firearm and related violence prevention and intervention strategies that can be implemented at the community level which function by modifying characteristics of organizations, environments and settings such as schools, workplaces, and neighborhoods. See NIMHD’s research framework (https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html) for more details. These community-level interventions, in which interventions target determinants of health outcomes that are associated with community physical, built, sociocultural or institutional environments; resources; or functioning, address many of the HHS-identified priorities. By necessity, such interventions require community engaged research strategies, including but not limited to community-based participatory research, in order to develop, evaluate, and implement successfully. In addition, collaboration and coordination across research teams implementing these interventions can maximize impact through data harmonization and sharing that can enhance the generalizability or applicability of findings.

Key Definitions for this FOA:

Community: A specific group of people, often living in a defined geographic area, who share a common culture, values, and norms and who are arranged in a social structure according to relationships the community has developed over a period of time. The term community encompasses worksites, schools, and health care sites (see https://www.cdc.gov/healthyplaces/terminology.htm). Communities may be self-defined (e.g., the SGM community in a city or county) or defined by the catchment area of local government or service providers (e.g., residents served by a county school district or community clinic). Additional examples of communities include but are not limited to neighborhoods, reservations or tribal communities, military bases, or college campuses. Virtual or other communities that do not reside in the same geographic location are not a priority for this initiative.

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

Community-level intervention: An intervention that modifies community-level or community organization/institution characteristics. This could include, but is not limited to:

the physical/built environment (e.g. restoration of vacant lots or abandoned buildings)

the social environment (e.g., community investment in private and public spaces; increasing options and opportunities for access to mental health and/or substance use services);

policies or practices of organizations, institutions or governmental agencies that have community-level health impacts (e.g., zoning or permit policies to reduce the density of alcohol outlets; alternatives to incarceration/justice/legal system involvement or linking of services across sectors for individuals with substance use or mental health disorders; policies to increase quality housing or employment opportunities; school discipline policies and practices);

norms, attitudes, or collective behaviors of community residents (e.g., community surveillance efforts, bystander de-escalation strategies).

Interventions that are delivered in community settings and/or use community-based outreach or enrollment but intervene only at the individual level and do not target community-level determinants of health are NOT considered community level interventions.

CLIF-VP Research Network Structure:

The CLIF-VP Research Network consists of a Coordinating Center (CC) and several UG3/UH3 Research Projects testing a community or community organization level prevention program designed to prevent firearm and related violence, injury, and mortality. The CC and each of the Research Projects will also work collaboratively with one or more Science Officers and Program Officers from NIH institutes, centers, and offices (ICOs). The CLIF-VP Research Network will include at least one Stakeholder Board (SB) to ensure that the Network research and priorities align with the current needs in the field and to increase the likelihood that the interventions being tested can be feasibly adopted and sustained if found to be effective.

The CLIF-VP Research Network priorities and activities will be governed by a Steering Committee (SC) which at a minimum will include at least two representatives from each of the Research Projects (e.g., both academic PI and community organization/partner key personnel or MPI), the CC, and at least one NIH representative. The CLIF-VP Research Network Steering Committee will meet at least monthly and be chaired by a person (or people) with relevant expertise who will be determined by NIH, the CC and all Research Projects. Based on the priorities set by the Steering Committee, workgroups will be established to carry out cross-project activities. For example, NIH anticipates there will be at least three workgroups, one on data harmonization, one on community engagement, and one on network dissemination activities.

Research Objectives:

The CLIF-VP Research Network will support a network of research projects to develop and test prospective interventions at the community or community organization level that aim to prevent firearm and related violence, injury and mortality.

Research questions could include but are not limited to:

What new and innovative violence intervention practices can be developed from existing theory and/or basic social and behavioral research that would provide additive or complementary effectiveness to existing programs and practices?

How can the type and dose of various intervention components be combined and/or sequenced to optimize effectiveness and/or adoption potential in a broad range of communities to reduce violence, especially firearm violence? This could include examination of dosing and timing of intervention components that occur in different sectors such as healthcare, education, and policing.

What role do the unique contextual factors of communities and/or community organizations play in enhancing or inhibiting the potential effects of intervention programs? Which program components are generalizable across communities/organizations and which may be effective only under certain contextual conditions? This could include examination of whether interventions are effective across different socially marginalized populations (e.g., LGBTQ, disability) that are known to be disproportionally impacted by firearm and related violence.

How do various sources of adaptation (e.g., intervention content, mode of delivery, population, setting) within a range of community or community organizational contexts impact the effectiveness of the intervention on both (firearm) violence prevention and implementation outcomes? What are the community, organizational and contextual level barriers and facilitators to adoption, scale up, and sustainability of programs and practices and what are the best implementation strategies to address those barriers?

In order to foster scientific planning activities, applications are expected to have the following features:

Led by or conducted in collaboration with appropriate community organizations. A representative from a community organization must serve as the Principal Investigator (Pl), multiple principal investigator (MPI) or other key personnel; the budget allocated to each entity appropriately; and there must be joint development of the research and intervention plan.

Include multi-sectoral (e.g., education, physical and behavioral health, justice/legal, social services) collaborations involving partnerships with multiple types of stakeholder organizations in the public and private sector are encouraged, when possible, in order to facilitate sustainability once project funding is complete. Interventions focused solely on the health care setting are not a priority for this initiative, though interventions that seek to integrate healthcare interventions with those from other sectors are encouraged. For example, multidisciplinary research teams, include researchers from areas outside of the health sciences, such as data science, economics, education, history, criminology, law, and political science.

Propose interventions that seek to foster change in the environment (physical, built or sociocultural) at the organizational and/or community level. Multi-level interventions that also include intervention elements addressing individual- or family-level determinants are encouraged.

Be guided by a conceptual model identifying hypothesized pathways between the community or organizational level intervention, community- or organizational level determinants, and (firearm) violence related injury or mortality. Additionally, projects should propose to use appropriate measures and analytic methods to examine community-and organizational-level mechanisms of action and (firearm) violence related outcomes. Research designs that allow for the assessment of mechanisms through which the intervention impacts individual, community or population level violence outcomes are encouraged. Mechanisms of interest include changes to behaviors, environments, or policies at the interpersonal, organizational, or neighborhood/community level.

Research designs (e.g., cluster randomized trials or rigorous quasi-experimental designs) should include the community or organization as the unit of analysis. Individual-level randomized designs are not appropriate for this initiative. More information is available here: https://researchmethodsresources.nih.gov/methods/grt

Collect or obtain data beyond individual self-report to determine how the intervention is impacting community- or organizational-level determinants of firearm and related violence. Violence related outcomes can be assessed at a combination of the individual, interpersonal, organizational, and/or community level.

Be supported by relevant preliminary data from at least one setting. It is not required for the intervention to have been pilot tested in multiple communities, organizations, or settings.

Prospectively test the impact of community level interventions on firearm and related violence and victimization outcomes. The intervention(s) may include interventions already planned by community organizations but not yet implemented or new interventions developed as part of this research study. However, regardless of the nature of the intervention, it must be rigorously tested prospectively as outlined above.

Applicants are strongly encouraged to consider and assess the role of intersecting social determinants of health in developing interventions, including the use of measures available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org), as appropriate.

NIMH encourages applications consistent with NIMH priorities for research on violence and aggression towards others as described inNOT-MH-22-095. All applications to NIMH that involve clinical trials are expected to follow the NIMH mechanism-based, experimental therapeutics approachto intervention development and testing (seeSupport for Clinical Trials at NIMH and contact NIMH program staff for more information about NIMH clinical trials practices and research priorities).

UG3/UH3 Phased Innovation Awards:

This UG3/UH3 Phased Innovation Award supports bi-phasic projects for up to five years. The UG3 (Phase 1) will be a one to two-year award for a milestone-driven developmental/exploratory study that can demonstrate sufficient preparation, feasibility, capacity and leveraging of foundational activities needed for the implementation studies planned in Phase 2 (UH3). Phase 1 includes scientific, operational and collaborative planning activities as well as tangible deliverables/preliminary findings that could be informative to the field as appropriate.

Scientific planning activities may include: development, adaptation or refinement of interventions or strategies; feasibility, acceptability and pilot testing of a proposed intervention or strategy; and development and testing of engagement and implementation strategies (e.g., fidelity monitoring, training). Operational planning activities may include development of: the intervention, strategy or model protocol; the intervention manual or equivalent (as appropriate); data collection and management safety and operational oversight plans; recruitment, engagement and retention strategies, regulatory approvals (e.g., IRB, DSMP); and other essential documents and procedures. Collaborative planning activities may include: finalizing MOUs with collaborators, forming additional partnerships as needed with community based organizations or service providers, forming advisory boards, and other related activities.

The UH3 phase will provide support for up to four additional years (for three years if the UG3 phase lasts two years) to conduct the implementation phase of research that will advance our knowledge of community or community level interventions to reduce firearm and related violence injury and mortality. The UH3 phase award will support the implementation and evaluation of the interventions or strategies planned or developed in the UG3 phase. UG3 projects that have met the milestones for the first phase (e.g., scientific, operational, collaborative) will be programmatically considered and prioritized for transition to the UH3 phase.

Funding of the UG3 (Phase 1) does not guarantee support of the UH3 (Phase 2) award for research implementation, and all funded UG3 projects may not transition to the UH3 phase. Transition to the UH3 phase will be determined by the availability of funds and the outcome of a programmatic evaluation at NIH that is based on 1) appropriate sustainability plans with successful engagement of local collaborating agencies and partners and 2) Go/No-Go Transition Milestone accomplishment specific to the project being proposed [e.g.; establishment of relevant collaborations with community and other sector partners needed to advance achievement of the research objectives as demonstrated by the execution of necessary agreements with these agencies for committed financial and/or human resources, data sharing, etc.; demonstrated ability to recruit appropriate individual and/or organizational population samples, conduct data collection, access to data for appropriate data linkages, etc.]. Continued programmatic priorities and availability of funds will impact the decision to transition to the UH3 award. Appeals of the transition decision will not be accepted.

Applications Not Responsive to the FOA:

Applications that do not include specific aims for both a UG3 and a UH3 phase.

Applications that do not specify a well-defined set of milestones for the planning phase (UG3), the transition to the UH3 phase, and annual milestones for the implementation phase (UH3).

Projects that focus exclusively on virtual or other communities that do not reside in the same geographic location.

Projects that do not prospectively test a community level intervention. Retrospective analysis of existing or past community or organizational level interventions or initiatives are not responsive to this initiative.

Projects that do not include baseline data (i.e., prior to the implementation of the intervention) on the outcomes of interest in the populations receiving the intervention.

Projects that use only individual-level data, are exclusively qualitative (though mixed-methods are encouraged) or that focus on helping individuals or populations cope with the impacts of (firearm) violence and do not directly address community- or organizational-level root causes of firearm and related violence.

Projects that do not involve one or more community partners who are responsible for implementing or delivering the community-level intervention as indicated by inclusion of representatives of community organizations as key personnel and/or proposed subcontracts to collaborating institutions.

Projects that propose data collection or testing of interventions outside of the U.S.

Projects that include prohibited policy lobbying or advocacy activities (see https://grants.nih.gov/grants/lobbying_guidance.htm for more information).

Non-responsive applications will not be reviewed. Applicants are strongly encouraged to reach out to the relevant scientific contacts to discuss whether their applications are responsive.

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.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

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

Other

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

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

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

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

Applicant Organizations

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

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Dara Blachman-Demner, Ph.D.
Telephone: 301-496-8522
Fax: 301-402-1150
Email:dara.blachman-demner@nih.gov

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

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

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.

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

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

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

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

R&R Budget

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

R&R Subaward Budget

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

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

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

Research Strategy

This UG3/UH3 Phased Innovation Award has two phases. The UG3 (Phase 1) will be a one to two-year award for milestone-driven developmental/exploratory studies to demonstrate sufficient preparation, feasibility ,capacity and leveraging of foundational activities needed for the implementation studies planned in Phase 2 (UH3). Phase 1 includes scientific, operational and collaborative planning activities as detailed in the "phased innovation award section of the FOA Background. The UH3 phase award will support the implementation and evaluation of the interventions or strategies planned or developed in the UG3 phase.

All applications must provide the overall goals and hypotheses for the entire project and indicate separate specific aims to be accomplished in the UG3 phase and the UH3 phase. In addition, projects must include clearly identified Go/No-Go transition milestones to be assessed at the end of the UG3 phase. These Transition Milestones must be specific to the project being proposed, discrete and measurable, and must be clearly defined. Milestones must relate to the scientific, operational and collaborative planning activities and must demonstrate readiness to launch into the implementation phase of the research. Separate sections that describe the research strategy for the UG3 and the UH3 phases are required. Investigators should consider that the application will be assigned a single overall impact score. Thus, clarity and completeness of the application with regard to specific goals, feasibility, approach, and the transition milestones are critical. It is not necessary to repeat information or details that are described in the UG3 section in the UH3 section.

Applications should also clearly describe:

The theoretical basis for the proposed intervention, including the level(s) of influence addressed by the intervention, and the process for developing, adapting, and tailoring the intervention to the community proposed.

The primary and secondary outcomes that will be evaluated and the proposed measures for both the UG3 and UH3 phases.

The analytic plans for the UG3 and the UH3 phases of the research, including statistical and other methods to be employed to address multi-level factors, intervention effects, and outcomes as appropriate.

Partnerships with relevant community stakeholders and collaborators other than the MPI and their respective roles in the project.

The team’s experience with developing/testing/implementing community interventions and working with the community in which the research will be conducted.

The team's experience conducting multi-site or multi-project studies that require collaboration among project sites such as common protocols and data harmonization.

Any impediments that could require an addendum to the research plan, milestone, or timeline and alternative approaches.

The potential for the intervention to be sustained after the project is over and/or scalable to other settings.

Provide a plan for participating in CLIF-VP Research Network activities (e.g., participation in workgroups and Steering Committee meetings, data harmonization and ,cross-site dissemination products, etc.). Describe how the project team will work with the CLIF-VP Research Network Coordinating Center (CC), considering the CC’s role to provide administrative coordination, data harmonization, measurement, and analytics support and consultation, and public/stakeholder engagement and dissemination support.

Letters of Support:

Provide all appropriate letters of support, including any letters necessary to demonstrate the support of collaborators, stakeholders (e.g., end users), and others. If co-funding or in-kind support is planned from non-NIH sources, letter(s) outlining details of the commitment (e.g. type, amount and source of support), signed by a business official on organization letterhead, and must be included in the Letters of Support.

.

Projects funded under this FOA are expected to work collaboratively toward core data collection measures and methods, as appropriate, that will enable the construction of harmonized data sets.

After all awards have been made, the network will develop a unified policy for data and resource release, and the application is expected to include a statement that the investigators will abide by the network’s data and resource policy, consistent with the relevant NIH policies, laws and regulations.

Use of Common Data Elements (CDEs) such as those defined on the on the National Library of Medicine website (https://www.nlm.nih.gov/cde/) is encouraged.

It is anticipated that applicants may propose new approaches for informed consent that improve participant understanding and allow for use of data across a range of health and other electronic platforms.

The following modifications also apply:

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.

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.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Applicants are required to follow the instructions for post-submission materials, as described in the policy

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.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

For this particular announcement, note the following:

The UG3/UH3 exploratory/developmental phased grant supports investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research. A UG3/UH3 grant application is not required to have extensive preliminary data, background material or preliminary information, but these may be included if available. Appropriate justification for the proposed work can also be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, the potential to significantly advance knowledge or understanding and have an impact. Reviewers will assign a single impact score for the entire application, which includes the UG3 and UH3 phases.

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

Overall Impact

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

Scored Review Criteria

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

Significance

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

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

Specific to this FOA:

Is a clear and appropriate theoretical basis provided for both the proposed intervention, (including the level(s) of influence addressed), as well as for the process for developing, adapting, and tailoring the intervention to the community proposed?

Does the intervention have potential to be sustained after the project is over and/or scalable to other settings?

Investigator(s)

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

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

Specific to this FOA:

Do the investigators have relevant experience developing/testing/implementing community interventions and working with the community in which the research will be conducted?

Do the investigators have relevant experience with conducting multi-site or multi-project studies that require collaboration among project sites such as common protocols and data harmonization? Are the roles and responsibilities of collaborators clearly defined and appropriate?

Are appropriate stakeholders, relevant to the population to be included in the research and the system/setting proposed for the project, included on the research team or on the project?

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?

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

Approach

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

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

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

Specific to this FOA:

How well does the research project clearly identify a scientifically justifiable strategy for the UG3 phase of the project? How well does the project's conceptual framework clearly inform the analysis of data and potential pathways for the UH3 phase? How successful is the UH3 phase in proposing strategies and approaches that have a clear pathway from the UG3 data? Are the proposed Timelines f and the Transition Milestone well-defined, feasible, quantifiable, and appropriate?

Does the application include an adequate plan for participating with the CLIF-VP Research Network Coordinating Center, considering the CC’s role to provide administrative coordination, data harmonization, measurement, and analytics support and consultation, and public/stakeholder engagement and dissemination support?

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 project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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

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

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

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

Additional Review Criteria

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

Study Timeline

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

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

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

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

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

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

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

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

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

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

Prior to the end of the UG3, recipients will submit the transition package, which will include the UG3 progress report delineating progress toward achieving UG3 milestones.

All aspects of their study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators.

The recipient agrees to accept close coordination, cooperation, and participation of NIH staff in those aspects of scientific and technical management of the study including those outlined under "NIH Staff Responsibilities" and to work cooperatively with other recipients and the Coordinating Center where it is scientifically advantageous to pursue common methods and protocols.

Recipients will participate in annual meetings of the recipients and will support any committees, task forces, and advisory panels related to the project, as needed and will participate in regularly scheduled conference calls with the awarding agency. Project budgets should include travel for participation in these activities.

Upon implementation of the project, each recipient will follow the procedures required by the protocol regarding study conduct and monitoring and data collection.

Support or other involvement of industry or any other third party in the study--e.g., participation by the third party; involvement of project resources or citing the name of the project or the NIH support; or special access to project results, data, findings, or resources--may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur with the concurrence by the NIH Program Officer to ensure objectivity of research.

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

Award recipients should aim to make resulting publications, code, and to the extent possible, the underlying primary data immediately and broadly available to the public. See Section 8.2.3.1of the NIH GPS.

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

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

The NIH Project Scientists will have access to the data and work with the PD(s)/PI(s) to ensure the objectives of the program are being met. The primary responsibility for the program resides with the recipient, although specific tasks and activities will be shared among the recipient and the NIH Project Scientists.

NIH staff will act as resources and facilitators for activities of the recipient, and will coordinate activities with federal and non-federal agencies outside of the project recipients.

The NIH, as primary funder and administrator reserves the right to phase out or curtail the award (or an individual component of the award) in the event of inadequate progress or data reporting. NIH support of this study is contingent upon adequate participant recruitment based on the Grantee’s Milestone Accrual Plan submitted at the time of funding.

NIH staff will ensure the recipient demonstrates best effort compliance. Failure to achieve minimally acceptable milestone recruitment levels may result in the withholding future support and/or negotiating an orderly close-out of this study.

NIH staff will serve as resources to provide: scientific/programmatic support in the development and modification of study protocols and the design of project activities; advice in the selection of sources or resources; advice in management and technical performance; and assistance in the preparation of publications, as warranted.

NIH staff will participate in the monitoring of issues relating to recruitment, retention and follow-up of study participants, and monitoring of data integrity and quality control through consideration of the annual reports, site visits, patient logs, etc. This review may include, but is not limited to, compliance with the study protocol, meeting enrollment targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting as needed to the coordinating center.

NIH Scientific Officers will interact with the PD(s)/PI(s) on a regular basis to monitor progress. Monitoring may include: regular communication with the PD(s)/PI(s) and his/her staff, periodic site visits for discussion with the recipients research team, observation of field data collection and management techniques, fiscal reviews, and other relevant stewardship matters.

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

Areas of Joint Responsibility include:

The PD(s)/PI(s) provide, in concert with the NIH staff, support necessary to ensure that sites and investigators, and NIH and other research partners fully comply with federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events.'

Recipients and NIH will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data.

All recipients and NIH will cooperate to ensure the timely and broad dissemination of lessons learned, to inform researchers and health care, justice, education, social services and other systems as appropriate.

The Steering Committee (managed by the Coordinating Center) is the primary governing body of the network. Recipients must participate in the Steering Committee. The Steering Committee reviews and approves the agenda for collaborative research activities, develops and monitors policies and procedures guiding the research activities, and oversees communications. Recipients agree to abide by the procedures and policies established by the Steering Committee.

The Steering Committee, with the support of the Coordinating Center, will facilitate these and other joint activities including, but not limited to: coordination of research protocols when appropriate, human subjects and other regulatory protocols when appropriate, data harmonization and archiving, manuscript and other information dissemination planning, and initial clearance of manuscripts or other dissemination products resulting from collaborative projects across the network.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. 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.

4. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 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 75 and 2 CFR Part 200 Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: 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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

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

The Office of Behavioral and Social Sciences (OBSSR) does not accept assignment of applications or manage awards that are funded. Please contact one of the ICs listed below for inquiries regarding the suitability of the proposed project for the FOA and the IC’s research portfolio.

Dara Blachman-Demner, Ph.D.

Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-496-8522
Email: dara.blachman-demner@nih.gov

Valerie Maholmes, PhD, CAS
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1514
Email: maholmev@mail.nih.gov

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

Lisa Begg, Dr.P.H.,RN
Office of Research on Women's Health (ORWH)
Phone: 301-496-3975
E-mail: begge@mail.nih.gov

Stephen O'Connor, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-480-8366
Email: stephen.o'connor2@nih.gov

Robert Freeman, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-8820
Email: rfreeman@mail.nih.gov

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

Barbara Ann Oudekerk
National Institute on Drug Abuse (NIDA)
Phone: (301) 827-0641
E-mail: barbara.maurer@nih.gov

Melissa Gerald, Ph.D.
National Institute on Aging (NIA)
Phone: 301-402-4156
E-mail: melissa.gerald@nih.gov

Crystal Barksdale, PhD, MPH
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-402-1366
E-mail: crystal.barksdale@nih.gov

Dionne Godette-Greer, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-827-0095
Email: dionne.godette@nih.gov

Lanay M. Mudd, Ph.D., FACSM
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-9346
Email: lanay.mudd@nih.gov

Center for Scientific Review (CSR)

Email: FOAReviewContact@csr.nih.gov

Not Applicable for OBSSR

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

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4707
Email: jfox@mail.nih.gov

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

Ryan Blakeney
National Institute on Aging (NIA)
Phone: 301-451-9802
E-mail: blakeneyr@mail.nih.gov

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

Kelli Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: osterk@mail.nih.gov

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.