Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Behavioral and Social Sciences Research (OBSSR)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

National Center for Complementary and Integrative Health (NCCIH)

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

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

Sexual and Gender Minority Research Office (SGMRO)

Office of Research on Women's Health (ORWH)

Funding Opportunity Title
Coordinating Center to Support Research on Community Level Interventions for Firearm and Related Violence, Injury and Mortality Prevention (CLIF-VP) (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
PAR-22-120
Companion Funding Opportunity
PAR-22-115 , UG3/ UH3 Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II
Assistance Listing Number(s)
93.313, 93.273, 93.213, 93.307, 93.361, 93.866, 93.865
Funding Opportunity Purpose

The purpose of this FOA is to seek applications for a Coordinating Center (CC) for Community-Level Interventions for Firearm Violence Prevention (CLIF-VP) Research Network. Members of the CLIF-VP Research Network, including the CC, will work collaboratively with the NIH to develop and test interventions at the community or community organization level that aim to prevent firearm and related violence, injury, and mortality. The CLIF-VP Research Network will include the CC funded under this Cooperative Agreement and up to 10 Research Projects funded under the companion UG3/UH3 Phased Cooperative Agreement FOA, Research on Community Level Interventions for Firearm and Related Violence, Injury, and Mortality Prevention (CLIF-VP) PAR-22-115 . In phase 1 (1-2 years) the Research Projects will need to demonstrate sufficient preparation, feasibility, and capacity for the planned intervention study. Those that pass their milestones will transition into phase 2, during which they will implement their proposed intervention. The CC will provide overarching support and guidance to the network in three domains: (1) administration, coordination, and communication; (2) data, measurement, and analytic support and consultation; and (3) public/stakeholder engagement and dissemination support. It is important that applicants for the CC also read the companion FOA to understand the full mission and structure of the research network.

Key Dates

Posted Date
March 04, 2022
Open Date (Earliest Submission Date)
March 22, 2022
Letter of Intent Due Date(s)

March 22, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
April 22, 2022 Not Applicable Not Applicable July 2022 August 2022 September 2022

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.

Expiration Date
April 23, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this FOA is to seek applications for a Coordinating Center (CC) for Community-Level Interventions for Firearm Violence Prevention (CLIF-VP) Research Network. Members of the CLIF-VP Research Network, including the CC, will work collaboratively with the NIH to develop and test interventions at the community or community organization level that aim to prevent firearm and related violence, injury, and mortality. The CLIF-VP Research Network will include the CC funded under this Cooperative Agreement and up to 10 Research Projects funded under the companion UG3/UH3 Phased Cooperative Agreement FOA, Research on Community Level Interventions for t Firearm and Related Violence, Injury, and Mortality Prevention (CLIF-VP) PAR-22-115 . In phase 1 (1-2 years) the Research Projects will need to demonstrate sufficient preparation, feasibility, and capacity for the planned intervention study. Those that pass their milestones will transition into phase 2, during which they will implement their proposed intervention. The CC will provide overarching support and guidance to the network in three domains: (1) administration, coordination, and communication; (2) data, measurement, and analytic support and consultation; and (3) public/stakeholder engagement and dissemination support. It is important that applicants for the CC also read the companion FOA to understand the full mission and structure of the research network.

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, firearm violence, sexual violence, and youth violence (including bullying). Firearm homicide is the third leading cause of death among persons aged 10 to 24 years and the leading cause of death among Black men (<45 years of age). The firearm homicide rate is over 10x higher for Black than White men ages 20-24. Homicide has been the leading cause of death for non-Hispanic Black youth for more than three decades and is the second leading cause of death for Hispanic youth. 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.

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. 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://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-of-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.

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. 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. retoration of vacant lots or abandoned buildings)
  • the social environment (e.g. community investment in private and public spaces)
  • 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 for individuals with substance use or mental health disorders);
  • norms 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 will consist of a Coordinating Center (CC) and up to 10 UG3/UH3 Research Projects testing a community or community organization level prevention program designed to prevent firearm and related violence, injury, and mortality (see PAR22-115). 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.

Scope of Work for the CLIF-VP Research Network Coordinating Center

The CC will serve as the workforce for the priorities set by the CLIF-VP Research Network Steering Committee and provide a wide range of support and guidance across the individual Research Projects.

Specifically, support will be provided in three main areas:

1) Administration, coordination, and communication: The administrative functions include facilitating the work of the CLIF-VP network and NIH scientific staff in the overall program management of the network.

Activities will include, but not limited to:

Leadership and project management for the administrative, coordination and communication functions including logistics and management support, such as organizing all network-related meetings and maintaining documentation (tracking and reporting) on activities of the network

Establish, in coordination with NIH staff, a CLIF-VP Research Network Steering Committee to develop policies governing matters such as authorship, communications, data sharing, etc.

Support collaboration and communication among the CLIF-VP PIs, NIH program and scientific staff, Steering Committee, Stakeholder Board, and other individuals or groups associated with the network as appropriate

Develop and facilitate working groups on topics of specific interest to the work of the network

Develop an organizational and administrative structure to promote collaboration, provide technical assistance, and facilitate interaction across the consortium, including maintaining a network directory (sites, partners, and stakeholders) and a web-portal to assist with information sharing

2) Data, measurement, and analytics support and consultation:

Activities may include but are not limited to:

Support data harmonization and sharing and preparing data for archival in an NIH-approved repository. Provide consultation on harmonized existing social determinants of health (SDOH) including, but not limited to the Data Harmonization for Social Determinants of Health via the PhenX Toolkit (www.phenxtoolkit.org).

Identify, facilitate access to, and compile public access and/or restricted access databases (e.g., risk factor, criminal justice, education or other relevant data) and provide linkages to medium and long term outcomes (e.g., linkage to National Death Index) to enable CLIF-VP network sites to supplement primary data collection to build scientific knowledge on firearm violence as appropriate. A centralized data warehouse with integrated data across the CLIF-VP network (as appropriate and determined by the steering committee) and related administrative data should be available for secondary data analysis to the network research sites and the broader research and practice community, upon archival or as appropriate. See https://www.norc.org/Research/Projects/Pages/expert-panel-on-firearms-data-infrastructure.aspx for examples of potential data sources.

Collate administrative, geo-coded and/or other community level data from the research projects as appropriate to facilitate and/or conduct cross-site analyses. As appropriate, integrate different streams of data, including direct data collection of contextual, geographical, environmental and social determinants of health, with administrative data. Develop agreements about the structure of content used across projects to enable sharing and aggregation required by multiple projects.

Provide methodological and statistical consultation on cross consortium and/or individual research project design and analytics as needed. Expertise in design and analytic methods appropriate for studies that evaluate community level interventions is expected. Such studies may propose a parallel group- or cluster-randomized trial, an individually randomized group-treatment trial, a stepped-wedge design, pragmatic clinical trials, rapid cycle testing, adaptive intervention methods, rigorous quasi-experiments, and other dissemination and implementation science methods (including hybrid effectiveness/implementation designs). In these studies, special methods are often required for analysis and sample size estimation. Additional information is available at https://researchmethodsresources.nih.gov/

Communicate and provide technical assistance, as needed on data sharing, IRB or other human subject issues and adherence to any relevant federal data standards.

3) Public/stakeholder engagement and dissemination support:

Activities include but are not limited to:

Create and support a Stakeholder Board representing appropriate members of the public, government agencies, relevant communities, systems and settings to provide support for research and dissemination activities as appropriate

As needed, provide support in convening and exchanging best practices for engagement across communities on recruitment approaches, communications, retention; identify and address barriers to implementation, and facilitate strong community impact

Create public facing communications materials (including social media) designed for study partners to promote the CLIF-VP network, including a study logo with input from the stakeholders, a network newsletter (for research teams, communities, and participants), and coordinate with other NIH funded firearms mortality prevention awards and other Federally funded firearms violence prevention programs as appropriate

Provide support for dissemination activities initiated by the Steering Committee or other network partners

Lead a multi-modal, theoretically driven effort to rapidly and broadly disseminate information generated by the CLIF-VP Research Network, including but not limited to project summaries and updates; lessons learned; preliminary and overall research findings; and messaging about the network priorities and how they advance the science of firearm violence prevention research to a broad audience (e.g., academic community, practitioners, policymakers, community service providers, etc.).

Data and Resource Sharing

Applicants are required to provide an overarching data and resource sharing plan. The NIH expects awardees to implement a Resources and Data Sharing Plan consistent with achieving these program goals, with full understanding that Data and Resource sharing may not be applicable for all research sites (e.g., Tribal sites). The final Resources and Data Sharing Plan is expected to be developed in conjunction with research grantees post award.

Applications Not Responsive to the FOA

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.

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

NIH intends to fund one award for up to $2,000,000, pending available appropiated funds          

Award Budget

Application budgets must not exceed $1.5 million in direct costs for any year of the project

Award Project Period

The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

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

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

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

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

Required Registrations

Applicant organizations

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

  • 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. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, 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:

Jacinta Bronte-Tinkew, Ph.D.
Telephone: 301-806-0009
Email: brontetinkewjm@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the followng exception:

For this specific FOA, the Research Strategy section is limited to 30 pages.

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

R&R or Modular Budget

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy

The research strategy should include a description of the proposed Coordination Center (CC) structure, as well as activities, strategies, timeline, platforms and available resources to use. Applicants must provide evidence that the infrastructure, resources, and institutional support needed to achieve the goals are available. Applications should include a plan that demonstrates they have ready access to infrastructure and personnel to accomplish CC activities and processes, including relevant support services, data management and analytic support, and real-time analytic capacity. A single research plan narrative covers all the activities of the various central functions. The application should describe a plan for carrying out the responsibilities of the CC in the following areas.

1) Administration, coordination and communication

The CC will support collaborations and communication across the CLIF-VP Research Network Research Projects and other components (e.g., NIH, Steering Committee, workgroups, public/stakeholder board).

The application should describe a clear and detailed plan for:

Providing logistical support for in-person CLIF-VP Research Network meetings (including at least a kickoff meeting and annual meetings thereafter) that will take place in the Washington DC area or other locations (including virtually if needed) designated by the Steering Committee/NIH staff and work with NIH to use government meeting space where possible. Also, providing support needed to facilitate the meetings, including note takers, booking travel, and other needed supports.

Working with the Steering Committee to create, establish a plan for, and facilitate meetings of a Public/Stakeholder Board which will provide input and feedback regarding the Research Projects.

Providing operational, logistical and technical support for all virtual CLIF-VP Research Network meetings, for example virtual monthly Steering Committee meetings, Stakeholder Board meetings, potential virtual workgroup meetings, and webinars.

Identifying and providing software platforms and resources needed to enable conference calls, conduct virtual meetings, share documents internally and externally, conduct webinars, and carry out other related work of the CLIF-VP Research Network.

Developing and maintaining a website, ensuring compliance with all applicable Federal and NIH requirements, including Section 508 compliance, security protocols, and plain language requirements.

Supporting and coordinating the activities of the Steering Committee and any workgroups established by the Steering Committee, including scheduling meetings, coordinating meeting agendas, preparing meeting materials, taking notes, maintaining up-to-date documentation and files, communicating with the Steering Committee chair, and other support services.

Tracking and reporting internal network activities and outputs, including publications, subcommittee meetings, etc., and facilitating dissemination of updates and emerging findings within the Network.

Tracking and reporting to NIH on progress and milestone achievement across the CLIF-VP Research Network Research Projects and CC activities.

2) Data, Measurement, and Analytics Support and Consultation

The CC will provide data, measurement, and analytics support and consultation across the network Research Projects throughout the UG3/UH3 phases.

The application should include a detailed plan for:

Providing methodological and statistical expertise, consultation, and support as needed across a broad range of topics, particularly those relevant to community or organizational level interventions. Example areas of relevant expertise include but are not limited to: community-engaged research methods; multi-level modeling; longitudinal data analysis; mediational analysis; missing data techniques; data linkages; cultural intervention tailoring; cluster-randomized trials; rigorous non-randomized intervention designs; intervention optimization designs, intervention implementation frameworks; analysis of clinical trial data collected using methods designed to deconstruct multi-component interventions (e.g., factorial designs); data visualization and visual analytics; geo-spatial analysis, and administrative data management, harmonization, integration and analysis.

Providing scientific, logistical, and technical support for the CLIF-VP Research Network Research Projects in harmonizing measures and/or selecting core common data elements relevant across all or subsets of the preventative interventions.

Developing and executing a plan for data sharing among the Research Projects over the life-course of the CLIF-VP Research Network. Include a clear plan for supporting the Research Projects in developing data sharing policies and procedures.

Working collaboratively with the CLIF-VP Research Network Research Projects to prepare de-identified public use and/or restricted access data files and documents for submission into an NIH supported repository for long-term archival as appropriate. This will include coordinating data transfer and data use agreements with each of the CLIF-VP Research Network Research Projects, compiling integrated datasets, developing codebooks, and other data file documentation across projects and supporting individual Research Projects with archival activities as needed.

Providing a federally compliant online infrastructure to support the submission/transmission of research data, including clinical data. This includes addressing issues such as HIPAA compliance, as well as procedures for de-identification of clinical or research data.

Providing expertise in and coordinating ethical, regulatory, and other required activities for research involving human subjects that involve data sharing, archiving, integration and harmonization.

Identifying, compiling, integrating and facilitating access to a range of existing public-use databases that have the potential to enhance the funded Research Projects (e.g., provide additional community level geo-coded data on risk/protective factors; criminal record date; firearm fatality data) and/or provide opportunities to study firearm violence across the network.

Collating administrative, geo-coded and/or other community level data from the research projects as appropriate and in consultation with the Steering Committee to facilitate and/or conduct cross-site analyses. For example, proposals to utilize data science, advanced analytic or modeling approaches to integrate community level data across projects to inform individual projects and the broader firearm violence prevention field.

3) Public/Stakeholder Engagement and Dissemination Support

The CC will support all network engagement and dissemination activities.

The research strategy should provide a plan for:

Creating and supporting a Stakeholder Board representing appropriate members of the public, government agencies, relevant communities, systems and settings to provide support for research and dissemination activities as appropriate.

Overseeing coordination of network publication activities based on procedures developed through working groups and topics prioritized by the Steering Committee (e.g., collaborative papers using data across Research Projects and/or public-use datafiles, conference submissions, research briefs, etc.).

Designing and implementing a coordinated innovative communication strategy across diverse audiences, including providing updates about CLIF-VP Research Network activities and dissemination of research findings to academic audiences, practitioners, policy makers, and the general public. The plan should include a strategy for engaging in outreach and communication across all phases of the projects, including relevant findings that could be rapidly disseminated from the initial UG3 phase given that intervention findings will not be generated until later years of the initiative.

In addition, the following information should be provided if not included in above descriptions:

Describe without duplicating information in the biosketches, the applicant’s team and level of experience in coordinating large-scale and diverse research networks including degree of scientific emphasis on underserved and/or vulnerable populations, and community engagement activities.

Describe an overall strategy for addressing the aims of the CC. Describe how the proposed CC and will interact with funded network projects to accomplish these goals. Provide a governance approach, logic model, timelines, plans for conflict resolution, and an organizational chart as appropriate.

Describe the existing infrastructure at the applicant’s institution(s), current capacity, research activities, data platforms, and how it will support the network.

For each of the three identified CC functions, describe specific activities that will innovatively meet and expand the goals of the network, how the various activities will interact/intersect, and how they will interact with other NIH funded firearms mortality prevention awards and any other relevant Federally funded firearm prevention programs as needed.

Describe plans for monitoring progress of the network and CC functions. Briefly describe how the CC will flexibly adapt or eliminate processes based on the needs of network investigators, NIH science officers, and/or stakeholders and the continuing need to provide innovative approaches to management of the network.

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

The following modifications also apply:

  • Applicants to this funding opportunity are expected to submit a data sharing plan that describes their proposed process for making resulting publications, code, and to the extent possible, the underlying primary data immediately and broadly available to the public. See Section 8.2.3.1 of the NIH GPS.

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 data sets that are harmonized and facilitate progressive data sharing models.

Steps also are expected that enable sharing of research findings with the broader research, public health, social service and other relevant communities. Applications are, therefore, expected to provide a well-thought-out plan for widely sharing data (e.g., through archiving at an NIH supported repository) and resources as appropriate. 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.

Appendix:

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

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time will not be accepted.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential 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 (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the {IC} Referral Office by email at {xxxx@mail.nih.gov} when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:
Overall Impact

Overall Impact

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

Scored Review Criteria

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

 

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

Specific to this FOA:

Does the proposed CC address the needs of the network that it will coordinate? If fully successful, will completion of the Coordinating Center's aims improve the engagement of multiple stakeholders (e.g., researchers, communities, systems) in the development, evaluation, adoption, implementation and sustainability of interventions and strategies that are found to be successful in preventing firearm and related violence, injury and mortality?

 

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?

Specific to this FOA:

In particular, how adequate is the demonstrated capacity, expertise, and productivity within the Coordinating Center related to (a)

 

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 FOA:

Does the application indicate creativity and flexibility to innovate on an ongoing basis?

 

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?

Specific to this FOA:

Is the management plan well-described and commensurate with the level of complexity required for the CC? Is the leadership and governance approach, plans for conflict resolution and organizational structure appropiate for the CC?

Does the application include an adequate plan for convening the appropriate committees and boards in the CLIF-VP Research Network?



Does the CC provide adequate processes for coordinating with NIH and other Federally funded firearms prevention studies as needed?

How well does the application demonstrate an understanding of the types of available data related to firearm violence and the challenges underlying the integration of large and complex data sets?

How well does the application demonstrate an understanding of and capacity for the statistical techniques necessary to conduct cross-site analyses for a range of data types including: , multi-level, administrative, qualitative and quantitative?

How well does the application demonstrate an understanding of the applicable IRB requirements and Federal laws and the implications of these laws and policies for aspects of project execution and public release of data including information security requirements, plain language requirements, and Section 508 compliance?

 

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?

Specific to this FOA:

Does the proposed approach account for dynamic change in work environment and how CC will coordinate meetings when in-person meetings may not be viable?

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.

   

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

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

 

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

 

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

 

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

 

N/A

 

N/A

 

N/A

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

 

N/A

 

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

 

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

 

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

 

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

2. Review and Selection Process

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

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

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

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

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 . 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.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 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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient 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.

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:

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

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

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

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.

Cooperative Agreement Terms and Conditions of Award

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

Agreeing to accept close coordination, cooperation, and management of the project with NIH, including establishment of Steering Committee and Stakeholder Board.

Providing salary support to the Chair of the Steering Committee. Budget for the Steering Committee Chair should also include reimbursement for travel expenses to all in-person Steering Committee Meetings.

Participating in cooperative activities, including annual project update meetings.

Planning and hosting the face-to-face or virtual annual meetings of the cooperative PIs.

Facilitating comparability (e.g., common data elements) across the data from the network research projects, when feasible and appropriate to scientific research questions.

Providing integrative, organizational, and logistical support for the entire program, including tracking, scheduling, facilitating work group meetings and conference calls, and preparing concise minutes or summaries of meetings for distribution.

Coordinating the eventual release to the scientific, public health and other relevant methods, tools, data, results, and other resources.

Providing high-quality documentation as needed, particularly of protocols or approaches that have broad applicability across the program that will be sufficient for outside users to understand and apply to their research projects with minimal assistance.

Integrating and managing administrative or other data sets as needed. Facilitating data quality monitoring through rigorous data management and identification of data biases and errors as they arise.

Supporting the conduct of data analyses and defining approaches, innovations, and methods related to data integration methods, metrics, and any harmonized network dataset.

Providing expertise and leadership in addressing issues of broad scientific applicability, such as informed consent, data sharing standards, advanced analytics and methodological consultation, and dissemination of findings to NIH and research project grantees in the network related to methods, strategies and approaches within and between the projects.

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 8.2.3.1 of 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:

NIH Project Scientist(s). Designated NIH Program Official(s) acting as Project Scientist(s) will have the following responsibilities:

Serve as a resource for specific information on NIH's programmatic intentions and priorities, and help to foster collaborations between researchers, public health, and public policy partners both within and across other Federal agencies to increase the value of research to these participants. Similarly, the project scientist will facilitate communication involving the Coordinating Center, the network grantees and others in the network as needed.

Play an active role in developing innovative methodological strategies to support data collection, management, and analysis (e.g. data quality control, assessing and resolving cross project and site variation, ensuring data comparability).

Identify research questions relevant to the network objectives based on the integrated cross-project/cross-site datasets. They may cooperate with recipients in development, design, and coordination of research plans and study reports emerging from the harmonized dataset. In instances where significant involvement in the design of studies and/or analysis of results has occurred, the NIH Project Scientist(s) may cooperate with recipients as coauthor in preparing publications of data resulting from the research. In this regard, they will be subject to the publication/authorship policies governing all participants. In addition, publications involving NIH staff require internal clearances.

The NIH Program Official, who will not participate in the research or the preparation of publications, will be responsible for the oversight of the research project and award. The Program Official carries primary responsibility for:

(1) periodic review and monitoring and approval of the progress of the research plans in relation to their stated objectives, including consistent communication with the PI and the Coordinating Center staff as well as requests for additional reports or documentation; and,

(2) making recommendations regarding continuance of the program. The NIH Program Official will be responsible for monitoring the conduct of the project and overseeing the Coordinating Center.

The Program Official will receive all required progress reports to determine that satisfactory progress is being made and will work collaboratively with the NIH Grants Management Specialist to assure high quality business management of the program, including the most effective use of Federal financial assistance provided through this cooperative agreement.

Additional NIH staff may participate in all cooperative-related meetings and work groups, as appropriate. Participation by staff from other federal agencies may also be appropriate and advantageous to facilitate the activities of the program.

The NIH reserves the option to recommend withholding or reduction of support from activities that fail to achieve their goal or comply with the Terms and Conditions.

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 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. 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 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 75.113 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 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.

Application Submission Contacts

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

Scientific/Research Contact(s)

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

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

Elizabeth Anne Barr
ORWH - Office of Research on Women's Health
Phone:301-402-7895
E-mail: elizabeth.barr@nih.gov

Robert Freeman
NIAAA - NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
Phone: 301443-8820
E-mail: rfreeman@mail.nih.gov

Melissa S. Gerald, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: melissa.gerald@nih.gov

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

Shalanda A. Bynum, PhD, MPH
National Institute of Nursing Research (NINR)
Telephone: 301-755-4355
Email: shalanda.bynum@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

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

Peer Review Contact(s)

Jacinta Bronte-Tinkew, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-806-0009
Email: brontetinkewjm@mail.nih.gov

Financial/Grants Management Contact(s)

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

Judy Fox
NIAAA - NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
Phone: (301) 443-4704
E-mail: jfox@mail.nih.gov

Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: ryan.blakeney@nih.gov

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

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

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.

Authority and Regulations

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

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