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 National Institute on Drug Abuse (NIDA) seeks applications for a Coordination Center to create synergy and linkages across projects funded under NIDA's Racial Equity Initiative (REI) funding opportunity annoucements. The Center will provide coordination for collaborative products and activities while housing shared resources. In addition, the Center will optimize the impact of individual REI projects by strengthening community-engaged research efforts and supporting the dissemination and usage of research products and innovations.

Background

The NIH is committed to supporting health equity research to 1) improve minority health and reduce health disparities and 2) remove the barriers to advancing health disparities research (for more information, see the NIH Minority Health and Health Disparities Strategic Plan 2021-2025. In alignment with this NIH-wide effort, NIDA established the Racial Equity Initiative (REI), with goals that include promoting racial equity in NIDA's research portfolio. Among the actions taken by NIDA, which were informed by internal and external meetings and listening sessions, the Institute has committed to a significant increase in funding for research to address racial and ethnic disparities in outcomes related to drug use and HIV. The REI funding opportunity announcements (FOAs) seek to advance equity by supporting research and research training efforts that are consistent with NIDA’s mission and with best practices for conducting research with racial and ethnic minority populations.

NIDA seeks applications for a Coordination Center to establish a learning community to maximize the impact of NIDA’s Racial Equity Initiative research projects. NIDA has issued several REI funding opportunity announcements (FOAs) to support highly innovative, solution-focused research studies to address persistent disparities in the United States affecting racial and ethnic minority communities. These disparities in outcomes related to substance use, consequences of substance use, and substance use disorder prevention and treatment, are driven by social, structural, and systemic factors. Thus, effective solutions should be grounded in an understanding of these factors and responsive to the needs of communities and resources available within communities. The Coordination Center will create synergy around innovations and best practices for working with underserved populations to address persistent disparities.

Center Objectives and Scope

The proposed Coordination Center should maximize the impact of the NIDA REI research projects by 1) facilitating cross-fertilization of ideas and interactions among awardees, 2) enriching the ongoing work products and scholarly output from the REI research projects, 3) facilitating the conduct of community-engaged research, and 4) supporting the robust dissemination of REI research findings. The Center should provide technical assistance and consultation to the research project awardees regarding unique aspects of working with racial and ethnic minority and health disparity communities, such as accessing hard to reach populations, establishing trust within the community, overcoming recruitment challenges, appropriately securing informed consent, selecting valid measures, and reducing barriers to participation in research. In addition, the Center is expected to provide consultation on theories, measures, and best practices in research involvingstructural racism, social determinants of health as well as the conduct of moderate to large-scale intervention and non-intervention research projects. The Center is expected to provide intervention researchers with support and resources to enable broad dissemination, uptake, and sustainability of effective strategies.

Center Activities

The Center is expected to provide learning opportunties for scientists, as well as end users of research products, such as clinicians, public officials, patients and members of the public. The activities planned and promoted by the Center should feature essential knowledge and skills to support the activities of NIDA REI research projects. Independently or collaboration with REI awardees, the Center investigators may engage in various efforts such as (but not limited to):

• convening workgroups on the recommendation of REI awardees
• providing consultation on the conduct and interpretation of subgroup analyses within a dataset
• providing services to make research products or instruments accessible to persons who have limited English proficiency or accessibility challenges
• providing consultation and resources related to quality control in data management, analysis of intensive, longitudinal data, data security, and data sharing
• developing novel assessment tools and methodologies that will be widely used by researchers who study substance use and health equity
• creating and making accessible resources to facilitate engagement of racial and ethnic minority or other health disparity populations in research
• organizing efforts to create special issues for peer-reviewed journals
• creating lecture series focused on innovations in community-engaged research
• creating opportunities for researchers to learn about the needs and concerns expressed by community advocates and community members
• hosting networking events for health equity scholars
• conducting trainings or producing materials to support efforts to mentor early career investigators conducting racial equity research
• hosting Health Equity Grand Rounds or a journal club
• conducting trainings or preparing written materials related to research ethics
• leading reviews or publications on topics of critical importance to the REI efforts
• maintaining an online resource to share NIDA REI research news, press releases, publications and presentations

The Center will be responsible for planning, organizing, notetaking, summarizing, evaluating, and archiving information regarding planned events and ongoing meetings and workgroups.

Communication, and Collaboration, and Data Sharing Resources

The Center is expected to host online collaboration/productivity tools and resources to benefit the ongoing studies. This includes developing and hosting internal and outward-facing websites related to the research studies. The Center will support the use of technology to enable cross-project collaboration (e.g., tools for hosting meetings, sharing/transferring files, etc.).

The REI research projects are required to share data. To facilitate the data and resource sharing needs for the REI awards, the Center should propose to provide consultation, training, and tools to facilitate the use of established data sharing practices that give study participants agency in data sharing and protect the identity of research study participants. Another function of the Center should be to guide REI awardees in the use of FAIR (Findable, Accessible, Interoperable, Reusable) principles for data sharing.

REI Commitment to Community-Engaged Research and Research Dissemination

Research projects supported under the NIDA REI initiative are expected to 1) incorporate community-engagement activities in their research and 2) commit to broad dissemination of their research findings to researchers, practitioners and impacted communities. Thus, the Center should support the efforts of the REI awardees to promote community-engaged research and dissemination of research findings to various audiences beyond traditional academic outlets. This should involve the use social media platforms and other creative channels to communicate with health professionals and community members. Infrastructure for activities or materials designed to support community-engaged research and research dissemination should be provided through the Center. Expertise in conducting community-engaged research within U.S. racial and ethnic minority population groups (see Public Law 106 525 Nov. 22, 2000) is essential.

Center Advisory Groups

In consultation with NIDA staff, the Center is expected to constitute and seek consultation from two external advisory groups throughout the duration of the award period:

• A Steering Committee, consisting of a chairperson selected by NIDA, select REI awardees, and NIDA program staff. This group will contribute to strategic planning for the Center and review of Center products. While the meeting schedule will be determined post-award, it is advised that applicants plan for meetings to occur every two months during the first year of the award.

• An Expert Panel of researchers, practitioners, public officials, and community members to provide outside perspectives and feedback on Center operations. While the meeting schedule will be determined post-award, it is advised that applicants plan for quarterly meetings of this panel.

The Center will plan, convene, staff, and take minutes for the the Steering Committee and Expert Panel meetings. The Center should plan to provide salary support for the chair of the Steering Committee and an honorarium to members of the expert panel group.

Investigators Meetings

In the first 4 months of the award, the Center will organize a 2-day kickoff meeting for REI awardees. If possible, this introductory meeting should be in-person in the Washington, D.C. metro area. This meeting will provide an opportunity for REI awardees to learn about other REI projects and to establish workgroups and collaborative teams. In subsequent years, the Center should plan an annual meeting. The annual meeting may involve REI awardee presentations, workgroup meetings, group discussions, or networking events as determined in collaboration with members of the Steering Committee. The logistics, plans, and agenda for this meeting are the sole responsibility of the Center. For the annual meeting, the Center should be capable of hosting an in-person event or a hybrid (in-person and virtual) event as needed. Funds should be allocated by the Center to provide travel awards for a limited number of speakers or special guests who conduct health equity research or who collaborate with health equity researchers to attend the kickoff and annual meetings.

Center Governance and Oversight

The Center PI should propose an organizational structure that will ensure the efficient operation and use of Center resources. The Center PI will manage the selection and scheduling of activities in consultation with REI awardees and NIH Staff. Applicants should describe a collaborative process for making decisions about Center activities and products. The Center PIs should plan to communicate directly with each REI awardee about the Center's services and products. In addition, Center applicants should describe how the team will evaluate the individual work products and the overall functioning of the Center.

Diverse perspectives

NIH supports the formation of research teams that represent diverse perspectives, backgrounds and academic and technical disciplines (see NOT-OD-20-031 and NOT-OD-22-019), as well as the submission of research applications from all eligible institutions. Applications from researchers with diverse backgrounds and underrepresented across roles and positions in research, including underrepresented racial and ethnic groups, persons with disabilities, and women, are strongly encouraged to apply to this FOA.

Applications submitted under this FOA must include a Plan for Enhancing Diverse Perspectives (PEDP), which details the research team’s approach to fostering diversity, inclusivity, and accessibility in the project. Instructions for completing the PEDP are provided in Section IV. of this announcement. The PEDP will be evaluated as part of the application by the review committee and by the program staff for scientific and technical merit. Applications submitted without a PEDP will be considered incomplete and will be administratively withdrawn.

Special consideration

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants:

The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth regarding existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. Please see https://nida.nih.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/points-to-consider-regarding-tobacco-industry-funding-nida-applicants for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit:

NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.

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

Section II. Award Information

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

Applicant Organizations

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

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

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

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

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

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

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

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

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

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

Other Attachments:

Plan for Enhancing Diverse Perspectives (PEDP)

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

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

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

R&R Budget

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

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

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

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

Research Strategy

Include the following in the Research Strategy section:

Program Administration:

Describe the strengths, leadership and administrative skills, and scientific expertise of the Center PD/PI(s) investigators. Particular attention should be paid to the qualifications of the PD/PI(s) to lead and oversee the Center. This can include scholarship, leadership, and prior experience related to health disparities research, racial equity research, and research on social determinants of health. Describe the administrative structure that and how it will contribute to the planning, execution and monitoring of the program.

Needs and Strengths Assessment:

Describe the proposed process for ongoing assessment of the needs and strengths of the REI research project awardees over the course of the Center’s project period. Describe plans for communicating the breadth of consultation services that can be offered based on the needs identified by the project PIs.

Activities and Resources:

Describe the types of activities that the Center would be well-suited to conduct in support the REI research programs. Describe the process for soliciting input and developing plans for Center workgroups, projects, and events. Describe plans to create synergy among the REI awardees with common interests. Describe potential trainings that could be offered through the Center on innovative topics. Describe resources that the Center would make available to REI awardees and audiences of scientist and non-scientists.

Communication, and Collaboration, and Data Sharing Resources:

Describe the Center's plan for supporting real-time and asynchronous collaborations in support of the REI project activities. Describe the role of the Center in using innovative technology to support these efforts. Provide details describing the capabilities of the Center to facilitate the implementation of the research projects' Data Sharing Plans.

Community-Engaged Research:

Describe how the Center plans to support awardees efforts related to community-engaged research. Describe prior experience collaborating with multiple racial-ethnic minority population groups. Explain how diverse perspectives, including those of people with lived experience, will be included in these efforts.

Research Dissemination:

Describe how the Center plans to disseminate information on scientific and methodological innovations in racial equity research that are produced through the efforts of the Center and REI research project awardees. Describe plans to create research products for scientists and non-scientists. Describe plans to track the success, or limitations, of information dissemination strategies.

Annual Meeting:

Describe objectives for an annual meeting of the REI investigators and explain how the program would be organized to best serve the REI research project awardees and advance progress and innovation in research on racial equity.

Center Evaluation:

Describe a self-assessment plan that involves developing objective criteria by which to measure the success of the Center and support continuous improvement of Center operations.

Letters of Support

Letters of support should include a letter from the PD/PI’s sponsoring institution that assures support for the proposed Center, including assurance that sufficient time will be allowed for the PD/PI(s) to direct the proposed Center. A minimum of 2.4 person months per year (20% effort) should be maintained throughout the project period.

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

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data/Resource Sharing Plan.
• NIDA Centers are supported both for their expected crucial scientific accomplishments and for their role as vital resources to the research community. The proposed Coordinating Center is expected to make resources, data, and findings (if relevant) available in a timely manner to NIDA REI awardees and other researchers. A description of resources that the Center will generate and a general publication plan are also expected.

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 NIDA, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

Section V. Application Review Information

1. Criteria

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

Overall Impact

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

Scored Review Criteria

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

Significance

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

Specific to the FOA: How will successful completion of the aims contribute to the concepts, methods, and technologies utilized in research on substance use and health equity? What value will the proposed application bring to researchers seeking solutions to advance health equity? Does the Center plan increase the value of the individual REI studies through supporting team science and fostering cross-project interacations?

Investigator(s)

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

Specific to the FOA: Is there a clear description of roles for all personnel? Are investigators experienced in conducting research with underserved racial and/or ethnic minority groups and fostering collaborations between investigators of diverse backgrounds? Does the investigative team have adequate knowledge of research related to substance use? Do the personnel have appropriate backgrounds to support investigators conducting complex community or population-level studies and clinical trials? Does the research team have sufficient expertise in community-engaged research and dissemination of research findings? Is there adequate expertise to manage communications across teams, with stakeholders and outreach to the community?

Innovation

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

Specific to the FOA: Does the application include innovative approaches to create synergy among REI awardees? Does the discussion of community engagement and dissemination of findings to scientific and non-scientific audiences reflect innovative ideas? Does the application demonstrate an appreciation for advances in research on health equity?

Approach

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

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

Specific to the FOA: How well does the application demonstrate an understanding of best practices in research with underrepresented racial/ethnic minority populations? Does the research plan propose ideas for valuable events, products, and resources to advance research on health equity? How well-specified is the plan for establishing and maintaining collaboration and communication across the REI research sites? Does the Center propose the use of state-of-the-art web-based platforms or tools for collaboration and communication? How well does the Plan for Enhancing Diverse Perspectives reflect plans and strategies that will strengthen inclusivity and enhance the scientific and technical merit of the proposed project?

Environment

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

Specific to the FOA: Are the space and technological institutional resources appropriate to support the Center infrastructure and provide a shared resource environment for REI investigators? Are the facilities available suitable for hosting virtual or hybrid in-person and virtual meetings as required?

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.

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

If a foreign component is proposed, reviewers will assess whether it will advance the overall research program because the foreign component provides unusual talent or resources that are not available domestically.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute on Drug Abuse, 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 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 National Advisory Council on Drug Abuse. 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.

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:

• 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 award recipient(s) in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipient(s) for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PI(s) primary responsibilities:

The PI(s) of the Coordinating Center, in consultation with NIDA program staff, will provide consultation and resources to support the NIDA Racial Equity Initiative projects funded under RFA-DA-23-013, RFA-DA-23-023, RFA-DA-23-024, RFA-DA-23-026, RFA-DA-23-028, RFA-DA-23-029, RFA-DA-23-031, and RFA-DA-23-032. New research projects may be added each year during the Coordinating Center’s project period. Each individual REI research award project acts independently to accomplish its specific aims. The Coordinating Center PI(s) agree to

• Accept close coordination, cooperation, and participation of NIDA staff in those aspects of scientific and technical support of the REI projects as stated in these terms and conditions.
• Provide theoretical and conceptual consultation related to research on racial equity and best practices for community-engaged research to complement the expertise of project teams.
• Provide expertise to project teams on issues of broad scientific applicability, such as informed consent, responsible data sharing practices, measurement tools and resources, analysis/interpretation of complex data (biomarkers, surveys, qualitative interviews, administrative, geo-spatial, ecological momentary assessment, etc.), and communication of findings to scientific and non-technical audiences.
• Initiate white papers, manuscripts, special issues of peer-reviewed journals, and develop other research resources. This may be decided independently, on the advice of the Center Steering Committee/NIDA staff, and/or in collaboration with the REI awardees. The purpose of these products is to contribute to the scientific and non-scientific literature on the conduct of research related to racial equity.
• Provide consultation to grantees and provide access to resources and state-of-the-art tools to conduct community-engaged research at multiple points in the research process.
• Advise grantees and provide access to resources to support robust dissemination of research findings to the scientific community, research collaborators, practitioners, research participants, and groups or organizations interested in project outcomes, particularly those who seek evidence to support decision making regarding practices or policies.
• Provide operational support for project collaborations, including scheduling, facilitation, and logistic support for all meetings (e.g., workgroup meetings, networking meetings) and preparing concise minutes or summaries of meetings for distribution. Such meetings will include an annual, on-site or virtual, PI and collaborator meeting as well as periodic Steering Committee and Expert Panel meetings.
• Host file sharing hub and website that makes resources accessible to REI Project PIs, non-REI researchers, and community collaborators, as appropriate.
• Track research project metrics, publications, products, and other reports; track and report the usage of Center Resources by Project Investigators, other researchers, and non-researchers.
• Provide salary support (not less than 1.2 person-months/year) to the Chair of the Steering Committee, to be named. Provide reimbursement for the Steering Committee Chair’s travel expenses to attend two in-person meetings/year (Project Annual Meeting or meeting with Center Staff).
• Provide travel reimbursement/stipends for 3-4 speakers or special guests to travel to the annual meeting when held in-person.
• Recipients(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.

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

The cooperative agreement will be assigned to one or more Project Scientists (PS). The PS will have substantial programmatic involvement that is above and beyond the normal stewardship role in the award and will be named in the award notice. The responsibilities of the PS include involvement through technical assistance, advice, coordination, and/or other assistance activities that are above and beyond normal program stewardship for grants. The PS will participate in advising the Center PI(s) with regard to the overarching goals of the NIDA REI and will contribute substantively to publications and other products.

Areas of Joint Responsibility include:

Under this cooperative agreement, Center PI(s) will work closely with the Steering Committee and NIDA staff to select the most appropriate activities to conduct (e.g., workgroups, seminars/webinars, workshops, networking events) to support the funded REI Projects. The Steering Committee Chairperson and Expert Panel members will be determined jointly by the Center PI(s) and NIDA staff. All REI funded research projects and the Center will cooperate to ensure the timely and broad dissemination of lessons learned and resources to REI project PIs, non-REI researchers, and community collaborators.

Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIDA may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three academic members who are not involved in the study will be convened. The first member will be named by the Center PI(s); the second will be named by NIDA; and a third individual with relevant expertise will be named by the other two appointees. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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

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

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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

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

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

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

Aria Davis Crump
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-0881
Email: [email protected]

Dharmendar Rathore, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-6965
Email: [email protected]

Amy Bucheimer
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6694
Email: [email protected]

Section VIII. Other Information

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

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