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.

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

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

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



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

This notice of funding opportunity (NOFO) is designed to catalyze scientific progress by funding a Translational Resource Center that will create sustainable bridges between the fields of 1) substance use epidemiology and etiology and 2) substance use prevention intervention.The overall objective is the creation of cross-disciplinary research teams with diverse scientific perspectives that enable active partnership between epidemiology/etiology and prevention science. Effective translation and cross-fertilization between research disciplines are long-standing and challenging problems. The Resource Centers are meant to address the fact that translation often takes many years or never occurs. Epidemiology/etiology projects may be conducted with the intention of informing prevention, but without specific aims or collaborations already in place that translation and impact may not be realized. Similarly, prevention intervention studies may generate new hypotheses about substance use development or etiology, but these hypotheses may remain untested without collaboration between the prevention team and epidemiological researchers. The Translational Resource Center is expected to conduct activities that bring investigators in these fields together for active collaboration to develop research questions, design study approaches (with either collection of new data or analysis of existing data), and to develop strategies for application of findings from one field into research in the other field. Collaborative activities supported by the Center should have specific goals that lead to concrete products (e.g., publications, grant applications, intervention development or adaptation) and must include a plan for evaluating Center success. 

Definitions for this NOFO:

• Epidemiology/etiology. In this NOFO, the term epidemiology/etiology is meant to broadly encompass research that identifies malleable mechanisms that can be targeted for change, either by having immediate implications for individuals, communities, policymakers, or having clearly translatable outcomes. These include identifying precise subgroups who have varying courses and outcomes; research that considers integration, cooperation, and synergy with multilevel end users; and/or focuses on increasing health equity and reducing health disparities. Further, it includes research to understand the distribution of substance use and/or risk and protective factors and identification of subgroups with varying courses and outcomes. Also included is research that examines the etiology of substance use trajectories, manipulable individual, familial, behavioral, developmental, and socio-cultural/ environmental factors with the potential for multidirectional transfer of knowledge to advance the health of the population.
• Prevention. In this NOFO, prevention refers to universal, selective, and indicated prevention strategies. These strategies may prevent the initiation of substance use and the escalation from experimentation to regular or disordered use. Also included is the prevention of polysubstance use, and/or substance use disorder (SUD) among individuals who are already misusing substances but do not have SUD (for additional information on the definition of intervention levels see: https://nap.nationalacademies.org/resource/25552/Prevention%20Models%20-%20FINAL.pdf). 
  • Research with those in recovery from SUD is not within scope of this NOFO. 
  • Please note: Overdose prevention among those who are experimenting with substances or who are already misusing substances but do not yet have SUD is within scope of this NOFO. Overdose prevention among those with SUD or in recovery from SUD is not within scope of this NOFO.
• Prevention Intervention Research. In this NOFO, prevention intervention research includes research to develop, adapt or tailor a prevention intervention, to test an intervention’s feasibility, efficacy, or effectiveness, or to study intervention implementation, cost-effectiveness, or acceptability within specific service systems. Research to understand mechanisms of action of an intervention is within scope if there is a strong rationale for how the mechanistic findings will inform intervention content design, delivery, or implementation. 

Research Objectives

The Translational Resource Center is expected to address the needs of researchers interested in advancing translational research plans for substance use epidemiology/etiology and prevention by providing support for the early stages of research project planning. This includes support for matching investigators with similar interests, providing forums to refine ideas and develop approaches, and providing opportunities for analysis of existing data to inform hypothesis formation or testing. Where possible, the networks and resources set up by the Center should be designed to be sustained beyond the life of the award.

The Center should have a well-defined scientific focus to facilitate the identification and connection of researchers with overlapping interests into functional teams. However, the scientific scope should be broad enough that many new research ideas can be developed and researchers from many different institutions can participate. Proposed activities and research should be informed and guided by a clear theoretical framework and/or logic model as well as the empirical literature relevant to the scientific focus.

Applications must address the six core components listed below, though the specific activities within the components are at the discretion of the applicant (see Section IV below for application instructions). In addition to the core components, applications may include other activities or research to further translational science theory or practice as budgets allow.

1. Plan for recruitment and engagement of Affiliate Researchers. Applicants must provide specific plans to recruit and engage researchers to participate in center activities (termed Affiliate Researchers). Such plans must include a strategy for the recruitment of early career investigators and investigators from diverse backgrounds, including individuals from groups underrepresented in the scientific workforce (see NOT-OD-20-031 Notice of NIH’s Interest in Diversity); this plan should apply to all Center activities as appropriate.
2.  One or more interactive convenings. Applicants must plan to support one or more interactive meetings designed to help Affiliate Researchers form new multidisciplinary teams in order to pursue a specific translational research question. These meetings may take different forms and have different specific objectives (e.g., sandpits, match-making or networking events, design sprints, workshops, etc.). These meetings may be large or small, virtual or in-person as appropriate for the meeting’s objectives.
3.  One or more “active-data” events. At least one proposed meeting must involve hands-on, active work by Affiliate Researchers on analysis of an existing dataset or datasets with the goal of generating or testing hypotheses or research questions relevant to prevention of substance use and addiction (i.e., an “active-data” meeting, similar to a hackathon). The format may be a collaborative or a competitive format as best fits the objectives. Applicants may propose multiple active-data events and/or combine them with other convenings as appropriate to achieve the Center’s goals. The active-data event(s) are expected to be in-person and held in the DC area.
4. Ongoing Affiliate Researcher support activities. Applicants must provide resources and support to Affiliate Researchers to sustain new partnerships beyond the meetings and help Affiliate Researchers reach their goals of writing papers or applying for funding for the translational research projects they developed in the meetings. Applicants are encouraged to create sustainable, supported networks to connect researchers across epidemiology/etiology and prevention intervention research that could continue beyond the life of the award. Some illustrative examples of Affiliate Researcher support are listed below, but the applicant may propose whichever activities will best support the specific goals of the Center.
   • Supports or work groups for writing or data analysis
   • Formal or informal information-sharing or consultation platforms (e.g., chat and discussion boards, listservs, wikis)
   • Mock peer review structures for research applications or products
   • Support for small-scale pilots for Affiliate Researchers to follow up on research questions developed in the active-data event, sandpits, design sprints, or other research development activities held by the center
5. Educational resources. Provide educational resources or activities aimed at facilitating the generation of cutting-edge research questions relevant to the Translational Resource Center. Educational resources may be used within meetings for Affiliate Researchers, provided as part of a centralized website, and/or provided in other formats. Some illustrative examples of educational resources are listed below, but the applicant may propose whichever activities will best support the specific goals of the Center
   • Compiling existing prevention interventions for which there is an established or developing evidence-base that are related to the scientific focus of the Center
   • Products or symposia that describe the state of the science with respect to the epidemiology/ etiology relevant to the scientific focus of the Center
   • Conducting trainings or producing materials to support institutions or individuals interested in more effectively conducting multidisciplinary, translational research related to the prevention of substance use and addiction
   • Providing consultation on evidence-based team science best practices (e.g., https://cancercontrol.cancer.gov/brp/research/team-science-toolkit)
6. Dissemination of Center processes and products. Applicants must include a plan to document and publicize Center activities, logic or theoretic models, and related data in peer-reviewed and lay venues to allow for the models and approaches used by the Translational Resource Center to be replicated in the future. Whenever possible, Center products and resources should be made available to the field at large. Some illustrative examples of dissemination activities are listed below, but the applicant may propose whichever activities will best support the specific goals of the Center.
   • Organizing special issues for peer-reviewed journals
   • Maintaining online websites or resources to communicate the accomplishments of the Center and its Affiliate Researchers
   • Convening symposia, workshops, round-tables, or other sessions either independently or as part of general scientific meetings or conferences that will highlight the Center’s work and the work of its Affiliate Researchers

The Center will be responsible for planning, organizing, note-taking, summarizing, evaluating, and archiving information regarding planned events and ongoing meetings, activities, and work groups.

Multiple Principal Investigators

Applicants are required to use a Multiple Principal Investigator (MPI) structure, with the MPI team representing appropriate expertise across epidemiology/etiology and prevention intervention research. The application should demonstrate the MPI and study team’s ability to recruit and engage investigators at different institutions across epidemiology/etiology and prevention intervention research, as well as their scientific and administrative expertise relevant to the Center’s scientific focus and activities.

Applications Not Responsive to this NOFO

The following types of studies are not responsive to this NOFO and will not be reviewed:

• Applications that do not include all six core components
• Applications that propose resource centers focused on developing research that does not involve substance use prevention as defined in this NOFO (e.g., focused on research with people with SUD, or focused on tertiary prevention)
• Applications that only propose recruiting Affiliate Researchers from within a single institution.
• Applications that propose research with those in recovery from SUD
• Applications that propose overdose prevention among those with SUD or in recovery from SUD 
• Applications that focus exclusively on alcohol use (i.e., do not include any other licit or illicit substances)

Special Considerations

National Institute on Drug Abuse (NIDA) applicants are strongly encouraged to review the guidelines and adhere to the requirements applicable to their research listed in the Special Considerations for NIDA Funding Opportunities and Awards. Upon award, these considerations will be included in the Notice of Grant Award.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal 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 (Organizations)

Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information. 

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their 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 How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - 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
• Names, addresses, and telephone numbers of the MPIs
• 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 How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

Please note The maximum project period is 4 years.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy

The Research Strategy should consist of the following sections:

Overall Goals and Significance

Applicants must describe how completion of the aims will advance replicable frameworks and/or supports for translational research and for the formation of multidisciplinary research teams and agendas. Describe how research proposed for the Center will advance our understanding of translational science and/or the epidemiology/etiology and prevention of substance use and addiction.

The Translational Resource Center is required to have a well-defined scientific focus to facilitate the identification and connection of researchers with overlapping interests into functional teams. However, the scientific scope should be broad enough that many new research ideas can be developed and researchers from many different institutions can participate. Provide a rationale for the scientific focus that includes empirical and theoretical evidence whenever possible. If the scientific focus is related to understanding mechanisms of action of an intervention(s), provide a rationale for how the mechanistic findings will inform intervention content design, delivery, or implementation.

Explain how addressing research questions related to the Center’s scientific focus will enable innovation in substance use prevention intervention science.

Investigator Expertise and Center Structure

Clearly describe how the expertise of the Multiple Principal Investigators (MPIs) prepares them to lead the Translational Resource Center from a scientific and administrative perspective. Describe the study team’s prior experience with 1) developing scientific research agendas relevant to the Center’s scientific focus, 2) supporting or guiding individuals from diverse backgrounds, including individuals from underrepresented backgrounds  in activities for developing a scientific approach or agenda, 3) prior experience successfully executing the types of activities planned for the Center, including the recruitment plans for Affiliate Researchers.

Describe the Center’s structure and the specific roles of the MPIs, other key personnel, and Center staff. Describe how the Center’s structure will facilitate innovative research agendas and approaches among the Affiliate Researchers. Describe how the diverse perspectives of the study team will further the Center's goals.

Required Core Components

For the required core components below,

• Applicants must address the innovation of the proposed activities, individually or as a whole. Describe how the Center will expand beyond current approaches to translation in novel ways.
• Applicants must provide a timeline for the planning and execution of activities.

1. Plan for recruitment and engagement of Affiliate Researchers

• Applicants must include specific plans to recruit and engage researchers to participate in center activities, including early career investigators, investigators from diverse backgrounds, and investigators from groups underrepresented in the scientific workforce (see NOT-OD-20-031 Notice of NIH’s Interest in Diversity).
• Provide evidence of feasibility for recruitment approaches.
• Provide a clear rationale for the number of Affiliate Researchers the Center will engage as well as evidence of feasibility for achieving that number.
• Address anticipated challenges and alternative solutions if initial efforts to recruit and engage Affiliate Researchers underperform.

2. One or more interactive convenings

Include the following information for as many proposed meetings as possible:

• Provide clear meeting objectives. Explain how the objectives and planned activities further the Center’s overall goals. Provide a plan for assessing the meeting’s impact and whether objectives were met.
• Justify the target number of Affiliate Researcher participants in the meeting (meetings may be large or small) and whether there will be an application/selection process.
• Describe whether the meeting will be in-person, fully virtual, or hybrid and provide a justification for the format. Provide information about potential locations for in person meetings and platforms for hosting or facilitating virtual or hybrid meetings.
• Describe plans for ensuring the meeting is inclusive and accessible for a broad range of researchers, including any plans to provide travel funding (if applicable) and implement a code of conduct

Specific details for some meetings may need to be determined during the award period (e.g., in response to feedback from Affiliate Researchers or to address a new need identified). In that case, provide any available details and describe the process and information that will be used to determine the meeting’s objectives, participants, or format.

3. One or more “active-data” events

At least one active-data event must be fully described, including all information in the bullets below. If additional active-data events are proposed, as many details for the additional meetings should be included as possible, with a description of the process and information that will be used to determine any remaining details during the award period.

• Provide clear meeting objectives. Explain how the objectives and planned activities further the Center’s overall goals. Provide a plan for assessing the meeting’s impact and whether objectives were met.
• Justify the target number of Affiliate Researcher participants in the meeting and whether there will be an application/selection process.
• Describe the data set(s) that will be used for active data work and provide a scientific rationale for their choice. Demonstrate the study team’s familiarity with and access to the proposed data.
• Describe how access to the data will be provided for participating Affiliate Researchers, including the securing of any needed data use agreements and software or hardware support. Will data be cleaned or prepped in any way?
• Describe how Affiliate Researchers without prior experience with those specific data will be supported in their participation.
• Describe plans for ensuring the meeting is inclusive and accessible for a broad range of researchers, including any plans to provide travel funding and implement a code of conduct

4. Ongoing Affiliate Researcher support activities. Applicants must provide resources and support to Affiliate Researchers to sustain new partnerships beyond the meetings and help Affiliate Researchers reach their goals of writing papers or applying for funding for the translational research projects they developed in the meetings. Applicants are encouraged to create sustainable, supported networks to connect researchers across epidemiology/etiology and prevention interventions that could continue beyond the life of the award.

5. Educational resources. Applicants must provide educational resources or activities aimed at facilitating the generation of cutting-edge research questions relevant to the Translational Resource Center. Educational resources may be used within meetings for Affiliate Researchers, provided in a centralized website, and/or provided in other formats.

6. Dissemination of Center processes and products. Applicants must include a plan to document and publicize center activities in peer-reviewed and lay venues to allow for the models and approaches used by the Translational Resource Center to be replicated in the future. Whenever possible, Center products and resources should be made available to the field at large.

The specific design for some activities may need to be finalized during the award period, for example, in consultation with expert panels or Affiliated Researchers. In that case, the activities should be described in enough detail for reviewers to understand their likely impact and outcomes and the process for refining the design should be clearly specified.

Additional research or activities to be conducted by the Center (optional)

• Describe additional research or other activities to be conducted by the center, their significance and how they will further the center's overall goals
• Applications proposing small-scale pilot programs must describe how pilot projects will be sought and reviewed.

Center Evaluation

Applicants must describe a self-assessment plan that involves objective benchmarks or criteria by which to measure the success of the Center and support continuous improvement of Center operations.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide. 

• All applications must include a Resource Sharing Plan.
• NIDA Centers are supported both for their expected scientific accomplishments and for their role as resources to the research community. The Resource Sharing Plan should describe how Center-developed resources will be disseminated to the public (e.g., researchers and institutions not affiliated with the Center). The plan must include a timeline for dissemination.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

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

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

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 How to Apply - 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 How to Apply - 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 How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

Foreign Organizations

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – 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 Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the How to Apply - 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 field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO 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 How to Apply - 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.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]. 

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

Section V. Application Review Information

1. Criteria

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

Overall Impact

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

Scored Review Criteria

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

Significance

Does the proposed Center address the needs of the research programs 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 programs?

Specific to this NOFO: 

• To what extent will completion of the aims advance replicable frameworks and/or supports for translational research and for the formation of multidisciplinary research teams and agendas?
• To what extent is the scientific focus appropriate and significant?

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 multidisciplinary research? Do the investigators demonstrate significant experience with coordinating collaborative 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?

Innovation

Does the application propose novel approaches in coordinating the research program the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of team building, team science, or research development concepts proposed?

Specific to this NOFO:  

• To what extent do the proposed activities, individually or as a whole, demonstrate innovation? 

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research programs the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the programs, 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 Center? 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 this NOFO:

• To what extent will the plans to recruit Affiliated Researchers expand the pool of early career investigators and investigators from diverse backgrounds, including individuals from groups underrepresented in the scientific workforce?
• To what extent will the objectives and activities for the hands-on meeting(s) further the Center’s overall goals? How strong is the scientific rationale for the dataset(s) proposed for the active-data meeting?
• To what extent will the support provided to Affiliate Researchers sustain new partnerships beyond the meetings? If proposed, how well is the approach for seeking and reviewing pilot projects aligned with network goals and likely to advance progress in the field at large?
• To what extent will the educational resources facilitate the formation of multidisciplinary teams and the generation of cutting-edge research questions relevant to the Center.
• To what extent will the dissemination plan ensure awareness of Center activities and products for relevant research or lay audiences not affiliated with the Center?

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research programs 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?

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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

For programs 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 NIDA, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

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 (HHS) grant administration regulations at  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 NIH as defined below.

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

• Accept close coordination, cooperation, and management of the project with NIDA, including those outlined below in the "NIH Staff" section. The PD(s)/PI(s) will be expected to maintain close communications with the NIH project scientist(s) and, where appropriate, the program officer(s).
• Developing objectives, approaches, and strategies for the Translational Resource Center.
• Defining general structure and governance of the Center with well-delineated roles and responsibilities.
• Managing and coordinating project activities scientifically and administratively at the recipient institution and with any collaborating institutions.
• Provide operational support for Center activities and research, including scheduling, facilitation, and logistic support for all meetings and preparing concise minutes or summaries of meetings for distribution.
• Updating milestones and timelines at the time of award and provide summaries of progress toward those milestones at least yearly, or as requested by NIH.
• Planning, scheduling and coordinating the meetings associated with the Center. Working with NIH staff to determine appropriate format (e.g., in-person, virtual, hybrid) and location for any meetings. The active-data meeting is expected to be in-person and held in the DC area.
• 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 HHS, PHS, and NIH policies.

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

• NIDA will assign one or more Project Scientists (PS) to the project. 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 Project Scientist will provide input, expert advice, and suggestions in the design, development, coordination, and implementation of the Center activities, including the active data event(s).
• The Project Scientist will join regular meetings and be in regular communication with the MPIs and study team to further the Center’s goals.
• The Project Scientist may contribute to Center products, including lay or peer-reviewed publications.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• None; all responsibilities are divided between recipients and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: 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 HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting.  To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

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

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

Alexa Romberg, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-0264
Email: [email protected]

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

Nicole Franklin
National Institute on Drug Abuse (NIDA)
Telephone: 301-594-3380
Email: [email protected]

Section VIII. Other Information

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

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