Part 1. Overview Information

Key Dates

The following table includes NIH standard due dates marked with an asterisk.

Dates in bold and italics reflect changes per NOT-DA-24-030

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 NOFO or in a Notice from NIH Guide for Grants and Contracts).

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

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

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

The goal of this Notice of Funding Opportunity (NOFO) is to support doctoral candidates from a variety of academic disciplines for up to two years for the completion of the doctoral dissertation research project. Dissertation research topics should align with the National Institute on Drug Abuse (NIDA) strategic plan (https://nida.nih.gov/about-nida/noras-blog/2022/09/nida-releases-its-2022-2026-strategic-plan), or with the NIDA HIV/AIDS research priorities (https://nida.nih.gov/about-nida/organization/offices/hiv-research-program-hrp/about-hiv-research-program). This program will ultimately facilitate the entry of promising new investigators into the field of substance use/substance use disorder (SU/D) research.

Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission. (NOT-OD-20-031).

Research Objectives

Research supported by NIDA encompasses the underlying mechanisms and health effects of SU/D. This NOFO provides students with funding to conduct dissertation research in support of NIDA's mission. Research may be related to basic neuroscience, etiology, epidemiology, prevention, treatment, services, or women and sex/gender differences. Please view NIDAs current Strategic Plan (https://nida.nih.gov/about-nida/noras-blog/2022/09/nida-releases-its-2022-2026-strategic-plan) for more information. This program is intended to encourage investigators to seek research careers that will reduce the health, social, and financial costs of substance use disorders (SUD) to society.

NIDA supports projects that enable doctoral degree candidates to receive training in clinical research, including clinical trials. However, trainees cannot be supported under the R36 mechanism to conduct independent clinical trials (see https://grants.nih.gov/policy/clinical-trials/definition.htm for a definition). If the R36 project involves a proposed or ongoing clinical trial, the trial must be led by a mentor or a more experienced investigator, who is responsible for completing all required approvals. The doctoral candidate can be a part of the research team and can use the data generated during the clinical trial in the proposed project. However, the research experience of the doctoral candidate must be supervised by a more experienced Principal Investigator (PI).

The descriptions below are examples of research areas supported by this program and are provided to help potential applicants determine whether a particular scientific topic is appropriate for this initiative. These descriptions are not intended to be comprehensive. In addition, given the complexity of SU/D research, it is permitted to conduct the proposed dissertation research in conjunction with an ongoing research study or to use extant data. Research studies focused on high-priority NIDA HIV/AIDS topics (https://nida.nih.gov/about-nida/organization/offices/hiv-research-program-hrp/about-hiv-research-program) and minority health and NIH-designated populations that experience health disparities (including racial and ethnic minority populations, less privileged socioeconomic status (SES) populations, underserved rural populations, and sexual and gender minorities (SGM)) are also encouraged. Applicants are strongly encouraged to discuss their proposed research plan with a program official.

Basic Neuroscience

• Studies in cognitive neuroscience to understand the neural basis of interrelationships between addictive and cognitive processes. Studies of innovative methods for the design of probes and new chemical entities that include the application of computer-aided discovery and drug design methods.
• Studies of pharmacokinetics and pharmacodynamics of substances to characterize drug absorption, disposition, elimination, and kinetics.
• Studies of the genetic and epigenetic basis of vulnerability and adaptation and the identification of molecular mechanisms underlying substance preference and related behaviors.
• Both methodological and applied studies using data analytic strategies applied to data with exceptionally complex volume, velocity and variety (i.e. big data approaches).
• Studies of basic HIV and substance use using big data approaches to understand interactions of substances of abuse with non-neuronal cells and tissues impacted by HIV infection.
• Studies in the clinical neurobiology of HIV/AIDS to investigate how substance use affects the onset, progression, and severity of HIV/AIDS-related alterations of the CNS.

Etiology and Epidemiology

• Studies of multiple factors that influence drug use outcomes. That is, studies that examine genetic, neurological, biomedical, familial, behavioral, environmental, social, cultural, developmental, psychopathological, and psychological factors, their interactions, and mediating characteristics.
• Studies of the underlying physiological and psychosocial mechanisms associated with the transition from lower to higher levels of drug involvement and from higher levels of drug involvement to substance use disorders, including addiction.
• Development and improvement of techniques for studying substance misuse, including enhancements in measurement, development of improved sampling procedures, and refinement of analytic methods for various populations across human development.
• Development of innovative approaches to identify both physical (ecological) and social environmental/contextual characteristics of local communities that influence substance use, emerging substance use patterns, and adverse drug-related outcomes.
• Delineation of the underlying dynamic causal mechanisms associated with substance use patterns and adverse drug-related outcomes by integrating individual, family, peer, and community level factors. Mechanistic studies and research that address critical time points in development which may influence risk or resilience.
• Studies of emerging trends (e.g. synthetics, opioids, marijuana products, different modes of consumption), including studies that relate these trends to influences such as changes in social attitudes, new substances of abuse, new patterns of social interaction and social media, new technologies, and similar macro-level changes. Research on substance use and substance-related consequences for minority health and NIH-designated populations that experience health disparities. This includes studies that uncover the basis for racial/ethnic/gender disparities in substance use and social, behavioral, and health outcomes related to substance use across development.
• Research to assess the impact of mental health interventions in childhood on subsequent substance use.
• Studies to assess the nature, scope, and consequences of substance-related trauma, violence, and crime, including violent and nonviolent crime.
• Research to assess the impact of substance use on adverse behavioral, social, and health consequences (e.g., trauma, violence, educational attainment, HIV) as well as the role of adverse consequences on further drug involvement.

Prevention

• Studies that apply insights from genetics, neurobiology, neurocognition, and physiology to inform prevention interventions and test the effects of prevention interventions.
• Studies on the efficacy or effectiveness of substance use prevention programs to address emerging drug trends (e.g. e-cigarette use, synthetic drug use, resurgent drug epidemics).
• Studies on interventions and approaches to prevent opioid misuse and opioid use disorder in older adolescents and in adults.
• Studies to develop and test the efficacy or effectiveness of interventions in contexts opportune for providing/delivering preventions and services, including health care, criminal/juvenile justice, workplace, and child welfare, among other systems and settings.
• Methodological research to improve the analysis of complex prevention trial data for example, statistical modeling for multi-level data, analysis of longitudinal data, and research examining complex interactions between qualitative and quantitative outcome data.
• Studies on the adoption, implementation, and sustainability of evidence-based substance use prevention interventions, including analysis of data to determine factors that account for quality of implementation and outcomes, or program sustainability.
• Pilot substance use prevention or drug-related HIV prevention studies designed to identify novel approaches to risk reduction, such as through new technologies or new modalities.
• Research aimed at developing improved substance use and HIV prevention strategies for high-risk populations, understudied populations, and populations who experience greater rates of substance use and/or serious adverse consequences of substance use.

Treatment

• Utilizing relevant research from the animal model literature (e.g., avoidance and impulsivity paradigms) to develop or improve treatments/interventions. Utilizing relevant research from the developmental (e.g., basic research on familial and peer influences during adolescence) or social psychology (e.g., basic research on stereotyping) literature to improve treatments
• Stage I studies developing or adapting behavioral interventions that promote adherence to pharmacotherapy to treat substance misuse.
• Developing and assessing treatment provider training procedures for evidence-based treatments (e.g., computerizing training procedures; this can include initial training as well as supervision requirements). Developing interventions to promote adherence to medical treatment regimens. Computerizing, or partially computerizing evidence-based treatments for SUDs, as well as for HIV prevention interventions for individuals in substance use treatment. Developing interventions to reduce pain in individuals dependent on prescription drugs or individuals with co-occuring substance use and chronic pain. Research involving secondary analyses of existing behavioral treatment research data sets to identify predictors, moderators, or mediators of treatment outcome, mechanisms of action of treatment, or secondary effects of treatment on participants in various contexts (e.g., peer group, school, work, family) or on participants' family members (e.g., children). Conducting secondary analysis of combined behavioral and pharmacological treatment clinical trials. Research on instrument development and/or psychometric analysis of tools for the clinical assessment of substance use, treatment efficacy, treatment fidelity, and HIV risk, or for constructs believed to be related to mechanisms of action of behavioral treatment efficacy. Research to develop and test a therapy module to be added to an existing therapy to address targeted issues (e.g., adding an HIV risk reduction module to a family therapy for substance using adolescents). Research to integrate innovative health technologies into new or existing behavioral and integrative treatments. Research testing a principle of behavior change among substance users in treatment (e.g., by adding more frequent or multi-method assessments to an existing study in order to track behavior change over time).
• Development of improved medication compliance markers.
• Development of medications to treat substance use disorders, including medications for smoking cessation.
• Studies of developmental cognitive processes of rewards, losses, social cues in decision-making, and value incentives relevant to treatment and integration of relevant developmental cognitive processes into the development of treatments. Studies to inform our understanding of how peer influence contributes to decision-making processes in group treatment settings. Studies that use neuroimaging and other techniques to characterize specific neurobiological circuitry during adolescence to inform treatment development (e.g., to determine incentive-motivational circuitry that can be involved in emotional regulation, drug seeking, addiction, reward, relapse, and maintenance of behavioral change).
• Development of devices to treat SUDs.
• Development of the Digital Therapeutics Program, which takes advantage of the growing opportunities in remotely delivering effective interventions for SUDs.
• Development of novel clinical outcome assessment, which measures and instruments that can be used to evaluate the safety and efficacy endpoints in clinical trials of treatments for SUDs.

Services

• Clinical quality improvement studies to examine factors that may improve the appropriateness, effectiveness, safety, and efficiency of treatment and recovery interventions, as well as services delivered to individuals, individuals experiencing substance misuse and chronic pain, sexual and gender minorities, and racial and ethnic minorities, in a variety of settings including substance use and mental health treatment programs, schools, general health care settings, criminal and juvenile justice systems, child welfare systems and social service agencies.
• Quality improvement studies in services organization and management studies that address organizational contexts and service delivery models, the interaction of providers and programs within and across systems, and at multiple levels (e.g., program, practice network, state), and their collective impact on the quality of service delivery.
• Implementation science studies that seek to identify effective strategies for enhancing the adoption, adaptation, and sustainment of evidence-based treatment practices. Studies that examine causal models of implementation success or failure are especially encouraged.
• Studies examining the effects of practice and policy changes on service quality and outcomes, including unintended consequences.
• Economic studies falling within NIH’s priorities for health economics research as described in NOT-OD-16-025.
• Studies developing or applying new methods, technologies or other innovative tools to improve the rigor and reach of health services research.
• Studies to identify and address barriers and facilitators to implementing evidence-based prevention interventions in settings and systems.
• Studies on strategies for implementation of evidence-based prevention interventions and approaches into health care and other service systems and settings (e.g., juvenile justice, child welfare, FQHCs, community-based organizations).

Women and Sex/Gender Differences

Through this dissertation award program, NIDA seeks to foster research on females (both humans and in animal models) and sex/gender differences in all areas of substance use research. From basic cellular and genetics research to epidemiology, prevention, treatment, and services research, investigators are encouraged to explore the possible importance of sex/gender differences in their chosen area of study and to explore substance use issues specific to females.

Examples of research areas appropriate for this announcement include:

• Sex/Gender differences in the basic behavioral, physiological, neurobiological, and genetic mechanisms underlying substance use; and laboratory (both human and animal), clinical, and epidemiological studies of sex/gender differences in the determinants of initiation, progression, maintenance of substance use, and responsiveness to treatment.
• Laboratory (both human and animal), field, and clinical research aimed at: (1) identifying sex/gender differences in the consequences of substance use, misuse, and addiction following acute use, chronic use, as well as residual effects following prolonged abstinence, and (2) examining substance-related consequences that are unique to females.
• Clinical studies aimed at characterizing sex differences in the effects of substance exposure on the developing brain, or studies aimed at detecting sex differences in acute and chronic substance use effects (and abstinence effects) on the brains of children, adolescents and adults.
• The application of sex/gender-specific theories and empirical research on the origins, pathways, and risk and protective factors related to substance use, progression/transition, and maintenance, to the design, development, and testing of gender-sensitive prevention and treatment strategies and interventions to determine effectiveness and efficacy.
• The development and testing of theoretically-based drug treatment approaches (including behavioral treatment and pharmacotherapies) that address sex/gender-specific topics related to the effective and efficient delivery of substance use treatment services.
• Substance use and HIV/AIDS research from a sex/-gender-based perspective that addresses the high priority topics of research listed here: https://nida.nih.gov/about-nida/organization/offices/hiv-research-program-hrp/about-hiv-research-program.

Applications Not Responsive to this NOFO

Application lacking the following will be considered non-responsive and will not be reviewed:

• applications that lack a Plan for Instruction in the Responsible Conduct of Research
• applications that lack a Scientific Support Plan

Special Considerations

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 (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 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.

By the time of award, the dissertation candidate must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status). Furthermore, at the time of award the applicant must have completed all institutional requirements to enter the dissertation stage of their research program.

Trainees who have received F31 funding are ineligible for the R36 Dissertation Award. Concurrent F31 and R36 applications are not allowed. Multiple PD/PI applications are not allowed.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, 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 SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity 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.

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 NOFO.

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.

Other Attachments:

Instruction in the Responsible Conduct of Research (required): All applications must include a plan to fulfill NIH requirements for Instruction in the Responsible Conduct of Research (RCR). The attachment is limited to one page. The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the instruction; 4) Duration of Instruction - the number of contact hours of instruction; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. Document any prior instruction during the applicant’s current career stage, including the inclusive dates instruction was last completed. See also NOT-OD-10-019.

Scientific Support Plan (required): All applications must include a plan for scientific support of the PD/PI. The attachment is limited to two pages. Outline activities that will ensure that the PD/PI has a thorough understanding of the scientific principles and methods required for the proposed study. Describe plans for professional skills development to assist the PD/PI to transition to the next stage of their research career. Highlight the time to be allocated by the advisor to guide and support the PD/PI so that they will complete the dissertation in a timely manner.

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

Biographical Sketches must be provided for the PD/PI and the dissertation project advisor, and include the following:

• Highlight details that demonstrate the promise of the PD/PI as a research investigator in research areas relevant to the application.
• Document the mentoring experience of the advisor.

R&R Budget

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

R&R Subaward Budget

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

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

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

Research Strategy

• Explain how completion of the project will help the PD/PI to advance their research career goals.
• Explain how the level of innovation for the project is appropriate for the PD/PI’s career stage.
• If the candidate is proposing to gain experience in a clinical trial as part of their research training, describe the relationship of the proposed research project to the clinical trial.

Letters of Support: All letters must be combined into a single PDF file.?

Letter of Certification (required): The faculty advisor, dissertation committee chair, or university official directly responsible for supervising the dissertation research must submit a letter certifying that the PD/PI meets the eligibility criteria for this award.

Advisor and Reference Letters (required): The faculty advisor and at least one other member of the dissertation committee must submit letters, each no longer than 2 pages, that assess (a) the doctoral candidate’s progress to date; and (b) the candidate’s commitment to SU(D) research and their prospect of becoming an independent investigator in this area. The letters must address the institutional support and resources available to foster the completion of the dissertation project in a timely manner.

Resource Sharing Plan:

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

Other Plan(s):

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

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

A Data Management and Sharing Plan is not applicable for this NOFO.

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

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

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 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 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

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

Specific to this NOFO: significance should be evaluated within the context of a doctoral dissertation: to what extent will successful completion of the project help the PD/PI to advance their research career goals?

Investigator(s)

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

Specific to this NOFO: How strong is the promise of the PD/PI as a research investigator in research areas relevant to the application, as evidenced in their Biographical Sketch and letters of support? How well-qualified is/are the advisor(s) to provide guidance, i.e., how strong is their mentoring experience? How adequate is the time allocated by the faculty advisor to guide and support the PD/PI so that he/she will complete the dissertation in a timely manner?

Innovation

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

Specific to this NOFO: Innovation should be considered within the context of the doctoral dissertation - how appropriate is the level of innovation as compared to the PD/PI’s career stage?

Approach

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

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

Specific to this NOFO: How adequate are the proposed activities in ensuring that the PD/PI will have a thorough understanding of the scientific principles and methods required for the proposed study? How strong are plans for professional skills development to assist the PD/PI to transition to the next stage of their research career? How strong is the proposed plan for instruction in the responsible conduct of research?

Environment

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

Specific to this NOFO: is there sufficient institutional support to foster completion of the dissertation project in a timely manner, as evidenced by the letters of support?

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 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not applicable

Revisions

Not applicable

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

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

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for 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 NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: 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:

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

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

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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

Not Applicable

3. Data Management and Sharing

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

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

4. Reporting

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

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $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 and 2 CFR Part 200 Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [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]

Marsha F. Lopez, Ph.D., M.H.S.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6504
Email: [email protected]

Keisher Highsmith, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1984
Email: [email protected]

Guifang Lao, M.D., Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-5931
Email: [email protected]

Beth Babecki, M.A.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-0899
Email: [email protected]

Lindsey Friend, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1428
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Ericka Wells
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6705
Email: [email protected]

Section VIII. Other Information

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

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