Part 1. Overview Information

Key Dates

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 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. Funding Opportunity Description
Section II. Award Information
Other Award Budget 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. Funding Opportunity Description

The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers.

The overarching goal of this R25 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research.

Background

Every facet of the United States scientific research enterprise, from basic laboratory research to clinical and translational research to policy formation, requires 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.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

In spite of tremendous advancements in scientific research, information, education, and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations, through means consistent with applicable law, to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences. For more information, see NOT-OD-20-031: Notice of NIH's Interest in Diversity

In addition, evidence suggests that there is a need to facilitate transitions along the pathway from early career scientist to independently-funded investigator and diversify STEM fields (see: Expanding Underrepresented Minority Participation: America's Science and Technology Talent at the Crossroads, National Academy of Sciences, National Academy of Engineering, and Institute of Medicine 2011 and Advancing the Nation’s Health Needs: NIH Research Training Programs; Table 3-4, https://ncses.nsf.gov/pubs/nsf23300/data-tables). Moreover, students from certain racial and ethnic groups, including Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders currently comprise ~37 percent of the college age population (see Figure 7.4, NSFOverall S&E Degrees Earned by Underrepresented Minorities), but earn only ~26 percent of science and engineering bachelor's degrees (see Figure 7.4, NSFOverall S&E Degrees Earned by Underrepresented Minorities) and ~14.5 percent of the Ph.D.s in the biological and biomedical sciences (see Table 3-4, https://ncses.nsf.gov/pubs/nsf23300/data-tables) .

Need for the Program

This R25 Education Program will provide research experiences to prepare individuals from diverse backgrounds to successfully transition to the subsequent professional career stage. This NOFO invites established researchers with a record of NIH funding, who can demonstrate that they have successfully guided previous early career scientists to independent research careers and are able to direct an educational research capacity building program to work with their institutions to submit an application for support. This R25 program is designed to strengthen the pipeline of individuals in biomedical, behavioral, and clinical substance use and addiction research across various stages of the research pipeline to enhance the number of independently funded investigators and help promote diversity and inclusion throughout the research workforce.

It is expected that efforts and resources from this program will foster a greater understanding of the implications of substance use and addiction nationwide and contribute to the biomedical research workforce which will help to develop solutions to reduce the burden of substance use, addiction, and their health-related consequences across all populations. The specific NIH Institute and Center scientific areas supported through this NOFO include the following:

The National Institute on Drug Abuse (NIDA) encourages research experiences to include, but not limited to: cellular and molecular neuroscience, neuroimaging, genetics, medication and treatment development, development of new and improved strategies to prevent substance use and its consequences, pain and analgesia, neuroimmune signaling, neuropathology in brain systems, cognitive processes, population neuroscience, delivery of HIV and substance use prevention and treatment services, medication development, epidemiology of substance use, identifying the biological, environmental, behavioral, and social causes and consequences of substance use and addiction across the lifespan, and implementation science, including secondary data analysis. In addition, American Indians and Alaska Natives experience tremendous disparities in substance use and addiction, having the highest rates of substance use and addiction relative to other racial or ethnic groups, and experience high rates of negative consequences from substance use. Research addressing American Indian and Alaska Native substance use and addiction health related disparities is particularly encouraged.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) encourages research experiences across a broad spectrum of inquiry related to alcohol use and alcohol use disorder. The areas of interest include but are not limited to genetics/epigenetics, neuroscience, including cellular and molecular and clinical, neuroimaging, development of novel medications and behavioral treatments, psychiatric comorbidities, pain; basic and translational research on the health consequences of alcohol consumption; applied, translational, and methodological research on the epidemiology and prevention of hazardous alcohol consumption and related behaviors, alcohol use disorder, alcohol-related morbidity and mortality; health services, stigma, fetal alcohol exposure and fetal alcohol spectrum disorder, dissemination and implementation, and health disparities. NIAAA also encourages research aimed at reducing alcohol-related health disparities within American Indians and Alaska Native populations.

In addition to the above, proposed research education activities must reflect areas of science within the mission of NIDA and/or NIAAA. The mission of NIDA is to advance science on the causes and consequences of substance use and addiction and to apply that knowledge to improve individual and public health. NIAAA's mission is to generate and disseminate fundamental knowledge about the effects of alcohol on health and well-being, and apply that knowledge to improve diagnosis, prevention, and treatment of alcohol-related problems, including alcohol use disorder, across the lifespan. For further information, please consult with the current Strategic Plans for NIDA (https://nida.nih.gov/about-nida/noras-blog/2022/09/nida-releases-its-2022-2026-strategic-plan) and NIAAA (https://www.niaaa.nih.gov/strategic-plan).

This NOFO will support creative educational activities with a primary focus on:

Research Experiences: Activities include hands-on exposure and research experiences for undergraduate students, postbaccalaureate students, predoctoral students, postdoctoral fellows, and/or early-stage faculty. The nature of research experiences should be tailored to the needs and career level of participants. It is expected that mentoring will be provided in conjunction with planned research experiences. Research experiences must also be designed to address some area of NIDA and/or NIAAA extramurally supported research via research projects for the participants. Programs are also expected to include complementary activities that support the participants' scientific development, such as scientific writing and presentation skills and training in rigor and reproducibility. Programs should consider the needs of the intended participants and the likelihood of improving their knowledge and/or skills when designing the research program. Programs should have clear goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome(s).

Courses for Skills Development: Providing innovative, state-of-the-art, evidence-based education that relates to the mission of NIDA and/or NIAAA, and is derived from biomedical, behavioral, or clinical research findings, e.g.,advanced courses in a specific discipline or research area, clinical procedures for research, specialized research techniques, or research methodology. The courses may include elements that promote research skills, career development skills, and/or transitioning to the next career stage. For example, short courses, boot camps, or seminars on NIH grant application development and submission, manuscript preparation and publication, survival skills for early-career scientists, and statistical methods. The format of the courses may involve a traditional in-person approach, online activities, a hybrid of both approaches, and/or other methods.

A milestone plan with concrete goals for participants, timelines for proposed research and professional development activities, and evaluation metrics is required for all applications. The milestone plan will be used to evaluate: participant research experiences, technical skill development opportunities; formal mentoring plans, professional career development activities, NIH application and manuscript submissions, plans, courses and seminars for skills development, participant feedback, and the successful graduation or transition of participants to the subsequent career stage.

Applicants can focus on a single career stage or encompass multiple career stages (undergraduate students, postbaccalaureate students, predoctoral students, postdoctoral fellows, and/or early-stage faculty) within their approach, but must include research experiences and courses for skills development to prepare participants to successfully transition to the subsequent professional career stage as key components of the program. Partnerships between institutions are allowed and encouraged. Institutions that have a documented historical mission or commitment to educating underrepresented students or have a record of providing clinical services to medically underserved communities are encouraged to apply.

Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. Research education programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs. Because the research education program is not intended as a substitute for an NRSA institutional training program (e.g. T32), costs to support full-time participants (supported for 40 hours/week for a continuous, 12-month period) are not allowable.

A goal of this initiative is to gather participants and program directors for an annual meeting to discuss best program practices, professional development activities, NIH funding opportunities, and to network with other participants and NIH Program Staff. Funds should be budgeted within the application to cover the costs associated for each participant and program director to attend the meeting.

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.

Applications not responsive to this NOFO

• Applications that do not include research experiences and/or courses for skills development.

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

Section II. Award Information

Other Award Budget 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 Governments

• 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

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving federal support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.

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

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF424 (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. 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 individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

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.

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).

Program Faculty

Researchers from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.

Participants

Participants supported by this research education program should be U.S. citizens and permanent residents.

Participants may be undergraduates, postbaccalaureate students, predoctoral students, postdoctoral researchers, and/or early career faculties.

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 Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions will not be reviewed.

Letter of Intent

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

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

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

The letter of intent should be sent to: NIDALetterofIntent@mail.nih.gov.

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.

Follow all instructions provided in the SF424 (R&R) Application Guide.

Follow all instructions provided in the SF424 (R&R) Application Guide.

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

Facilities & Other Resources. Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

Other Attachments

Enhancing Workforce Diversity Statement: Fostering workforce diversity is a key strategy to uphold the quality of scientific innovation and discovery. NIH encourages institutions to diversify their trainee and faculty workforce, through means consistent with applicable law, to enhance the participation of individuals from groups identified as underrepresented in the biomedical sciences (e.g., see the Notice of NIH's of Interest in Diversity). For the purposes of this NOFO, the applicant must include an Enhancing Workforce Diversity Statement (page limit is two pages). The statement should include a description of the applicant’s commitment to workforce diversity in the biomedical sciences. In addition, applicants should include a description of past and present mentoring and outreach activities to enhance workforce diversity, including efforts focused on groups identified as underrepresented in the U.S. biomedical research enterprise. Describe ongoing and planned outreach, mentoring activities, and actionable milestones to enhance workforce diversity and inclusivity in the applicant’s laboratory, institution, and/or research program. Describe planned activities during the grant period designed to develop or enhance skills of talented scientists from a wide variety of backgrounds.

Advisory Committee: An Advisory Committee is not a required component of a Research Education program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the research education program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application only if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. Please name your file Advisory_Committee.pdf .

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

Follow all instructions provided in the SF424 (R&R) Application Guide.

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

• Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.

Follow all instructions provided in the SF424 (R&R) Application Guide.

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

Research Strategy

Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below:

• Proposed Research Education Program
• Program Director/Principal Investigator
• Program Faculty
• Program Participants
• Institutional Environment and Commitment
• Recruitment Plan to Enhance Diversity
• Plan for Instruction in the Responsible Conduct of Research
• Evaluation Plan
• Dissemination Plan

Research Education Program Plan

Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program. As a reminder, applicants may choose to address one or more of the activities listed in Section I. Funding Opportunity Description.

The description should include the educational and/or career stages(s) of the participants. It should also provide details on the proposed research areas of study and on courses or seminars for skills development. The application should also detail plans for providing strong mentoring. A milestone plan with a timeline is required for all applications, including for example, didactic courses, professional development workshops/seminars, research goals, and mentoring activities as well as mentoring activities (including mentoring activities would fully prepare participants for the NIH grant submission and review process). In addition, since the intent of this program is to assist in the transition of participants to the subsequent research career stage, plans to do so must be included in the application. The proposed research education program should include benchmarks and metrics used to meet the overall program goals. Provide support for the feasibility of the proposed activities and how they relate to the strengths of the institution. The description should also discuss any perceived impediments to implementing the proposed activities and alternative strategies to achieve the measurable objectives. Importantly, the description should detail how the progress of the participants and mentorship activities will be monitored and documented, and what steps will be in place for mediation should problems occur. As a component of the oversight of the participant's progress, it is highly encouraged that an individual development plan (IDP) (NOT-OD-14-113) is developed with the PD/PI and/or their mentor. Describe innovative strategies that could serve as a model for other institutions.

Program Director/Principal Investigator. Describe arrangements for administration of the program. Provide evidence that the Program Director/Principal Investigator is actively engaged in research and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple PDs/PIs, describe the complementary and integrated expertise of the PDs/PIs, their leadership approach, and governance appropriate for the planned project.

Provide evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished.

The responsibilities of the PD(s)/PI(s) include recruitment, selection, placement, and retention of participants in research laboratories; managing mentor-mentee relationships, ensuring the research experience is advancing the skills and development of the participants, as well as coordination and implementation of developmental and mentoring activities. For example: preparing manuscripts for peer-reviewed publications, submitting NIH grant applications, participating in professional development workshops, attending scientific conferences to present research findings, and preparing participants to successfully transition to the subsequent career stage.

Program Faculty. Faculty with a track record of mentoring, advising, and guiding participants to the subsequent career stage should be included in the program faculty. Faculty should have experience needed to coordinate and implement the program. Researchers from diverse backgrounds, including individuals from underrepresented racial and ethnic groups , persons with disabilities, and women are encouraged to participate as program faculty. Faculty should have research and mentoring expertise and experience relevant to the proposed program and career stage and demonstrate a history of, or the potential for, their intended roles. It is essential that participants have exposure and access to a broad range of appropriate mentors. This includes senior faculty who have the benefit of long experience, and junior faculty who have more recent experience in transitioning to independent positions. Programs should describe efforts to achieve diverse representation, through means consistent with applicable law, in program leadership, participating faculty and mentors, and invited speakers. List the Program Faculty whose role is to develop, direct, mentor, and evaluate the proposed research experiences program as Key Personnel and provide their biographical sketches. Describe the experience of the participating faculty in mentoring students and/or investigators, as well as their ability to serve as good role models for the participants by virtue of their own scientific accomplishments.?

Program Participants. Applications must describe the intended participants. They must also identify and justify the career levels for which the proposed program is planned. Participants may be from a single career stage, or programs may propose to bridge several career stages of participants. Describe the process for selection of the program-supported participants. Examples of accepted indicators include, but are not limited to, previous academic success, academic area of specialty, previous research experience, written statements that express interest and commitment to a long-term career in substance use, and addiction research. Include the candidate qualification process, final selection process, and mentor matching. Describe the retention strategies and follow-up activities across the program that would ensure participants remain engaged and are receiving high quality experiences, mentorship, and guidance within the program and assistance as they transition to the subsequent career stage.

Institutional Environment and Commitment. Describe any additional aspects of the Institutional Environment and Commitment not addressed under Facilities & Other Resources or the required Institutional Commitment Letter of Support, described below. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. This section should not duplicate information provided elsewhere.

The scientific environment and institutional commitment should clearly contribute to the probability of success for each supported participant. The institutional support, equipment, and other physical resources available to the participants should be clearly described and detailed relative to the implementation of quality research experiences for the participants. Research activities provided through the institution should foster career development for lead the participants to applying for independent grants.

The program environment (e.g., cohort structure, opportunities for interaction and engagement with both advanced and early career scholars, exposure to scientific or career development seminars) should help to foster career development and success of the participants, and provide enriching and novel research experiences for participants.

Where appropriate, describe any unique features of the scientific environment, subject populations, or collaborative arrangements that may be leveraged to the advantage of the proposed research experiences program. Describe efforts to enhance diversity and promote inclusion through an environment that promotes the success of individuals with a wide variety of backgrounds and perspectives (i.e. institutional and departmental environments in which scholars from all backgrounds feel integrated into and supported by the biomedical community).

Recruitment Plan to Enhance Diversity.

Applications should identify and address gaps, challenges, or other barriers in recruiting diverse groups in the substance use and addiction research workforce and propose a sustainable plan to address these challenges.

Plan for Instruction in the Responsible Conduct of Research. All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). 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 program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019. The plan should be appropriate and reasonable for the nature and duration of the proposed program. Renewal (Type 2) applications must, in addition, describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

Applications lacking a plan for instruction in RCR will not be reviewed.

Evaluation Plan. A milestone plan with timelines and metrics is required for all applications. The detailed milestone plan will be used to evaluate the application during peer review and in consideration of the awarded project for funding of non-competing award years. The milestone plan will be used to evaluate the research experiences and technical training of participants; formal mentoring plans and professional career development activities completed by participants; NIH application and manuscript submissions from participants; courses for skills development offered, participant participation, and feedback; and when appropriate, the successful graduation or transition of participants to the subsequent career stage. The evaluation plan should align with program goals and assess program effectiveness. Applications must include a plan for evaluating the milestone plan supported by the award. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.

Dissemination Plan. A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program, e.g., sharing course curricula and related materials via web postings, presentations at scientific meetings, workshops. Also, there should be a plan for identifying successful and unsuccessful best practices.

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support (see section above: Institutional Environment and Commitment").

Resource Sharing Plan
Note: Effective for due dates on or after January 25, 2023, a Data Management and Sharing Plan is not applicable for this NOFO.

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

When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

• Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
• The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

4. Submission Dates and Times

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

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

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential 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.

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, NIH. Applications that are incomplete or non-compliant 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.

The goal of this R25 program is to support educational activities that will improve the knowledge and research skills of a diverse workforce to meet the nation’s biomedical, behavioral and clinical substance use and addiction research needs. Applicants can focus on a single career stage or encompass multiple career stages (undergraduate students, predoctoral students, postdoctoral researchers, and/or early-stage investigators) within their approach, but must provide comprehensive research experiences to prepare participants to successfully transition to the subsequent professional career stage as a key component of the program.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research education by fulfilling the goal of this research education program, in consideration of the following review criteria and additional review criteria, as applicable for the project proposed.

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.

Significance

Does the proposed program address a key audience and an important aspect or important need in research education? Is there convincing evidence in the application that the proposed program will significantly advance the stated goal of the program?

Investigator(s)

Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? 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 for this NOFO:

• How strong is the PD/PI's track record in mentoring early career scientists and preparing them to successfully transition to the next career stage?
• To what extent does the PD/PI have the experience needed to coordinate and implement the program including: selecting program participants, managing mentor-mentee relationships, and guiding early career scientists through the preparation of presentations for scientific conferences and manuscripts for peer-reviewed publications?
• To what extent does the PI have experience with the NIH grant application and review process?

Innovation

Taking into consideration the nature of the proposed research education program, does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?

Approach

Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome? Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program? If the proposed program will recruit participants, are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a highly qualified participant pool?

Specific for this NOFO:

• To what extent is the proposed milestone plan well-detailed, including meaningfully and measurable benchmarks?
• As appropriate for the program, how does the approach fully prepare participants for the NIH grant submission and review process?
• To what extent does the plan for evaluation align with program goals and assess program effectiveness?
• Is there a plan for dissemination of best practices that identifies both successful and unsuccessful practices?

Environment

Will the scientific and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there tangible evidence of institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions?

Specific for this NOFO:

• How adequate are the institutional support, equipment and other physical resources available to the participants for the development, and implementation of quality research projects?
• How adequately does the applicant discuss how the program will benefit from unique features of the scientific environment or collaborative arrangements?
• How will the program environment (e.g., cohort structure, opportunities for interaction and engagement with both advanced and early career scholars, exposure to scientific or career development seminars) help to foster career development and success of the participants, and provide enriching and novel research experiences for participants?

In the Enhancing Workforce Diversity Statement:

• How adequately does the applicant describe a plan to enhance the participation of diverse groups in the biomedical sciences?
• How adequately does the applicant describe institutional support/commitment to workforce diversity in the biomedical sciences?
• How adequately does the applicant discuss how ongoing and planned outreach, mentoring activities and actionable milestones, will enhance workforce diversity and inclusivity in the applicant’s laboratory, institution, and/or research program?
• How adequately does the applicant describe past and present efforts to increase workforce diversity?
• How adequately does the applicant discuss how planned activities will enhance the skills and knowledge of participants from diverse backgrounds?

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.

Enhancing Workforce Diversity . When the proposed project involves enhancing workforce diversity in the biomedical sciences, the committee will evaluate and assess how the proposed planned activities will encourage participants to pursue further studies or careers in research. The committee should also assess if the proposed scholar recruitment and retention plan to enhance the scientific biomedical workforce is justified and feasible. The committee should also consider whether the proposed plans and activities are appropriate for the proposed career stages that will be supported.

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.

Training in Methods for Enhancing Reproducibility

Does the Instruction in Methods for Enhancing Reproducibility plan describe how trainees will be instructed in principles important for enhancing research reproducibility including, at a minimum, evaluation of foundational research underlying a project (i.e., scientific premise), rigorous experimental design, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, data and material sharing, record keeping, and transparency in reporting? Are the rigor and transparency components sufficiently well integrated into the overall curriculum? Are they taught at multiple stages of trainee development and in a variety of formats and contexts? Does the teaching synergize with elements of the curriculum designed to enhance trainees' abilities to conduct responsible research? Is there evidence that all program faculty reiterate and augment key elements of methods for enhancing reproducibility when trainees are performing mentored research in their laboratories?

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.

Revisions

Not applicable

Renewals

For renewals, the committee will consider the progress made in the last funding period in accomplishing the goals of the program. .

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.

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the Recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of individuals from underrepresented groups. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the proposed research education program, the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 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 program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also: NOT-OD-10-019. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Applications from Foreign Organizations

Not applicable

Select Agent Research

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable. If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination plan.

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 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.

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

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

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

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

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this 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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Standard Terms and Conditions for Research Grants
• 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.

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 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.

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 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

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

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 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), 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 agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Failure by the recipient institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Other Reporting Requirements

• The institution must submit a completed Statement of Appointment (PHS Form 2271) for each participant appointed full time for eight weeks or more or the equivalent. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
• Participant Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each participant appointed full time for eight weeks or more, or the equivalent.

A final RPPR 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.

5. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH or its Institutes and Centers will periodically evaluate their R25 research education programs, employing the measures identified below. In assessing the effectiveness of its research education investments, NIH may request information from databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be contacted after the completion of a research education experience for periodic updates on participants subsequent educational or employment history and professional activities.

Upon the completion of a program evaluation, NIH and its ICs will determine whether to (a) continue a program as currently configured, (b) continue a program with modifications, or (c) discontinue a program.

In evaluating this research education program NIDA expects to use the following evaluation measures:

For Research Experience and Mentoring Programs Involving the Following Groups:

Undergraduate Students:

• Aggregate number and demographic characteristics of participants
• Subsequent educational/career progress, including:

Successful completion of an undergraduate degree in a STEM field
Enrollment in an advanced degree program in a STEM field

Postbaccalaureates:

• Aggregate number and demographic characteristics of participants
• Subsequent educational/career progress, including:
• Successful transition to an advanced degree program in a STEM field
• Hands on exposure and research experience/training in a biomedical laboratory

Graduate Students:

• Aggregate number and demographic characteristics of participants
• Subsequent educational/career progress of participants, including:

Successful completion of a STEM graduate program
Subsequent participation in a formal research training or career development program in a STEM field
Subsequent participation in research
Subsequent employment in a research or research-related field
Subsequent authorship of scientific publications in a STEM field
Subsequent independent research grant support from NIH or another source

Postdoctorates and Early Career Faculty:

• Aggregate number and demographic characteristics of participants
• Subsequent educational/career progress of participants, including:

Subsequent participation in research
Subsequent employment in a research or research-related field
Subsequent authorship of scientific publications in a STEM field
Subsequent independent research grant support from NIH or another source

Formal participant feedback on their research experience while supported by the Research Education Program.

Section VII. Agency Contacts

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

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

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg

Yohansa Fernandez, Ph.D.
National Institute on Drug Abuse (NIDA)
Phone: 301-480-6906
Email: yohansa.fernandez@nih.gov

Laura E. Kwako, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-451-8507
Email: laura.kwako@nih.gov

Dharmendar Rathore, PhD
National Institute on Drug Abuse (NIDA)
Phone: 301-402-6965
Email: Dharmendar.Rathore@nih.gov.

Ranga Srinivas, Ph.D.
National Institute of Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-451-2067
Email: srinivar@mail.nih.gov

Ericka Wells
National Institute on Drug Abuse (NIDA)
Phone: 301- 827-6705
Email: wellse2@nida.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-443-4704
Email: jfox@mail.nih.gov

Section VIII. Other Information

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

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