Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the Training (T) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the 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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall goal of the NIH Ruth L. Kirschstein National Research Service Award (NRSA) program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. In order to accomplish this goal, NRSA training programs are designed to train individuals to conduct research and to prepare for research careers. More information about NRSA programs may be found at the Ruth L. Kirschstein National Research Service Award (NRSA) website.

The NRSA program has been the primary means of supporting predoctoral and postdoctoral research training programs since enactment of the NRSA legislation in 1974. Institutional NRSA programs allow the Training Program Director/Principal Investigator (Training PD/PI) to select trainees and develop an enhanced program of coursework, mentored research experiences, and technical and professional skills development appropriate for the appointed trainees that provides added value to already existing programs.

The grant offsets the cost of stipends, tuition and fees, and training related expenses, including health insurance, for the appointed trainees in accordance with the approved NIH support levels.

Purpose

The purpose of the Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grant (T32) program is to develop and/or enhance research training opportunities for individuals interested in careers in biomedical, behavioral or social sciences, and clinical research, in health services research, or in any other research discipline relevant to the NIH mission.

Each proposed program should provide high-quality research training, and mentored research experiences, and are expected to help trainees develop:

• A strong foundation in scientific reasoning, rigorous and reproducible research design, experimental methods, analytic techniques, including quantitative/computational approaches, and data gathering, storing, analysis, interpretation and sharing appropriate for the proposed research area.
• Their individual development plans to identify areas of strengths and areas of career and personal growth with the ability to identify and engage mentors.
• Skills in engaging in their chosen area of science including networking, presentation and publication skills and opportunities to interact with members of the broader scientific community at appropriate scientific meetings and workshops.
• The competencies needed to advance to independent careers in their chosen field.
• The ability to think critically, independently, and to develop important research questions to initiate and conduct research and approaches that push forward their areas of study.
• An understanding of the relationship of their research training to health, diseases, and disorders.
• A commitment to approaching and conducting research responsibly and with integrity.
• The competencies to work effectively with colleagues from a variety of backgrounds and scientific disciplines to contribute to inclusive and supportive scientific research environments.;
• The knowledge, professional skills, and experiences required to identify and transition into careers that sustain biomedical research in areas that are relevant to the NIH mission.

The proposed institutional research training program may complement other ongoing research training and career development programs at the applicant institution but must be clearly distinct from related programs currently receiving Federal support.

Program Considerations

The duration of training, the transition of trainees to individual support mechanisms, and their transition to the next career stage are important considerations in institutional training programs. Also, an important consideration is the engagement of trainees in their training goals, process and activities through the program that enhances what they may be getting in existing programs within the institution.

Training PD/PIs should:

• Limit appointments to individuals who plan to remain in the training program for no less than two years, whether that support comes from a training grant or some combination of NRSA and non-NRSA programs. Short-term training is not intended, and may not be used, to support activities that would ordinarily be part of a research degree program, nor for any undergraduate-level training. Short-term positions should be requested at the time of application, as described in the NIH Grants Policy Statement. Research training programs solely for short-term research training should not apply to this announcement, but rather the T35 NRSA NOFO, which can be found in the NIH Training Kiosk.
• Within the full-time training period, research trainees who are also training as clinicians must devote their time to the proposed research training and confine clinical duties to those that are an integral part of the research training experience or can be conducted in the allowable additional 25% of their time (e.g., 10 hours per week) that may be devoted to clinical employment. The program may not be used to support studies leading to the MD, DDS, or other clinical, health-professional degrees except when those studies are part of a formal combined research degree program, such as the MD/PhD. Similarly, trainees may not accept NRSA support for clinical training that is part of residency training leading to clinical certification in a medical or dental specialty or subspecialty.
• Encourage and make available appropriate training so that trainees are prepared to apply for subsequent independent support for their training, career development or research program (e.g., an individual fellowship award, mentored career development award, or research project grant), as appropriate for their career stage.
• In addition, past studies have shown that health professional trainees who train in programs with postdoctoral researchers who have intensive research backgrounds are more likely to apply for and receive subsequent research grant support. Therefore, programs that emphasize research training for individuals with the MD or other health-professional degrees are encouraged to develop interactions with basic science departments and include trainees with research doctorates when this approach is consistent with the goals of the proposed training program.
• Encourage the development of institutional training programs that will provide trainees with education and experience in rigorous, reproducible, and transparent scientific approaches, systems for study, tools and technologies.
• Consider team-based research approaches as may also be warranted depending upon the goals of the proposed training program.

Within the framework of the NRSA program’s longstanding commitment to excellence, attention should be given to recruiting and retaining trainees from diverse backgrounds, including groups underrepresented in the biomedical, clinical, behavioral and social sciences, as described in the Notice of NIH's Interest in Diversity (NOT-OD-20-031).

Institutional commitment and support for the proposed training program are important elements of the application.

The career outcomes of individuals supported by NRSA training programs are intended to include both research-intensive careers in academia and industry, and research-related careers in various sectors, e.g., academic institutions, government agencies, for-profit businesses, and private foundations. Training programs should make available structured, career development advising and learning opportunities (e.g., workshops, discussions, Individual Development Plans). Through such opportunities, trainees are expected to obtain a working knowledge of various career paths that would make strong use of the knowledge and skills gained during research training and the steps required to transition successfully to the next stage of their chosen career.

Short-term training is not intended, and may not be used, to support activities that would ordinarily be part of a research degree program, nor for any undergraduate-level training. Short-term positions should be requested at the time of application as described in the NIH Grants Policy Statement. Research training programs solely for short-term research training should not apply to this announcement, but rather the T35 NRSA NOFO, which can be found in the NIH Training Kiosk.

This Notice of Funding Opportunity (NOFO) does not allow appointed Trainees to lead an independent clinical trial, but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor. NIH strongly supports training towards a career in clinically relevant research and so gaining experience in clinical trials under the guidance of a mentor or co-mentor is encouraged.

Purpose

ODP and participating NIH ICs are soliciting T32 applications to train predoctoral scholars from diverse backgrounds, including those from groups underrepresented in prevention relevant fields, in three integrated areas: 1) health disparities/health equity research, 2) development and implementation of multi-level preventive interventions, and 3) methods for the design and analysis of studies to evaluate multi-level preventive interventions (see Notice of NIH's Interest in Diversity).

Background

The NIH Office of Disease Prevention (ODP) is coordinating the new NIH-wide research effort, ADVANCE: Advancing Prevention Research for Health Equity, which grew out of the ODP’s portfolio analysis of NIH research. In an examination of NIH-funded grants and cooperative agreements between fiscal years 2012 and 2017, the ODP found that only 8.5% of all projects focused on preventing the leading risk factors or causes of death and disability (e.g., poor nutrition, low physical activity, smoking), falling well below their burden on the nation’s health. An additional analysis of the NIH research portfolio showed that between fiscal years 2016 and 2019, only 3.6% of NIH-funded prevention projects included a randomized intervention to address a leading risk factor in NIH-designated populations that experience health disparities. More prevention research promoting health equity is clearly needed, and it is critically important to develop a diverse research workforce to conduct this work.

Statement of NIH and ODP Interest in Diversity

NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to enhance health, lengthen life, and reduce illness and disability. To achieve this mission, NIH invests in research to improve public health; it also devotes substantial resources to identify, develop, support and maintain its scientific resources, including human capital. NIH’s ability to ensure that it remains a leader in scientific discovery and innovation is dependent upon a pool of highly talented researchers. Promoting diversity in the extramural prevention workforce is critical to the success of NIH mission and is consistent with the mandates of the 21st Century Cures Act.

Behavioral and social science 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 NIH-designated populations that experience health disparities participate in, and benefit from health research, and enhancing public trust. While scientific workforce diversity supports the NIH mission (see, NOT-OD-20-031), expanding the pool of investigators from nationally underrepresented backgrounds in biomedical, behavioral, social science, and clinical research remains an elusive goal (see: Policy Supporting the Next Generation Researchers Initiative, NOT-OD-17-101).

ODP’s mission is to improve public health by increasing the scope, quality, dissemination, and impact of prevention research supported by the NIH. ODP’s ADVANCE: Advancing Prevention Research for Health Equity is an NIH-wide effort to develop and evaluate preventive interventions that address health disparities. ADVANCE was launched to develop and test (1) new interventions and (2) new strategies to disseminate existing interventions that address the leading risk factors for death and disability in populations that experience disparities.

Similar to the biomedical research workforce as a whole, the prevention research workforce is characterized by underrepresentation of certain population groups relative to the general US population. For example, individuals from underrepresented racial/ethnic groups and individuals with disabilities comprise only 7-11% of individuals awarded doctorates in prevention related fields such as psychology, health sciences, social sciences, and biological and biomedical sciences. In addition, individuals from underrepresented racial/ethnic groups are particularly underrepresented among doctoral degree recipients in biostatistics, making up only 7% of doctorates awarded in 2017-2018. Thus, there is an opportunity to diversify the workforce of scientists who can appropriately design and evaluate preventive interventions.

Funded programs are also expected to implement robust plans to promote inclusive, safe, and supportive research environments. Specifically, funded programs should have institutional and departmental environments where individuals from all backgrounds are welcomed and feel integrated into and supported by the biomedical community. Programs are also expected to implement plans to enhance trainee retention, i.e., to sustain the scientific interests and participation of trainees from all backgrounds. Additionally, safety in research training should encompass (1) environments free from harassment and intimidation, in which everyone participating is treated in a respectful and supportive manner, (2) laboratory and clinical settings where individuals exercise the highest standards of practice for chemical, biological and physical safety, and (3) practices at the institutional leadership and research community levels that demonstrate core values and behaviors to emphasize safety over competing goals.

Institutions are encouraged to diversify the trainee applicant pool by recruiting potential candidates who are from groups underrepresented in prevention research, the biomedical, clinical, behavioral, and social sciences (see, e.g., NOT-OD-20-031) including:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) ) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering ). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in NIH programs to enhance diversity. For more information on racial and ethnic categories and definitions, see the OMB Revisions to the Standards for Classification of Federal Data on Race and Ethnicity (https://www.govinfo.gov/content/pkg/FR-1997-10-30/html/97-28653.htm ).

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended . See NSF data at, https://www.nsf.gov/statistics/2017/nsf17310/static/data/tab7-5.pdf.

C. Individuals from disadvantaged backgrounds, defined as those who meet two or more of the following criteria:

1. Were or currently are homeless, as defined by the McKinney-Vento Homeless Assistance Act (Definition: https://nche.ed.gov/mckinney-vento/);

2. Were or currently are in the foster care system, as defined by the Administration for Children and Families (Definition: https://www.acf.hhs.gov/cb/focus-areas/foster-care) ;

3. Were eligible for the Federal Free and Reduced Lunch Program for two or more years (Definition: https://www.fns.usda.gov/school-meals/income-eligibility-guidelines);

4. Have/had no parents or legal guardians who completed a bachelor’s degree (see https://nces.ed.gov/pubs2018/2018009.pdf);

5. Were or currently are eligible for Federal Pell grants (Definition: https://www2.ed.gov/programs/fpg/eligibility.html);

6. Received support from the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) as a parent or child (Definition: https://www.fns.usda.gov/wic/wic-eligibility-requirements).

7. Grew up in one of the following areas: a) a U.S. rural area, as designated by the Health Resources and Services Administration (HRSA) Rural Health Grants Eligibility Analyzer ((https://data.hrsa.gov/tools/rural-health ), or b) a Centers for Medicare and Medicaid Services-designated Low-Income and Health Professional Shortage Areas (qualifying zipcodes are included in the file). Only one of the two possibilities in #7 can be used as a criterion for the disadvantaged background definition.

Students from low socioeconomic (SES) status backgrounds have been shown to obtain bachelor’s and advanced degrees at significantly lower rates than students from middle and high SES groups (see https://nces.ed.gov/programs/coe/indicator_tva.asp), and are subsequently less likely to be represented in biomedical research. For background, see Department of Education data at, https://nces.ed.gov/; https://nces.ed.gov/programs/coe/indicator_tva.asp; https://www2.ed.gov/rschstat/research/pubs/advancing-diversity-inclusion.pdf.

D. Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., From the NIH: A Systems Approach to Increasing the Diversity of Biomedical Research Workforce https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5008902/).

Women have been shown to be underrepresented in doctorate-granting research institutions at senior faculty levels in most biomedical-relevant disciplines, and may also be underrepresented at other faculty levels in some scientific disciplines (See data from the National Science Foundation National Center for Science and Engineering Statistics: Women, Minorities, and Persons with Disabilities in Science and Engineering, special report available at https://www.nsf.gov/statistics/2017/nsf17310/, especially Table 9-23, describing science, engineering, and health doctorate holders employed in universities and 4-year colleges, by broad occupation, sex, years since doctorate, and faculty rank).

Need for the Program:

To effectively address health disparities, preventive interventions must address social determinants of health, including the conditions and stressors that individuals, groups, and populations experience in their homes, schools, workplaces, healthcare settings, and communities. Addressing these social determinants requires moving beyond individual attitudes, knowledge, and behaviors to address factors at the interpersonal, family, organizational, community, and societal levels. Rigorous evaluation of multi-level preventive interventions requires special research designs in which participants are prospectively assigned to intervention conditions in groups or clusters (e.g., families, clinics, schools, worksites, communities, counties, states). Training in appropriate methodology will be critical for new investigators who wish to evaluate multi-level preventive interventions to address health disparities. Training for mentors and predoctoral fellows in strategies to improve engagement in service areas of the interventions is critical to the effectiveness of the intervention.

Key Definitions

Populations that experience health disparities (HD Populations): Populations defined in section 464z-3(d)(1) of the Public Health Service Act, 42 U.S.C. 285t(d)(1) as health disparity populations based on higher overall rates of disease incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general population. NIH-designated U.S. health disparity populations currently include Black Americans and African Americans, Hispanics and Latinos, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minority (SGM) populations.

Primary prevention involves interventions or policies designed to prevent or reduce risk factors for developing a new condition before health effects occur.

Secondary prevention involves interventions or policies designed to prevent the development of a new condition among those with identified risk factors, recurrence of a condition, or progression of an early-stage condition.

Levels of Influence: The socio-ecological levels (e.g., individual, interpersonal, organizational, community, or societal) at which specific determinants operate to influence risk factors and subsequent health outcomes (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for examples of health determinants at different levels of influence). A multi-level intervention is an intervention that impacts determinants at two or more socio-ecological levels.

Program Description & Requirements

T32 applications should train predoctoral scholars from diverse backgrounds, including those from groups underrepresented in prevention relevant fields, in three integrated areas: 1) health disparities/health equity research, 2) development and implementation of multi-level preventive interventions, and 3) methods for the design and analysis of studies to evaluate multi-level preventive interventions (see Notice of NIH's Interest in Diversity).

Institutions may offer training activities directly within their institution and/or leverage collaborations with other institutions. All three areas must be addressed as training or professional development components of the award.

Appropriate research training and professional development topics include, but are not limited to, those listed below.

Health Disparities/Health Equity Research

• Community-engaged research strategies to obtain input and perspectives from community members, organizations, service providers, and policymakers, such as intervention mapping, engagement studies, etc.
• Adaptation or tailoring of evidence-based preventive interventions for specific populations that experience health disparities
• Co-creation of new preventive interventions by researchers and community collaborators
• Structural interventions that address social or environmental determinants of health disparities in preventable health conditions
• Dissemination and implementation of evidence-based interventions in populations that experience health disparities
• Examination of health impacts among populations experiencing health disparities of policy interventions within systems, institutions, and local/state government

Development and Implementation of Multi-level Preventive Interventions

• Primary or secondary preventive interventions implemented in community settings (e.g., schools, health clinics, workplaces, etc.)
• Healthcare-based interventions to increase engagement in screening or preventive services
• Multi-sectoral interventions that involve collaborations among two or more service sectors (e.g., health, public health, housing, education, labor, transportation, parks and recreation, criminal/legal, etc.).

Methodological or Statistical Approaches

• Randomized intervention study designs for testing interventions across multiple groups, organizations, or communities, such as parallel group-,cluster-randomized trials, or stepped-wedge group- randomized trials
• Effectiveness-implementation hybrid randomized trials
• Adaptive or optimization intervention designs, including Multiphase Optimization STrategy (MOST) or Sequential, Multiple Assignment, Randomized Trial (SMART) designs
• Rigorous quasi-experimental designs to test prospective interventions, such as group- or cluster-level regression discontinuity designs or interrupted time-series designs
• Rigorous quasi-experimental designs to evaluate natural experiments of existing policy and practice implementation
• Methods for the statistical analysis of longitudinal multidimensional, multi-level, or clustered data to assess intervention outcomes
• Advances in data science including artificial intelligence, machine learning, deep learning, natural language processing, large generative language models (such as GPT), to inform preventive intervention research design, execution, and impact assessment.

Additional information and examples are available at https://researchmethodsresources.nih.gov/ and https://prevention.nih.gov/research-priorities/research-needs-and-gaps/pathways-prevention/methods-evaluating-natural-experiments-obesity.

Applications Not Responsive to the NOFO

• Training programs that do not provide research training and professional development activities in all three required areas (health disparities/health equity; development and implementation of multi-level primary or secondary preventive interventions; and methods for the design, analysis, and sample size estimation for studies to evaluate multi-level preventive interventions).
• Applications that do not include a Recruitment Plan to Enhance Diversity

Non-responsive applications will not be reviewed. Applicants are strongly encouraged to reach out to the relevant scientific contacts to discuss whether their applications are responsive.

Clear Goals or Outcomes

The expectation is that through enhanced training or professional development activities, predoctoral fellows will be able to accelerate their independent research careers and become competitive for support from new research project grant (R01) and other NIH funding.

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)

Governments

• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations

Federal Governments

• U.S. Territory or Possession

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.

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.

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. 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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (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 responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the day-to-day administration of the program and is responsible for appointing members of the Advisory Committee (when applicable), using their recommendations to determine the appropriate allotment of funds.

2. Cost Sharing

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

3. Additional Information on Eligibility

Applicant organizations may submit more than one application, provided that each application is programmatically 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).

Programs are encouraged to build a broadly diverse team of preceptors/mentors that includes, for example, faculty at different career stages (i.e., junior as well as senior faculty). Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are encouraged to participate .

Trainees

The individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship, training period, and aggregate duration of support are available in the NIH Grants Policy Statement.

All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the awarding unit, or when trainees are appointed to approved, short-term training positions.

Predoctoral trainees must be enrolled in a program leading to a PhD or in an equivalent research doctoral degree program. Health-professional students who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs, are also eligible.

Not Applicable

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 Training (T) 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.

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:

JoyAnn Courtney, Ph.D.
Office of Disease Prevention
Telephone: 301-402-3911
Email: [email protected]

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424 (R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed. The additional instructions apply:

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design and key activities of the training activities related to health disparities/health equity research, development, and implementation of multi-level preventive interventions, and methods for the design and analysis of multi-level preventive interventions. Indicate the planned duration of appointments, the projected number of trainees and intended trainee outcomes.

Letters of Support: If applicable, please provide letters of support of collaborations or partnerships that will be leveraged to provide training activities related to health disparities/health equity research, development, and implementation of multi-level preventive interventions, and methods for the design and analysis of multi-level preventive interventions.

Other Attachments.

Institutional Environment and Commitment to Training. The application must include a signed letter on institutional letterhead from a President, Provost, Dean, or key institutional leader that describes the activities and resources provided by the institution that will ensure the success of the planned training program and productivity of its trainees. The letter should include a description of the financial and non-financial resources that are directly committed or available to the proposed T32 program. Applicants may use this section to expand upon the Facilities & Other Resources section and the Letters of Support section, as necessary, to provide additional information regarding the institutional, departmental, or community collaborator commitments to the program. Do not repeat information contained elsewhere in the application. Please name your file Institutional_Commitment.pdf.

Recruitment Plan to Enhance Diversity. Applicants are required to provide a Recruitment Plan to Enhance Diversity. The application should include outreach strategies and activities designed to recruit potential predoctoral scholars who are from diverse backgrounds, including underrepresented groups in the biomedical research workforce (see Notice of NIH's Interest in Diversity). The application should describe the specific efforts to be undertaken by the training program and how these might coordinate with trainee recruitment efforts of the institution. Participating faculty are expected to be actively involved in recruitment efforts. Please name the file Recruitment_Plan.pdf .

Advisory Committee. An Advisory Committee is not a required, but a highly recommended component of a training program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the training 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 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.

SF424(R&R) Senior/Key Person Profile Expanded

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

PHS 398 Cover Page Supplement

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

PHS 398 Training Subaward Budget Attachment(s)

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

Training Budget

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

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

PHS 398 Research Training Program Plan

The PHS 398 Research Training Program Plan Form is comprised of the following sections:

• Training Program
• Faculty, Trainees, and Training Record
• Other Training Program Sections
• Appendix - Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials or if the NOFO specifically instructs applicants to do so.

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

Particular attention must be given to the required Training Data Tables. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of past participants, and other factors that contribute to the overall environment of the program.

Training Program

Program Plan

Proposed Training.

The PD/PI should describe program activities intended to develop the working knowledge needed for trainees to select among and prepare for the next step in varied research career options available in the biomedical workforce. For example, programs should provide all trainees with instruction and training in oral and written presentation and in skills needed to apply for individual fellowship or grant support.

For programs that propose short-term training, any didactic training must be well structured and appropriately justified for the duration of the training experience. Short-term trainees must have the opportunity to carry out supervised biomedical, behavioral, or clinical research with the primary objective of developing or enhancing their research skills and knowledge in preparation for a health-related research career.

For renewal applications, highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, and to evaluation of the training program.

?????Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide.

Training Program

Program Plan

The PD/PI should describe program activities intended to develop the working knowledge needed for predoctoral trainees to select among and prepare for the next step in varied prevention research career options available in the biomedical, clinical, behavioral, and social sciences workforce. For example, programs should provide all trainees with instruction and training in oral and written presentation and in skills needed to apply for individual fellowship or grant support.

Proposed Training

The application should describe how the program will develop predoctoral trainees from diverse backgrounds, including those from groups underrepresented in biomedical, clinical, behavioral and social sciences research workforce, (see Notice of NIH's Interest in Diversity). The application should describe how the program will specifically provide training and professional development activities for the trainees to conduct health disparities/health equity research, development and implementation of multi-level preventive interventions, and methods for the design and analysis of studies to evaluate multi-level preventive interventions in an ethically responsible and rigorous manner.

Training Area 1: Health Disparities/Health Equity Research

Describe the program’s approach to providing training activities that promote research in health equity and/or health disparities. Involvement of community partners in training activities is strongly encouraged. Appropriate research training and professional development topics for applications include, but are not limited to, the following:

• Community-engaged research strategies to obtain input and perspectives from community members, organizations, service providers, and policymakers, such as intervention mapping, engagement studies, etc.
• Adaptation or tailoring of evidence-based preventive interventions for specific populations that experience health disparities
• Co-creation of new preventive interventions by researchers and community collaborators
• Structural interventions that address social or environmental determinants of health disparities in preventable health conditions
• Dissemination and implementation of evidence-based interventions in populations that experience health disparities
• Examination of health impacts among populations experiencing health disparities of policy interventions within systems, institutions, and local/state government

Training Area 2: Multi-level Preventive Interventions

Describe the principals and strategies for development and implementation of multi-level prevention intervention designs that will be covered in training activities, including the format and timeframe for instruction. Describe plans to expose predoctoral trainees to these approaches and how the program will ensure that each predoctoral trainee will develop a practical understanding of these principles and their application to their individual research. Multi-level prevention intervention topics can include, but are not limited to the following:

• Primary or secondary preventive interventions implemented in community settings (e.g., schools, health clinics, workplaces, etc.)
• Healthcare-based interventions to increase engagement in screening or preventive services
• Multi-sectoral interventions that involve collaborations among two or more service sectors (e.g., health, public health, housing, education, labor, transportation, parks and recreation, justice, etc.).

Training Area 3: Methodology

Applications should describe how the methodological and statistical training will be provided to the predoctoral trainees. Research training and professional development topics may include, but are not limited to, those listed below:

• Randomized intervention study designs for testing interventions across multiple groups, organizations, or communities, such as parallel group-,cluster-randomized trials, or stepped-wedge group- randomized trials
• Effectiveness-implementation hybrid randomized trials
• Adaptive or optimization intervention designs, including Multiphase Optimization STrategy (MOST) or Sequential, Multiple Assignment, Randomized Trial (SMART) designs
• Rigorous quasi-experimental designs to test prospective interventions, such as group- or cluster-level regression discontinuity designs or interrupted time-series designs
• Rigorous quasi-experimental designs to evaluate natural experiments of existing policy and practice implementation
• Methods for the statistical analysis of longitudinal multidimensional, multi-level, or clustered data to assess intervention outcomes
• Advances in data science including artificial intelligence, machine learning, deep learning, natural language processing, large generative language models (such as GPT), to inform preventive intervention research design, execution, and impact assessment.

Additional information and examples are available at https://researchmethodsresources.nih.gov/ and https://prevention.nih.gov/research-priorities/research-needs-and-gaps/pathways-prevention/methods-evaluating-natural-experiments-obesity.

Integration Across the Three Training Areas

Describe how the proposed activities across the three areas (health disparities/health equity research, development and implementation of multi-level preventive interventions, and methods for the design and analysis of studies to evaluate multi-level preventive interventions) will be integrated to provide a cohesive training experience.

Faculty, Trainees, and Training Record

Program Faculty (Preceptors/Mentors)

The application should include information about the program faculty who will serve as preceptors/mentors and, if relevant, distinguish between faculty members who will serve as primary mentors and those who have other roles in the training program (e.g., community mentors). Describe the current or proposed preceptor/mentor’s expertise to provide training, implement, and/or mentorship in the proposed health disparities, multi-level preventive interventions, and methodology research training activities. It should expand on the information in the biosketches (see "Participating Faculty Biosketches") to address the following:

• How the program faculty have time to commit to training given their other professional obligations.
• How the program faculty composition will ensure that trainees will gain training to advance health disparities/health equity research, development and implementation of multi-level preventive interventions, and methods for the design and analysis of studies to evaluate multi-level preventive interventions.
• How the program faculty are trained to ensure the use of training and mentoring practices that promote the development of trainees from all backgrounds.
• How the program faculty will provide supportive mentoring.
• How the program faculty will be evaluated as teachers and mentors.
• In programs where trainees will have multiple mentors, how the faculty will effectively coordinate training and mentorship responsibilities.
• Identify potential pitfalls and alternative approaches to overcome obstacles to the proposed training activities that may impact the trainees careers.

Trainee Candidates/Predoctoral Trainees

The application should describe the pool of prospective candidates for the predoctoral training program. The application should also describe the plans for a candidate selection process consistent with applicable law that considers metrics beyond undergraduate institution, GPA, and standardized test scores, which will identify candidates who are committed to contributing to the prevention research enterprise.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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. The National Research Service Award (NRSA) policies apply to this program. An NRSA appointment may not be held concurrently with another Federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement. Note, however, that pre-award costs are not allowable charges for stipends or tuition/fees on institutional training grants because these costs may not be charged to the grant until a trainee has actually been appointed and the appropriate paperwork submitted to the NIH awarding component. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form.Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:
Reviewers should evaluate the candidate’s potential for developing an independent research program that will make important contributions to the field, taking into consideration the years of research experience and the likely value of the proposed research career development as a vehicle for developing a successful, independent research program

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, 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 the merit of the training program and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

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 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 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 Council of Councils.

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.

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

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.

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

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.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

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.

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.

The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant for 8 weeks or more. Recipients 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.

• A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.
• Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each trainee appointed for eight weeks or more. Trainees with service payback requirements must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS Form 6031-1) until the payback service obligation is satisfied.

A final RPPR, the expenditure data portion of the Federal Financial Report, and Termination Notices for all Trainees, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Within ten years of making awards under this program, NIH will assess the program’s overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program. Upon the completion of this evaluation, NIH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.

The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:

For programs involving graduate students:

• 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 or employment in a STEM field
• Authorship of scientific publications in a STEM field
• Subsequent independent research grant support from NIH or another source

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 on-time submission, 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 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]

Susan E. Lim, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5630
Email: [email protected]

JoyAnn Courtney, Ph.D.
Office of Disease Prevention
Telephone: 301-402-3911
Email: [email protected]

Nicole Redmond, MD, PhD
NHLBI - NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
Phone: 301-435-0379
E-mail: [email protected]

Gregory Bloss, M.A., M.P.P.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-3865
Email: [email protected]

Belinda Sims, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-435-7155
Email: [email protected]

Marsha Lopez
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-402-1846
E-mail: [email protected]

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: [email protected]

Lanay M. Mudd, Ph.D., FACSM
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-9346
Email: [email protected]

Neeraj Agarwal
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8155
E-mail: [email protected]

Anissa Brown
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: 301-594-5006
Email: [email protected]

Sung Sug (Sarah) Yoon, RN, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: [email protected]

Angela Fernandez, PhD, MPH, LCSW
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-402-1366
Email: [email protected]

Dara R. Blachman-Demner, Ph.D.
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-496-8522
Email: [email protected]

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

Please contact [email protected] for inquiries about peer review.

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

Diane Lynne Zwinak
NHLBI - NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
Phone: 301-402-5266
E-mail: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: [email protected]

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: [email protected]

Karen Robinson Smith
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8178
E-mail: [email protected]

Gabriel Hidalgo
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: 301-827-4630
Email: [email protected]

Randi Freundlich
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
Email: [email protected]

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: [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 Section 487 of the Public Health Service Act as amended (42 USC 288) and under federal regulations, 42 CFR Part 66 .