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

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

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

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

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

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.

To accomplish the stated overarching goal, this FOA will support creative educational activities with a primary focus on:

• Research Experiences: For example, to provide hands-on exposure to research, to prepare participants for graduate school admissions, successful completion of a research-focused doctoral degree, and careers in the biomedical research workforce.
• Courses for Skills Development: For example, to provide advanced courses in a specific discipline, research technique or research area, and/or courses or workshops to develop scholarly potential to prepare participants for graduate school admissions, successful completion of a research-focused doctoral degree, and careers in the biomedical research workforce.

Applications are encouraged from doctoral degree granting research-intensive institutions that propose to develop recent baccalaureate science graduates from diverse backgrounds (e.g., see the Notice of the NIH's Interest in Diversity) so that they have the necessary knowledge, skills, and networks to transition into and complete rigorous, research-focused biomedical doctoral degree programs (e.g., Ph.D. or M.D./Ph.D.).

Purpose and Background Information

The National Institutes of Health (NIH) recognizes the need to diversify the scientific workforce by enhancing the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral, and social sciences (collectively termed "biomedical") research workforce. Diversity at all levels -- from the kinds of science to the regions in which it is conducted to the backgrounds of the people conducting it -- is integral to excellence in research training environments and strengthens the research enterprise. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual interests to address complex scientific problems. There are many benefits of a diverse NIH-supported scientific workforce including fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of research, enhancing public trust, and increasing the likelihood that health disparities and the needs of underserved populations are addressed in biomedical research. NIH strives to ensure that future generations of researchers will be drawn from the entire pool of talented individuals, bringing different aptitudes, perspectives, interests, and experiences to address complex scientific problems. NIH seeks to enhance the diversity of the biomedical research workforce by supporting individuals from a variety of backgrounds at multiple training and career stages in a variety of institutions and educational settings across the country.

Need for the Program

Promoting diversity in the extramural scientific workforce is critical to the success of the NIH mission and is consistent with the mandates of the 21st Century Cures Act. While scientific workforce diversity supports the NIH mission, expanding the pool of academic investigators from nationally underrepresented backgrounds in the biomedical research workforce has remained an elusive goal. NIH has a longstanding commitment to training the next generation of biomedical scientists and supporting training of students from diverse backgrounds, for example groups underrepresented in biomedical research, through a variety of fellowships, career development awards, and institutional training and student development programs.

In spite of recent advances, individuals from certain groups and backgrounds are underrepresented in the biomedical sciences research workforce as described in the Notice of NIH's Interest in Diversity. The severity of the underrepresentation of these groups increases throughout the training stages. For example, students from certain racial and ethnic groups, including Black or African American, Hispanic or Latino/a/x, American Indian or Alaska Native, Native Hawaiian and other Pacific Islander comprise ~38 percent of the college age population, but earn only ~23 percent of bachelor’s degrees and ~15 percent of Ph.D. degrees in the life sciences (as per data from the National Center for Science and Engineering Statistics). Additionally, while the United States has seen a significant increase in the number of Ph.D. degrees in the biomedical sciences earned by scientists from historically underrepresented racial and ethnic groups in the biomedical research workforce, a corresponding increase in the ranks of the faculty in basic science departments (Gibbs, et al., eLife 2016; Valantine, Lund & Gammie, CBE-Life Sciences Education, 2016) or NIH-funded investigators (Hoppe et al., 2019; Lauer, 2020) have not occurred.

Several reports (see for example,ACD Working Group on Diversity in the Biomedical Workforce, 2012; PCAST Report, 2012; From College to Careers: Fostering Inclusion of Persons with Disabilities in STEM, 2014; Increasing College Opportunity for Low Income Students, 2014; Barriers and Opportunities for 2-Year and 4-Year STEM Degrees, 2016; and Indicators for Monitoring Undergraduate STEM Education, 2018) recommend supporting programs that strive to recruit, train, and mentor students from nationally underrepresented groups who have an interest in science, technology, engineering and math (STEM) as a means to effectively build a diverse and competitive scientific workforce.

Programmatic Approach

The Postbaccalaureate Research Education Program (PREP) provides institutions the resources to support and provide research experiences and courses for skills development to research-oriented postbaccalaureate participants from diverse backgrounds who upon completion of a one-year research education program are likely to successfully transition into and complete rigorous research-focused doctoral degree programs (e.g., Ph.D. or M.D./Ph.D.) in biomedical fields relevant to the NIGMS mission. This FOA is intended to enable the community to develop and implement evidence-informed approaches to biomedical research education and mentoring to enhance diversity in the biomedical research workforce. Funded programs are expected to provide activities that will build a strong cohort of research-oriented individuals while enhancing the science identity, self-efficacy, and a sense of belonging among the cohort members in the biomedical research community. Programmatic activities include, but are not limited to, providing authentic research experiences, courses for skills development, and additional mentoring -- activities proven to increase persistence in STEM fields (cited in PCAST Report, 2012, Graduate STEM Education for the 21st Century, 2018, and The Science of Effective Mentoring in STEMM, 2019). Program activities should build upon the strengths and assets of PREP participants and should not reflect deficit-models (i.e., those that focus primarily on remediation of perceived weaknesses) of career development.

Each program should provide high-quality research education experiences that equip participants with the technical (e.g., appropriate methods, technologies, and quantitative/computational approaches), operational (e.g., independent knowledge acquisition, rigorous experimental design, and interpretation of data) and professional (e.g., management, leadership, communication, and teamwork) skills required for careers in the biomedical research workforce. Funded programs are expected to promote inclusive research environments (i.e., institutional and departmental environments where researchers from all backgrounds are and feel integrated into and supported by the biomedical research community).

Program Objective

The overarching objective of PREP is to develop a diverse pool of well-trained postbaccalaureate participants who will transition into and complete rigorous, research-focused doctoral degree programs (e.g., Ph.D. or M.D./Ph.D.) in biomedical fields relevant to the NIGMS mission and have the following technical, operational, and professional skills:

• A broad understanding across biomedical disciplines and the skills to independently acquire the knowledge needed to advance their chosen fields;
• The ability to think critically and independently, and to identify important biomedical research questions and approaches that push forward the boundaries of their areas of study;
• A strong foundation in scientific reasoning, rigorous research design, experimental methods, quantitative and computational approaches, and data analysis and interpretation;
• The skills to conduct research in the safest manner possible, and a commitment to approaching and conducting biomedical research responsibly, ethically, and with integrity;
• Experience initiating, conducting, interpreting, and presenting rigorous and reproducible biomedical research with increasing self-direction;
• The ability to work effectively in teams with colleagues from a variety of cultural and scientific backgrounds, and to promote inclusive and supportive scientific research environments;
• The skills to teach and communicate scientific research methodologies and findings to a wide variety of audiences (e.g., discipline-specific, across disciplines, and the public); and
• The knowledge, professional skills and experiences required to identify and transition into careers in the biomedical research workforce (i.e., the breadth of careers that sustain biomedical research in areas that are relevant to the NIH mission).

Diversity is integral to excellence in research environments and strengthens the research enterprise. This FOA is intended to support outstanding research education programs that will enhance diversity at all levels of the research environment.

Program Considerations

NIGMS intends to fund applications that propose feasible research education programs that will enhance diversity in the biomedical workforce. Programs are expected to have mentors from a broad range of biomedical disciplines relevant to the NIGMS mission to provide a breadth of research experiences to participants. Proposed programs focused on a single discipline (e.g., neuroscience, immunology, etc.) will be low priority for funding.

As postbaccalaureate scientists, the participants will be involved in independent research projects where they will learn to develop and answer scientific questions, allowing them to experience the fulfillment of discovery as scientists. The research environment should be inclusive, supportive and safe, and should include opportunities for the participants to interact with doctoral student peers, postdoctoral researchers, and other investigators who could contribute to their growth and will allow them to thrive in rigorous doctoral programs. PREP participants will be required to work as research postbaccalaureates at 9 person-months (75% full-time) effort, with the other 3 person-months (25% full-time effort) devoted to further skills development. Academic preparations may include courses, workshops, seminars, supplemental instruction, or lectures that will enhance the technical, operational and professional skills of the participants. The courses taken should be appropriate to the requirements for admission to, and successful completion of rigorous research-focused biomedical doctoral degree programs.

Funded programs are also expected to implement robust plans to enhance diversity and 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.

Program training objectives (i.e., specific, measurable, and obtainable outcomes the program intends to achieve), evidence-informed training interventions, and mentoring activities should be grounded in the literature and from evaluations of existing relevant programs. Program objectives must align with the overarching goal of PREP. Funded programs are expected to provide evidence of accomplishing the training objectives in progress reports and upon renewal, to make training and career outcomes publicly available, and are strongly encouraged to disseminate successful training practices to the broader community.

PREPs should generate carefully designed Individual Development Plans (IDPs) that build upon the participant’s experience, combined with research projects mentored by faculty members with active extramurally funded research programs. The development plans will typically be designed within the context of a one-year research education program to provide the necessary skills to prepare the participants to transition into and complete rigorous research-focused biomedical higher degree programs (e.g., Ph.D. or M.D./Ph.D.).

Participants should not be appointed for less than one year, and it is expected that most PREP participants will transition to a rigorous, research-focused biomedical doctoral degree program following a one-year postbaccalaureate experience. NIGMS also recognizes that each participant has individual strengths and areas of academic development, and that a one-year program may not be sufficient for some to fully prepare to be competitive for a rigorous, research-focused biomedical doctoral degree program. Therefore, a second year of support is allowable at the discretion of the PREP Program Director/Principal Investigator (PD/PI) if within the awarded costs of a particular program. This does not require NIGMS preapproval but should be used selectively for those participants who would benefit from a second year in the program. The second-year experience must enhance participants' competitiveness to enter a rigorous doctoral program and not simply allow participants more time to decide if they wish to obtain a graduate degree or to explore other career options. This program will not support individuals earning master's degrees or individuals who have previously earned a graduate or professional degree.

PREP applications are institutional in nature and should reflect the plans and priorities of the applicant institution. Institutional commitment and support for the proposed training program are important elements of the application. The PREP program may complement and synergize with other ongoing federally-supported research training programs at the applicant institution (e.g., in the development of skills needed for careers in the biomedical research workforce); however, the PREP goals and activities to achieve those goals must be distinct from related programs currently receiving federal support at the same institution. In cases where an institution has multiple NIGMS training and diversity enhancing programs, it is expected that these programs will seek to create administrative efficiencies to reduce costs and improve participant services and outcomes. The research education grant should be well integrated within one or more department(s)/program(s) relevant to NIGMS mission areas. It is also anticipated that PREP awards will have an institutional impact by helping awardee institutions to achieve greater diversity in their doctoral programs (e.g., through adoption of effective practices of the PREP program to create institutional change, through recruitment of successful PREP participants into doctoral programs). PREP grants are usually awarded for five years.

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. R25 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.

It is expected that upon completion of the program, PREP participants transition into and complete rigorous, research-focused biomedical doctoral programs (e.g., Ph.D. or M.D./Ph.D.). Since PREP participants should have an interest in obtaining a research-focused biomedical doctoral degree as a condition of enrollment in the program, NIGMS expects that a successful PREP will provide the knowledge and skills such that the vast majority (e.g., greater than 75%) of its participants enter such programs within two years of completing PREP. Furthermore, with this expertise and experience, NIGMS expects that PREP participants who enter research-focused biomedical doctoral degree programs will complete the degree at rates comparable to or greater than students in similar disciplines at their institutions. Applicant institutions should design their program strategies within the context of the NIGMS' expectations and in line with their institutional settings and missions.

This FOA does not allow appointed participants 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 permitted.

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 FOA.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
• Predominantly Black Institutions (PBI)
• American Indian/Alaska Native Serving Non-Tribal Institutions (AI/AN)

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 research education and training programs to enhance diversity, NIGMS recognizes separate institutional eligibility tracks: research-intensive, i.e., those with NIH research project grant (RPG) funding averaging greater than or equal to $7.5 million in total costs (direct and F&A/indirect) per year over the last three fiscal years; and research-active, i.e., those with NIH research project grant (RPG) funding averaging less than $7.5 million in total costs per year over the last three fiscal years (RPG data are available through NIH RePORT). For example, FY 2020, FY 2021 and FY 2022 for applications submitted in January 2023.

Institutional eligibility for this FOA is limited to research-intensive institutions (as defined above) that have strong biomedical Ph.D. degree programs in NIGMS mission areas. That is, institutions that are eligible for MARC or IMSD are eligible to apply, but those that are eligible for U-RISE or G-RISE are not eligible for this program. Further, NIGMS encourages applications from highly research-intensive institutions (i.e., those with an average of NIH funding greater than or equal to $20 million total costs per year over the last three fiscal years) that have a significant number of faculty mentors with active and extramurally funded research programs (e.g., R01, R35, or equivalent awards) and robust research education environments.

An institution (normally identified by having a Unique Entity Identifier) can have no more than one PREP award.

The sponsoring institution must assure support for the proposed program through an Institutional Support Letter within the Letters of Support attachment. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. Additionally, a signed letter is required from the Authorized Organization Representative/Business Official or similar official with institution-wide responsibility verifying the eligibility of the applicant institution at the time of application submission according to the eligibility criteria indicated above. See the application instructions for the required Letters of Support attachment in Section IV.2

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 Institutions) are not eligible to apply

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

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

Applicant Organizations

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

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

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

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

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

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

As described in the instructions for the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) in Section IV.2 below, NIGMS encourages multiple PD(s)/PI(s), particularly when each brings a unique perspective and skill set that will enhance the research education program. The PD(s)/PI(s) must be able to provide both administrative and scientific leadership to the development and implementation of the proposed program. At least one of the PD(s)/PI(s) should be an investigator with an active research program in the biomedical sciences (e.g., as demonstrated by recent publications and current research support). Additional PD(s)/PI(s), including individuals with experience in the science of education, relevant social science disciplines, program evaluation, mentoring, diversity, equity, inclusion and accessibility (DEIA) work, or university administration may be included to achieve the program goals. Any of the PD(s)/PI(s) may serve as the contact PD/PI. The contact PD/PI is expected to have a full-time appointment at the applicant institution unless extremely well-justified. If the full-time status of the contact PD/PI changes after the award, the institution must obtain prior program approval to appoint a new PD/PI or request a deviation from the full-time rule. The PD(s)/PI(s) will be responsible for the selection and appointment of participants to the approved research education program, and for the overall direction, management, administration, and evaluation of the program. The PD(s)/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required. The PD(s)/PI(s) have responsibility for the day-to-day administration of the program and are responsible for appointing members of the Advisory Committee (when applicable) and using their recommendations to determine the appropriate allotment of funds.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a Unique Entity Identifer or NIH IPF number) is allowed.

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.

Program Faculty

The selected faculty should be trained researchers in the biomedical sciences as demonstrated by recent publications and research support. When building a team of mentors, programs should include faculty who are committed to training, mentoring, fostering diversity, and providing supportive and inclusive research environments. Programs are encouraged to build a diverse team of preceptors/mentors that includes, for example, faculty from underrepresented groups (Notice of NIH's Interest in Diversity), women, and faculty at different career stages (i.e., early stage as well as senior faculty). Faculty should come from a wide variety of disciplines relevant to the NIGMS mission. Mentors must be committed to continue their involvement throughout the total period of the mentee's participation in this award.

Participants

The applicant institution will select the PREP participants who will receive salary support. It is the responsibility of the institution to establish the qualifications of the participants before they are supported by the program.

In order to receive salary support, the participant 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. Additionally, participants must have a baccalaureate degree that prepares them to pursue a research-focused biomedical doctoral degree from an accredited college or university awarded no more than 36 months prior to applying to a PREP, and must not be currently enrolled in a degree program. Parental, medical, or other well-justified leave for personal or family situations is not included in the 3-year eligibility limit, nor is national service (e.g., Peace Corps, or service in the National Guard or Armed Forces Reserves). All individuals selected as participants should intend to apply to research-focused biomedical doctoral degree programs (e.g., Ph.D. or M.D./Ph.D.) during or immediately following completion of the research education program.

The overarching goal of this program is to develop a diverse pool of well-trained postbaccalaureate participants who will transition into and complete rigorous, research-focused biomedical doctoral degree programs. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student, postdoctorate and faculty populations 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 purpose of this announcement, institutions are strongly encouraged to identify candidates who will enhance diversity on a national basis. 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 this program.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions will not be reviewed.

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

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.

Provide a brief description of the mission of the institution and its academic components. The application should describe how the level of institutional (and as appropriate, departmental) commitment to excellence in research education will promote success of the participants and program. A letter providing assurances of the institutional commitment must be included in the Letters of Support section of the application. Detailed instructions on the types of support are found below in the Letters of Support section of the FOA.

Other Attachments.

Advisory Committee Plan (1 page maximum): 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 .

Program Faculty Biosketches: Biosketches of Program Faculty must be included. The personal statement should describe a commitment to scientific rigor, training, mentoring, as well as promoting diverse, inclusive, safe, and supportive scientific environments. Please upload all of the biosketches as a single pdf and name your file Program Faculty Biosketches.pdf .

Applications lacking a "Program Faculty Biosketches" attachment will be considered incomplete and will not be reviewed.

Outcomes Data Collection and Storage Plan (2-page maximum): Funded programs are expected to track participants for a minimum of 15 years beyond participation in the program. The applicant must provide a plan to track the outcomes for all supported participants. Programs are encouraged to make the aggregate outcome data available on the institution's website. If the applicant intends to make the data available, describe how the aggregate data will be deidentified before public posting. The applicant must include a strategy to ensure the secure storage and preservation of program data and outcomes. Describe how the data will be centralized, safeguarded, and retrievable during leadership changes. Please name the file Data_Collection_Storage_Plan.pdf .

Applications lacking an "Outcomes Data Collection and Storage Plan" attachment will be considered incomplete and will not be reviewed.

Training Data Table 4, Research Support of Participating Faculty Members, is a required attachment. Please follow the Instructions for the Data Tables [All Training Tables (Undergraduate Programs)]. Please name your file "Table 4 Research Support.pdf".

Applications lacking the "Training Data Table 4"attachment will be considered incomplete and will not be reviewed.

Training Data Table 8D,Part I, Program Outcomes: Undergrad:

• For renewal applicants: This is a required attachment to provide data on PREP postbaccalaureate participant outcomes. Please follow the Instructions for the Data Tables [All Training Tables (Undergraduate Programs)]. Please name your file "Table 8D Participant Outcomes.pdf". Renewal applications lacking this attachment will be considered incomplete and will not be reviewed.
• For new applicant institutions: Training Table 8D (parts I and II) is not required and should not be included. Any relevant data can be summarized in the Research Education Program Plan.

No other data tables are permitted in the "Other Attachments" section of the application. Inclusion of additional Training Data Tables will result in application withdrawal before peer review.

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.

Biographical Sketch: The personal statement should describe a commitment to diversity, scientific rigor, training, mentoring, as well as to promoting inclusive, safe, and supportive scientific environments.

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.

• Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.

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
• Recruitment Plan to Enhance Diversity
• Plan for Instruction in Methods for Enhancing Reproducibility
• 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.

The plan should describe an integrated set of activities that will develop a diverse pool of well-trained postbaccalaureate scientists who have the technical, operational and professional skills required to conduct research in an ethically responsible and rigorous manner, and to transition into and succeed in rigorous biomedical doctoral degree programs as described in the Program Objective. It is anticipated that several departments representing multiple biomedical disciplines relevant to the NIGMS mission will be involved in the institutional PREP. Hence, the Proposed Research Education Program section of the PREP application should be organized to reflect the institutional scope of the proposed program. Applicants are encouraged to summarize what they view as especially important results contained in the data tables within the Research Education Program Plan of the application. This summary does not replace the data tables, and applicants are urged to ensure consistency between the summary and the relevant table information.

Include the following items in this section:

Current Status of the Graduate Biomedical Science Academic Programs: Describe the size of the graduate student body (Ph.D. level) in biomedically relevant disciplines. Provide institutional data on Ph.D. student enrollment from the last five years and indicate the percentage of students from underrepresented groups. Provide the number of Ph.D. students (overall and underrepresented groups) from the participating departments or programs, and their graduation rates for the last 5 years. Present this data in table format within the text (not in the appendix or with the required data tables).

Program Rationale, Mission, Objectives, and Overall Research Education Plan: Applications must include the rationale for the proposed PREP program as well as the feasibility of success in the context of the institutional setting. Describe and summarize institutional and externally sponsored programs to enhance diversity in the biomedical sciences at the participating institution within the last 5 years. Specifically, the application should describe the following:

• The rationale for the proposed program. The application should describe the current institutional efforts to promote diversity and to create inclusive research environments, and how the PREP program will enhance, but not duplicate, these efforts.
• The program mission (i.e., broad statement of purpose of the program), and objectives (i.e., specific measurable outcomes the program intends to achieve). Objectives should include, but not be limited to, program completion rates, percentage of participants who will complete the program in one year, the rate of transitioning into and completing research-focused biomedical doctoral degree programs. The program-specific mission and objectives should align with the Overarching Objective of this funding opportunity announcement described above.
• How the research experiences and courses for skills development will accomplish the specific program mission and objectives. Explain how these research education activities are designed to develop the technical, operational, and professional skills of participants (applications must include the Required Research Education Activities appendix to provide material for required activities that all PREP participants will complete and may include the Elective Activities appendix for up to four additional activities).
• How the activities will employ evidence to inform approaches to postbaccalaureate participant learning, critical thinking, mentorship, inclusion, and professional development.
• Representative examples of research education programs for individual participants. Examples may include laboratory experiences, courses for skills development, and other activities, such as seminars, journal clubs, mini-committee meetings, etc. Describe how each participant's program will be guided, and how the participant's performance will be monitored and evaluated. Discuss the anticipated time required to complete the research education program, and how a need for a second year in the research education program will be assessed.
• The rationale and strategies used for selecting participants and a clear description of why the participants selected need additional preparation prior to applying to and attending research-focused biomedical doctoral degree programs.
• The activities that will build a strong cohort of research-oriented postbaccalaureate participants while enhancing the science identity, self-efficacy, and a sense of belonging among the cohort members.
• The strategy that will be used to develop the appropriate IDP for each participant in order to leverage their unique assets and address their specific points of development to enhance their ability to transition into and successfully complete a research-focused biomedical doctoral degree program.

Career Development: The application should describe how the program participants will:

• Be provided with information about the career outcomes of previous participants who have completed the program (e.g., on publicly accessible websites) and about the overall biomedical research workforce employment landscape;
• Be provided with adequate and appropriate information regarding the variety of careers in the biomedical research workforce for which their training would be useful; and
• Learn the skills, knowledge, and steps needed to attain positions in the sectors of the biomedical research workforce that are of interest to them.

Program Oversight, Participating Faculty Selection, and Mentor Training: The application should include the planned strategy and administrative structure to oversee and monitor the program and to ensure appropriate participant progress. The application should describe how the participating faculty are trained to ensure the use of evidence-informed approaches to teaching, training, and mentoring practices that promote the development of participants from all backgrounds, including participants from underrepresented groups in the biomedical sciences (e.g., Notice of NIH's Interest in Diversity). The application should describe the following:

• How the program will ensure that participating faculty employ the highest standards of laboratory safety and scientific rigor, and impart those standards to program participants;
• How the program will ensure that participating faculty reinforce and augment the curricular material on responsible conduct of research and methods for enhancing reproducibility;
• The mechanism for matching participants with the appropriate participating faculty (e.g., mini-rotations, faculty forums, and interviews);
• How the program will ensure that participating faculty engage in activities that promote participant career development (including but not limited to the utilization of IDPs); and
• A mechanism to monitor mentoring, including oversight of the effectiveness of the participant/faculty match, and a plan for removing faculty displaying unacceptable mentorship qualities from the research education program (the application may include the appendix labeled Conflict Resolution Protocols to provide details of the plan).

If a program coordinator or administrator position is planned to enhance oversight, a description of the person's administrative capabilities that are essential to coordinate the program must be included in the application.

Progress Report: For renewal applications, include a detailed Progress Report. State the original specific measurable objectives, anticipated milestones, and outcomes. Provide a summary of the accomplishments of the PREP during the previous project period, with reference to participant research and/or other PREP-supported development activities, e.g., workshops, scientific meetings, or lectures. Summarize program outcomes (e.g., number of participants who matriculated into and completed PREP, percentage of participants who complete in one year, number who matriculated into a biomedical research-oriented doctoral degree program and the number of these students who progress in good standing in their degree programs). Applications must provide PREP postbaccalaureate participant outcomes for all previous funding cycles up to 15 years by submitting Training Table 8D as an Other Attachment on the SF424 (R&R) Other Project Information form. Describe what has been learned through program assessment and any changes made in the program because of the assessment. Indicate the institutional impact of the program (e.g., on the curriculum, training environment, or institutional practices). Describe any dissemination of findings or materials developed under the auspices of the program to the broader training community.

Program Director/Principal Investigator: The application should describe how the Research Education Program PD(s)/PI(s) will promote the success of the participants and research education program. NIGMS encourages multiple PD(s)/PI(s) (MPI), particularly when each brings a unique perspective and skill set that will enhance the research education program as described in the Eligible Individuals section above. The application should expand on the information in the biosketch(es) to address how the PD/PI or PD/PI team has:

• The administrative and training experience and skills to provide strong leadership, direction, management, and administration of the proposed research education program;
• The time to commit sufficient effort to ensure the program’s success given other professional obligations (the application should indicate the program director’s effort in person months in the proposed program);
• At least one member who has scientific expertise in the biomedical sciences and who has a record of using rigorous and transparent methods in experimental design, data collection, analysis and reporting;
• A demonstrated commitment to the development of the next generation of the biomedical research workforce, leading recruitment efforts to enhance diversity, and fostering inclusive research environments. As with all participating faculty, the PD(s)/PI(s) should have received training on how to effectively mentor participants from all backgrounds, e.g., individuals from groups underrepresented in the biomedical sciences (Notice of NIH's Interest in Diversity).

The application must also describe the administrative structure and leadership succession plan for critical positions (e.g., PD(s)/PI(s)).

Program Faculty: The application should describe how the participating faculty will promote the success of the participants and research education program. Describe how the program has or will build a diverse team of participating faculty (e.g., individuals from underrepresented backgrounds, women, and faculty at different career stages) to help participants gain access to potential role models within the research education program and to enhance the excellence of the research environment. Summarize and expand on the material presented in the Training Data Table 4 and biosketches. The application should address how the participating faculty:

• Have sufficient time to commit to the research education program given their other professional obligations;
• Receive training in the use of effective, evidence-informed mentoring and teaching practices;
• Cooperate, interact, and collaborate (which can include joint sponsorship of participants' research);
• Promote the development of program participant skills in approaches to rigorous experimental design, methods of data collection, data analysis and interpretation, and reporting;
• Provide opportunities for program participants to initiate, conduct, interpret, and present rigorous, reproducible, and responsible biomedical research with increasing self-direction;
• Demonstrate a commitment to effective mentoring and to promoting inclusive, safe, and supportive scientific and training environments; and
• Are evaluated as mentors and teachers.

Program Participants: Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Provide the criteria and strategy for PREP participant selection. Program candidates should have the potential to strongly benefit from, and with proper support, succeed in the program and transition into rigorous research-oriented biomedical doctoral degree programs. Applications should explain why participants will strongly benefit from being in the PREP program rather than going directly to doctoral-degree granting programs. Strategies for ensuring that participants have sufficient commitment to careers in biomedical research should be described.

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 research education program participants who are from diverse backgrounds, e.g., recent baccalaureate graduates from underrepresented racial and ethnic groups, students from disadvantaged backgrounds, and individuals with disabilities (see Notice of NIH's Interest in Diversity). Applicants are encouraged to consult the NIGMS webpage for strategies to enhance diversity in training programs when designing their plans. Describe the specific efforts to be undertaken by the training program and how these might coordinate with recruitment efforts of the institution. Centralized institutional efforts alone will not satisfy the requirement to recruit individuals from underrepresented groups. Participating faculty are expected to be actively involved in recruitment efforts.

New applications must include a description of plans to enhance recruitment, including the strategies that will be used to enhance the recruitment of participants from underrepresented backgrounds and may wish to include data in support of past accomplishments. Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period, including successful and unsuccessful recruitment strategies. Information should be included on how the proposed plan reflects the program’s past experiences in recruiting individuals from underrepresented groups.

Applications lacking a recruitment plan to enhance diversity will be considered incomplete and will not be reviewed

Plan for Instruction in Methods for Enhancing Reproducibility: Applicants are required to provide a Plan for Instruction in Methods for Enhancing Reproducibility. The plan must describe how participants will be instructed in principles important for enhancing research reproducibility including, at a minimum, critical evaluation of foundational research underlying a project, rigorous experimental design and data interpretation, 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. Applicants are encouraged to consult the NIGMS Clearinghouse for Training Modules to Enhance Data Reproducibility and other resources when developing the plans.

Describe how instruction strategies are well integrated into the overall curriculum, that is, how they are taught at multiple stages of participant development and in a variety of formats and contexts. Describe how all participating faculty will reiterate and augment key elements of methods for enhancing scientific rigor and reproducibility when program participants are performing research in their laboratories.

Applications lacking a plan for instruction in methods for enhancing reproducibility will be considered incomplete and will not be reviewed.

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 (NOT-OD-10-19 and NOT-OD-22-055):

1. Format - The required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only video conferencing 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, societal impacts of scientific research;
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 responsible conduct of research will be considered incomplete and will not be reviewed.

Evaluation Plan: NIGMS funded research education programs must conduct ongoing evaluations to monitor the success of the programmatic and mentoring activities. The application should:

• Describe the evaluation or assessment process to determine whether the overall program is effective in meeting its mission and objectives, and whether the scientific research climate is inclusive, safe, and supportive of participant development (the application may include the "Evaluation and Assessment Instruments" appendix to provide blank survey instruments, rubrics or forms);
• Detail the plans for being responsive to internal and external outcomes analyses, critiques, surveys and evaluations; and
• Expand upon the information in the Outcomes Data Collection and Storage Plan attachment and explain how the plan will effectively track participant career outcomes, provide information to prospective and current program participants about outcomes, and ensure the data collection and storage methods will be safeguarded and preserved.

Applications lacking an evaluation plan will be considered incomplete and will not be reviewed.

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.

Applications lacking a dissemination plan will be considered incomplete and will not be reviewed.

Letters of Support

The application must include the following two letters of support.

1. Institutional Support Letter (10-page maximum): The application must include a signed letter on institutional letterhead from a President, Provost, Dean, or similar key institutional leader that describes the activities and resources provided by the institution that will ensure the success of the planned research education program and its participants. As applicable, the letter should address how the institution:

• Promotes a culture in which the highest standards of scientific rigor, reproducibility and responsible conduct are advanced;
• Provides opportunities for early stage faculty and those with a hiatus in research support to participate in training;
• Supports core facilities and technology resources that can be used to enhance the research education program;
• Provides adequate staff, facilities, and educational resources to the planned program;
• Supports the PDs/PIs and other key staff associated with the planned research education program;
• Ensures that faculty have protected time available to devote to mentoring, training and research;
• Fosters and rewards excellence in research training and mentoring (e.g., through institutional policies such as tenure and promotion);
• Provides support for remediation or removal of Participating Faculty who are poorly performing mentors;
• Promotes diversity and inclusion at all levels of the research training environment (trainees, staff, faculty, and leadership);
• Ensures that the research and clinical facilities as well as the laboratory and clinical practices promote the safety of the participants;
• Ensures that the research and clinical facilities are accessible to participants with disabilities;
• Promotes a positive, supportive and inclusive research, clinical and training environment for individuals from all backgrounds;
• Ensures that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices and to appropriately respond to allegations of such discriminatory practices, including providing any required notifications to NIH (e.g., requesting a change of PD/PI status; see NOT-OD-19-029);
• Ensures participants have access to appropriate support services, such as healthcare, counseling services, and housing; and
• Provides resources and expertise for evaluating the outcomes of the program.
• For institutions that have multiple NIGMS training and research education programs, the letter should also explain how the programs will synergize and share resources when appropriate. All information related to institutional support, as defined above, must be included within the 10-page limit of this letter.

Applications lacking the Institutional Support Letter will be considered incomplete and will not be reviewed.

2. Institutional Eligibility Letter. (1-page maximum): The Authorized Organization Representative/Business Official or similar official with institution-wide responsibility must certify that all the components of the institution under the applicant Unique Entity Identifier together have received support from the NIH greater than or equal to an average of $7.5 million per year (in both direct and F&A/indirect costs) in the past 3 fiscal years, as described in Section III, "Eligible Organizations".

Applications lacking the Institutional Eligibility Letter will be considered incomplete and will not be reviewed.

Other Letters of Support. Additional letters of support (such as those from partner institutions or organizations) are permitted; however, these letters may not contain any information required in the Institutional Support Letter.

Resource Sharing Plans

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

Generally, Resource Sharing Plans are not applicable to this Program.

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.

The Appendix is meant to provide additional details to the following topics, but not meant to substitute for clear descriptions in the body of the application. Do not include items other than the allowable materials described below, as doing so will result in administrative withdrawal of the application. A summary sheet listing all the items included in the Appendix may be included in the first page of the Appendix attachment.

The following are required Appendix materials:

• Required Research Education Activities (2 pages maximum per activity): To adequately assess the content of the didactic portion of the research education program, the application must include brief descriptions of all required training activities (e.g., streamlined syllabi for courses, mentor training materials, professional development workshops, career exploration opportunities, skills development activities).
• Responsible Conduct of Research Syllabi (2 pages maximum total): In addition to the Plan for Instruction in the Responsible Conduct of Research, the application must provide syllabi/outlines of materials relating to Responsible Conduct of Research and descriptions of when in the participants career path the material is taught.

The following are allowable Appendix materials:

• Elective Activities (2 pages maximum per activity): The application may include summary content for up to four additional elective courses, workshops, and/or training activities (e.g., streamlined syllabi with topics, timelines, activities, credits, etc.; or summaries for courses, mentor training materials, outlines of professional development workshops, career exploration opportunities, or skills development activities).
• Evaluation and Assessment Instruments: The application may include blank surveys, rubrics, and/or forms used to (a) document and monitor participant progress and (b) determine whether the research education environment is effective, inclusive, safe, and supportive.
• Conflict Resolution Protocols (3-page maximum total): The application may include detailed protocols for addressing problems with program participant and faculty matches, removal of faculty from the research education program with unacceptable training/mentoring skills and for conflict resolutions for multi PD(s)/PI(s) and mentor/mentee relationships.

PHS Human Subjects and Clinical Trials Information

Generally, Human Subjects are not applicable to this Program.

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 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.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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 NIH Center for Scientific Review and NIGMS. Applications that are incomplete or non-compliant will not be reviewed.

For the purpose of this FOA, follow the post-submission instructions for institutional training and training-related (e.g. T32 and T34) grants.

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.

For this particular announcement, note the following:

The goal of this R25 program is to support educational activities that prepare postbaccalaureates from diverse backgrounds to transition into and complete rigorous, research-focused biomedical doctoral degree programs (e.g., Ph.D. or M.D./Ph.D.).

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 R25 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?

Specific to this FOA: Is there convincing evidence that the proposed research education program will provide participants from diverse backgrounds with the experiences and skills that will allow them to transition into and complete rigorous, research-focused biomedical doctoral degree programs?

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 to this FOA:

Do the PD(s)/PI(s) have a demonstrated commitment to training the next generation of the biomedical research workforce, leading recruitment efforts to enhance diversity, and fostering inclusive research environments?

Does at least one member of the PD/PI team have a demonstrated record of using rigorous and transparent methods in experimental design, data collection, analysis, and reporting in a biomedical field?

Have the PD(s)/PI(s) received training on how to effectively mentor participants, including those from underrepresented groups, and promote inclusive, safe, and supportive research training environments?

Do participating faculty come from a broad range of biomedical disciplines relevant to the NIGMS mission to provide a breadth of potential research experiences to participants?

Do the participating faculty have a record of conducting ethically sound and responsible scientific research, and of rigorous and unbiased experimental design, methodology, analysis, interpretation, and reporting of results?

Do the selected participating faculty come from diverse backgrounds (e.g., for individuals from groups underrepresented in the biomedical sciences, women, as well as faculty at different career stages)? If not, are there plans to recruit faculty to enhance the program faculty diversity?

Do the participating faculty have the time to commit sufficient effort to ensure the participants' development and success, given their other professional obligations?

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 to this FOA:

Will the research experiences, courses for skills development, and structured activities achieve the stated mission and objectives of the research education program?

Are the rationale and strategies for recruiting and selecting participants who strongly benefit from being in the PREP program rather than going directly to research-focused biomedical doctoral degree programs well conceived?

Does the program provide research experiences in a broad range of biomedical disciplines relevant to the NIGMS mission?

Does the program employ modern, evidence-informed approaches to training, mentorship, inclusion, and professional development?

Are the activities likely to build a strong cohort of research-oriented individuals while enhancing the science identity, self-efficacy, and a sense of belonging among the cohort members?

Does the application describe an effective strategy and administrative structure to oversee and monitor the program to ensure appropriate and timely progress for the participants?

Is there a clear mechanism for matching the participants with appropriate participating faculty, and for monitoring mentoring, including oversight of the effectiveness of the participant/faculty match?

Is there a plan for removing participating faculty displaying unacceptable mentorship qualities from the training program?

If a program coordinator or administrator position is planned, is there a description of the person's administrative capabilities that are essential to coordinate the program?

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 to this FOA:

Is there clear institutional commitment to develop and promote a culture in which the highest standards of safety, scientific rigor, reproducibility, and responsible conduct of research are advanced?

Are the core facilities and technology resources necessary for the success of the program well supported?

Is there evidence that the research facilities and laboratory practices ensure the safety of program participants (and trainees generally)?

Is there evidence that the institution fosters and rewards excellence in training and mentoring (for example, through institutional policies)?

Are diversity and inclusion promoted at all levels of the research environment (participants/trainees, staff, faculty, and leadership)?

Are appropriate policies and procedures in place to protect the participants from harassment and other prohibited practices?

Are the research facilities accessible to participants/trainees with disabilities?

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.

Training in Methods for Enhancing Reproducibility

Does the Instruction in Methods for Enhancing Reproducibility plan describe how participants will be instructed in principles important for enhancing research reproducibility including, at a minimum, evaluation of the rigor of the prior research that serves as the key support for a proposed project, 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 research education program? Are they taught at multiple stages of participant development and in a variety of formats and contexts? Does the teaching synergize with elements of the curriculum designed to enhance participants' abilities to conduct responsible research? Is there evidence that all program faculty reiterate and augment key elements of methods for enhancing reproducibility when participants are performing mentored research their laboratories? The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Recruitment Plan to Enhance Diversity

Reviewers will examine the strategies to be used in the recruitment of prospective participants from underrepresented groups. The plan 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, societal impacts of scientific research; 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 and NOT-OD-22-055. Plans will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Protections for Human Subjects

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Revisions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period, and the success of the program in recruiting individuals from diverse populations, including populations underrepresented in biomedical, behavioral and clinical research on a national basis, consistent with the PREP Program Objective. Did most participants transition into rigorous, research-focused biomedical doctoral degree programs? Is the program having a broader impact (e.g., on the curriculum, training environment, or institutional practices; are training practices and outcomes being shared with the broader biomedical training community)?

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

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 the NIGMS Office of 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 FOA. 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 (e.g., breadth of disciplines relevant to the NIGMS mission represented by the proposed program).
• Contributions to portfolio breadth and diversity as outlined in the NIGMS Strategic Plan.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.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 FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board (IRB) or Independent Ethics Committee Approval (IEC): Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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

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

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

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

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

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

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

3. Reporting

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.

Programs that involve participants should report on education in the responsible conduct of research and complete a Trainee Diversity Report, in accordance with the RPPR Instruction Guide.

NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees 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 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 45 CFR Part 75 and 2 CFR Part 200 and Appendix XII to 45 CFR Part 75.113 and 2 CFR Part 200.113, 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.

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. 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 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.

4. 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 progress reports, public 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.

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

• Characteristics of the applicant and awardee pool for the program, such as:
  • Geographic distribution
  • Investigator/participant demographics
  • Institution types
• Indicators of scientific accomplishments / productivity, such as:
  • Peer-reviewed research publications, citations, and related bibliometrics
  • Presentations at scientific conferences (e.g., talks, posters)
  • Professional recognitions (e.g., poster or travel awards, invited talks)
• Measures of educational outcomes or career progression, such as:
  • Successful transitions to subsequent stages of training (e.g., a research-oriented biomedical doctoral degree program such as Ph.D. or M.D./Ph.D.)
  • Degree completions and time-to-degree in biomedical science fields
  • Subsequent research grant support from NIH or other sources
  • Participation in the biomedical research workforce

Section VII. Agency Contacts

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

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

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

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

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

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

Laurie Stepanek, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Lameese Akacem, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

National Institute of General Medical Sciences
Email: [email protected]

Justin Rosenzweig
National Institute of General Medical Sciences
Email: [email protected]

Section VIII. Other Information

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

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