Part 1. Overview Information

Key Dates

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

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

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

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

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

IMPORTANT: Per NOT-OD-24-086 updated application forms (FORMS-I) will be used for this opportunity. The updated forms are not yet available and will be posted 30 calendar days or more prior to the first application due date. Once posted, you will be able to access the forms using one of the following submission options:

1. NIH ASSIST
2. An institutional system-to-system (S2S) solution
3. Grants.gov Workspace

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background 

Promoting broad participation in the extramural scientific workforce is critical to the success of the NIH mission and is consistent with the mandates of the  21^st Century Cures Act . Benefits of a diverse scientific workforce include fostering scientific innovation, enhancing global competitiveness, building robust learning environments, improving research quality, advancing participation of underserved populations as research participants, and strengthening public trust.

Resource-limited institutions (RLIs) have lower research capacity, creating obstacles to research and research training for both faculty and students such as limited access to research facilities, equipment, and supplies as well as less time to engage in research because of competing professional or educational demands. The Biomedical Research Environment & Sponsored Program Administration Development (BRE-SPAD) program aims to promote broad participation in the biomedical research ecosystem by supporting RLIs with few to no biomedical research doctoral students to conduct research, enhance the research environment, and increase sponsored programs administration capacity. By supporting research capacity building at RLIs, the BRE-SPAD program will broaden the pool of faculty conducting biomedical research and the organizational settings where NIH-funded research is performed. 

Program Considerations

The BRE-SPAD program is intended to support the development of biomedical research capacity. The biomedical research enterprise includes a range of research, including basic science, behavioral, social science, as well as translational and clinical research, and will be described hereafter as biomedical research. The BRE-SPAD program aims to support the needs of organizations that are in different stages of biomedical research capacity building. The BRE-SPAD program will support activities in the following areas (1-3). All applications should propose plans in at least two of the funding areas listed below:

1. Sponsored Programs Administration Development: For activities to increase sponsored programs administration capabilities, including staff, resources, training, policy development and other activities related to grants, contracts, activities to increase organizational funds available for research, and technology transfer.
2. Research Environment: For activities to cultivate growth in research and research education activities. Example activities include, but are not limited to, faculty grant writing training, student research training activities, course-based research development, research symposia, and research oversight policies and implementation.
3. Pilot Research Project Program: For the development of a program to administer internal pilot research project funding to faculty conducting biomedical research with the goal of generating preliminary data to enhance the competitiveness of securing external research funding. For more information see Section VI. 

 NIH anticipates the following organizations may be involved in the BRE-SPAD program:

• Applicant organization is the organization submitting the BRE-SPAD application. The applicant organization is also considered to be a participating organization and should propose to receive developmental funds described above and must meet eligibility criteria as defined in Section III.
• Optional additional participating organization(s) work with the applicant organization and propose to receive developmental funding in at least one of the funding areas above. All additional participating organizations must meet eligibility criteria as defined in Section III. Only one member organization of a group of participating organizations serves as the applicant organization.
• Optional partner organization(s) will collaborate with the participating organization(s) to provide expertise and services. If partner organization(s) do not meet the eligibility criteria as defined in Section III, they may not receive funding to develop capacity in the three areas above, but may receive consulting or service fees, for example.

Applications among multiple participating organizations are encouraged and may promote sharing of research administration functions, personnel, electronic systems, or forming alliances to organize central offices such as Institutional Review Boards (IRBs) or Institutional Animal Care and Use Committees (IACUCs). If multiple participating organizations are proposed, all participating organizations should benefit from the BRE-SPAD program. 

Eligible organizations are expected to propose plans for at least two of the funding areas based on the needs identified in an organizational assessment (see Research Strategy section below). Synergy and overlap across the three funding areas are allowed and encouraged, if applicable.

BRE-SPAD programs are expected to assemble a team of individuals who will promote lasting change at the participating organization(s). This team should include organizational leaders, administrators, and biomedical research faculty, experienced mentors, and knowledgeable steering committee members.

The award may be renewed once, for a maximum of up to 10 years of funding per organization; however renewal applications are not guaranteed funding and are dependent upon successful outcomes. 

BRE-SPAD funding may help organizations become more competitive for further biomedical funding such as NIH Research Enhancement Award (R15), Support for Research Excellence (SuRE) Program, Instrumentation Grant for Resource-Limited Institutions (RLI-S10), Undergraduate Research Training Initiative for Student Enhancement (U-RISE) or programs from other funding agencies.

BRE-SPAD Funding Priorities: All prospective applicants are strongly encouraged to contact a Scientific/Research Contact(s) (see Part 2. Section VII. Agency Contacts) in advance of preparing and submitting an application. The following applications will be considered low priority for funding, even if other aspects review favorably. Low priority applications include those that:

• Fail to demonstrate that there will be sufficient faculty or staff time for research, mentoring of student researchers, grant writing, or student activities.
• Propose to fund ongoing activities currently supported through organizational funds. BRE-SPAD is intended to build capacity that would not be possible without the funds, not to free up organizational funds.

Plan for Enhancing Diverse Perspectives (PEDP)

The NIH recognizes that teams comprised of investigators with diverse perspectives working together and capitalizing on innovative ideas and distinct viewpoints outperform homogeneous teams. There are many benefits that flow from a scientific workforce rich with diverse perspectives, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, the NIH encourages inclusivity in research guided by the consideration of diverse perspectives. Broadly, diverse perspectives can include but are not limited to the educational background and scientific expertise of the people who perform the research; the populations who participate as human subjects in research studies; and the places where research is done.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation.  Assessment of applications containing a PEDP are based on the scientific and technical merit of the proposed project. Consistent with federal law, the race, ethnicity, or sex of a researcher, award participant, or trainee will not be considered during the application review process or when making funding decisions.  Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

The PEDP will be submitted as Other Project Information as an attachment (see Section IV).  Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP Guidance materials.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

Multiple Resource-Limited Institutions (RLIs) may collaborate in a BRE-SPAD program, but there must be a single organization that will submit the application known as the applicant organization. An RLI is defined as a:

• Historically Black College or University (HBCU) (see 20 U.S.C. 1061(2)), OR
• Tribal entity defined as:
  • A federally recognized AI/AN Tribe, as defined under 25 U.S.C. 1603(14); or
  • A Tribal college or university, a Tribal health program, or a Tribal organization as defined under 25 U.S.C. 1603 (24), (25), and (26), respectively; or
  • A consortium of two or more of those Tribal entities. OR
• Non-HBCU or non-Tribal entity with the following: 
  • At the time of the application, have not received support from the NIH totaling more than $6 million per year (in both direct and F&A/indirect costs) in 4 of the last 7 fiscal years, excluding C06, S10 and all G activity codes, calculated using NIH RePORTER; AND
  • Have awarded five or fewer biomedical research doctorates (Ph.D.s) on average per year in the most recent five years of data reported in publicly-available NSF NCSES data (for example, the earned doctorates by major field of study including biological sciences, health sciences, chemistry, and biological/biomedical sciences within engineering). 

Based on language in recent Executive Orders, HBCUs (Executive Order 14041) and Tribal entities (Executive Order 14049) are considered RLIs and eligibility is not defined by total NIH funding or numbers of biomedical research doctorates granted.

Refer to the BRE-SPAD webpage for assistance determining eligibility.

Applicant organizations must address eligibility for each participating organization in the Organizational Eligibility and Commitment Letter (see Section IV).

The application must be submitted by an eligible organization with a unique entity identifier (UEI) and a unique NIH eRA Institutional Profile File (IPF) number. For organizations with multiple campuses (for example, main, satellite), eligibility can be considered for an individual campus only if a UEI and a unique NIH eRA IPF number are established for the individual campus. For organizations that use one UEI or NIH IPF number for multiple campuses, eligibility is determined for the campuses together.

Sponsored programs or research development associations can be applicant organizations provided other BRE-SPAD eligibility criteria are met. However, if such organizations apply, any funds requested cannot go towards development of the professional association, but must go toward building research capacity at one or more organizations of higher education that meet the NIH funding level and doctoral degree conferment, or HBCU, Tribal entity status eligibility criteria above.

Partner organizations (See Section I) are defined as organizations that will not receive development funding in the three BRE-SPAD areas (Sponsored Programs Administration Development, Research Environment, Pilot Research Project Program) thus they do not need to meet the eligibility criteria defined for BRE-SPAD participating organizations.

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

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov 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 their organization to develop an application for support. Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

All PDs/PIs should be assigned the "PD/PI" role. The role of "Co-PD/PI" is not currently used by NIH or other PHS agencies to designate a multiple PD/PI application. Do not use the role of "Co-PD/PI.”

The contact PD/PI must be from the applicant organization. The contact PD/PI is expected to have a full-time appointment at the applicant organization unless extremely well-justified. If the full-time status of the contact PD/PI changes after the award, the applicant organization must obtain prior program approval to appoint a new PD/PI or request a deviation from the full-time rule.  

Each participating organization(s) that is an organization of higher education should have at least one PD/PI that is an academic administrator (for example, Chair, Dean, Provost). For applicants that are not organizations of higher education, a PD/PI in a leadership position, as defined by the applicant organization, is required.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

 An applicant organization can only hold one BRE-SPAD award at a time, but may simultaneously participate in BRE-SPAD programs awarded to other organizations.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

Page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed, with the following exception:

The Research Strategy is limited to 30 pages, however the 30-page maximum is designed for applications requesting support in all three funding areas. Applicants are not required to submit a 30-page Research Strategy, especially if not applying for all three areas of support.

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

SF424(R&R) Cover

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

Descriptive Title of Applicant's Project: Use the format “BRE-SPAD at [name of applicant organization]”

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Other Attachments 

Plan for Enhancing Diverse Perspectives (PEDP)

• In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of actionable strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. 
• Applicants should align their proposed strategies for PEDP with the research strategy section, providing a holistic and integrated view of how enhancing diverse perspectives and inclusivity are buoyed throughout the application.
• The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured.
• The PEDP may be no more than 2 pages in length and should include:
  • Actionable strategies using defined approaches for the inclusion of diverse perspectives in the project;
  • Description of how the PEDP will advance the scientific and technical merit of the proposed project;
  • Anticipated timeline of proposed PEDP activities;
  • Evaluation methods for assessing the progress and success of PEDP activities.

Examples of items that advance inclusivity in research and may be appropriate for a PEDP can include, but are not limited to:

• Partnerships with different types of institutions and organizations (e.g., research-intensive; undergraduate-focused; HBCUs; emerging research institutions; community-based organizations).
• Project frameworks that enable communities and researchers to work collaboratively as equal partners in all phases of the research process.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as human subjects in clinical trials, including those from underrepresented backgrounds.
• Description of planned partnerships that may enhance geographic and regional diversity.
• Outreach and recruiting activities intended to diversify the pool of applicants for research training programs, such as outreach to prospective applicants from groups underrepresented in the biomedical sciences, for example, individuals from underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Plans to utilize the project infrastructure (i.e., research and structure) to enhance the research environment and support career-advancing opportunities for junior, early- and mid-career researchers.
• Transdisciplinary research projects and collaborations among researchers from fields beyond the biological sciences, such as physics, engineering, mathematics, computational biology, computer and data sciences, as well as bioethics.

Examples of items that are not appropriate in a PEDP include, but are not limited to:

• Selection or hiring of personnel for a research team based on their race, ethnicity, or sex.
• A training or mentorship program limited to certain researchers based on their race, ethnicity, or sex.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see PEDP Guidance materials.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

A. Senior/Key Personnel

There is an expectation that the organization(s) will fully support any requested positions beyond the BRE-SPAD funding period.

B. Other Personnel

Examples of other personnel include academic and sponsored programs administrators, student interns in sponsored programs offices or other such relevant areas, research and administrative support personnel (for example, to order supplies, prepare research materials), up to one-month personnel time for the required BRE-SPAD PD/PI mentors (see Section IV, Research Strategy), research-teaching postdocs to help with teaching load and research, hiring of adjunct instructors or others to offset teaching load, and other personnel time needed to develop curriculum, resources, new policies and procedures and implement award activities. Wages to support students in any capacity can only go to individuals enrolled full-time at the recipient organization(s). There is an expectation that the organization(s) will fully support any requested positions when the BRE-SPAD funding period.

C. Equipment Description

Total funding requested for equipment is not limited, however, only up to $75,000 can be requested towards any single piece of equipment. Requests for general use equipment (for example, autoclaves, hoods, refrigerator) that will be broadly shared are allowed. Single-user equipment can be requested within post-award Pilot Research Project funding only, which is not detailed in this application. Single-user equipment is defined as items for which at least 75% of the total time used is from a single research team.

D. Travel

The travel budget should include PD(s)/PI(s) attendance at an annual BRE-SPAD or equivalent meeting (see the Cooperative Agreement Section below). Examples of potential travel costs include student and faculty travel to biomedical research conferences (excluding travel for potential Pilot Research Project funding activities), BRE-SPAD PD/PI mentor travel (to the applicant organizations and/or relevant events), invited speakers, and competency-based training at professional society conferences or other venues (for example, National Council of University Research Administrators, National Organization of Research Development Professionals).

E. Participant/Trainee Support Costs

Not Applicable. Funding for trainee stipends or tuition is not allowed. Wage compensation for students involved in biomedical research can be requested in post-award Pilot Research Project funding, as applicable.

F. Other Direct Costs

For Section 1. Materials and Supplies: Allowable costs for BRE-SPAD include, but are not limited to, support for the following types of activities.

• Research supplies for individual faculty research projects and student researchers should be requested in post-award Pilot Research Project funding. Research supplies for broader or general use purposes, such as course-based research, may be requested in this application.
• Equipment service contract costs for up to 5 years may be included in the budget but must be paid during the period of the award.
• Development and implementation of research training materials and services.
• Development and implementation of pre-award and post-award policies, processes and services.
• Development of communications and information systems (such as websites, grants management systems, and databases).
• The development of systems to enhance regulatory compliance.
• The development of activities that enhance faculty competitiveness for accessing external research support or organizational research environment.
• Non-travel-based competency-based training for research administrators/grant managers to ensure that staff have the requisite knowledge and skills to provide efficient pre- and post-award services throughout the life cycle of the research award. Travel-based training is listed above.

For Section 7. Alterations and Renovations 

• Not applicable 

If requesting items that are normally treated as F&A costs (for example, general office supplies) as direct costs, the applicant must provide a strong justification in the Budget Justification section for those items and demonstrate that the cost is commensurate with the benefit that a particular item will have on the associated component. Failure to adequately justify such costs will likely result in their deletion from the requested budget.

PEDP implementation costs:

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7): https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: Include Specific Aims for the BRE-SPAD funding areas sought (Sponsored Programs Administration Development, Research Environment, Pilot Research Project Program). Applicants are not required to apply to all funding areas. Include goals for and a description of activities planned in each funding area proposed. Describe the sustainable impact the aim(s) will have on the participating organization(s).

Research Strategy: For the Research Strategy section, do not use the “Content” instructions in the application guide for Significance, Innovation, and Approach. Instead, applications must include information in the required sections below (1-11), unless indicated as optional. Applications should include the names of the headings below to organize the Research Strategy. 

1. Organizational Assessment: All applications should address each section of the Organizational Assessment for the funding areas sought using the following instructions (1a-1b). Applicants are encouraged to be brief and include the information in tables or bullets.

1a. Organizational Overview: Describe each participating organization, for example, size and relevant historical mission. Please note that the race, ethnicity, or sex of an institution’s current students and faculty will not be considered in the application review process or when making funding decisions.  For organizations of higher education, the organizational overview should also include the following (applicants are encouraged to visit the BRE-SPAD webpage for more detailed instructions on locating the data): 

• Percentage of all undergraduate students currently supported by Pell grants (see also IPEDS).
• Current numbers of students pursuing biomedical research related baccalaureate degrees and master’s degrees.
• Explanation of the faculty research, teaching, and service responsibilities. Describe how teaching load is determined. Include existing incentives, programs, or structures to support faculty participation in biomedical research. 
• Describe outcomes of any NIH research capacity-building, construction, or infrastructure funding that the organization has received over the past 10 years (at minimum).

1b. Biomedical Research Environment: For the participating organization(s), briefly describe:

• Faculty and student participation in biomedical research, including any research structures/programs such as summer programs, mentored research, or course-based research and collaborations, if applicable. 
• The research culture and environment, such as seminars, research events, policies, research development services, and research resources.
• Modes of faculty and/or student input into research policies.
• Sponsored programs personnel and services.
• Number of external biomedical grants or contracts submitted and funded in the past five years.

2. Need for the Proposed Programming: 

• Describe organizational barriers to increasing biomedical research capacity that will be addressed with the funding. For example, include potential reasons that faculty and/or student participation in biomedical research are limited, challenges with applying to external funding, or barriers in post-award management, particularly for federal funds.
• Describe the need for funding to conduct the proposed activities in the context of the current organizational resources and priorities.

3. Impact on Contributing to Broad Participation in the Biomedical Research Workforce: Applications should describe the following:

• How the proposed program aligns with the goal of promoting broad participation in the biomedical research workforce.
• The current and proposed recruitment efforts to reach prospective students and faculty from groups underrepresented in the biomedical research workforce (for examples, see NOT-OD-20-031). Expand on areas of success and areas for improvement.
• Plans to increase the interest and persistence of students and faculty from a variety of backgrounds in biomedical research.
• Plans to track student and faculty success in biomedical research and how the data will capture potential disparities of outcomes across demographic groups. If baseline data are available, they may be included.

4. Innovation: For BRE-SPAD, innovation is the creation or adaptation of sustainable and effective processes or products to increase faculty research and sponsored programs administration development, cultivation of biomedical research environment, enhancement of biomedical research activities, and/or advancement of student biomedical research training or activities. Innovative programs have different, expanded, or significantly more impactful offerings than what is currently available at the participating organization(s). Proposing to continue previous, or currently supported activities are considered less innovative. Briefly explain how the proposed plans are innovative.

5. Goals: State the primary goals for the proposed plans. These should be specific, measurable, and obtainable. Include goals for each of the BRE-SPAD funding areas sought in the application (Pilot Research, Research Environment, and/or Sponsored Programs Administration Development). Describe how the proposed plans will advance overall biomedical research capacity goals at realistic rates, tailored to the participating organization(s).

6. Funding Area(s): Applications should include at least two of the BRE-SPAD funding areas below (6a-6c). Note that funding areas not proposed here could be included in future renewal applications.

6a. Sponsored Programs Administration Development Funding: Applications may propose activities to enhance sponsored programs administration development (such as pre- and post-award functions, contracts, fundraising practices, or technology transfer) by including, for example, descriptions of the following potential areas:

• Partnerships. Describe planned partnerships, including any participating and partner organizations, to share sponsored research administration functions, such as regional alliances for central offices (IRBs, IACUCs, etc.), shared personnel, electronic research administration systems, or other resources.   
• Sponsored programs personnel. Hiring or contracting of sponsored programs personnel or services is allowed if justified and with an appropriate sustainability plan (see below). Describe and justify any new personnel to be hired. For organizations proposing to share sponsored programs personnel, provide the hiring organization with primary responsibility for the personnel and the reporting hierarchy. Include the logistics of personnel time, division of labor, and potentially competing priorities for each organization.
• Sponsored program internship program. If including a sponsored program internships, describe the planned activities and methods for determining the success of the program.
• Staff training. Describe proposed personnel training activities, including courses, meetings, workshops, or consultant interactions. Training topics may include, pre- and post-award functions, policies and procedures, compliance, electronic research administration, indirect cost rate negotiation.
• Technology. Describe any need for and plans to acquire electronic research administration systems. For multi-organizational shared technology plans, include a brief description of the sharing agreement.
• Updates to policies and procedures. Describe any plans for revising or creating internal policies and procedures.
• Sustainability plans. Participating organizations should describe plans to sustain the enhancements to sponsored program administration functions after potential BRE-SPAD funding ends. These plans should pay particular attention to how any staff hired using BRE-SPAD funds will be supported, as well as how new contracts and electronic systems will be maintained.

6b. Research Environment Funding: Applications may propose enhancements to the organizational research environment by including descriptions of the following potential areas:

• Broadly useful research equipment and supplies. For example, equipment or supplies needed for improvements to biomedically-relevant curriculum or broadly used biomedical research equipment or supplies. Briefly explain plans for usage, users, and how equipment and supplies will significantly impact biomedical research activities of the organization.
• Enhancements to encourage student research. For example, developing course-based research experiences or integrated science curricula, creating a student research office, or academic credit for research experiences.
• Student research training and mentoring activities. For example, research training activities that address quantitative and computational skills development, reading the primary scientific literature, experimental design, data analysis, safety, rigor and reproducibility, record keeping, and the responsible conduct of research. Applicants are encouraged to include plans for mentor training and mentoring activities. Topics and plans for implementation should be evidence-informed.
• Faculty development activities (if not described in the section above). For example, activities aiming to increase faculty competitiveness for externally-funded biomedical research or research training awards, such as grant writing or research design workshops, writing groups, research or grant writing mentoring.
• New policies or procedures affecting the research culture. For example, promotion and tenure policies to recognize research and research training, protected time for research, research incentives, credits for mentoring students in research, allocation of teaching loads to recognize research training. Explain the ways faculty and student input will be incorporated into the design or allocation of research resources and policies.
• Events or activities planned to enhance the research culture. For example, holding campus research symposia, creating speaker series, supporting regional biomedical research group meetings.
• Organizational partnerships to support proposed activities, as relevant.
• Sustainability plans. Applicants should describe plans to sustain the enhancements of the research environment and culture and encourage broad participation in the organization's/organizations' biomedical research programs after possible BRE-SPAD funding ends.

6c. Pilot Research Project Funding: Applicants may propose a biomedical pilot research project program. The program is intended to provide short-term funds for faculty to initiate research projects involving students to gather preliminary data for future grant applications. Pilot research projects must be for biomedical and biomedical-related research supported by the missions of the NIH institutes and centers. Pilot research projects may include human subject research, but not clinical trials. The principal investigators for the pilot research projects should be independent investigators, not trainees. Applications proposing pilot research projects should describe the following:

• The scope and general types of biomedical projects that would be supported. Specific research projects should not be described.
• The qualifications of individuals identified to manage the program, the expected number of projects and students to be supported each year, estimated duration of the projects, range of funding proposed for each project, and eligibility requirements.
• The process for solicitation, submission, review, selection, and evaluation of program outcomes.
• The rationale and expected impact on faculty, student researchers and the organization, including beyond the pilot research funding and award period.   
•  Data on the number of current faculty at the institution(s) with biomedical research expertise and interests who could apply to and benefit from the program. Also include information on the fields of study of these faculty. If current faculty are insufficient, describe plans to recruit additional biomedical faculty. Applicants are encouraged to include letters of support from faculty to demonstrate interest and commitment of prospective faculty participants (see Letters of Support).
• Faculty grant writing development activities. For example, describe the process of pairing faculty with external research or grant writing mentors in their fields or any other development activities.
• Recruitment, training, and involvement of student researchers. Describe plans to promote broad participation in the pilot research projects.
• How the pilot research project program will impact the organizational research environment, for example applications for external biomedical research funding or promotion of broad participation in biomedical research.

7. Faculty, Staff, and Student Time for BRE-SPAD Implementation: Describe the plans for ensuring faculty, staff, and students will have sufficient time to engage in the activities proposed in the application. Based on the Organizational Assessment, describe changes needed to accommodate the participation of key individuals in the proposed activities. Applications should address plans for the following groups (additional groups may be added):

• Biomedical faculty participating in the proposed BRE-SPAD program. The application must demonstrate there is, or will be, sufficient time for research, mentoring of student researchers, and grant writing. Explain how the BRE-SPAD faculty will have the time and resources needed given their teaching and service responsibilities. Proposed changes could include, but are not limited to, adjustments to teaching or committee loads to allow time for research, mentoring and grant writing.
• BRE-SPAD staff. Describe any plans for hiring, protected time, or additional support for staff to conduct the proposed activities. If staff hiring is proposed, ensure that appropriate sustainability plans have been included.
• Student researchers. Discuss any proposed changes to support student research either in the classroom, for independent research course credits, or for paid summer internships. Examples include course credits, stipends or hourly wages.

8. Multiple Participating Organizations (optional): Describe the role of each participating organization and how the collaboration is beneficial for all involved. Depending on the nature of the collaboration, include division of responsibilities and administrative duties, as well as communication and conflict resolution plans.

9. Structure & Governance: Governance plans should include communication strategies, processes for making decisions, and procedures for resolving conflicts. The roles, responsibilities, and reporting structure for the program should be briefly described for the following (additional roles may be added):

• Academic Administrator or Leadership PD/PI (at the level of Chair, Dean, Provost, or equivalent) from each participating organization.
• Each PD/PI.
• Steering Committee(see Part 2. Section VI. Award Administration Information. Cooperative Agreement Terms and Conditions of Award for expected members). The Steering Committee is expected to contribute to the development of a cohesive and sustainable program, provide advice on key issues, ensure that the implementation is occurring on schedule and in alignment with the strategic vision for biomedical research enhancements, and alert NIH to emerging needs and impediments. Describe the recruitment process, frequency of meetings and any other relevant information. Only pre-existing Steering Committee members should be named in the application. Potential Steering Committee members should not be identified or contacted prior to receiving an award.
• BRE-SPAD PD/PI Mentors. PD/PI's are expected to have at least one mentor from a non-participating organization. Ideal mentors are employed at an organization with a level of biomedical research capacity similar to that which the participating organization is trying to attain. The BRE-SPAD PD/PI mentors are expected to be members of the BRE-SPAD Steering Committee (note that PD/PI mentors are the only Steering Committee members that are expected to be named in this application.)  Describe the frequency of mentoring meetings, the mode of the meetings, and potential mentoring topics. A letter of support from each mentor should be submitted with the application, as described below.

10. Evaluation Plan and Timeline:

• Describe the evaluation plan with milestones and measures for both short-term and long-term goals. Describe the evaluation process to determine whether the overall program is effective in meeting its goals. The evaluator(s) should not be involved in conducting any BRE-SPAD activities but can be employed by any of the participating or partnering organizations. Applicants should describe plans to collect the applicable evaluation data described (Section VI. Award Administration Information. 4. Reporting). Other appropriate project and organization specific evaluation plans should also be described.
• Describe the timeline for the goals and indicate measurable milestones. The timeline should be realistic and comprehensive.

11. Overall Sustainability Plan: This section should describe plans for how impactful BRE-SPAD activities will be continued beyond the funding period. While BRE-SPAD is renewable for a total of 10 years of support, continued funding is dependent upon successful completion of the proposed goals. Recipient organizations should not expect future funding and should have sustainability plans that do not depend on future BRE-SPAD funding. This plan should include strategies to obtain support for personnel, activities, and projects after the award. Plans should go beyond the dependence upon indirect funds from anticipated external grants. This section should expand upon, but not duplicate information provided above for the BRE-SPAD areas (6a-6c).

Letters of Support: Provide letters of support for the proposed BRE-SPAD program following instructions in the SF424 Application Guide and the details below.

Organizational Eligibility & Commitment Letter (Required). The applicant organization must include a letter from the President, Provost or other senior organizational official with organization-wide responsibility from the participating organization(s). The letter should:

• If applicable (see Section III), confirm that all components of the participating organization under the UEI or IPF number have not received support from the NIH totaling more than $6 million per year (in both direct and F&A/indirect costs) in 4 of the last 7 fiscal years, excluding C06, S10 and all G activity codes. Refer to the BRE-SPAD program page for further guidance on how to determine the NIH support.
• If applicable (see Section III), confirm that the participating organization has not awarded more than an average of five or fewer biomedical research doctorates (Ph.D.s) in the most recent five years of data reported in publicly-available NSF NCSES data: earned doctorates by major field of study including biological sciences, health sciences, chemistry, and biological/biomedical sciences within engineering. Refer to the BRE-SPAD program page for further guidance.
• Include a description of the ways in which the proposed plans are congruent with organizational priorities, culture, goals, and strategic aims. 
• Provide assurances of a commitment to providing adequate funding, facilities, and resources to implement the proposed plans.
• Provide assurances of a commitment to maintaining and improving biomedical research and research training during and after the BRE-SPAD funding period.
• Be signed by a senior organizational official from each participating organization. 

PD/PI Mentor Letters of Support (Strongly Encouraged): Applicants are expected to include a letter from each designated mentor for the PD(s)/PI(s) of the participating organizations. The mentors should identify their organization(s) and describe their experience with biomedical research, capacity building, administration, and NIH and other federal funding agencies of biomedical research and research training grant mechanisms. The letter should agree to the frequency of meetings, the mode of the meetings, and the topics outlined in the application.

Potential Pilot Research Project Funding Candidates (Optional): If a pilot research project program is proposed, participating organizations are encouraged to submit letters from potential biomedical researchers who would be candidates for the program. The potential candidates should describe their general research area and indicate how it is within the mission of the NIH.

Other letters of support may be included.
 

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

Other Plan(s): 

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

• All applicants planning research (funded in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing (DMS) Plan. All applications, regardless of the amount of direct costs requested for any one year, must include a DMS Plan.
• If no funding from this award will directly support research, in other words applying only for Sponsored Programs and Research Environment funding that will not be used to conduct research, state this in the DMS plan as it is still required for submission. State that funds from this award will not be used for research and indicate that the plan is not applicable at this time.
• If applying for Pilot Research Project funding, the research projects and associated data are not known at the time of application, therefore a detailed plan is not required. Applications should include general plans for complying with the DMS policy, including any foreseeable issues. These issues may include, but are not limited to, the following examples:
  • A description for anticipated projects involving American Indian/Alaska Native (AI/AN) participant data and/or engagement with AI/AN tribes, including any necessary Tribal approvals, Tribal sovereignty and privacy considerations, or Tribal community review.
  • Restrictions related to research that is also supported by the private sector that may result in proprietary data.
  • A commitment to identify appropriate methods/approaches and repositories for future scientific data resulting from the award that will make it findable and identifiable. 

The plan should also indicate a commitment to update the DMS Plan at the time of RPPR.

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

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply-Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and NIGMS. Applications that are incomplete and/or non-compliant will not be reviewed. 

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

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

For this NOFO, note that depending on the developmental stage, participating organizations may vary in current biomedical research activity, research funding levels, experience with securing NIH or other extramural funding, capacity to collect baseline data, or BRE-SPAD goals. Accordingly, reviewers should:

• Assess the extent to which the plan is realistic and attainable (including whether individuals will have sufficient time to engage in the activities proposed in the application) and will advance biomedical research capacity of the participating organization(s) with respect to baseline organizational data. 
• Consider whether the plan will result in significant and sustainable levels of change specific to organizational needs and proposed area(s) of development.
• Evaluate the impact of successful outcomes on promoting broad participation in the biomedical research workforce.
   

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following scored review criteria and additional review criteria (as applicable for the project proposed).  An application does not need to be strong in all categories to be judged likely to have a major scientific impact. As part of the overall impact score, reviewers should consider and indicate how the Plan for Enhancing Diverse Perspectives affects the scientific merit of the project.

Reviewers will evaluate Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate criterion score. 

As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

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.

2. Review and Selection Process

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

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions, consistent with applicable law.

• Scientific and technical merit of the proposed project, including the PEDP, as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

Please note that reviewers will not consider race, ethnicity, age, or gender of a researcher, award participant, or trainee, even in part, in providing critiques, scores, or funding recommendations. NIH will not consider such factors in making its funding decisions.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

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

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

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

• Participating in a required recipient training webinar(s) and online or in person meeting(s), such as a BRE-SPAD program meeting. A designated representative of the recipient organization’s administrative or scientific leadership (for example, Vice President for Academic Affairs, Research, or Finance and Administration, the Provost, Dean) is also encouraged to attend the required training webinar(s). The purpose of the training webinar(s) is to familiarize the recipient organization’s leadership with the strategic mission of the BRE-SPAD program as well as to ensure concurrence of the recipient organization's priorities with BRE-SPAD program goals.
• Implementing the proposed plans, including the plans for sustainability.
• Contributing to the cooperative nature of the effort.
• Participating in scheduled meetings with the designated mentors, Steering Committee members, and NIH officials.
• Evaluating progress using defined milestones and metrics. Recipient organizations will provide NIH with progress reports at regular intervals and refer to evaluation metrics described on the BRE-SPAD program webpage.
• Sharing evaluation-related data with the NIH at the end of the award (see the BRE-SPAD program webpage). Recipient organizations will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
• Provide updates at least annually on progress in PEDP implementation. 

NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. 

The NIH Project Coordinator will:

• Advise the recipient organization in performing project activities.
• Facilitate, not direct, activities.
• Participate on the Steering Committee (see below) or in other functions to guide the course of the program (for example, BRE-SPAD recipient organization meetings).
• Ensure that the directions taken are consistent with the BRE-SPAD program mission and goals.
• Serve as a liaison between the recipient organization and the NIH.

The Project Coordinator will not participate in the oversight of the funding opportunity, application review, funding recommendations, or programmatic and budgetary stewardship of the award.

The Program Official will be responsible for the normal programmatic stewardship of the award, including funding recommendations, and will be named in the award notice. The Program Official is not a member of the Steering Committee and will not partake of the duties of the Project Coordinator.

Areas of Joint Responsibility:

The Steering Committee is the governing and oversight body for the BRE-SPAD Program. Members, who are appointed by the PDs/PIs of the award, will be composed of the following:  

• Two senior level stakeholders from each participating organization’s research and/or training enterprise (for example, Department Chair, Dean of the Sciences, Director of Finance, Dean of Administration, Vice President/Director of Development, Vice President/Director of Faculty Development). One senior level stakeholder will serve as the Steering Committee Chair, selected by the PDs/PIs.
• End-users of sponsored program activities, such as biomedical research faculty.
• Participating Organization PD/PI Mentor(s). Additional mentors from partner organizations are optional.
• NIH Project Coordinator. 

The Program Official is a central contact for all fiscal issues and serves as a resource to the project regarding DHHS and NIH recommendations and policies. The Program Official is not a member of the Steering Committee and cannot routinely attend meetings. In cases where specific questions or issues must be addressed by the Program Official, they can be invited to attend that portion of a meeting.

Additional members who are not federal government employees may be appointed to the Steering Committee by the PDs/PIs as needed to guide the project. .

The Steering Committee will:

• Serve as the primary governing and oversight board for the grantee organization(s).
• Decide on the schedule of meetings. The Steering Committee should meet at a minimum of twice per year. The Steering Committee may also call meetings to address urgent needs and will participate in network meetings and teleconferences as needed.
• Contribute to the development of a cohesive and sustainable program.
• Provide advice on key issues such as relevant resource allocation, existing organizational policies and capabilities, and opportunities for growth.
• Ensure that the implementation of the proposed aims and sustainability plan is occurring on schedule and continues to align with the recipient organization's strategic vision for biomedical research and/or research training.
• Alert NIH to emerging needs and impediments.
• Prepare concise (1-2 page) summaries of the Steering Committee recommendations, which will be delivered to the PDs/PIs and members of the group within 30 days after each meeting.

Dispute Resolution:

Disagreements between award recipients and the NIH that arise regarding matters related to the scientific direction of the funded program may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: A designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

Prior Approval of Pilot Projects

Pilot project that do not include human subjects or vertebrate animals research will only require official notification to NIGMS with appropriate documentation at least 14 days before the projects begin. Prior approval by NIGMS is not required to initiate these projects.

Pilot projects that include human subjects or vertebrate animals research require NIGMS prior approval before the projects can begin. The following documentation for each project must be submitted to NIGMS Program Official and Grants Management Specialist listed on the Notice of Award for administrative review at least 30 days before the projects begin:

Using PHS398 forms and instructions, only the following sections need to be submitted:

• Face page (signed by an institutional signing official)
• Project Summary (page 2)
• Research Strategy
• If the proposed project involves human biospecimens or data, include:
  • Current PHS Human Subjects and Clinical Trials Information Form
• If the proposed project involves Human Subjects, include:
  • Current PHS Human Subjects and Clinical Trials Information Form
  • Institutional Review Board (IRB) approval
  • Human Subjects Education Certification (required even when research is exempt)

Note: For human subjects research, the grantee must enter study data in the Human Subjects System (HSS) before requesting NIGMS approval.

• If the proposed project involves Vertebrate Animals, include:
  • IACUC approval
  • Vertebrate Animals Section

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

4. Reporting

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

• Recipients will provide updates at least annually on implementation of the PEDP.

Tracking progress of biomedical research activities and environment and sponsored programs administration development is critical to increasing biomedical research capacity. Recipient organizations should refer to the BRE-SPAD program web page when preparing RPPRs. Data examples include the following, that should be attributed to Pilot Research Project funding where applicable:

• Research projects or research-related activities for faculty and/or students funded by this award.
• Research development activities for faculty.
• Research experiences and research training for students.
• Changes in biomedically relevant degree attainment and career outcome trends.
• Changes to research environment or research culture.
• New or expanded sponsored programs infrastructure or services.
• Changes in sponsored programs personnel and their training.
• New or revised policies or organizational programs.
• Activities or efforts impacting broad participation in the biomedical research workforce.  

If applicable, approved Pilot Research Project Funding projects should be reported as separate components in the RPPR. Progress reports should briefly describe status of Pilot Research Funding projects, including data and safety monitoring, compliance with the approved Data Management and Sharing Plans (DMS Plan) and should notify NIH of serious adverse events, and unanticipated problems for human subjects. In the event that new research supported by BRE-SPAD is not covered by the current DMS Plan, an updated DMS Plan not exceeding 2 pages should be submitted as part of the RPPR.  

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

In carrying out stewardship of grant programs, NIGMS will periodically evaluate BRE-SPAD, employing the representative measures identified below. In assessing the effectiveness of research capacity building investments, NIH may use information from progress reports and public databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be appropriately contacted after the completion of the grant period for updates on participants’ subsequent outcomes.

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

• Indicators of organizational and investigator capacity building, such as:
  • Recruitment and development of faculty or staff
  • Changes to faculty or student research activities, resources, and events 
  • New or expanded sponsored programs administration and research development infrastructure
  • Progression towards sustainability
  • Increased use of scientific research infrastructure and equipment
  • Subsequent submission of peer-reviewed grant proposals and other scholarly products
  • Subsequent external funding obtained with support of the BRE SPAD program
• Characteristics of the applicant and awardee pool for the program, such as:
  • Geographic distribution
  • Investigator and participant demographics
  • Organization types
  • Scientific areas of focus
• Indicators of scientific productivity and impact among awardees (all) and their participants and partners, such as:
  • Peer-reviewed research publications and citations
  • Conference presentations
• Outcome measures for educational activities, such as:
  • Curriculum development and courses offered for enhanced scientific skills development
  • Number of students pursuing degrees in biomedical fields
  • Research experiences obtained by students
  • Mentoring activities conducted with students
  • Student authorship o n scientific research publications
  • Subsequent participation of students in the biomedical research workforce
  • Successful transitions to subsequent stages of training
  • Degree completions and time-to-degree in biomedical science fields 

Section VII. Agency Contacts

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

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

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

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

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

Sydella A. Blatch Alexander, Ph.D. and Marie Harton, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: NIGMSBRE-SPAD@nigms.nih.gov 

Laura Juliette Biven, Ph.D.
ODSS - Office of Data Science Strategy
Phone: none
E-mail: laura.biven@nih.gov

Marguerite Matthews, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-3272
Email: marguerite.matthews@nih.gov

Christy Carter, Ph.D. 
National Institute on Aging (NIA) 
Phone: 301-451-9827
E-mail: christy.carter@nih.gov

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

Lanay M. Mudd, Ph.D., FACSM
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-9346
Email: lanay.mudd@nih.gov

Shoba Thirumangalathu, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: (301) 594-0652
Email: shoba.thirumangalathu@nih.gov

Brittany Haynes, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-496-2767
Email: brittany.haynes@nih.gov

Kristy Nicks, Ph.D.
NIAMS - National Institute of Arthritis and Musculoskeletal and Skin Diseases
Phone: (301) 594-5055
E-mail: kristy.nicks@nih.gov

Tony Douglas Gover, Ph.D.
NEI - National Eye Institute
Phone: 301-529-7370
E-mail: tony.gover@nih.gov

Elizabeth Powell, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0786
Email: elizabeth.powell3@nih.gov

Center for Scientific Review (CSR)
Email: NOFOReviewContact@csr.nih.gov

Justin Rosenzweig 
National Institute of General Medical Sciences (NIGMS) 
Email: rosenzwj@nigms.nih.gov 

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

Laura Pone
National Institute on Aging (NIA) 
Phone: 301-555-1212
E-mail: laura.pone@nih.gov

Pamela G Fleming
NIDA - National Institute on Drug Abuse
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov

Gabriel Hidalgo
National Institute of Dental and Craniofacial Research (NIDCR)
Phone: 301-827-4630
E-mail: hidalgoge@mail.nih.gov

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email:siscor@mail.nih.gov

Erik Edgerton
NIAMS - National Institute of Arthritis and Musculoskeletal and Skin Diseases
Phone: 301-594-7760
E-mail: erik.edgerton@nih.gov

Karen Robinson Smith
NEI - National Eye Institute
Phone: 301-435-8178
E-mail: kyr@nei.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: judy.fox@nih.gov

Section VIII. Other Information

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

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