National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
National Eye Institute (NEI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Office of Data Science Strategy (ODSS)
UC2 High Impact Research and Research Infrastructure Cooperative Agreement Programs
Only one application per organization is allowed. See Section III. 3. Additional Information on Eligibility.
The Biomedical Research Environment & Sponsored Programs Administration Development (BRE-SPAD) Program aims to promote broad participation in biomedical research by supporting resource-limited institutions to conduct research, enhance their research environments, and increase sponsored programs administration capacity.
This Notice of Funding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP).
Not Applicable
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
January 27, 2025 | Not Applicable | Not Applicable | July 2025 | October 2025 | December 2025 |
January 27, 2026 | Not Applicable | Not Applicable | July 2026 | October 2026 | December 2026 |
January 27, 2027 | Not Applicable | Not Applicable | July 2027 | October 2027 | December 2027 |
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.
Not Applicable
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:
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 21st 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.
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:
NIH anticipates the following organizations may be involved in the BRE-SPAD program:
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:
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.
Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.
The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Not Allowed: Only accepting applications that do not propose clinical trials.
The number of awards is contingent upon NIH appropriations and the number of meritorious applications submitted.
Application budgets for direct costs should not exceed $500,000/year.
The maximum project period is five years. The scope of the proposed project should determine the project period.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits 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:
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.
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.
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.
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:
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.
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.
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 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.
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]
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
Other Attachments
Plan for Enhancing Diverse Perspectives (PEDP)
Examples of items that advance inclusivity in research and may be appropriate for a PEDP can include, but are not limited to:
Examples of items that are not appropriate in a PEDP include, but are not limited to:
For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see PEDP Guidance materials.
All instructions in the How to Apply- Application Guide must be followed.
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.
For Section 7. Alterations and Renovations
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.
All instructions in the How to Apply-Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
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 institutions 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):
1b. Biomedical Research Environment: For the participating organization(s), briefly describe:
2. Need for the Proposed Programming:
3. Impact on Contributing to Broad Participation in the Biomedical Research Workforce: Applications should describe the following:
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:
6b. Research Environment Funding: Applications may propose enhancements to the organizational research environment by including descriptions of the following potential areas:
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:
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):
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):
10. Evaluation Plan and Timeline:
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:
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:
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.
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.
All instructions in the How to Apply- Application Guide must be followed.
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
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, NIHs 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.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement 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 organizations 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.
Applicants are required to follow the instructions for post-submission materials, as described in the policy
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:
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.
Significance
Innovation
.
Approach
Investigator(s)
Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.
Environment
Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.
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.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects; 2) adequacy of protection against risks; 3) potential benefits to the subjects and others; 4) importance of the knowledge to be gained; and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, evaluate: 1) the justification for the exemption; 2) human subjects involvement and characteristics; and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.
Not Applicable
Not applicable
Not applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Not Applicable
Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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.
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 applicants 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 applicants 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.
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.
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 recipients 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.
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
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:
NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.
The NIH Project Coordinator will:
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:
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:
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.
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:
Note: For human subjects research, the grantee must enter study data in the Human Subjects System (HSS) before requesting NIGMS approval.
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.
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.
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:
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:
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
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.