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 Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered.

Authorized by the U.S. Congress in 1993, the National Institutes of Health (NIH) established the Institutional Development Award (IDeA) program to build biomedical research capacity in 23 U.S. states and Puerto Rico (See Section III for IDeA state eligibility), which had historically low NIH grant funding success rates. IDeA funding programs collectively support biomedical research in basic, clinical, behavioral, and translational science in IDeA-eligible states by developing faculty investigators, providing research opportunities to students, and enhancing research infrastructure. 

One of the components of IDeA is the Centers of Biomedical Research Excellence (COBRE) program, which supports the establishment and development of innovative biomedical research centers of excellence in an area of strategic importance to the organization and in alignment with the mission and priorities of the NIH. The COBRE program has two tracks that provide grant recipients with the means to build biomedical research capacity:

• The COBRE D-E-S track (three phases, maximum 15 years of support) targets institutions without existing research capacity in the proposed broad area of research. 
• The COBRE E-S track (two phases, maximum 10 years of support) targets institutions with an existing degree of research capacity amenable to expansion and growth in the proposed area of research. 

This Notice of Funding Opportunity (NOFO) only supports applications to the COBRE-D phase of the program. The companion NOFO (PAR-27-055) supports applications to the COBRE-E and COBRE-S phases of the program. 

The five-year phases of the COBRE program are:

• COBRE-D (Development Phase): Supports a long-term institutional vision leading to the creation of a center in a broad area of biomedical research that is currently not supported at the applicant organization by recruiting early career faculty, establishing research facilities, and enhancing research administration.
• COBRE-E (Expansion Phase): Expands research capacity by growing the institutional faculty base, research projects, and core facilities.
• COBRE-S (Sustainability Phase): Sustains the expanded research infrastructure by continuing to grow the faculty and consolidating research cores to maintain research excellence beyond COBRE support.  

COBRE-D Program Overview

Applicant organizations must identify a key strategic biomedical scientific area where existing research infrastructure and early- and mid-career investigators are currently lacking. The proposed research area should be sufficiently broad to establish the scientific foundation for the growth and development of biomedical research capacity in alignment with the organization's strategic priorities. Applications proposing partnerships between two organizations lacking biomedical research capacity in the planned area of research are allowed. 

The COBRE-D structure includes an initial ramp-up period (up to 12 months) during the first budget period to build the necessary organizational framework necessary to develop outreach, recruit faculty, and strengthen research infrastructure. This will involve recruitment of 3 to 6 early to mid-career investigators during the span of the award and integration of the following cores:

• Administrative Core (required) to manage operations and ensure compliance with COBRE award requirements. The Administrative Core will handle reporting and evaluation of progress, recruitment of faculty, and coordination of research space alterations and renovations.
• Faculty Development Core (required) to manage activities (for example, professional and research development, mentoring, grant-writing workshops) involving the development of faculty hires and center investigators and ensure their continued scientific and career advancement and retention.
• Research Core(s) (optional) to support proposed research if they do not duplicate existing services or facilities at the participating organization(s). Sharing research facilities supported by other IDeA programs (such as INBRE, CTR, and other COBREs) is strongly encouraged. Enhancements to existing research services to transition into a research core is also supported.

COBRE-D grant recipients are expected to accomplish the following measurable objectives:

• Demonstrate organizational support for building capacity in the broad biomedical research area(s) of strategic importance to the institution.
• Conduct recruitment activities for early- and mid-career investigators in the center's proposed research area.
• Develop strategies to establish individual research, career development, mentorship, and grantsmanship plans for the investigators supported by this award. 

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 - Includes all types

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

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)

Eligibility is restricted to institutions that:

• Are located in an IDeA-eligible state, commonwealth, or jurisdiction, which are Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Puerto Rico, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, and Wyoming; and
• At the time of submission have no active COBRE grants, including those in no-cost extension.

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organization) 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. 

Note:

• Unfunded foreign components are allowed with prior approval.
  • An unfunded foreign component would be a collaboration with investigators at a foreign site anticipated to result in co-authorship, when no IDeA funds are transferred via subcontract to an institution in a foreign country. Please also see NOT-OD-26-084.
• Foreign PIs or organizations may use center resources as a fee-for-service.
  • In such cases, resulting publications cannot cite or acknowledge NIH grant support.

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 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. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. Obtaining an eRA Commons account can take up to 2 weeks.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help. 

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. 

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.

The PD/PI is expected to be an established biomedical research scientist with the mentoring and administrative experience necessary to lead the Center. At the time of submission, the PD/PI must have a primary appointment at the applicant organization and be the PD/PI on at least one active, peer-reviewed and externally funded research grant within the same general scientific area of the proposed COBRE. If a COBRE PD/PI's qualifying research grant is a multiple PD/PI award to a different organization, the applicant organization must receive funds via a subcontract. For multiple PD/PI COBRE applications, all non-contact PDs/PIs must have at least one active, peer-reviewed, and externally funded research grant within the same general scientific area of the center.

A COBRE PD/PI may not simultaneously lead more than one IDeA (INBRE, CTR, or other COBRE) program award. Previous PDs/PIs of other COBRE Centers, except those who served in that capacity on an interim basis, are not eligible to lead a COBRE-D application. All investigators who intend to apply as PDs/PIs are encouraged to consult with the Scientific/Research Contact listed in Section VII prior to preparing an application to confirm eligibility. 

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one COBRE-D application per institution (normally identified by having a unique entity identifier (UEI) number or NIH IPF number) is allowed.

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).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - 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

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component

When preparing the application, use Component Type 'Overall'.

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

Biographical Sketch: Each PD/PI should include a description of their scientific, mentoring, and administrative experience in the Personal Statement of the NIH Biographical Sketch Supplement. The Biographical Sketch Common Form and NIH Biographical Sketch Supplement should provide evidence of the PD/PI's leadership experience in the center's broad area of research, mentoring of early and mid-career investigators, and administration. Each PD/PI should describe how their mentoring track record promotes independence, retention, and long-term success of early- and mid-career faculty.

Current & Pending Support: Attach a copy of the PD/PI's Current and Pending (Other) Support Common Form, which is critical information for determining the PD/PI's eligibility and suitability to lead the proposed center.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Revision applications, an Introduction to Application is required in the Overall component.

Research Strategy: This section must include the following elements:

A. Justification for Establishment of the Center

Applicants should provide a strong rationale for the need to request support for the Center in the chosen scientific area and how it fits within the applicant organization's strategic plan. The Center's research area should be sufficiently broad and cohesive to enable the development of long-term biomedical research capacity and to catalyze the recruitment and retention of early and mid-career investigators. 

The justification should describe the organization's:

• Existing research infrastructure, resources, services, and how they will be organized and developed to serve the center's activities,
• Strategies for early- and mid-career faculty recruitment and retention (for example, new positions, co-funded hires, protected research time, competitive start-up packages, and clear pathways for career advancement),
• Vision for how the proposed activities will measurably and significantly enable the establishment of research capacity in the target area and position the organization to compete for and progress to the COBRE-E phase, and
• If the application proposes a partnership between two organizations lacking research capacity in the proposed broad area of research, the applicants should justify the need for the partnership and clearly describe how each will benefit from it.

B. Organization and Management Plan

The overall Organization and Management Plan for the Center should clearly convey a strategy that demonstrates an effective use of the available funding, the proposed configuration of the Center and its cores, and the approaches to develop biomedical research capacity. Describe:

• How each of the components will contribute to the Center's goals and synergize with each other, and
• How Research Cores (if applicable), fit with existing resources at the organization(s) without being duplicative.

C. Plan for an Internal Advisory Committee

An Internal Advisory Committee (IAC) composed of one senior institutional official (for instance, Dean, Vice-President for Research), two senior faculty members appointed by the senior organizational official, and two other institutional stakeholders (for example., facility or sponsored programs managers) must be assembled to advise the PD(s)/PI(s). 

Applicants should describe the IAC's planned composition, organization, and operation plans. The IAC is expected to meet frequently as the proposed plans are implemented. An IAC member may not hold any other position in the Center.

Responsibilities of the IAC include but are not limited to:

• Making recommendations to the PD(s)/PI(s) on the suitability of prospective early- and mid-career faculty hires, including the alignment of their research with the center's research focus and their potential for success in advancing the center's goals,
• Advising the PD(s)/PI(s) on strategies to facilitate the recruitment of investigators and the setup of their research programs,
• Assessing the Faculty Development Plan and recommending strategies to effectively support the professional development and research success of new faculty hires, and
• Providing guidance on the development of research infrastructure and its management.

D. Faculty Development Plan

A Faculty Development Plan is required and will be implemented by the Faculty Development Core to support the success of the early- and mid-career investigators hired into the center. Leadership and research management training should be integrated throughout center activities to foster career and professional advancement. Plans must address how new faculty will establish independent research programs and how, collectively, these investigators will enable scientific advances in a coherent, relevant, and broad area of biomedical research in alignment with organizational priorities. 

Applicants should describe the characteristics that will be sought in prospective faculty hires with an eye towards strengthening the scientific coverage of the center. As part of the career development efforts, each early- and mid-career investigator supported by the center must be assigned a mentor. The mentor should be an established investigator who can provide both scientific guidance and career development advice. If a suitable mentor is not available at the applicant organization (or partner institution, if applicable), an appropriate mentor from another organization, including those in non-IDeA states, may be enlisted. 

The Faculty Development Plan should describe:

• Structured activities that will equip early- and mid-career investigators with professional and leadership skills (for example., emotional intelligence, conflict resolution, laboratory and team management, balancing competing priorities, and financial management) necessary for effective research leadership,
• Strategies for promotion and retention of hired early- and mid-career investigators,
• Expectations for early- and mid-career investigators to achieve milestones in career progression, to engage with institutional resources, and to participate in professional development activities,
• Plans for the recruitment of mentors, including their qualifications to provide scientific and career development guidance, and their selection and assignment to Center investigators,
• Plans for training mentors to ensure the use of evidence-informed strategies that promote the development and success of early- and mid-career investigators,
• Assessment of mentor performance and development of strategies to remediate and/or remove mentors demonstrating unsatisfactory mentorship qualities and practices, and
• Plans to accommodate differences in career progression of early- and mid-career investigators who do not meet established milestones and resolve conflicts between mentors and investigators.

Letters of Support: A single letter of support from a senior institutional official (for example., President or Dean) must be included outlining the institution's strategic plan and how the proposed COBRE-D aligns with institutional priorities for developing biomedical research capacity and addressing documented gaps in infrastructure or expertise. The letter must also provide detailed evidence of existing institutional resources and commitment to the Center's future vision for growth and long-term sustainability, including plans to build capacity toward future competitiveness for COBRE-E support.

If the application proposes a partnership between two institutions, each must provide a letter of support that outlines each partner's respective role in administering the center including how they will collaborate and share resources. The letters should describe how institutional support will be synergized to maximize the success of the center and must address plans for each institution to transition independently to COBRE-E.

Applications that do not include the required Letter(s) of Support will be considered incomplete, and the application will be withdrawn prior to review. Do not include any additional Letters of Support. 

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:

A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

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 (Overall)

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

Administrative Core

When preparing your application, use Component Type 'Admin Core.' All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Follow standard instructions. 

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries. 

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Director' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch Common Form and NIH Biographical Sketch Supplement for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

The Administrative Core includes the faculty start-up and all administrative funds. The budget of the Administrative Core is limited to $1,300,000 in direct costs per year during years 2-5. 

A minimum level of effort (LOE) of three person-months is required of each PD/PI to devote to administrative oversight of the center and provide career guidance to investigators. A maximum of two PDs/PIs are allowed in an MPI application. A PD/PI may not use COBRE funds to supplement research activities for their laboratory or research team and is not eligible for research support from this COBRE or any other COBRE, INBRE, or IDeA-CTR award.

 Funds may be requested to:

• Pay mentors for up to one person-month of effort. Mentors from non-IDeA states can be compensated as consultants or via a fee-for-service arrangement
• Recruit faculty at the early- and mid-career stage within the center's area of research who will develop and broaden the proposed program. These funds may be used for salary, supplies, and/or equipment costs
• Support limited alterations and renovations or for equipment purchases to update research spaces associated with the work of the center. Requests must be justified, may not support phased or cumulative construction projects, and are limited to a maximum of $300,000 during years 2 and/or 3 of the award,
• Support for administrative management costs. This amount is limited to $200,000 in each of the years 2-5. Administrative management costs may be higher in the early years of the program and lower in the later stages.

Funds cannot be used by collaborators or for collaboration at organizations in non-IDeA states or at foreign sites. Funds may be used at other U.S. organizations for fee-for-service activities, such as learning new techniques, carrying out sample and data analysis, attending workshops, or obtaining scientific advising/consulting/mentoring (as described above).

The PD(s)/PI(s) of the center and faculty supported by the COBRE must attend the National IDeA Symposium of Biomedical Research Excellence (NISBRE) biennial meeting.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply. (STANDARD TEXT)

PHS 398 Research Plan (Administrative Core)

Research Strategy: The Administrative Core implements the Center's plan, manages operations, and fulfills the COBRE award requirements. Include a description of:

• The necessary administrative, fiscal, scientific, and reporting aspects of the center,
• Plans to attract, recruit, and retain early- and mid-career faculty hires within the center's area of research, including strategies to ensure a timely hiring of candidates and the related faculty search approaches (for example., search committees, collaborations across departments and organizations),
• An annual evaluation plan with clear timelines and milestones to monitor and evaluate the performance of all components of the center, the mentors, the hiring of faculty and their career and scientific progress.
• Strategies to identify and remedy lack of career and scientific progress by faculty hires,
• Procedures to implement IAC recommendations, as needed,
• Plans for proposed alterations and renovations or equipment, if applicable,
• Strategies to enhance the institution's research administration services,
• Plans to sustain organizational commitment, policies, and practices that support a developing biomedical research environment and position the organization(s) to compete for COBRE-E awards.

Letters of Support: Not allowed.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

Not applicable to this component.

Research Core

Research Core(s) should be made available to other investigators at the organization(s) as well as those from other IDeA state institutions. Core(s) that duplicate services already available at the applicant organization are not allowed. Utilization, modification, or expansion of existing resources supported by institutional funds, other IDeA programs, or federal funds to accomplish the goals of proposed COBRE research is strongly encouraged.

When preparing your application, use Component Type 'Core'. All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Core)

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Core)

Follow standard instructions. 

Research & Related Other Project Information (Research Core)

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Core)

Research Cores must be located at the primary performance site, or as applicable, at performance sites at a partner organization. 
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachments for additional entries.
 Research & Related Senior/Key Person Profile (Research Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Director' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons who are working in the component.
• Include a single Biographical Sketch Common Form and NIH Biographical Sketch Supplement for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

The Director of a Research Core facility must be an experienced full-time staff member at the performance site with the requisite knowledge, authority, leadership, and administrative skills to direct the core. The Core Director will lead a team that:

• Develops or improves standard operating procedures for the utilization and management of core expertise and resources,
• Establishes plans for disseminating information, training, and serving as subject-matter experts to investigators,
• Maintains state-of-the-art technologies and capabilities, and
• Recommends to the COBRE PD(s)/PI(s) any equipment upgrades and/or replacement.

Budget (Research Core)

Budget forms appropriate for the specific component will be included in the application package. Funds may be requested to establish Research Core facilities and/or to use, modify, or expand existing resources needed to accomplish the scientific goals of the Center. In addition to personnel and supplies, acquisition of new equipment and modernization of instrumentation may be proposed. Alteration and Renovation (A&R) of core facilities is not allowed under this component. Core facilities should include a detailed budget for the entire proposed project period (five years).

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
 

PHS 398 Research Plan (Research Core)

Research Strategy: Describe and justify:

• How the core's resources will support the scientific breadth of the center and complement research resources already available at the applicant organization,
• The technology, instrumentation, and/or services the core will provide,
• Instruments, equipment to be acquired, and any modifications to existing core facilities, in the context of the organization's current infrastructure and relevant services,
• The core's anticipated user base and how its services will enhance research capacity, address the needs of early- and mid-career investigators, and be developed into a shared resource for the center, and
• The business plan for core operations including prioritization of service requests, user fee structure, and maintenance costs.

Letters of Support: Not allowed.

PHS Human Subjects and Clinical Trials Information (Research Core)

Not applicable to this component.

Faculty Development Core

When preparing your application, use Component Type 'Faculty Core.' All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Faculty Development Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project
• Proposed Project Start/Ending Dates 

PHS 398 Cover Page Supplement (Faculty Development Core)

Follow standard instructions. 

Research & Related Other Project Information (Faculty Development Core)

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions. 

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question. Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components. 
 

Project /Performance Site Location(s) (Faculty Development Core)

List all performance sites that apply to the specific component. 
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries. 
 

Research & Related Senior/Key Person Profile (Faculty Development Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Director' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons who are working in the component.
• Include a single Biographical Sketch Common Form and NIH Biographical Sketch Supplement for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Faculty Development Core)

Budget forms appropriate for the specific component will be included in the application package.

Funds should be requested to develop and support center-wide career, scientific, and professional development activities in alignment with the Faculty Development Plan. These may include seminar series, workshops, training programs, grant writing courses, and retreats, as well as access to consultants and training resources for COBRE-supported investigators. Faculty development costs may be higher in the early years of the program and lower in the later stages for managing the efforts, such as salaries for Faculty Development Core key personnel, travel for key personnel, and supplies to support faculty development.
 

PHS 398 Research Plan (Faculty Development Core)

Research Strategy: The Faculty Development Core manages activities involving the development of faculty hires and center investigators and ensures their continued scientific and career advancement through implementation of the Faculty Development Plan. Applicant organizations should outline strategies for creating individual research development plans, career development approaches, and professional development activities for early- and mid-career faculty hires. The plans should aim to support career progression and foster a culture of excellence to retain faculty. 

This section should include a description of:

• Strategies for the implementation of the Faculty Development Plan,
• Coaching on funding programs for faculty hires, expectations for competitive grant applications (for example, independent NIH R-type or equivalent), and how mentors will be assigned and tailored to individual faculty needs,
• Opportunities for networking among peers, senior faculty, institutional leaders, and the broader scientific community, and
• Potential impact of faculty hires on expanding research capacity at the applicant organization, and as applicable, partner organization.

Letters of Support: Not allowed.

PHS Human Subjects and Clinical Trials Information (Faculty Development Core)

Not applicable to this component. 

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) using ASSIST or other electronic submission systems. 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 How to Apply- Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

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

See more tips for avoiding common errors.

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

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 4.1.36.

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

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 review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Is the proposed area of the center sufficiently broad and cohesive to enable the development of biomedical research capacity at the applicant organization? Is the proposed strategic research area clearly justified as an institutional infrastructure gap and sufficiently broad to support a cohesive program that will build sustainable biomedical research capacity at the applicant organization? Will the plan effectively catalyze the recruitment and retention of early- and mid-career investigators in the proposed area of the center, develop essential research facilities, and strengthen research administration? Will the proposed activities measurably and significantly enable the establishment of research capacity in the targeted area and position the applicant organization to compete and progress to the COBRE-E Phase?

Investigator(s)

Does the PD(s)/PI(s) have the appropriate scientific and administrative expertise to lead the center and establish, develop, and enhance research capacity at the institution in the proposed biomedical scientific area? Does the PD(s)/PI(s) demonstrate a commitment to mentoring that enables early- and mid-career investigators to achieve independence while fostering an environment that supports faculty retention and success? Does the PD(s)/PI(s) have a record of sustained leadership of a productive and independently funded research group in the scientific area of the center? If the center is multi-PD/PI, do the investigators have complementary and integrated expertise and are their leadership approach, governance and organizational structure appropriate for the center?

Innovation

Does the center's scientific focus and capacity-building model position the applicant organization for future growth and competitive advances in the field? Do the plans creatively leverage and integrate existing resources and investigators across the applicant organization and partner institutions without duplicating capabilities? To what extent do the plans position the institution and its investigators to conduct innovative research across the center's broad scientific area?

Approach

Does the Organization and Management Plan clearly define roles, decision-making processes, and oversight, and is it feasible for achieving the center's goals? Does the IAC plan describe an appropriate composition and suitable collective scientific and administrative expertise to assess progress? Does the plan address the IAC's role in advising the PD(s)/PI(s) on research and career development, including evaluating prospective faculty hires, and their research, and is its role and engagement plan clearly described? Does the Faculty Development Plan include clear strategies to prepare, train, and guide faculty hires? How well-designed is the Faculty Development Plan to support early- and mid-career investigators and advance the center's capacity building goals? Does the Overall Plan set clear, realistic capacity-building milestones during the award and substantiate plans and institutional commitments for transition to COBRE-E and long-term sustainability? If the application proposes a partnership between two institutions, will the proposed plans provide meaningful benefits to each institution equally and enable both to implement a vision to establish biomedical research capacity at each organization?

Environment

To what extent is the institutional support, equipment, and other physical resources available to the investigators adequate for the proposed center? How well is the vision for the proposed center aligned with the institution's strategic priorities? Does the application indicate how the center will leverage existing infrastructure and/or develop new and collaborative resources via existing IDeA and non-IDeA funding mechanisms? Are the institutional commitments sufficient to ensure the availability of resources and facilities needed to develop and grow the center?

Additional Review Criteria - Overall

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.

Inclusion of Human Subjects Policies

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research. 

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions (as applicable), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals (as applicable), the committee will consider the progress made in the last funding period.

Revisions

For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Review Criteria for Cores

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Core to exert a sustained impact on the research field(s) involved, in consideration of the following review criteria and additional review criteria.

Administrative Core

Is there a plan to manage and coordinate the center components, the Internal Advisory Committee, and mentors to achieve the center's goals? Are recruitment strategies for new early- and mid-career faculty consistent with the goals of developing biomedical research capacity at the center? Are the plans for the enhancement of research administration services in line with the need to strengthen the organization's management of grant applications? Is there a clear plan to carry out COBRE award responsibilities, including timely and accurate progress reporting, ensuring all center activities comply with federal regulations, and managing the center's budget and financial reporting? Are appropriate strategies described for conducting annual evaluations of the center? Are there suitable plans for implementing recommendations of the IAC?

Research Cores

Does the core director have the scientific and administrative expertise to oversee the operation, maintenance, and expansion of core resources and laboratory facilities to achieve the center's scientific objectives? Are the proposed enhancements to any existing services well-justified and supported by appropriate scientific expertise to meet the needs of the center's scientific focus and new faculty hires? Are collaborations with IDeA programs (INBRE, CTR, other COBREs) clearly defined and feasible, advancing technology and administrative efficiency while avoiding duplication of existing institutional facilities or services? Does the business plan include realistic projections for user growth and a feasible plan for expanding services as a shared resource and sustain the core to support federal and non-federal funded research over the long term? 

Faculty Development Core

Is there a well-conceived and feasible plan to support the scientific and career advancement of center investigators hired under this award through mentoring and guidance, career progression strategies, and tailored professional development? Are there effective tools and approaches within the core to ensure the career development and success of hired faculty? Does the core foster a culture of excellence and promote faculty retention?
 

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by CSR, 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. 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:

• The scientific merit of the proposed plans as determined by peer review.
• Availability of funds
• Portfolio balance
• Geographical and institutional distribution
• Relevance of the proposed project to NIH and NIGMS programmatic priorities, including:
  • Scientific breadth of the center and its relationship to institutional strategic goals.
  • Institutional need for biomedical research capacity growth in the proposed area of research, and
  • Need for continued development of investigators in the center's scientific area.

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 their 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 organizations 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.

Post-Award Program Requirements

Administrative Core

PD(s)/PI(s) of COBRE Centers, Research Core Director(s), Faculty Development Core Director(s)  and early and mid-career investigators hired under this NOFO must attend the National IDeA Symposium of Biomedical Research Excellence (NISBRE) biennial meeting. 

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.

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.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy." 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on  MAT/MOUD.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

In administering programs under this and all funding announcements, NIH prioritizes: 

• Research involving rigorous scientific methods, including for studies related to children and adolescents, where NIH is committed to approaches that reflect the highest standards of clinical care and child safety. 
• Biological and physiological integrity: Recognizing the relevance of biological sex to health outcomes, NIH encourages applicants to account for sex-based health factors in program design, data collection, and service delivery where scientifically appropriate.
• NIH will implement these priorities consistent with applicable laws, regulations, court orders, and all required administrative procedures. Applicants are encouraged to describe how their proposed programs align with these priorities in their project narratives. Funded activities must advance NIH's vision of protecting and improving the health and well-being of Americans. The particular focus is on those who are medically vulnerable, or live in areas with limited access to care. NIH's duty is to serve wisely, effectively, and with measurable results that justify every taxpayer dollar invested. 

Not Applicable

3. Data Management and Sharing

A Data Management and Sharing Plan is not applicable for applications to this NOFO.

• 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.

5. Evaluation

In carrying out the stewardship of grant programs, NIGMS will periodically evaluate the COBRE program employing the representative measures identified below. In assessing the effectiveness of research capacity building investments, NIGMS may use information from progress reports and public databases, PDs/PIs, and from participants themselves. Where necessary, PDs/PIs and participants may be appropriately contacted after the completion of the grant period for updates on participants subsequent outcomes, as appropriate. The overall evaluation of the program will be based on metrics that may include, but are not limited to, the following:

• Indicators of institutional and investigator capacity building, such as
  • Recruitment, development, and retention of faculty
  • Improved access to scientific research infrastructure
  • Subsequent submission of peer-reviewed grant proposals
  • Subsequent external funding obtained by participants in the program
• Characteristics of the applicant and awardee pool for the program, such as:
  • Geographic distribution
  • Institution types       
  • Scientific areas of focus
• Indicators of scientific productivity and impact among grant recipients, such as:
  • Peer-reviewed research publications and citations
  • Conference presentations

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.

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.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

NIGMS COBRE D
National Institute of General Medical Sciences (NIGMS)
Email: NIGMS_COBRE_D@mail.nih.gov

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

NIGMS RCB GAB NOFO
National Institute of General Medical Sciences (NIGMS)
Email: NIGMSRCBGABNOFO@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.