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 SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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.
   
   



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

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 the 23 U.S. states and Puerto Rico that 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.

A key IDeA program component is the Centers of Biomedical Research Excellence (COBRE) awards that support research capacity building at IDeA-eligible organizations through the establishment and development of innovative biomedical research centers of excellence for up to three sequential five-year phases. A Phase 1 award aims to enhance an organization's capacity in one area of biomedical research by developing a critical mass of investigators who can compete effectively for independent funding in the scientific area supported by the Center and improving research infrastructure.  A COBRE Phase 2 award is intended to strengthen successful Phase 1 Centers through continued development of investigators and further improvements to research infrastructure. This Notice of Funding Opportunity (NOFO) supports COBRE Phase 3 awards.

COBRE Phase 3 Program Description and Requirements

Overall Plan (required): A COBRE Phase 3 award will provide continued support to solidify successfully established research programs and infrastructure built in prior COBRE phases and to implement strategies to sustain the organization's research excellence in the Center’s scientific area beyond COBRE funding.  To submit a Phase 3 application in response to this NOFO, the applicant organization institution must have an active COBRE Phase 2 award on the submission due date.  All proposed components must be integral to the goals of the Center and are expected to interact with each other and with relevant existing programs at the institution to foster a collaborative research environment.  An established investigator with scientific expertise in the research area of the Center, as well as mentoring and administrative experience, is expected to lead the Center as the Program Director/Principal Investigator (PD/PI) of the award. An Advisory Committee (AC) comprised of institutional leadership and external experts in the research area is required to provide advice on scientific administrative matters critical to the success of the Center.

Administrative Core (required): The Administrative Core, to be led by the PD/PI, or the contact PD/PI of a multiple PD/PI application, implements the Center's overall plan and manages the Center’s operation. It administers a required Pilot Projects Program (PPP) to solidify and expand the Center’s strength in its research area. The PPP is expected to build on the Center’s scientific strengths and encourage the exploration of new ideas, concepts, and approaches. Although independent investigators of all ranks are eligible to lead Pilot Projects, priority should be given to those who qualify as NIH Early Stage Investigators (ESIs) or New Investigators (NIs). Note that Pilot Projects should not be described in the COBRE Phase 3 application and will require post-award approval by NIGMS prior to initiation.

The Administrative Core may also assist the PD/PI in recruiting faculty researcher(s) to solidify and/or extend the research expertise of the Center’s current cadre of researchers, especially if one or more of the Research Project Leaders developed through the prior phases of the COBRE awards have left the organization.

Other responsibilities of the Administrative Core include:

• implementing the Center’s plans to sustain research excellence beyond COBRE funding
• preparing accurate and timely progress reports
• ensuring all Center activities are compliant with federal regulations
• managing the Center’s budget and financial reporting
• organizing Center-wide scientific and career development activities such as seminar series, workshops, and retreats
• conducting annual performance evaluations of the Center
• coordinating the activities of the Advisory Committee.

Research Core(s) (optional): A Phase 3 Center may support enhancements to a Research Core established in Phase 1 or 2. Consolidation of existing Cores, including those supported by the Phase 2 COBRE award and other IDeA programs (e.g., INBRE, IDeA-CTR, and other COBREs) for technology advancement and/or administrative efficiency is encouraged. New Research Core(s) may be proposed if they are essential to support anticipated research needs. Requests for continued support of existing Research Core(s) should be justified by the current and anticipated user base and research usage. 

Plan for Enhancing Diverse Perspectives (PEDP) (required): NIGMS recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, NIGMS encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:

• Transdisciplinary research projects and collaborations
• Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based)
• Individual applications and partnerships that enhance geographic and regional heterogeneity
• Investigators and teams composed of researchers at different career stages
• Participation of individuals from diverse backgrounds, including groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women
• Project-based opportunities to enhance the research environment to benefit early- and mid-career investigators.

This NOFO requires a PEDP as part of the application (see Section IV.2 SF424(R&R) Other Project Information. Other Attachments). For further information on the PEDP, please see https://braininitiative.nih.gov/vision/plan-enhancing-diverse-perspectives/pedp-key-elements-and-examples?search-term=pedp. The examples listed above may be followed should they be appropriate for the goals, structures, and requirements specific to the COBRE program.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Only recipient organizations with COBRE Phase 2 Center awards that are active, including those in a no-cost extension, on the application due date are eligible to apply.

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

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

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

Applicant organizations

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

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

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

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

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

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

The PD(s)/PI(s) is expected to be an established biomedical research scientist in or closely related to the Center’s research area who also has the mentoring and administrative experience necessary to direct the COBRE, The PD(s)/PI(s) may be the PD(s)/PI(s) of the COBRE Phase 2 award or be a replacement PD(s)/PI(s) appointed by the institution. 

Multiple PD/PI (mPD/PI) applications are allowed, although the total number of mPDs/PIs is limited to two. Both PDs/PIs should have qualifications required for the PD/PI of a single PD/PI applications.  At the time of submission, the contact PD/PI’s primary appointment must be at the applicant organization.

A PD/PI may not simultaneously lead more than one IDeA (INBRE, IDeA-CTR, or other COBRE) program award. Previous COBRE PD(s)/PI(s) of different Centers, except those who served in that capacity on an interim basis, are not eligible to lead a COBRE Phase 3 application. All investigators who intend to apply as PD(s)/PI(s) are encouraged to consult with the Scientific/Research Contact listed in Section VII prior to preparing an application.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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

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

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 SF424 (R&R) Application Guide, except where instructed in this notice of funding opportunity to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

All page limitations described in the SF424 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 the SF424 (R&R) 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 SF424 (R&R) 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)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Other Attachments: The application must include the following attachment.

Plan for Enhancing Diverse Perspectives (PEDP) (1-page maximum): All applications must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based)
• Description of any planned partnerships that may enhance geographic and regional diversity
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce
• Proposed monitoring activities to identify and measure PEDP progress benchmarks
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s)
• Publication plan that enumerates planned manuscripts and proposed lead authorship
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds

The examples listed above may be followed should they be appropriate for the goals, structures, and requirements specific to the COBRE program.  For further information on the PEDP, please see https://braininitiative.nih.gov/vision/plan-enhancing-diverse-perspectives/pedp-key-elements-and-examples?search-term=pedp.

This attachment should be titled “Plan for Enhancing Diverse Perspectives.”

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 mentoring and administrative experience in the Personal Statement of the Biographical sketch. The Biographical sketch should provide evidence of the PD/PI’s leadership experience in the Center’s research area, mentoring, and administration, including that in directing and managing the previous phases of COBRE awards, if applicable.

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)

Specific Aims: Provide Specific Aims for the Center.

Research Strategy: This section must include the following elements:

A. Program Accomplishments

The purpose of this NOFO is to allow recipient organizations holding successful COBRE Phase 2 grants to compete for continuation of support to advance the Center to Phase 3. To justify another five years of support, applicants must provide evidence that prior COBRE support has enabled the Center to achieve specific benchmarks in the following areas (use tabular format where appropriate):

• Investigators and funding:
  • List of RPLs supported by the Phase 1 and 2 awards and career advancements they achieved resulting from COBRE support
  • List of RPLs supported by the Phase 1 and 2 awards who have successfully completed their projects, including updates of their current funding and employment status
  • Number of research grants by RPLs submitted to, and awarded by, NIH or other agencies or foundations
  • List of investigators recruited to the organization in the Center’s research area during the Phase 1 and 2 awards
  • If a Pilot Projects Program has previously been in place, provide a list of PPLs supported, their current employment status, and any grants submitted or awarded that are attributable to the pilot support.
• Research productivity:
  • Number of scientific publications in peer-reviewed journals from Research Projects and Pilot Projects carried out with the support of COBRE
  • Patents filed and intellectual property generated.
• Development and use of research infrastructure:
  • Core facilities established or supported
  • Equipment procured
  • Description of current user base of core facilities, including users not directly supported by the COBRE award
  • Training provided to users.
• State of the Center
  • Describe the current state of the Center including the number of investigators at the organization in the Center’s research area and resources available to support their research
  • Summarize the overall impact of the Center over the past 10 years of funding in advancing the organization's research priorities.

B. Organization and Management Plan

The Organization and Management Plan for the Center should clearly convey a strategy for a successful Phase 3 COBRE that builds upon the previous phases. This should include effective use of available funding, configuration of the Center and its cores, and approaches for selecting pilot projects and supporting investigators. The plan should clearly describe why a third phase of support is needed and how it will allow the applicant organization to sustain the research capacity developed in the first two phases. Important elements to include are:

• The goals of the Phase 3 Center and how they support the organization's strategic objectives
• The Center and the organization's strategies to be implemented during the Phase 3 award to retain the research capacity and sustain research excellence beyond COBRE funding
• A description of the Center’s components and how they will interact with one another and contribute to the Center’s goals
• A description of how the Pilot Projects Program will build on the institutional research capacity in the research area of the Center established in prior phases
• A description of how the Research Cores complement and interface with existing resources at the organization without being duplicative; include equipment, instrumentation, and cores supported by current or prior IDeA (COBRE, INBRE, or IDeA-CTR) awards. If core enhancements or core consolidation are proposed, describe how the changes will contribute to the Center’s goals
• If the Center focuses on rural health and/or community-engaged research, detailed plans that outline stakeholder input, community outreach, and evaluation strategies for outcomes must be provided. 

C. Plan for an Advisory Committee

An Advisory Committee (AC) composed of three external, nationally recognized scientists with expertise directly relevant to the research area of the Center, one senior institutional official (e.g., Dean, Vice-President for Research), and one senior faculty member appointed by the senior institutional official must be assembled to advise the PD(s)/PI(s). AC members who previously served as external advisors on this COBRE may be appointed as Phase 3 AC members. An AC member may not serve as a core director or hold any other position in the Center.

Responsibilities of the AC include but are not limited to reviewing the annual Center evaluation provided by its Administrative Core and making recommendations to the PD(s)/PI(s) to improve the Center's performance.

The AC also assesses proposals for Pilot Projects when the need arises. The PD(s)/PI(s) must include the AC’s recommendations when requesting NIGMS’s approval to appoint new PPLs. The AC should meet at least twice per year.

Plans for the AC should detail:

• Name, position, scientific expertise, and qualifications of external AC members who are continuing their Phase 2 advisory roles. For new external AC members, only provide a description of the qualities and scientific expertise desired without naming specific individuals or contacting them prior to receiving the Notice of Award (NoA) for the application
• The names and positions of the senior official and senior faculty member from the applicant organization
• A description of how the AC will function
• Additional responsibilities, if any, that are proposed for the AC.

Letters of Support: A letter of support from a senior institutional official (e.g., President or Dean) must be included, outlining the institution’s strategic priorities in research and how the COBRE aligns with the institution’s strategic priorities. The letter must also provide: 

• A description of the size of the biomedical research faculty at the institution and the total external biomedical research and infrastructure grant support of the institution
• A description of the resources committed to sustaining the COBRE goals, including support for hiring new faculty members, retaining faculty, and maintaining infrastructure developed by the Center
• A description of the organization's commitment of resources to sustain the CORBE-related research and infrastructure beyond the period of COBRE support.  

If the application proposes subcontracts to another organization for Research Cores, a letter of support with similar content from a senior official of the participating organization must be provided.

Applications that do not include this Letter of Institutional Support will be considered incomplete, and the application will be withdrawn without review.

Additional letters demonstrating state-level and regional support for the Center may be included in this section only if they address a substantive and specific need.

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

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component. 

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

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Note: Any budget information for Data Management and Sharing Costs should be included in the Administrative Core Component, not the Overall Component.

Appendix:

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

PHS 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 SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, 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 SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form (Overall)

All instructions in the SF424 (R&R) 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)

Enter Human Embryonic Stem Cells in each relevant component.

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 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.

A maximum of 2.4 person-months effort maybe requested for the PD/PI.  For mPI applications, no more than 2 PDs/PIs are allowed and the  support for PDs/PIs remains at 2.4 person-months effort collectively.   A minimum level of effort of 1.2 person-months is required for each PD/PI. A PD/PI may not use COBRE funds to supplement research activities for their laboratory or research team and is not eligible for research project support from this COBRE or any other COBRE, INBRE, or IDeA-CTR award.  Each external expert serving on the Advisory Committee may be compensated for up to 1-person month of effort and should be listed in the Administrative Core's budget section of the application.  External expert from non-IDeA states can be compensated as a consultant or via a fee-for-service arrangement.

PEDP implementation costs: Budget request may include allowable costs associated with PEDP implementation, as outlined in the Grants Policy Statement.

Funds to compensate external members of the AC as consultants via a fee-for-service arrangement should be requested in the Administrative Core budget. Internal AC members may not receive compensation from the COBRE.

Direct costs of up to $400,000 annually may be requested to support the required Pilot Projects Program. Each individual Pilot Project may have a duration of up to one year with a maximum budget of $100,000 in direct costs. An investigator may receive support for no more than two one-year Pilot Projects during Phase 3. The budget should only include a placeholder for the Pilot Projects Program as prior approval is required before a Pilot Project can begin; see Section VI. Post-Award Program Requirements. The PDs/PIs of the COBRE are not eligible for Pilot Project funding.

Funds may be used to assist the organization's recruitment of additional faculty working in the Center’s research area. These funds are limited to $250,000 in annual direct costs and may be used to recruit investigators at any career stage in the Center's research area. These funds may be used for salary, supplies, and/or equipment costs.

Funds may be used to develop or enhance appropriate community-engaged research, including efforts to develop a coalition of community and academic stakeholders who can provide input on evaluation strategies and dissemination of the results.

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

Funds may be used for the PD(s)/PI(s) of the Centers to 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.

PHS 398 Research Plan (Administrative Core)

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: The important elements for this section include the following:

• A clear description of the necessary administrative, fiscal, and scientific aspects of the Phase 3 Center
• A description of the research and career development goals and capabilities of the Center, including plans to offer Center-wide scientific and career development activities such as seminar series, workshops, and retreats
• A description of activities and implementation plans that will sustain research excellence in the Center’s research area after COBRE funding has ended
• An evaluation plan with clear timelines and milestones to annually monitor and evaluate the performance of all components of the Center and the accomplishments of the PPLs it supports. Strategies to identify and remedy deficiencies such as poor performance and lack of progress should be described and procedures to implement the AC's recommendations should be included.
• A plan for a Pilot Projects Program (PPP) should include:. 
  • An outline of the objectives 
  • A description of the administrative structure during Phase 3
  • A description of the process for proposal solicitation, review, selection, and the anticipated numbers of applications and awards per year
  • Research and career  development activities for PPLs
  • Significant changes from the PPP of the Phase 2 award, if applicable

Research plans for individual Pilot Projects should not be included in the application.

• If funds will be used to help recruit additional faculty, include a recruitment plan that addresses the following:
  • A description of the desired research expertise for the recruitment and how it complements the expertise of the Center’s current investigators
  • A description of recruitment strategies including plans to enhance diversity in the pool of candidates and a timeline.

Letters of Support: Not allowed. Institutional Letters of Support, including support for the Administrative Core, should be included in the Overall Component.

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

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

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 SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

Do not complete. Human subjects research is not allowed in the Administrative Core.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Research Core

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)

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 (Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

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)

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 (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 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.

Director(s) of a Research Core facility must be experienced personnel with the requisite stature, knowledge, authority, leadership, administrative skills and capabilities to direct the resource. The Core Director will lead a team that provides services to: (1) develop or improve plans for standard operating procedures governing the utilization and management of core expertise and resources; (2) develop or improve plans for disseminating information, training, and serving as subject-matter experts to investigators; (3) maintain state-of-the-art technologies and knowledge capabilities; and (4) recommend to the COBRE PD(s)/PI(s) any updates and/or replacement of equipment.

Budget (Research Core)

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

Funds may be requested to enhance, expand, and consolidate existing cores, or to establish a new research core required for accomplishing the scientific goals of the Phase 3 award. In addition to personnel and supply costs, the acquisition of new equipment and modernization of instrumentation may be proposed. Alteration and Renovation (A&R) of core facilities cannot be proposed, nor can funds be used to support A&R.

Core facilities should have 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)

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: The important elements to include in this section are:

• A description of the technology, instrumentation, and/or services the Core will provide. If the Core requests instruments and/or equipment or involves modification and/or expansion of an existing core facility, include a description of the organization's  current infrastructure and services offered, and justify the proposed changes
• A description of how the Core will benefit investigators and enhance research infrastructure at the organization
• A description of the Core's current and anticipated user base, successful or planned strategies for increasing the numbers of users, and any plans to continue expansion of the Core
• A description of the business plan for operation of the Core, including prioritization of service requests, user fee structure, and maintenance costs
• A description of the plan, with revenue models, for supporting and sustaining the Core and its services after COBRE funding has ended
• A description of the plan to consolidate the Core with another existing Research Core at the organization during Phase 3 or after COBRE funding has ended, as applicable
• A description and justification for a proposed new Core, including why it is essential to the Center’s investigators, how it will improve the research infrastructure of the organization, and a description of other related research resources that are already available at the organization.

A Research Core should be made available to other investigators at the organization as well as those from other IDeA-state organizations. Cores that duplicate services already available at the applicant organization are not allowed. Utilization, modification, or expansion of existing Core resources supported by institutional funds or other IDeA programs to accomplish the goals of proposed COBRE research is strongly encouraged. It is expected that the Core will become self-sustaining by the end of Phase 3.

Letters of Support: A letter from an institutional leader demonstrating commitment to support and maintain the proposed facilities can be included but should not duplicate letters included elsewhere in the application. Letters from leaders of any established Cores that will be leveraged for the COBRE research should also be included.

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

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Research Core)

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 SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record. If a human subjects protocol(s) is used in a single Project or Core of the Center, the study record(s) must be included in the component where the human subjects research is being performed. 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 SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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 Policy on Late Application Submission.

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

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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 the SF424 (R&R) Application Guide.

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 or non-compliant will not be reviewed.

Post Submission Materials

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

In addition to the materials listed in the Post Submission policy, updates on funding obtained (not applications submitted) by RPLs or PPLs who participated in Phase 2 of the COBRE Center will also be accepted.

Section V. Application Review Information

1. Criteria

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center that by its nature is not innovative may be essential to advance a field.

Significance

Are the goals of the Center aligned with the organization's strategic priorities in developing research capacity? How well do the center's past performance and the plans proposed justify the continuation of the Center for another phase?  Do the plans for Phase 3 significantly increase the likelihood that the research capacity built in Phases 1 and 2 will be sustained after COBRE support ends?

To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the Center?

Program Accomplishments: Has the Center established a cadre of investigators working in the Center's research area? Has the organization invested in the recruitment of investigators working in the research area of the Center?  Has the Center achieved specific benchmarks proposed for previous phases, which for RPLs include career progression, attainment of independent research funding, and publishing their results in peer-reviewed journals? Is there evidence that the competitiveness of these investigators for NIH or other external peer-reviewed research grant support has been enhanced through COBRE support?

Investigator(s)

Does the PD(s)/PI(s) have the appropriate experience to lead, develop, and direct the Center to continue enhancing research capacity at the organization in the appropriate biomedical research area and to allow the research capacity the center has developed to be sustained beyond COBRE support? Has the PD(s)/PI(s) shown effective leadership in directing and managing the previous phases, if applicable? Has the PD(s)/PI(s) provided evidence of successfully mentoring and guiding early career investigators? Does the PD(s)/PI(s) have a record of leading a productive and externally-funded research group in the research area of the Center?

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the Center?

Innovation

Are innovative approaches for sustaining the research capacity developed by the center beyond COBRE support proposed? To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

Approach

How does the overall plan for the Center support the need for continuation of funding into Phase 3? 

Does the Organizational and Management Plan provide confidence?

Are plans for the recruitment of new investigators consistent with the goals of strengthening biomedical research capacity in the research area of the Center? 

Is the proposed composition and role of the Advisory Committee (AC) appropriate for assessing the research, career development and capacity building progress of the Center , including the assessment of new Pilot Projects? 

Does the application propose adequate strategies to sustain research excellence at the organization in the Center’s scientific area beyond COBRE funding?

Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

Environment

How will the scientific environment in which the work will be done contribute to the probability of success? Is the institutional support, including equipment and other physical resources provided to the investigators, adequate for the proposed Center? Does the application demonstrate sufficient organizational commitment to support the goal of strengthening the biomedical research capacity in the research area of the Center, including commitments to maintain a critical mass of faculty investigators in the research area of the Center and to sustain the research infrastructure? , 

How has prior COBRE support improved facilities or made available new and collaborative resources (e.g., laboratory facilities, patient populations, laboratory space and personnel)? How will the organizational environment influence the likelihood that the resources developed by the center can be sustained after COBRE support ends?

To what extent will features of the environment described in the PEDP (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

Additional Review Criteria - Overall and Core Components

As applicable for the overall application and cores 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.

Administrative Core

How strong is the plan to manage and coordinate the Cores, Pilot Projects, and Advisory Committee to achieve the Center's goals?

How strong is the plan to carry out the responsibilities required of the COBRE award including, administrative, fiscal, and scientific aspects of the Phase 3 Center, as well as  organizing Center-wide scientific and career development activities?

Are appropriate strategies described for conducting annual evaluations of the Center? Are there suitable plans for implementing recommendations of the AC?

How well designed are the plans for the Pilot Projects Program to meet the goals of the center, including selecting suitable Pilot Project Leaders and promoting their scientific and career success? ? Are suitable processes proposed to evaluate the progress and success of the Pilot Project leaders? If a Pilot Projects Program was in place prior to Phase 3, how successful were the previous Pilot Project Leaders at generating useful data, publishing their results and securing peer-reviewed independent funding?

Research Cores

Is the request to support the Research Core(s) well justified? Does the Core Director have the expertise to provide the necessary oversight to administer the maintenance and growth of existing core resources and laboratory facilities to carry out the scientific objectives outlined in the application? Is there sufficient organizational commitment to ensure that the resources required to sustain and enhance the Core will be available? How strong are the plans for the Research Core to become self-sustaining after COBRE support ends? How strong are plans to develop a larger user base and for generating new sources of support for the resource?

Protections for Human Subjects

Not Applicable

Inclusion of Women, Minorities, and Individuals Across the Lifespan

Not Applicable

Vertebrate Animals

Not Applicable

Biohazards

Not Applicable

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall and Core Components

As applicable for the overall application and core(s) 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

Not Applicable

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:

Not Applicable

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIGMS, 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. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions consistent with applicable law: 

• Scientific and technical merit of the proposed Center as determined by scientific peer review
• Availability of funds
• Portfolio balance
• Geographical and institutional distribution
• Alignment of the proposed Center to COBRE program priorities, including:
  • Plans for inclusion of Early Stage Investigators as Pilot Project Leaders
  • Research area(s) of the Center and its relationship to organizational strategic priorities
  • Need for continued development of research capacity at the organization in the Center's scientific area
  • Need for continued development of investigators in the Center's scientific area
  • Plans for sustaining research excellence and infrastructure beyond COBRE funding

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all 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.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Post-Award Program Requirements

Administrative Core

PD(s)/PI(s) of Centers funded through this NOFO are expected to attend the National IDeA Symposium of Biomedical Research Excellence (NISBRE) biennial meeting.

Pilot Projects

Pilot Project(s) must be reviewed by the AC. Independent investigators of all ranks are eligible, but it is strongly encouraged that Early Stage and New Investigators be given priority for leading a Pilot Project. Individuals holding postdoctoral, trainee, or similar non-independent positions are not eligible to lead COBRE Pilot Projects.

The Center must provide assurance of full compliance with all applicable federal policies, rules, and guidelines for research involving human subjects, vertebrate animals, select agents, and/or biohazards.

Prior approval by NIGMS is required to add a new Pilot Project. See "Prior Approval of Pilot Projects" below for documents that must be submitted to NIGMS.

A PPL is required to devote at least one person-month of effort to the Pilot Project but is not named as key personnel in the COBRE award. PPL removal from the COBRE or changes to their level of effort that remain above the minimum commitment do not require prior approval but must be reported in annual Research Performance Progress Reports.

A COBRE PPL cannot receive simultaneous research support as a project lead from any other IDeA parent award (e.g., COBRE, INBRE, IDeA-CTR), but may be eligible to serve as a project lead of a supplement to an IDeA award.

Prior Approval of Pilot Projects

Prior approval from NIH is required before a Pilot Project can begin. The following documentation for each Pilot Project (PP) must be submitted to NIGMS staff for administrative review:

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

• Face Page (signed by institutional signing official)
• Project Summary (Page 2)
• Research Strategy Section 
• Biographical Sketch 
• Advisory Committee approval - communication from the AC Chair (at a minimum) indicating the AC concurs with supporting the project.

If the proposed pilot project involves human biospecimens or data, include:

• Current PHS Human Subjects and Clinical Trials Information Form.

If the proposed pilot project involves Human Subjects, include:

• Current PHS Human Subjects and Clinical Trials Information Form
• Institutional Review Board (IRB) approval
• Human Subjects Education Certification (required even when research is exempt).

If the proposed pilot project involves Clinical Trials, include:

• Current PHS Human Subjects and Clinical Trials Information Form
• Institutional Review Board (IRB) approval
• Documentation of Investigational New Drug (IND)/Investigational Device Exemption (IDE) status for studies that are subject to FDA regulation
• Human Subjects Education Certification and Good Clinical Practice (GCP) Training Certification
• For all Clinical Trials, in addition to the information requested in Section 3.3 of the PHS Human Subjects and Clinical Trials Information form, the recipient organization  must provide NIGMS with a statement detailing the risks to study participants, the frequency of monitoring of clinical trial data and participant safety, and the name(s) of the responsible party/parties for regulatory and legal compliance, adverse event reporting, and clinicaltrials.gov registration and results reporting.

Note: For Human Subjects or Clinical Trials, the grantee must enter study data in the Human Subjects System (HSS) before requesting NIGMS approval.

If the proposed project involves Vertebrate Animals, include:

• Verification of a valid Animal Welfare Assurance on file with OLAW
• Verification of the date of IACUC approval
• Vertebrate Animals Section.

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

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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

•  For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

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

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

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

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

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

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

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. Recipients will provide updates at least annually on implementation of the PEDP.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

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 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 and development of faculty 
  • Progression through program phases and sustainability 
  • 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 
  • Investigator demographics 
  • Institution types 
  • Scientific areas of focus 
• Indicators of scientific productivity and impact among grantees, such as: 
  • Peer-reviewed research publications and citations 
  • Conference presentations

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&nbsnbsp;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

Crina Frincu, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: crina.frincu@nih.gov 

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

Courtney Tardd-Wright
National Institute of General Medical Sciences (NIGMS)
Email: courtney.tardd-wright@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 45 CFR Part 75 and 2 CFR Part 200.