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

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

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



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. 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. 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 component is the Centers of Biomedical Research Excellence (COBRE) program that supports the establishment and development of innovative biomedical research centers of excellence at institutions through awards for three sequential five-year phases. This Funding Opportunity Announcement (FOA) supports COBRE Phase 1 awards, which aim to enhance an institution's capacity in one area of biomedical research by developing a critical mass of investigators who can compete effectively for independent funding, as well as to improve the research infrastructure. COBRE Phase 2 awards are intended to strengthen successful Centers through the continued development of investigators and further improvements in research infrastructure. Phase 3 awards provide resources to transition COBREs to self-sustaining research programs.

COBRE Phase 1 Program Description and Requirements

Overall Plan (required): A COBRE Phase 1 award supports the establishment of a multi-component center of excellence in an area of biomedical research that aligns with the applicant institution’s strategic priorities for growing its research capacity. The COBRE Phase 1 program aims to develop a critical mass of investigators who can compete effectively for independent, external research funding. To achieve this goal, the COBRE award supports a Center that provides research support and mentoring to faculty investigators and funding for their recruitment. Enhancements to the institution’s research infrastructure that facilitate the proposed research are also supported. The Center’s scientific goals must be aligned with the applicant institution’s strategic priorities and cover a sufficiently broad scientific area to warrant the institution’s sustained support. Applicant institutions should demonstrate their commitment to the COBRE program goals by investing in the recruitment and long-term support of the Center’s investigators and the infrastructure required to carry out the scientific research. 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 scientific area should provide advice and oversight on critical scientific activities and administrative decisions. Applications proposing to establish a Center in a scientific area closely related to one previously supported by a COBRE award to the institution or in an area for which the institution already has a critical mass of funded investigators are of low programmatic priority.

Required components of the Center include an Administrative Core and 3-5 Research Projects. Optional components include Research Cores and an Alteration and Renovation Project. All proposed components must be integral to attaining 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.

Administrative Core (required): The Administrative Core implements the Center's overall plan, coordinates the Cores, Projects, AC, and mentoring activities, and carries out all responsibilities required of the COBRE award. These include preparing accurate and timely program and financial reports, ensuring all Center activities are compliant with federal regulations, managing the Center's budget, organizing Center-wide scientific and career development activities such as seminar series, workshops, and retreats, and conducting annual performance evaluations of the Center. The Administrative Core may also support an optional Pilot Project Program, which is intended primarily for developing future Research Project Leaders (RPLs).

Research Projects (required): A minimum of three and a maximum of five Research Projects related to the Center’s research area must be proposed. Each Research Project should propose innovative science that has the potential to advance the field and jumpstart the research program of the Research Project Leader (RPL). RPLs must qualify either as NIH Early Stage Investigators (ESIs) or as New Investigators (NIs), and must hold faculty appointments (or equivalent at research institutes) and lead their own research programs (see Section III. Eligibility Information for additional details). A senior faculty member is assigned to each RPL as a mentor to guide the RPL's research and professional development. Each Research Project is expected to be supported for 2-3 years. RPL graduation from COBRE support with research publications and independent grant funding is a key measure of the Center's success. Upon graduation of an RPL, a replacement RPL should be selected to fill the vacancy. Applications proposing ESIs in the RPL role are strongly encouraged.

Research Core(s) (optional): A Research Core may be requested if it is required to support the work of the Research Projects. The Research Core should also be made available to other investigators at the institution as well as those from other IDeA institutions. A Research Core should provide cutting-edge technologies and/or services that are not duplicative of existing services or facilities at the applicant institution. Upgrading existing research facilities including those supported by other IDeA programs (e.g., INBRE, IDeA-CTR, and other COBREs) is strongly encouraged.

Alteration and Renovation (optional): Alteration and Renovation (A&R) costs to improve existing research laboratories or animal facilities are allowed if they are relevant to the scope of the proposed research.

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 FOA.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

• 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 meet all of the following criteria:

• 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
• Award doctoral degrees in the health-related sciences or are independent biomedical research institutes/medical centers with ongoing biomedical research programs funded by the NIH or other federal agencies; and
• At the time of submission, (1) hold two or fewer active COBRE Phase 1 and/or Phase 2 awards, including those in no-cost extension, and (2) through subcontracts, hold five or fewer COBRE Research Projects and/or Cores from Phase 1 and Phase 2 COBREs awarded to other institutions. Please note that COBRE Phase 3 - Transitional Centers awards and their research cores are not counted for these eligibility requirements and that applications will not be accepted from institutions that hold three active Phase 1 and/or Phase 2 COBRE awards, including those in no-cost extension.

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

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

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

Applicant organizations

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.

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 with the mentoring and administrative experience necessary to lead the Center.

At the time of submission, the COBRE PD/PI's primary appointment must be at the applicant institution. The PD/PI must also hold, as PD/PI, at least one active, peer-reviewed and externally funded research grant in the scientific area of the COBRE that is awarded to the applicant institution. If a COBRE PD/PI’s qualifying research grant is a multiple PD/PI award to a different institution, the applicant institution must receive funds via subcontract toward supporting the COBRE PD/PI's research.

For multiple PD/PI COBRE applications, a non-contact PD(s)/PI(s) must also have at least one active, peer-reviewed and externally funded research grant in the scientific area of the COBRE that is awarded to the institution where they hold a primary appointment.

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 COBRE Centers, except those who served in that capacity on an interim basis, are not eligible to lead a COBRE Phase 1 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.

Eligible Individuals (Research Project Leaders)

RPLs must qualify either as NIH Early Stage Investigators (ESIs) or as New Investigators (NIs). They must also hold independent multi-year faculty appointments (or equivalent at research institutes) and be leading their own research programs. More than half the RPLs must hold primary appointments at the applicant institution. An RPL with a primary appointment at another IDeA institution may be proposed, provided that institution, through subcontracts, holds four or fewer COBRE Research Projects and/or Cores from active Phase 1 and Phase 2 COBREs awarded to other institutions; note that subcontracts for Research Cores from Phase 3 COBREs are not included in this calculation. An investigator cannot receive more than five years of support as a COBRE RPL in total, inclusive of any RPL support from another COBRE award. A COBRE RPL cannot receive simultaneous research support as a COBRE Pilot Project Leader (PPL). Furthermore, a COBRE RPL or 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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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).

One application per eligible institution is allowed for each submission due date.

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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are encouraged to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Federico Bernal, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: Federico.bernal@nih.gov

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 your 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.

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 FOA) 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.

Current and Pending Support Attachment: Include an attachment titled Current and Pending Support with the following information for each PD/PI’s current and pending research grants from both federal and non-federal sources, which is critical information for determining the PD/PI's eligibility and suitability to lead the proposed Center:

• Project Number
• Name of Recipient Institution
• Source of Support and Title of the Project (or Subproject)
• Role on the Project and Level of Effort (in calendar-months)
• Dates of Approved/Proposed Project
• Total Costs to the PD/PI’s laboratory for the period of performance
• Project Goal

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)

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment of the Overall Component in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

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. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Specific Aims: Provide Specific Aims for the Center.

Research Strategy: This section must include the following elements:

A. Justification for Establishment of the Center

Applicants should provide a strong rationale for establishing a Center in the chosen area of biomedical research. Important information to include are:

• A description of the institution’s research base (e.g., the size of the biomedical research faculty, the total external biomedical research and infrastructure grant support, etc.).
• A description of the investigators with external research funding in the Center’s scientific area.
• The goals of the proposed Center and their alignment with the institution’s strategic priorities for growing its research capacity.
• A description of how institutional commitments, including faculty recruitment plans, will ensure a timely and adequate supply of RPLs for the Center.

B. Organization and Management Plan

The overall Organization and Management Plan for the Center should clearly convey the strategy for accomplishing the Center’s goals. It should include:

• A description of the Center’s components and how each contributes to the Center’s goals and will interact with one another. Include all of the Research Projects (RPs) proposed in the application, but do not describe potential future RPs.
• A description of how Research Cores, if proposed, complement and interface with existing resources at the institution without being duplicative; include equipment, instrumentation, and cores supported by current or prior IDeA (e.g., COBRE, INBRE, IDeA-CTR) awards.
• If an increase in the total number of RPs after Year 1 is proposed, provide a timeline and strategy for RPL recruitment and identify the target area(s) of RPL scientific expertise.
• If the COBRE focuses on community-engaged research, detailed plans that outline stakeholder input, community outreach and input into evaluation strategies and dissemination of the results 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 scientific 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) after the proposed Center is funded. An AC member may not serve as an RPL mentor, core director/advisor, or hold any other position in the Center. Responsibilities of the AC include, but are not limited to, reviewing the annual evaluation of the Center provided by its Administrative Core, making recommendations to the PD/PI to improve the performance of the Center, and providing feedback to RPLs, their mentors, and the PD(s)/PI(s) regarding the RPLs' progress in research and career development. If an RPL is delayed in meeting milestones, the AC should provide advice to the PI on ways to address the shortcomings. The AC also assesses proposals for replacement Research Projects when the need arises. If a Pilot Project Program is proposed, the AC will also assess applications for Pilot Projects. NIGMS will only consider requests to appoint replacement RPLs and PPLs if the AC’s recommendations are included. The AC should meet at least twice per year.

Plans for the AC should detail:

• A description of the qualities and scientific expertise desired for external AC members and the process for their selection. External AC candidates should not be named or contacted 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 institution.
• A description of how the AC will function.
• Additional responsibilities, if any, that are proposed for the AC.

D. Mentoring Plan

The Center is required to assign a mentor to each RPL. The mentor should be an established investigator who is able to provide scientific advice and career guidance to the RPL. If a suitable mentor at the applicant institution is not available, it is acceptable to enlist an appropriate mentor from another institution, including those located in non-IDeA states. The Mentoring Plan should:

• Provide a description of how mentors are selected, including their qualifications to provide scientific advice and career development guidance to the RPLs, how mentors will be trained in mentoring best practices, and how mentor performance will be assessed.
• Describe how mentoring will be conducted.
• Include mentoring strategies for RPLs who fall short of meeting established milestones.

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 plan and how the COBRE aligns with the institution’s strategic priorities. The letter must also provide:

• A description of the institution's research base, including the size of the biomedical research faculty and the total external biomedical research and infrastructure grant support.
• A description of the commitment of resources and facilities to establish, sustain, and support the COBRE throughout the period of funding, including support to hire new faculty members, and to maintain the research, faculty, and infrastructure developed by the Center beyond the period of COBRE support.
• A list of the titles and periods of support of current and prior COBRE awards received by the institution as well as each active subcontract it receives for a COBRE Research Project and/or Research Core from a Phase 1 or Phase 2 COBRE awarded to another institution.

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

Additional letters demonstrating state-level, regional, and/or local 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.

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 (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 minimum level of effort (LOE) of three person-months is required of each PD/PI to devote to career guidance and administrative oversight of the Center. A maximum of six person-months of annual salary support may be requested collectively for all PD(s)/PI(s). A PD/PI may not use COBRE funds to supplement research activities for their laboratory or research team and is not eligible to serve as a project lead on any IDeA (e.g., COBRE, INBRE, IDeA-CTR) award.

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.

Funds to compensate mentors for up to one person-month of effort should be requested in the Administrative Core budget and not in the budget sections of individual Research Projects. Mentors from non-IDeA states can be compensated as consultants or via a fee-for-service arrangement.

Funds may be used to assist the institution's recruitment of additional faculty who complement the Center's research area. These funds are limited to $400,000 in annual direct costs and may be used to recruit investigators at any career stage. 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 institutions 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/mentoring (as described above).

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

Other Expenses: If the application proposes a Pilot Project Program, costs should be a line item under "Other Direct Costs." 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 1. The budget should only include a placeholder for the Pilot Project Programs as prior approval is required before a Pilot Project can begin; see Section VI. Post-Award Program Requirements. A COBRE Pilot Project Leader (PPL) cannot receive simultaneous research support as a COBRE RPL. Furthermore, a COBRE PPL cannot simultaneously receive research support as a project lead on any IDeA (e.g., COBRE, INBRE, IDeA-CTR) parent award but may be eligible to serve as a project lead on a supplement made to an IDeA award.

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 instructions in the SF424 (R&R) Application Guide must be followed.

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

• A clear description of the administrative, fiscal, and scientific aspects of the proposed Phase 1 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.
• An evaluation plan with clear timelines and milestones to annually monitor and evaluate the performance of all components of the Center and the progress of the RPLs it supports. Strategies to identify and remedy deficiencies such as lack of progress for an RPL should be described and procedures to implement the Advisory Committee's recommendations should be included.
• An RPL Development Plan addressing the development and transition of RPLs to independent research funding. This Plan should include details of how the Center, together with the institution, will assist its COBRE-supported investigators to transition to competitive grant support through applications submitted to relevant NIH Institutes and Centers or to other appropriate federal or non-federal agencies or organizations. The Plan should also describe strategies for the continued engagement of these investigators in the COBRE after their RPL support has ended. The Plan must also include both formative and summative evaluation strategies with specific milestones, including, but not limited to, acquisition of independent external, peer-reviewed research grant support and publication in peer-reviewed journals.
• A description of how mentor training and assessment will be managed.
• A description of the process for identifying replacement Research Projects and for their review and selection by the AC.
• A Pilot Project Program, if proposed, should primarily be used for projects that have the potential to develop into future COBRE Research Projects. Pilot Projects may be supported for up to one year in duration and $100,000 in direct costs. The plan for the Pilot Project Program should include: proposal solicitation, oversight and evaluation, and plans for AC review and funding prioritization. Complete eligibility information for PPLs is found in Section VI. Post-Award Program Requirements. Research plans for individual Pilot Projects should not be included in the application.

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 NIH-defined human subjects research, clinical research, and/or 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, and 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.

If an individual is serving in an advisory role or their inclusion is integral to the Core, they should be listed as a key person in the application.

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/expand existing resources that are necessary for accomplishing the scientific goals of the Center. In addition to personnel and supply costs, the acquisition of new equipment and modernization of instrumentation may be proposed.

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 instructions in the SF424 (R&R) 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 institution's current infrastructure and services offered, and justify the proposed changes/additions.
• A description of how the Core will impact the development of the Center and how the Core will serve the scientific needs of individual Research Projects and improve research infrastructure at the institution.
• A description of the proposed business plan for operation of the Core, including prioritization of service requests, user fee structure, and maintenance costs. A Research Core should be made available to other investigators at the institution as well as those from other IDeA institutions.

It is expected that every Core should be unique. Cores that duplicate services already available at the applicant institution 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.

Letters of Support: A letter(s) from an institutional leader(s) 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 be included here.

Resource Sharing Plan: Applicants 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 NIH-defined human subjects research, clinical research, and/or 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 Research 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.

Research Project

When preparing your application, use Component Type Project.

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

SF424 (R&R) Cover (Research Project)

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 Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

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 Project)

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 Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Research Project Leader 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.

Additional instructions:

• The RPL's mentor(s) should be listed as key personnel in this component.
• Each RPL should describe in the Personal Statement of the Biographical Sketch their current and previous peer-reviewed research support.

RPL Eligibility: At the time of submission, an RPL must qualify either as an NIH Early Stage Investigator (ESI) or as a New Investigator (NI), hold a multi-year faculty appointment (or equivalent at research institutes), and be leading their own independent research program. See Section III. Eligibility Information for details.

Budget (Research Project)

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

Applicants should propose a five-year budget for each Research Project. The proposed five-year budget should include up to 3 years total support for each RPL with future years designated for replacement RPLs.

RPLs must make a minimum level of effort commitment of six person-months annually.

Salary support for postdoctoral research associates, graduate and undergraduate research assistants, and other research assistants may be requested with justification to meet the needs of the Research Project.

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 Project)

Specific Aims: The instructions in the SF424 (R&R) Application Guide must be followed.

Research Strategy: The Research Strategy is intended to explain how the Center and the proposed Research Project (RP) will advance the independent career of the RPL, rather than to provide a detailed experimental plan for the RP. The RPL should describe how the COBRE support will impact long-term goals for their research program and how the Center will help advance the RPL's career goals. The roles of Research Cores in helping the RPL to accomplish the project's Specific Aims should be described. The RPL should describe how the mentoring provided by the center will be used and how it will benefit their career goals.

The Research Strategy should delineate the scientific questions to be answered and/or the design principles of the project but does not need to provide extensive experimental details, as it is expected these will be developed and evolve over time with appropriate mentorship provided by the Center. The Research Strategy should include a critical assessment of existing knowledge and approaches relevant to the project and provide possible strategies to address the key goals/questions proposed, while emphasizing how the anticipated outcomes of the Research Project will advance the field and concisely stating the importance of the proposed research. Preliminary data are not required but if present will be evaluated.

If the project involves community-engaged research, the RPL should select a health issue that fits community priorities and, as appropriate, should describe plans to develop a coalition of community and academic stakeholders to provide community input.

Letters of Support: Each RPL must provide an individual Letter of Institutional Support from an institutional leader such as a Department Head, Dean, or Provost from the RPL's home institution. The letter must demonstrate a clear commitment to support a multi-year, faculty-level appointment for the proposed RPL independent of the outcome of the COBRE grant application. Examples of strong institutional commitment include a start-up package provided by the institution, salary support, and/or independent research space within the institution. Applications that do not provide an individual Letter of Institutional Support for each RPL will be considered incomplete and the application will be withdrawn without review.

Additional letters demonstrating support to the proposed Research Project and/or the RPL may be included in this section if they do not duplicate letters included elsewhere in the application.

Resource Sharing Plan: Applicants 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 Project)

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 Research 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.

Alteration and Renovation

When preparing your application, use Component Type Alt and Renov.

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

SF424 (R&R) Cover (Alteration and Renovation)

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 (Alteration and Renovation)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Alteration and Renovation)

Human Subjects: Not allowed.

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.

Other Attachments: Line drawings must be submitted as described below:

• Submit line drawings but DO NOT SUBMIT BLUEPRINTS. All floor plans must be legible, with the scale clearly indicated.
• The line drawings of the proposed renovation must be at a scale adequate to explain the project. The drawings should indicate size (dimensions), function, and net and gross square feet of space for each room. The total net and gross square feet of space to be renovated should also be given.
• The floor plan should indicate the location of the proposed renovation area in the building.
• Include the as-built drawings of the proposed renovation area and indicate any areas that will be demolished.
• Changes or additions to existing mechanical and electrical systems should be clearly described in notes made directly on the plan or attached to the plan.

Project /Performance Site Location(s) (Alteration and Renovation)

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 (Alteration and Renovation)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead 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 (Alteration and Renovation)

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

Alteration and Renovation is allowed up to $300,000 in direct costs only in year one of the award as a one-time cost expenditure. Direct costs requested for A&R are not subject to facilities and administrative costs (F&A). This amount will be provided only in year one. If not expended in year one, prior approval for carryover will be required. It is expected that the funds be expended within three years of the award.

Sufficient detail must be provided to estimate the cost and suitability of the project. Failure to adequately justify an A&R request will likely result in its deletion from the requested budget. Funds designated for A&R under this FOA cannot support new construction, including completion of shell space, or the purchase of movable research equipment/instrumentation or equipment intended for teaching or other non-research related purposes. A&R costs will be approved only for facilities improvements at the applicant organization. Proposed improvements at consortia sites are not allowed.

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 (Alteration and Renovation)

Specific Aims: The instructions in the SF424 (R&R) Application Guide must be followed.

Research Strategy: A narrative summary as outlined below must be provided:

• A description of how proposed renovations relate to and support the Research Projects and Research Cores.
• If renovations to animal facilities are requested, they should be related to the projected animal populations (by species) in the proposed projects. Applicants must include the lines of authority and responsibility for administering the institution's animal care and use program. The role and composition of the Institutional Animal Care and Use Committee (IACUC) and how compliance with relevant laws, policies, and guidelines are achieved should also be included.
• List the functional components, including the size (dimensions) and square footage of each component (room, alcove, or cubicle) that will be directly affected by the renovation project.
• List engineering criteria applicable to each component (mechanical, electrical, and utilities). Include information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam.
• List appropriate architectural criteria (such as width of corridors and doors, surface finishes).
• List and justify all major equipment items requested for the renovated area. A list of allowable major equipment for alteration and renovation projects for the IDeA program can be found at https://www.nigms.nih.gov/Research/DRCB/IDeA/Documents/List_of_AME.pdf.
• Indicate the type(s) of new finishes to be applied to room surfaces.

Letters of Support: Letter(s) from institutional leader(s) and any letters of support for the proposed alteration and renovation should be included in this section. Only letters of support specific to the Alteration and Renovation should be included.

Resource Sharing Plan: Not Applicable

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 (Alteration and Renovation)

Human subjects research is not allowed in the Alterations and Renovation component.

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 your application will be automatically assembled for review and funding consideration after submission go 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.

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 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.

Section V. Application Review Information

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.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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 Center 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

Does the Center support the institution’s strategic priorities in developing research capacity? Does the institution demonstrate a need for the establishment of a Center in the proposed scientific area? Does the Center address an important problem or a critical barrier in the field? Do the Specific Aims of the Center outline how the proposed work will advance knowledge, technical capabilities, and/or clinical practice in the field of research?

Investigator(s)

Does the PD(s)/PI(s) have the appropriate background to establish, develop, and lead the COBRE to enhance research capacity at the institution in the proposed biomedical scientific area? Has the PD(s)/PI(s) provided evidence of successfully mentoring and guiding early career research investigators? 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?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex and age, for studies in vertebrate animals or human subjects?

If the Center involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults),

justified in terms of the scientific goals and research strategy proposed?

Does the overall plan provide confidence that a productive Center will be established?

Do the proposed Research Projects contribute appropriately to the overall enhancement of biomedical research capacity in the Center’s scientific area at the applicant institution? Do the proposed projects support the scientific goals of the Center and the strategic priorities of the institution?

Are plans for the recruitment of new investigators consistent with the goals of developing biomedical research capacity in the scientific area of the Center? Does the application provide viable plans for maintaining a pipeline of RPL candidates in the research field of the Center?

Are qualified established investigators assigned as mentors to RPLs? Does the Mentoring Plan include clear strategies to prepare mentors to provide advice and guidance to RPLs and evaluate their mentoring success?

Is the proposed composition of the Advisory Committee appropriate? Is the proposed scientific and administrative expertise of AC members adequate to assess the capacity building and scientific goals and progress of the Center and offer advice to the PD(s)/PI(s) on scientific and career development matters, including the assessment of new Research Projects and RPLs? Is the role of the AC in these matters adequately described?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the proposed Center? Will the Center benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Are the institution's strategic priorities in alignment with the proposed plans for a Phase 1 Center? Does the applicant institution demonstrate convincing commitment to recruit and provide long-term support for faculty investigators in the scientific area of the Center? Do the environment and resources available at the institution meet the needs of the Research Cores and the RPLs? Does the application indicate how the Center will improve facilities or make available new and collaborative resources (e.g., laboratory facilities, patient populations, laboratory space, and personnel)?

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

Does the Organizational and Management Plan for the Administrative Core provide confidence that the overall goals of the Center will be fully implemented?

Is there a well-integrated plan to manage and coordinate the Cores, Projects, Advisory Committee, and Mentors to achieve the Center's goals?

Is there a clear plan to carry out all responsibilities required of the COBRE award including, but not limited to, preparing accurate and timely program and financial reports, ensuring all Center activities are in compliance with federal regulations, managing the Center's budget, and organizing Center-wide scientific and career development activities?

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

Does the Administrative Core include a well-defined and appropriate RPL Development Plan for continued professional development of RPLs, with appropriate strategies to enable RPLs to successfully transition to independent research funding? Does it provide specific milestones for the acquisition of independent funding by the investigators and subsequent graduation from COBRE support?

Are appropriate plans in place to manage mentor training and evaluation?

Is the process of selecting candidate investigators and reviewing replacement Research Projects by the AC structured appropriately?

If a Pilot Project Program is proposed, are there well-developed plans for proposal solicitation, review, award selection, and performance evaluation?

Research Cores

Is the request to support the Research Core well justified? Does the Core provide suitable scientific support to the proposed Research Projects? Is the core complementary to and not redundant with existing facilities available to researchers at the institution? Does the Core Director have the expertise to provide the necessary oversight to administer the establishment, maintenance, and growth of Core resources and laboratory facilities to carry out the scientific objectives outlined in the application? Has the Core Director and/or the PD(s)/PI(s) (as appropriate) obtained sufficient institutional commitments to ensure that the resources and facilities required to establish and maintain the Core will be available?

Review Criteria for Individual Research Projects

For each Research Project, reviewers will provide an overall impact score to reflect their assessment of the merits of the RPL and proposed Research Project and the likelihood that the Center will advance the RPL's scientific career, in consideration of the following review criteria and the additional review criteria.

• Does the RPL have the necessary background and scientific expertise to lead the proposed Research Project? Does the RPL demonstrate the potential to compete successfully for independent grant support?
• Does the Research Project address an important problem or a critical barrier to progress in the field? Is there strong evidence that the proposed research topic will permit the RPL to establish a unique place in the field of research? Does the Research Project have strong potential to improve scientific knowledge, technical capability, and/or clinical practice? Is the proposed research innovative in one or more aspects: does it challenge or seek to shift/refine current research or clinical practice paradigms, make use of novel theoretical concepts, approaches, methodologies, instrumentation, or interventions?

• Is the overall research strategy outlined well-reasoned and appropriate to accomplish the goals? Is the prior research that serves as the key support for the proposed Research Project rigorous? If included, do the preliminary data support the Research Project’s hypothesis and/or objectives? Are potential problems, alternative strategies, and benchmarks for success presented? Are plans to address relevant biological variables, such as sex and age, for studies in vertebrate animals or human subjects adequate?

• Will the Research Project adequately develop important preliminary data and the scientific communication and lab management skills of the RPL that are important to leading a long-term, independently funded research program?

• Does the assigned Mentor(s) have the scientific expertise and experience to provide appropriate career advice to the RPL? Is the mentoring specifically tailored to the RPL and considered effective? Is the institutional support for the RPL sufficient for completion of the Research Project? Will the Research Project benefit from Research Cores?

• If the Research Project involves human subjects and/or NIH-defined clinical research, are the plans to address: 1) the protection of human subjects from research risks, and 2) the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (exclusion) of individuals across the lifespan (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

• If the Research Project involves community-engaged research, are there clear and detailed plans for developing a coalition of community and academic stakeholders who can provide input on evaluation strategies and the dissemination of the results?

In addition, for applications involving clinical trials: A proposed clinical trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

• Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is the trial needed to advance scientific understanding?
• With regard to the proposed leadership for the project, do the RPL and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multi-center trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
• Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
• Does the application adequately address the following, if applicable:
  • Study Design
    • Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the prior preclinical and/or clinical research that serves as the key support for the proposed project rigorous? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
    • Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
    • Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
  • Data Management and Statistical Analysis
    • Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
• If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate? If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Review Criteria for Alteration and Renovation (if included)

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the alterations and renovations to strongly benefit the Center, in consideration of the following review criteria and additional review criteria:

• Are requested alteration and renovation projects needed to support the goals of the Center?
• Are the costs and suitability of the project justified?
• If renovations to animal facilities are proposed, are the proposed renovations appropriate for the animal species and population to be used in the Research Projects? Are the lines of authority and responsibility for administering the institution's animal care and use program described?
• Do the descriptions of the alterations and renovations, including equipment requests, adequately describe what will be done and strongly justify the request? Do the line drawings provide sufficient detail to explain the project? Do they indicate that the proposed alteration and renovation is feasible and that it will serve its intended purpose?
• Are the functional components, including the size (dimensions) and square footage of each component (room, alcove, or cubicle) that will be directly affected by the renovation project appropriate for the intended use of the space? Are appropriate descriptions of the engineering criteria (mechanical, electrical, and utilities) provided, including information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam, as well as the appropriate architectural criteria (such as width of corridors and doors, surface finishes)? Is the need for all fixed equipment requested for the renovated area well justified?

As applicable for the overall application, core(s) and projects 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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal 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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the overall application, core(s), and projects 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 following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

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.

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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Portfolio balance
• Relevance of the proposed project to program priorities, including:
  • Inclusion of Early Stage Investigators as Research Project Leaders.
  • Scientific breadth of the center and its relationship to institutional strategic goals.
  • Need for developing a critical mass of investigators in the Center's scientific area.
  • Relationship of the Center’s scientific area to those supported by prior COBREs awarded to the institution.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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 COBRE Centers funded through this FOA are expected to attend the National IDeA Symposium of Biomedical Research Excellence (NISBRE) biennial meeting.

Research Projects

RPLs are named as key personnel on the Notice of Award.

Prior approval by NIGMS is required for adding or removing RPLs from Research Projects. See "Prior Approval of Pilot and Replacement Research Projects" below for documents that must be submitted to NIGMS.

When an RPL leaves the COBRE, the grantee must notify NIGMS immediately and not wait until a replacement RPL has been identified. The new COBRE Research Project that replaces the completed or terminated project must be reviewed by the PD(s)/PI(s) and the AC. The PD(s)/PI(s) must communicate the AC recommendation to NIGMS for its programmatic and administrative review.

An RPL must submit an independent investigator-initiated, peer-reviewed research project grant (RPG) application by the end of two years of COBRE support. It is expected that an RPL will be supported by the COBRE for three years and then move to independent research support. COBRE Research Project support beyond three years may be provided in circumstances where the COBRE PD/PI and the AC have carefully evaluated the Project’s progress and concluded that continued support is justified. Support of an RPL by the COBRE mechanism beyond a total of five years is not allowed.

An RPL may be removed from the COBRE program if a review by the AC indicates a failure by the investigator to make adequate progress toward achieving the specific aims of the Research Project or meeting milestones, including the failure to submit an investigator-initiated, peer-reviewed research grant application by the end of two years of COBRE support.

Reduction of an RPL’s effort below 6 months, or of any key personnel’s effort by 25% or more from the approved level, requires the prior approval of NIGMS. The PD(s)/PI(s) must consult with NIGMS program staff regarding such requests.

When submitting a new research grant application, an RPL should include a statement acknowledging COBRE program support and a plan for relinquishing COBRE support if the proposed research is funded and overlaps with or is similar to the COBRE Project.

When an RPL acquires independent research grant funding, NIGMS must be informed no later than the start date of the new award. If the new award overlaps with the work described in the COBRE Research Project, is a logical progression of the Research Project, or addresses a closely related topic, COBRE support must end when the new award begins. If the new funding is a substantial, independent NIH research award, such as an R01 or R01-equivalent award, but covers a different topic that does not overlap with or stem from the COBRE Research Project, the COBRE PD/PI may request prior approval for up to 6 months of continued COBRE RPL support with no reduction to the RPL’s level of effort on the COBRE project.

Pilot Projects

If a Pilot Project Program is proposed, the Pilot Project(s) must be reviewed by the AC. Faculty 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 and Replacement Research Projects" below for documents that must be submitted to NIGMS.

A PPL is required to devote at least 1 person-month of effort to the Pilot Project but is not named as key personnel. PPL removal from the COBRE or changes to their level of effort that remain above the minimum requirement do not require prior approval, but must be reported in annual Research Performance Progress Reports.

Prior Approval of Pilot and Replacement Research Projects

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

Using PHS 398 forms and instructions, only the following sections need to be submitted:

• Face Page (PP and RP, signed by institutional signing official)
• Project Summary (PP and RP, Page 2)
• Research Strategy Section (PP and RP)
• Updated Other Support (RP only)
• Biographical Sketch (PP and RP)
• Detailed budget and budget justification (RP only)
• Checklist Format Page with F&A cost breakdown (RP only)
• Advisory Committee approval - communication from the AC Chair (at a minimum) indicating the AC concurs with supporting the project (PP and RP)
• Letter of Support from a senior institutional official demonstrating a clear commitment to support a multi-year faculty appointment for the proposed investigator (RP only)
• Resource Sharing Plan (RP only)
• Data Management and Sharing Plan (RP only, if applicable)

• Authentication of Key Biological and/or Chemical Resources (RP only)

If the proposed RP or PP involves human biospecimens or data, include:

• Current PHS Human Subjects and Clinical Trials Information Form

If the proposed RP or PP 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 RP or PP 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 awardee institution will 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:

• IACUC approval
• Vertebrate Animal 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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

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

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

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

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

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

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

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

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

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

Not Applicable

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.

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 FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 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 75.113and 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.

4. 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. 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 submission by the due date, and post-submission issues)

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

Federico Bernal, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: Federico.bernal@nih.gov

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

Samantha Farrell, MHS
National Institute of General Medical Sciences (NIGMS)
Email: samantha.farrell@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.