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.

Part 1. Overview Information
Part 2. Full Text of the 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

Authorized by the U.S. Congress, the National Institutes of Health (NIH) established the Institutional Development Award (IDeA) program in 1993 to enhance biomedical research activities in states and territories that had historically low NIH grant funding success rates. The IDeA program currently supports competitive research in 23 states and Puerto Rico through four major funding initiatives: Centers of Biomedical Research Excellence (COBRE), IDeA Networks of Biomedical Research Excellence (INBRE), the IDeA Program Infrastructure for Clinical and Translational Research (IDeA-CTR), and co-funding of research and instrument grants with NIH Institutes and Centers.

The COBRE program seeks to promote the establishment and development or expansion of innovative, state-of-the-art biomedical and behavioral research centers at institutions in IDeA-eligible states. Research supported by this program spans the full spectrum of basic, clinical, and translational sciences and encompasses all areas of health-related investigations. The NIH recognizes that contributions from institutions in IDeA-eligible states are important and essential in fulfilling the promise of the NIH research agenda. The intent of this FOA is the continuance of support assisting these institutions to develop researchers and to utilize technologies and other resources needed to conduct state-of-the-art research.

The COBRE program consists of three sequential five-year phases. Phase 1 aims to strengthen an institution's biomedical research infrastructure through the establishment of a thematic multi-disciplinary center and enhance the ability of investigators to compete independently for NIH individual research grants or other external peer-reviewed support. Phase 2 is intended to strengthen the Center through further improvements in research infrastructure and to continue the development and support of a critical mass of investigators with shared scientific interests. After ten years of COBRE support, the centers and their aligned investigators are expected to be able to compete successfully for other sources of research funding, including individual and/or program project or center grants from other NIH Institutes and Centers, or other Federal and non-Federal entities.

COBRE Phase 3, the focus of this funding opportunity announcement primarily provides support for scientific and technical cores to become independent service research facilities in the institution. It has the following objectives:

• To facilitate the transition of research core resources developed during phases 1 and 2 into sustainable state-of-the-art core facilities capable of supporting the conduct of high-caliber biomedical research.
• To sustain the research environment developed in the first two phases by providing support for pilot research projects and career guidance and enhancement activities.

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

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

Eligibility is restricted to institutions with an active COBRE Phase 2 award on the application due date. This includes awards funded for the following previously published FOAs:

• PAR-18-264
• PAR-16-241
• PAR-13-243
• PAR-12-224
• PAR-09-180

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• 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.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and 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 underrepresented racial and ethnic groups as well as individuals with disabilities 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 current COBRE Phase 2 PD(s)/PI(s) may continue to serve in this role or a new PD(s)/PI(s) may be appointed. In either case, the PD(s)/PI(s) must be an established biomedical or behavioral research scientist with an on-going research program supported by extramural funding that is closely related to the scientific theme of the proposed COBRE. The PD(s)/PI(s) must have mentoring and administrative experience to lead the COBRE program and must be a faculty member at the applicant institution at the time of application.

A PD/PI of a previous COBRE Center that completed the three consecutive phases may not lead a COBRE Phase 3 application, with the exception of an investigator who served as the PD/PI of a previous COBRE on a temporary basis for no more than two years. Previous COBRE PD(s)/PI(s) who plan to apply as a PD/PI of a COBRE Phase 3 are encouraged to contact the Scientific/Research Contact name in the FOA prior to the preparation of the application. A PD/PI may not simultaneously lead two or more IDeA (INBRE, IDeA-CTR, and other COBRE) program awards.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 NOT-OD-11-101).

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.

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.

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (use for Administrative Core)	12
Core (use for each Scientific/Technical Core)	12
Project (use for Pilot Projects Program)	12

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required, maximum of 1
• Scientific/Technical Cores: required
• Pilot Projects Program: required, maximum of 1

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.

Complete entire form.

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

Follow standard instructions.

Facilities and Other Resource: Applications must briefly describe the institutional environment and resources available to investigators and indicate how prior COBRE support has improved facilities or made available new and collaborative resources (e.g., laboratory facilities, patient populations, laboratory space and personnel).

Other Attachments: A list of all publications produced in COBRE Phases 1 and 2 must be included here.

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.

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

The implementation of the activities detailed in the application is the ultimate responsibility of the COBRE PD(s)/PI(s). The PD(s)/PI(s) must demonstrate that they are an established biomedical or behavioral research scientist with demonstrated administrative leadership skills. As the director of the COBRE, the PD(s)/PI(s) will establish the overall direction and appropriate administrative structure of the center to support research efforts, including the efficient management of component facilities and resources, staffing and resource allocation, and the administration of the award in accordance with NIH policies. The PD(s)/PI(s) should demonstrate experience in developing a pilot grants program, selecting the core directors, resolving disputes arising in the usage of the core facilities, and determining final budget decisions.

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.

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.

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

Specific Aims: Provide the Specific Aims for the Center.

Research Strategy: The application must provide details of the program's accomplishments and the overall center organization and management plan that includes the following:

Program Accomplishments: The applicants must provide details of major progress and accomplishments made in the last 10 years of COBRE support (Phases 1 and 2) in the following areas:

• Research productivity as measured by scientific publications in peer reviewed journals, and presentations at scientific meetings and other conferences.
• Research grants submitted to and awarded by NIH or other funding agencies.
• Improvement of research infrastructure as measured by utilization of core facilities by COBRE and non-COBRE investigators, and increased research productivity associated with core support.
• Increased critical mass of investigators as evidenced by successful recruitment of senior faculty and/or retention and advancement of COBRE-supported investigators. The current career status of previous and ongoing COBRE target project leaders, including notable accomplishments (e.g., membership in editorial boards or review panels, scientific or academic awards, tenure promotion) must be provided.
• Other metrics as defined by the applicant that demonstrate accomplishments during the last 10 years of COBRE support.

Center Organization and Management: The applicants must provide details of the following:

• The organizational structure of the COBRE and overall vision and strategic plan for achieving the overall specific aims of the center. Crucial to the effective operation of the center is an Administrative Core that oversees the coordination and facilitation of all research and training activities supported by the COBRE cores.
• The scientific opportunities that the center intends to pursue over the next five years and beyond.
• Justification for the cores and facilities that will be supported, and the broad plans that are proposed to promote and ensure their sustainability beyond COBRE Phase 3. The host institution’s existing facilities and available services should be clearly delineated from the facilities and services that are proposed for funding via this FOA in the Facilities and Other Resources section of the Overall component of the application.
• Summary of the projected center participants, their respective projects, their anticipated scientific and core facility needs, and any career and research enhancement and guidance activities.

Letters of Support: Applicants must provide letters from the appropriate high-ranking institutional official(s) that define the resources and support for the COBRE that will be provided by the institution. A specific commitment is required. Non-Federal matching funds are not required and will not be considered as factors in the merit review of applications; however, the application must show clear evidence of strong and specific institutional commitment for the overall center and each center component. It is recognized that the availability of resources is variable among institutions. Consequently, the level of institutional commitment will differ among applicant institutions. The application must include a letter from a senior institutional official (e.g., President or Dean) outlining the resources and facilities that will be committed by the institution to support and sustain the COBRE throughout the period of funding, and the commitment to maintain these resources that will be made beyond the period of grant support. Some examples of institutional commitments that may be documented include direct research support, adequate space, release time agreements, tenured or tenure-track positions for faculty, full-time employees (FTEs) for core facility personnel, and core consolidation and maintenance.

As appropriate, letters from the PD(s)/PI(s) of other awardees of NIH and other Federal and non- Federal entities (e.g., INBREs, COBREs, CTSAs) may be included indicating their program’s role in supporting the COBRE's goals and proposed activities for achieving sustainability.

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; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

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.

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core 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.
• The Core Lead, who must be the PD/PI, may be assisted by Program Coordinator(s) (PC(s)) with administrative skills and experience that complement those of the PD(s)/PI(s). The PC(s) can provide day-to-day oversight of center operations and administration, including assisting core directors to set work priorities, coordinating recommendations for major purchases of supplies and equipment upgrades, recruiting of technical support staff, and assisting in the resolution of other budget issues with the core directors and the PD(s)/PI(s).

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

If items are requested as direct costs that are normally treated as F&A costs (for example, general office supplies), the applicant must provide a strong justification for those items and demonstrate that the cost is commensurate with the benefit that item of cost will have on the associated activity.

The COBRE PD/PI must devote a minimum time commitment of 1.2 person months for the administrative oversight of the COBRE, serving as the Administrative Core Lead. A maximum of 2.4 person months of effort may be supported with funds from this grant. Each individual named as a PC may devote 1.2 to 2.4 person months. The levels of effort specified for the PD/PI and the PC(s) are required, whether or not salary support is requested. If multiple PD(s)/PI(s) are proposed, each PD/PI must devote a minimum of 1.2 person months for administration of the center. PD(s)/PI(s) of the Centers funded through this FOA should budget for attending biennial two-day meetings in Bethesda, Maryland with NIGMS staff.

The PD(s)/PI(s) of the COBRE is not eligible for research project support from his/her COBRE or other COBRE (including all three phases), IDeA-CTR, or INBRE awards. He/she may not use COBRE funds to supplement research activities within his/her laboratory.

Each scientific advisor may be compensated for up to 1-person month of effort and should be listed in the Administrative Core's budget section of the application Advisors from non-IDeA states can be compensated as a consultant or via a fee-for-service arrangement.

Funds cannot be used at collaborative institutions in non-IDeA states. However, funds may be used in other IDeA and non-IDeA states for fee-for-service activities that include activities such as learning new techniques, sample and data analysis, workshops, etc.

Funds cannot be used for graduate student stipend and postdoctoral training. Funds cannot be used for alteration and renovation.

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.

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Provide the Specific Aims for the Administrative Core.

Research Strategy: The Research Strategy for the Administrative Core must provide descriptions of the following important elements:

• Implementation plans for accomplishing the proposed specific aims, including the management, coordination, and supervision of the entire range of center activities. An explicit discussion of how fiscal and other resources will be prioritized, allocated, and managed must be provided.
• Responsibilities of the PD(s)/PI(s) and PC(s).
• The policies and procedures that will govern the administrative and scientific operations of the COBRE, including the structure for decision-making on several levels (e.g., COBRE PD/PI and PC(s), Core Director (s), steering committee, external advisory committee (EAC), and COBRE investigators), and how each member of the COBRE would participate in the decision-making process.
• Operational plans that will govern the COBRE leadership's interactions with the proposed cores, advisory committees, and aligned investigators.
• Membership, functions, and responsibilities of steering and external advisory committees. The areas of expertise and requisite qualifications of EAC members and their terms of service must be clearly defined and appropriately aligned with the objectives of the Center. The application must provide functional and operational details of the duties and responsibilities of the group. Plans must be included as to how recommendations of advisory committees are secured, considered and, as appropriate, implemented by the COBRE leadership.
• Evaluation strategies that will be employed to assess core performance and achievements. Objective criteria and concrete metrics must be provided that include qualitative and quantitative measures of core usage, research productivity, scientific/technical breakthroughs, and revenue generation.
• Institutional plans for ensuring compliance with all regulatory guidelines pertaining to the protection of human subjects, and the care and welfare of vertebrate animals involved in research.

When completing the research strategy section, the following elements of the Administrative Core must be considered and described in detail:

• Leadership and Governance Plan: Detail how the Administrative Core oversees the overall governance, organization, and structure of the COBRE, including the functional relationships between the PD/PI, PC, and the Directors of Core Resources, and between the COBRE leadership and advisory committees. The efficient management of institutional resources, the various cores, and proposed center activities will depend on a strong Administrative Core.
• Steering Committee: Each Center will be directed by a Steering Committee chaired by the PD/PI of the Center grant. Members of the committee will include the PC(s), directors of the Individual Cores, and a senior institutional official. Representation in the Steering Committee should also come from the PD(s)/PI(s) of research projects that utilize core resources. The Steering Committee will establish guidelines to determine the most appropriate methods for providing access to the Core facilities and services. The Steering Committee will also advise the Center PD/PI on strategic and operational issues, to maximize the impact of the Center on biomedical research at the institution.
• External Advisory Committee: Describe a plan to establish an EAC of 3-5 members that will meet at least annually to review the structure and progress of the COBRE and to offer recommendations to the PD/PI. Only the established EAC members should be identified and named in the application. Potential new members should not be contacted or identified. An annual EAC report that summarizes discussions at EAC meetings, recommendations made, and actions taken by the COBRE leadership will be provided in yearly progress reports submitted to NIH. The EAC report must not be submitted separately to NIH Program staff.
• Evaluation Plan: Describe how the Administrative Core will oversee an internal evaluation plan for monitoring and documenting progress towards achieving target goals and timelines. The Steering Committee is expected to provide ongoing assessment and evaluation of the progress of the center. Annual evaluation reports, including plans for any corrective actions, must be provided to the EAC, Core Directors, other key personnel, institutional stakeholders, and NIH Program Staff.

Letters of Support: Letter(s) from institutional leader(s) demonstrating support for the

proposed Administrative Core should be included.

Additional letters demonstrating state-level, regional, and/or local commitment and support to

the Administrative Core may be included in this section.

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; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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.

When preparing your application, use Component Type Core.

It is expected that any proposed core should be unique and not duplicate services or facilities that already exist at the applicant institution. Utilization/modification/expansion of existing resources to accomplish the goals of proposed research is strongly encouraged.

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

SF424 (R&R) Cover (Scientific/Technical 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 (Scientific/Technical Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scientific/Technical 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) (Scientific/Technical 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 (Scientific/Technical Core)

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

Qualifications and Responsibilities of Core Directors: Directors of research core facilities 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 of specialists in the specific area of service to: (1) develop plans for standard operating procedures governing the utilization and management of core expertise and resources; (2) develop plans for disseminating information, user 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/PI and PC any updates and/or replacement of equipment or personnel.

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

Budget (Scientific/Technical Core)

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

The Core Director may devote 1.2 to 2.4 person months annually to direct the core.

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 (Scientific/Technical Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Provide the Specific Aims for the Core.

Research Strategy: The Research Strategy section for the Scientific/Technical Core must provide details of the following:

• Core description and justification
• Roles, and responsibilities of Core Director(s) and staff.
• Operating procedures of the core:

-Maintenance of state-of-the-art techniques and quality controls.

-Advising and training of investigators in the capabilities of the core.

-Allocation of core budgets.

-Process for reviewing, prioritizing, and supporting projects. The project prioritization plan must include a description of how the capacity and services of the proposed Core will be evaluated and allocated by the Steering Committee. For example, prioritization may be established by virtue of a differential fee structure or by a formal project evaluation mechanism.

-Resolution of disputes relating to core usage.

-Arrangements for support of the core's operations including and beyond COBRE Phase 3 support, which may include fee-for-service arrangements and procedures for waivers.

-Evaluation strategies to determine efficiency and effectiveness of the core, including mechanisms for tracking utilization of core resources and for adapting to the needs of investigators.

-Strategic plans for sustaining the core beyond COBRE Phase 3.

-Research pool and scientific projects that will utilize the resources in the core.

The following elements must also be considered and described in detail for the proposed scientific/technical core:

• Resources and services: The core must be well-justified and shown to be essential in meeting the scientific requirements of projected users. Consequently, the resources and services offered by the core facility must be adequate and appropriate in supporting ongoing and planned research projects. Describe essential services for the core including dissemination of core capabilities, advising and training in new technology and modern instrumentation, and providing scientific guidance in the design of research proposals and experiments. Other essential elements of the core are project prioritization and evaluation plans. Equally important are sustainability plans for the core beyond COBRE 3.
• Leveraging: Sharing research resources among IDeA programs is strongly encouraged. Applicants should provide plans to utilize existing equipment and instrumentation supported by other COBRE or INBRE awards. Requests that appear to be duplicative of existing equipment or instrumentation, including computational facilities and related bioinformatics resources, must be appropriately justified. Core facilities supported through this FOA must not duplicate currently available facilities at the institution. Additional support by the applicant organization or by outside sources is encouraged.
• Core Revenue: It is expected that the Cores will work to become self-sustaining through support arrangements and models whenever possible, in order to optimize efficient resource usage and enhance resource sustainability.

Letters of Support: Letter(s) from an institutional leader(s) demonstrating commitment to support and maintain the proposed facilities should be included.

Additional letters demonstrating state-level, regional, and/or local commitment and support to

the proposed scientific/technical cores may be included in this section.

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 (Scientific/Technical Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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.

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 (Pilot Projects Program)

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 (Pilot Projects Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot Projects Program)

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) (Pilot Projects Program)

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 (Pilot Projects Program)

• 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.

Faculty investigators of any rank are allowed to lead Pilot Projects, however, new and early stage investigators with tenure-, research-, or clinical-track faculty appointments should be given priority. Individuals holding postdoctoral training positions are not eligible to lead Pilot Projects.

Pilot Project Leaders are not allowed to receive simultaneous research support from other IDeA awards, including an INBRE, an IDeA-CTR, or a different COBRE.

Budget (Pilot Projects Program)

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

Direct costs of up to $250,000 annually can be used to support Pilot Projects and the administration of the Pilot Projects Program. Pilot Projects cannot overlap with ongoing funded projects. Funds cannot be used for graduate student stipend, postdoctoral training, or alterations and renovations. The PD/PI of the COBRE is not eligible for Pilot Project funding.

Pilot project support is limited to two 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 (Pilot Projects Program)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Provide the Specific Aims for the Pilot Projects Program.

Research Strategy: The Research Strategy section for the Pilot Grants Program must include the following:

• A plan for the solicitation of proposals, the review of their methodology and research performance, and prioritization and selection of the projects. Proposals that propose to conduct an NIH-defined clinical trial, must be evaluated using the NIH clinical trial-specific review criteria.
• The plans for defining the scope of the projects, eligibility requirements, the limit on the dollars available, and the number of years of support per project. The eligibility must indicate that Pilot Project Leaders hold a faculty appointment or equivalent at the time the NIH approval of the Pilot Project is sought.
• Governance, oversight, and evaluation procedures that include the EAC.
• If a pilot grants program has previously been in place during COBRE Phase 1 and/or 2, the applicant must provide data on the effectiveness of dissemination and review process of the program, including number of applicants and awardees per cycle, how many outside grant applications were submitted by Pilot Project Leaders and how many were funded, publications resulting from Pilot Projects, and any scientific/technical breakthroughs.
• The potential pool of qualified investigators from whom to solicit applications.
• Career and research guidance activities for Pilot Project Leaders.

Research plans for individual pilot projects should not be included in the application.

Letters of Support: Letter(s) from an institutional leader(s) demonstrating commitment to support for the proposed Pilot Projects Program should be included.

Additional letters demonstrating state-level, regional, and/or local commitment and support to

the proposed Pilot Projects Program may be included in this section.

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 (Pilot Projects Program)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

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.

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.

This initiative is not subject to intergovernmental review.

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

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

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 Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). 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.

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

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

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.

Does the Center address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, specific to this FOA: Are the Center's vision and strategy adequate to facilitate and sustain high-caliber research in the institution?

Progress and Accomplishments: Has previous support allowed the Center to achieve specific

benchmarks, which include the acquisition of independent status by the new and early stage investigators, publishing data in peer-reviewed journals, and evidence that the competitiveness of these investigators for other NIH, Federal, or non-Federal external peer-reviewed research grant support has been enhanced? Is there evidence that a critical mass of investigators has been (or is being) established? Have new investigators been recruited to the Center and have these efforts been successful in increasing the biomedical or behavioral research capacity of the institution? Is there evidence that the scientific cores supported by COBRE funds were sufficiently utilized and were instrumental in enhancing productivity of investigators associated with the COBRE?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the Center?

In addition, specific to this FOA:

Leadership: Does the PD(s)/PI(s) have the ability to provide scientific and administrative leadership and direction? Have the PD(s)/PI(s) and PC(s) proposed adequate time commitment to effectively manage the Center? Has the PD(s)/PI(s) shown effective leadership and judgment in the selection of research cores in terms of the cores being related to and consistent with the overall goals of the Center? Has the PD(s)/PI(s) presented a plan to develop and maintain core laboratories as state-of-the-art through the selection of appropriate Core Directors?

Program coordinator: Does the program coordinator have the requisite background and knowledge that complement that of the PD(s)/PI(s) with respect to managing core resources and overall operation of the Center? Has he/she demonstrated an ability to oversee and coordinate research activities?

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?

In addition, specific to this FOA: Is the Center positioned to develop new approaches to increasing the ease and efficiency of conducting research by the investigators associated with the COBRE? Is there a well-designed and innovative plan for enhancing communication, coordination, and collaboration among Center Investigators and the proposed cores?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? 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, 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?

In addition, specific to this FOA: Is the management plan appropriate for fiscal administration, resource procurement, property and personnel management, planning, and budgeting? Have the PD(s)/PI(s) presented a well-thought out plan for achieving sustainability of the cores beyond COBRE 3 support?

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 project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, specific to this FOA: Is the institutional environment supportive and conducive for achieving the objectives of the COBRE? Are there effective lines of communication and cooperation among the COBRE leadership, aligned investigators, Core Directors and Staff, and Institutional Leadership?

In addition to the above criteria, the following components of the COBRE Phase 3 application will be scored independently AND will be considered in the determination of the overall impact score for the whole application.

Administrative Core

Governance: Is the governance structure designed to ensure the optimal operations and accountability of the cores that comprise the COBRE? Is the COBRE guided by an appropriately constituted External Advisory Committee? Are appropriate and well-defined responsibilities described for the PD(s)/PI(s), PC(s), Steering Committee, External Advisory Committee, Research Core Directors, and other involved parties? Are the lines of administrative responsibilities within the COBRE and the relationships between the PD(s)/PI(s), PC(s), and the Core Directors clearly delineated?

Communication: Are the proposed dissemination and communication plans adequate for reaching a wide range of investigators, and promoting expansion of the pool of users of the Core facilities? Are there adequate plans for establishing communication lines between the COBRE leadership and the External Advisory Committee and Institutional Leaders?

Evaluation: Are there adequate plans for objectively evaluating the operations and activities of the Center by the COBRE leadership, with input from the Steering and External Advisory Committees? Has the applicant provided evaluation plans with feasible objectives and detailed quantitative and/or concrete criteria for assessing core effectiveness and efficiency? Are there appropriate plans for recommendations of the Steering and External Advisory Committees to be integrated into the effective fiscal, personnel, and scientific management of the COBRE over the course of the grant award?

Scientific/Technical Cores

Need: Does the core provide services and/or resources that meet the scientific needs of the projected COBRE research base? What is the likelihood that the core will increase efficiency, accelerate progress, and promote new research directions for investigators in the institution? Is there a significant pool of researchers and projects that will utilize the resources of the core? For requests of new core facilities, is the request well justified in terms of the need for the core?

Operations: Are the services and resources provided by the core likely to drive science with increasingly sophisticated and powerful technologies, and evolve with the science conducted by the Center investigators? Is the core structured to allow the development of novel concepts, approaches, and methodologies? Are the services and resources of the core of high quality and do they provide advanced techniques and services? Are quality control measures and procedures in place to ensure quality and consistency of services and resources? Are plans and procedures in place to ensure maintenance of cores as state-of-the-art facilities and the resolution of disputes of core usage? Is the core cost-effective in providing services and resources to the Center investigators? Will resource utilization be tracked and are mechanisms in place to adapt resources to the needs of investigators? Does the core effectively leverage existing resources at the institution? Does the proposed institutional commitment position the core for long-term sustainability? Has the applicant provided adequate sustainability plans for the core beyond COBRE 3 support?

Personnel: Are the qualifications, experience, and commitment of the Core Director and other core staff appropriate to the proposed scientific/technical area? Has the core leadership demonstrated expertise in the core technologies by specific training and/or publications using such methods and equipment? Do the core leadership and personnel have experience in advising investigators who use the cores? Are staff members of sufficient numbers and adequate training to support the needs of the projected pool of COBRE investigators? Do these individuals dedicate sufficient time?

Evaluation: Is an adequate plan in place to evaluate core performance, including usage, user needs, and core contributions? Are the evaluation metrics and timelines appropriate?

Pilot Projects Program

Significance: Is the Pilot Projects Program well integrated into the overall goals and objectives of the COBRE? If the Pilot Projects Program has been in existence in the previous COBRE phases, how effective has it been?

Reviewers: Are the plans for constituting the review panel, their qualifications and expertise, appropriate to evaluate Pilot Project applications?

Innovation: Is the program structured to allow the development of novel concepts, approaches, and methodologies?

Approach: Is there an adequate plan to solicit applications, to prioritize the projects, and to review research performance? Are plans adequate to assure compliance with applicable federal policies and guidelines for research and research protections, and to review their methodology?

Environment: Does the institution have a sufficient pool of qualified investigators from whom to solicit applications?

As applicable for the Center 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.

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.

When the proposed Center 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.

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.

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.

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

Not Applicable

Not Applicable

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

Not Applicable

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).

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 .

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.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by 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 will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the NIGMS national Advisory Council. 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.
• Relevance of the proposed project to program priorities.
• Geographic/institutional balance.

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.

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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. 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.

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

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 of all trials whether required under the law or not. For more information, see http://grants.nig.gov/ClinicalTrials_fdaaa/.

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).

Administrative Core

PD(s)/PI(s) will be expected to attend biennial two-day meetings in Bethesda, Maryland with NIGMS staff.

Awardee-selected projects require prior approval by NIH prior to initiation.

Prior to the commencement of any Pilot Project, the following documentation must be submitted to NIGMS staff for administrative review (see Notice NOT-GM-14-111 for details):

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

• Face Page (signed by institutional signing official)
• Project Summary (Page 2)
• Research Strategy Section

Rigor and transparency: As appropriate, include a description of the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of project, and a description of the experimental design and methods proposed and how the Pilot Project Leader will achieve robust and unbiased results. If applicable, also include a brief description of the methods to ensure the identity and validity of key biological and/or chemical resources used in the proposed project. See Notice NOT-OD-16-011 for details.

External Advisory Committee approval - communication from the EAC chair (at a minimum) indicating that the EAC concurs with supporting the Pilot Project.

If the proposed study involves human subjects:

• Current PHS FORMS E - Human Subjects and Clinical Trials Information Form
• Institutional Review Board (IRB) approval
• Written protocol addressing the risks and protections for human subjects, in
• accordance with NIH’s Instructions for Preparing the Human Subjects Section of the Research Plan.
• Human Subjects Education Certification (required even when research is exempt)
• Submission of new enrollment report in the Human Subjects System (HSS) https://era.nih.gov/erahelp/HSS_External/#access_hss.htm%3FTocPath%3DThe%2520Human%2520Subjects%2520System%2520(HSS)%7C_____1

If the proposed project involves clinical trials, in addition to above documents, following documents must also be submitted to NIH:

• Human Subjects Education Certification and Good Clinical Practice (GCP) Training Certification

If the proposed project involves Vertebrate Animals:

• IACUC approval
• Vertebrate Animal Section (see https://grants.nih.gov/grants/olaw/vertebrate_animal_section.htm)

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees 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 $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, 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 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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: [email protected] (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: [email protected]

Crina Frincu, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Courtney Tardd-Wright
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

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.