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 funding initiative supports establishment and development of innovative, state-of-the-art biomedical and behavioral research centers at institutions in IDeA-eligible states through awards supporting three sequential five-year phases. Phase 1 aims to (1) strengthen an institution's biomedical research infrastructure through the establishment of a thematic multidisciplinary center and (2) enhance the ability of investigators to compete independently for NIH individual research grants or other external peer-reviewed support. This funding opportunity announcement (FOA) supports the COBRE Phase 2 awards, which are 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. Phase 3 provides support for maintaining research cores developed during Phases 1 and 2.

Applicants must have an active COBRE Phase 1 award to submit a Phase 2 application in response to this FOA. Applicants to this FOA should be familiar with the structure and goals of a COBRE-funded Center.

An application to this FOA should further strengthen an institution's biomedical research infrastructure through continuing support of a multi-component center that enables multidisciplinary research in a thematic scientific area and develops a critical mass of investigators competitive for independent peer-reviewed external research funding.

As in in Phase 1, the proposed COBRE Phase 2 Center should develop a critical mass of investigators who can secure external funding to support their research programs. Therefore, providing research support and career development guidance to junior investigators must be one of the central focuses of the proposed Center. For this FOA and other IDeA program funding initiatives, a junior investigator is defined as an individual who does not have, or has not previously had, external peer-reviewed Research Project Grant (RPG), Program Project Grant (PPG) or equivalent awards from either Federal or non-Federal sources as the Program Director/Principal Investigator (PD/PI) or project PD/PI of a PPG. Providing research support and career development guidance to junior investigators should be one of the central focuses of the proposed COBRE Phase 2 Center.

This FOA also allows for the recruitment and/or support of established investigators as Research Project Leaders to facilitate the growth and independence of the Center as it seeks to transition beyond COBRE funding.

Overall Plan for the Center: A COBRE Phase 2 application must demonstrate research capacity growth in Phase 1 and include a sustainability plan for Phase 2 and beyond. Sustainability of the research infrastructure, investigators, and research facilities and resources are important elements of a Phase 2 application. Applications should include robust and thoughtful approaches that can deliver the strengthening and enhancement expected for a Phase 2 Center.

Organizational Plan: The proposed Center should continue to support required components, including an Administrative Core and at least three Research Projects. It is expected to support existing Research Cores as appropriate, as well as any new proposed cores Research Cores. As with Phase 1 COBRE Centers, Research Cores are optional. An organizational plan should detail the roles of each proposed component in attaining the goals of the Center and describe how the proposed components will interact with each other and with relevant existing programs and resources in the institution.

Plan for Advisory Committees: As with Phase 1 COBRE Centers, an External Advisory Committee (EAC) comprised of three to five nationally recognized scientists with expertise directly relevant to the scientific theme of the Center must be assembled to advise the PD/PI after the proposed Center is funded. While the EAC from the Phase 1 COBRE Center is expected to continue through the Phase 2 Center, new or replacement EAC expertise is allowed.

The role and requirements of the EAC remain the same as detailed for COBRE Phase 1 Centers. Responsibilities of the EAC include but are not limited to: evaluating scientific progress of the Center-supported Research Projects and Research Cores when applicable; evaluating Research Project Leaders' progress toward acquiring independent research funding; and reviewing replacement/substitute Research Project proposals when such a need arises due to completion or early termination of Research Projects. EAC's approval of replacement/substitute Research Projects is required for the PD/PI to present the request to NIGMS program staff for review. The EAC should meet at least twice per year. An Internal Advisory Committee (IAC) comprised of scientific and/or institutional leaders of the institution may also be proposed to advise the PD/PI. The IAC is optional and cannot act as a substitute for the EAC.

Mentoring Plan: As with Phase 1 COBRE Centers, the Center is required to assign a mentor to each Research Projector Leader with junior investigator status. The Mentor should be a senior faculty member who is able to provide scientific advice and career guidance to the Research Projector Leader. In instances where a suitable mentor is not available within the applicant's institution, it is acceptable to enlist an appropriate mentor from other institutions, including those in non-IDeA states. A mentoring plan should detail how mentoring activities will be conducted.

Evaluation Plan: Similar to Phase 1 COBRE Centers, the Center must develop an evaluation plan with clear timelines and milestones to monitor and evaluate the performance of all components of the Center and the progress of the investigators it supports. Strategies to identify and remedy deficiencies, such as poor performance and lack of progress should be described.

Administrative Core: As in Phase 1, the administrative core provides management in administrative, fiscal, and scientific aspects of the proposed Center. Plans for the Administrative Core should clearly describe how the PD/PI will manage and coordinate the Cores, Projects, Advisory Committees, and Mentors to implement the Center's overall plans and carry out all responsibilities required of the COBRE (P20) award. Responsibilities include, but are 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 such as seminar series, workshops, and retreats.

The Administrative Core, as in Phase 1, may also include an optional Pilot Project Program. Pilot Projects supported should be those that are within the scientific focus of the Center but are not yet ready to be supported as Research Projects. Pilot Projects are selected after an application is funded. Therefore, research plans for Pilot Projects should not be included in the application for review. The description of the Pilot Project Program in the application must include a plan for the solicitation of proposals, their review by the EAC, oversight and evaluation procedures, and assurance of full compliance with all applicable federal policies, rules, and guidelines for research involving human subjects, vertebrate animals, and/or biohazards (see information on Pilot Projects in Post-Award Program Requirements under Section VI of this FOA). Faculty investigators at any rank are allowed to lead Pilot Projects; however, junior 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.

Research Core(s): As with Phase 1 COBRE Centers, funds may be requested to support existing or establish new core facilities that are essential to support the research of the Center. Research Cores can also be consolidated or eliminated, with justification. All Center participants can use the core facilities. Other investigators at the institution may also use the core facilities provided Center participants' research needs are met first. The Director of a Research Core must be an experienced professional with the requisite stature, knowledge, authority, leadership, and administrative skills and capabilities to direct the resource.

Similar to Phase 1, it is expected that a proposed Research Core(s) should be unique and not duplicative of services or facilities that already exist at the applicant institution. Utilization/modification/expansion of existing resources to accomplish the goals of the proposed research is strongly encouraged. Sharing research facilities with INBRE, IDeA-CTR and other COBRE(s) at the institution or other institutions is strongly encouraged. Proposed Research Core(s) that replicate services already available at the applicant institution, including those supported by INBRE, IDeA-CTR and other COBRE(s), will not be allowed without extensive justification.

Research Projects: A minimum of three research projects must be proposed. Similar to Phase 1, each research project should stand alone but share the Center's common thematic scientific focus. Each research project should be led by an investigator who is responsible for ensuring that the Specific Aims of that project are met. Co-Research Project Leaders are allowed only if the research project's needs for complementary scientific leadership are well-justified in the application.

Research Project Leaders must hold a tenure-track faculty appointment (or equivalent at research institutes) at the time the application is submitted. A majority of the Research Project Leaders must hold such appointments at the institution submitting the application. Investigators holding tenure-track faculty appointments (or equivalent at research institutes) at other institutions in IDeA-eligible states may lead less than half of the total number of research projects. A majority of the Research Project Leaders must be junior investigators. Proposed Research Project Leaders who are established investigators must demonstrate a record of research productivity that contributes to the Center's strengthening and competitiveness. Individuals holding appointments that lack independent faculty status are not eligible to lead COBRE Research Projects.

All Research Project Leaders must submit an investigator-initiated Research Project Grant (RPG) application by the end of two years of COBRE support. It is expected a Research Project Leader will be supported by the COBRE for three years and then transition into non-IDeA external research support. COBRE support beyond three years may be provided in rare instances where the PD/PI and EAC are in agreement that progress of the Research Project Leader justifies the continued support. Support of a Research Project Leader by the COBRE award beyond five years is not allowed. The award of peer-reviewed external research funding to a Research Project Leader should be viewed as a milestone and a criterion for graduating from mentored COBRE support. Upon the graduation of Research Project Leader from the COBRE, a replacement/substitute Research Project must be reviewed and approved by the EAC before the PD/PI submits the project to NIGMS program staff for review.

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.

Only active COBRE Phase 1 awardees are eligible to apply.

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

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

Applicant Organizations

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

• 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 1 PD(s)/PI(s) may continue to serve in this role for the Phase 2 Center, 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 who leads, as the principal investigator, at least one peer-reviewed research grant from NIH, NSF or other Federal or non-Federal sources that is closely related to the scientific theme of the proposed COBRE and has mentoring and administrative experience to lead the COBRE program to meet its goals. The PD/PI must be a full-time 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 2 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 PDs/PIs who plan to apply as a PD/PI of a COBRE Phase 2 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 Research Core)	12
Project (use for Research Project)	6

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
• Research Core(s): optional
• Research Projects: required, minimum of 3

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).

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.

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 specific aims for the Center.

Research Strategy: Each application must describe program accomplishments and the Organization and Management Plan of the Center. The important elements that need to be included in the section are the following:

A. Program Accomplishments

The purpose of this FOA is to allow institutions holding COBRE Phase 1 grants to compete for continuation support of thematic, multidisciplinary centers. Thus, progress must be commensurate with previous support and must demonstrate the merit of continued NIH research funding. Applicants must provide evidence that previous support has allowed the Center to achieve specific benchmarks in Phase 1 in the following areas:

Research productivity: Number of scientific publications in peer-reviewed journals from Research Project and Pilot Project Leaders, and the investigators supported by COBRE core facilities, and presentations by junior investigators at scientific meetings and other conferences. This information may be presented in a tabular format.

• Transitions of junior investigators to independent status: Numbers of research grants from junior investigators submitted to and awarded by NIH or other funding agencies (federal and non-federal);
• Improvement of research infrastructure: Utilization of core facilities by COBRE and non-COBRE investigators, and increased research productivity associated with core support.
• Increased critical mass of investigators: Successful recruitment of research faculty through COBRE support.

B. Organization and Management Plan of the Center

The overall Organization and Management Plan for the Center should clearly convey an optimal strategy for a successful Phase 2 Center that has learned from and builds upon the Phase 1 efforts. This should include rigorous and smart uses of the available funding, configuration of the Center and its cores, and approaches for research projects and supporting investigators. The important elements that need to be included in the section are the following:

• Justification of continued support via a second five-year phase for a thematic multidisciplinary COBRE Phase 2 program.
• A description of the unique research opportunities that have been and will continue to be provided to the investigators and to the institution.
• A description of the organization and component functions of the COBRE. The plan should demonstrate the applicant's knowledge, ingenuity, practicality, and commitment to enhancing and maintaining a significant and productive research program.
• A description of how proposed components in the Center will interact with each other and with existing programs and resources in the institution.
• A description of plans for utilizing equipment and instrumentation supported by existing COBRE, INBRE, or IDeA-CTR awards.
• A plan for sustainability of the existing and proposed research capacity and infrastructure, both investigators and research facilities and resources, for the Phase 2 Center and beyond. This should include business and fiscal planning for the resources supported.
• A description of, and justification for, core service facilities that will collectively contribute to the Center.
• A description of how the efforts of each Research Project Leader will contribute to the continued growth of a multidisciplinary research center. Include the overall descriptions of at least three individual research projects. This should include appropriate descriptions of the proposed COBRE Research Projects for the Center, but should not include projects that are incomplete or have not yet been fully defined in terms of the proposed project leader and/or the research plan.
• If community engagement and outreach research is proposed, detailed plans for identifying a health issue that fits community priorities and academic capacity to respond, for developing a coalition of community and academic stakeholders, and for implementing evaluation strategies for the proposed projects must be provided.
• A description of how Mentors are identified. Qualifications of Mentors that make them appropriate to provide scientific advice and career development guidance to the Research Project Leaders should be described. A description of how mentoring will be conducted should be included.
• A description (including names) of the existing EAC members who will continue from their Phase 1 Center service, their relevant expertise, and the role of the EAC in advising the PD/PI to conduct the activities of the COBRE.
• A description of how new EAC members will be added, the expertise that will be expected of the new members (without naming individuals). To avoid potential conflict of interest during the peer-review process, the applicant cannot include the names of any potential new EAC members in the application or contact potential new EAC members prior to receiving the Notice of Award (NoA) for the application.
• A detailed evaluation strategy with specific milestones.

Letters of Support: A letter of support from a senior institutional official (e.g., President or Dean) must be included, outlining the institutional commitment of resources and facilities to sustain and support the COBRE throughout the period of funding and to maintain these resources beyond the period of grant support. The level of institutional commitment will differ among applicant institutions because of the variability of resources available among institutions

Additional letters demonstrating state-level, regional, and/or local commitment and support to the proposed Center 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 (Overall)

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, 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. 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. If human subjects research protocol(s) are used in multiple components or projects of the Center or if data and/or biospecimens from human subjects research protocol(s) are used in multiple components or projects of the Center, a Human Subjects Core should be proposed as one of the Research Cores. A study record(s) with sufficient information for all involved components and projects must be included in the Human Subjects Core.

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

If items are requested as direct costs that are usually treated as F&A costs (for example, general office supplies), the applicant must provide a strong justification for these items and specifically identify that the cost is commensurate with the benefit that particular item will have on the associated project.

A minimum level of effort (LOE) of three person-months is required for PD(s)/PI(s) to devote to career guidance and administrative oversight of the Center. Up to six person-months can be supported by the COBRE. If multiple PDs/PIs are proposed, each PD/PI must have a minimum level of effort of three person-months to devote to career guidance and administrative oversight of the Center. Up to six person-months can be supported for all PDs/PIs collectively by the COBRE. The PD(s)/PI(s) may not use COBRE funds to supplement research activities within his/her laboratory. He/she is not eligible for research project support from this COBRE or any other COBRE (including all three phases), INBRE, and IDeA-CTR awards.

Funds to compensate members of the EAC should be requested in the Administrative Core budget. EAC members can be compensated as consultants via a fee-for-service arrangement.

Funds to compensate Mentors should be requested in the Administrative Core budget. Each Mentor may be compensated for up to one person-month of effort and should be listed in the Administrative Core's budget section of the application and not in the individual research projects' budget sections. 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 scope of the proposed program. These funds are limited to $200,000 direct cost per year and may be used to recruit either junior or established senior investigators. These funds may be used for salary, supplies, and/or equipment costs.

Funds may be used to develop or enhance appropriate community engagement including recruitment and retention efforts by increasing community buy-in and trust, enhancing the reliability and validity of measurement instruments through in-depth and honest feedback during pre-testing, improving data collection through increased response rates, increasing relevance of intervention approaches and thus likelihood for success, targeting interventions to the identified needs of community members, developing intervention strategies that incorporate community norms and values into scientifically valid approaches, increasing accurate and culturally sensitive interpretation of findings, facilitating more effective dissemination of research findings to impact public health and policy, and increasing the potential for translation of evidence-based research into sustainable community change that can be disseminated more broadly.

Funds cannot be used by or for collaborators at institutions in non-IDeA states or 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, obtaining scientific advising/consulting/mentoring (as described above), etc.

PDs/PIs of the Centers funded through this FOA are expected to attend biennial two-day meetings in Bethesda, Maryland with NIGMS staff, as well as biennial regional IDeA meetings. Travel costs for these meetings can be included in the administrative core budget.

Other Expenses: If proposing a pilot project program, those costs should be a line item under "other direct costs". The amount requested in the line item should be for all pilot projects expected to be funded that year (i.e. $200,000 for four pilot projects at $50,000 each or two pilot projects at $100,000 each). Each pilot project can be up to two-years duration with an annual budget of $100,000 (direct cost) or less. The budget should only include a placeholder for the Pilot Projects as prior approval is required before starting any Pilot Projects. See Post-Award Program Requirements under Section VI of this FOA.

COBRE Research Project Leaders cannot receive simultaneous support from the same COBRE award as Pilot Project Leaders, nor can COBRE Pilot Project Leaders receive simultaneous support from the same COBRE award as Research Project Leaders. Furthermore, COBRE Research Project Leaders and Pilot Project Leaders cannot receive simultaneous support from other IDeA awards, including an INBRE, an IDeA-CTR, or a different COBRE.

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. The Introduction must include responses to the criticisms and issues raised in the prior Summary Statement and summarize the substantial additions, deletions, and changes.

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: The important elements that need to be included in this section include the following:

• A clear and full explanation of the necessary administrative, fiscal, and scientific aspects of the proposed Phase 2 COBRE.
• A description of the research and career development goals and capabilities of the proposed Phase 2 COBRE.
• A career guidance plan addressing the development of junior investigators for their transition to and attainment of independent investigator status.
• Since a Research Project Leader who no longer leads a research project may be replaced by a new Research Project Leader, describe the process of selecting candidate investigators and reviewing Research Projects by the EAC for replacement/substitute projects.

A clear plan addressing the development of junior investigators and for their transition to and attainment of independent investigator status must be included. This plan should detail the long-term goals as to how the institution intends to make the transition from the research support of multidisciplinary COBRE projects to competitive grant support through applications submitted by its faculty members to relevant NIH Institutes and Centers or to other appropriate Federal or non-Federal agencies or organizations.

The faculty development plan must include both formative and summative evaluation strategies with specific milestones, including, but not limited to, acquisition of independent status by the junior investigators, competition for complementary NIH, Federal or non-Federal external peer-reviewed research grant support, and publication in peer-reviewed journals.

A Pilot Project Program, to support research proposals of up to 2 years duration with an annual budget of up to $100,000, may be proposed. The description of a Pilot Project program must include a plan for the solicitation of proposals, their review by the EAC and funding prioritization, oversight and evaluation procedures, and assurance of full compliance with all applicable federal policies, rules, and guidelines for research involving human subjects, vertebrate animals, and/or biohazards. Complete eligibility information for Pilot Project Leaders is found in Post-Award Program Requirements under Section VI of this FOA, since Pilot Project Leaders are chosen after an application is awarded. Research plans for individual Pilot Projects should not be included in the application.

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

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.

When preparing your application, use Component Type Core .

If human subjects research protocol(s) are used in multiple components or projects of the Center or if data and/or biospecimens from human subjects research protocol(s) are used in multiple components or projects of the Center, a Human Subjects Core should be proposed as one of the Research Cores.

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 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 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 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, 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 or personnel.

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 maintain and/or establish core facilities. In addition to personnel and supply costs, the acquisition of new equipment and modernization of instrumentation may be proposed. Alteration and Renovation (A&R) of core facilities cannot be proposed, nor can funds be used to support A&R.

Core facilities should have a detailed budget for the entire proposed project period (five years).

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

PHS 398 Research Plan (Research Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed (but not required) in the Research Core component. The Introduction must include responses to the criticisms and issues raised in the prior Summary Statement and summarize the substantial additions, deletions, and changes.

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: The important elements that need to be included in this section are the following:

• A description of how each Core will impact the development and sustainability of the Center and how each core will serve the scientific needs of the individual Research Projects.
• A description of how the Core will operate.
• A description and justification for any support for instrumentation to augment existing or establish new Core facilities, including the needs of each research project for the Core(s) and how this instrumentation will benefit investigators and improve the research infrastructure of the institution.
• A description and justification for new Cores proposed, including how new Core facilities will benefit investigators and improve the research infrastructure of the institution.
• Each Core description should indicate the proposed business plan for operation of the core, including prioritization of the service requests.

It is expected that any proposed Core should be unique and not duplicate services or facilities that already exist at the applicant institution. When applicable, research cores currently funded by other COBRE, INBRE or IDeA-CTR awards must be described.

Utilization/modification/expansion of existing resources to accomplish the goals of proposed research is strongly encouraged. Extensive justification must be provided if proposed research Cores appear to replicate services already available at the applicant institution.

Although the COBRE award is not intended to replace support for ongoing investigator-initiated research projects, all center participants, including the Mentors, as well as other non-center investigators at the institution, may use research core facilities.

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

Additional letters demonstrating state-level, regional, and/or local commitment and support to the proposed research Core(s) 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 (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, 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. 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. If human subjects research protocol(s) are used in multiple components or projects of the Center or if data and/or biospecimens from human subjects research protocol(s) are used in multiple components or projects of the Center, a Human Subjects Core should be proposed as one of the Research Cores. A study record(s) with sufficient information for all involved components and projects must be included in the Human Subjects Core.

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 (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 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.

Research Project Leaders must hold a tenure-track faculty appointment (or equivalent at research institutes) at the time the application is submitted. Individuals holding postdoctoral fellowships or other positions that lack independent faculty status are not eligible to lead COBRE research projects. Established investigators can also serve as Research Project Leaders in a Phase 2 COBRE Center. A majority of the Research Project Leaders must be junior investigators. A junior investigator is defined as an individual who does not have and has not previously had an external, peer-reviewed RPG, Program Project Grant (PPG) or PPG subproject, or equivalent award from either a Federal or non-Federal source that names that investigator as the PD/PI. Grants that name an individual as a co-investigator, collaborator, consultant, or to a position other than PD/PI on research grants that allow multiple PD(s)/PIs, do not disqualify that investigator from junior status. Academic Research Enhancement Award (AREA) grants, exploratory/pilot project grants (such as NIH R03 and R21 awards), mentored career development awards (such as NIH K01 and K08 awards), or other Federal or non-Federal not characterized as research grants also do not disqualify the investigator. Since NIH K awards typically require nine person-month commitments, however, junior investigators that are also K awardees can serve as COBRE project leaders only during the last two years of the K awards when the commitments are allowed to be reduced to six person-month per NIH policy. Investigators who have obtained significant support in the form of an RPG or PPG (e.g., NIH R01, K99/R00, or P01, NSF, or other Federal or non-Federal agency awards) would not be considered junior investigators.

Each Research Project Leader should indicate in his/her Biographical Sketch their current and previous history of peer-reviewed research support. Research projects can have co-leaders if necessitated by the work proposed. These cases should include clear scientific justification for the inclusion of a co-leader for the project and how the co-leader will contribute to the strengthening of the overall COBRE, as appropriate. COBRE Research Project Leaders cannot receive simultaneous support from the same COBRE award as Pilot Project Leaders, nor can COBRE Pilot Project Leaders receive simultaneous support from the same COBRE award as Research Project Leaders. Furthermore, COBRE Research Project Leaders and Pilot Project Leaders cannot receive simultaneous support from other IDeA awards, including an INBRE, an IDeA-CTR, or a different COBRE.

Support of a Research Project Leader by the COBRE mechanism beyond a total of five years is not allowed. A researcher supported for less than five years on a COBRE Phase 1 can also be proposed to lead a project on a COBRE Phase 2, but the five-year total limit on project support still applies.

If an individual is serving in an advisory role, this person should be listed as a key person in the application.

Budget (Research Project)

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

The applicants should propose a five-year budget for each research project. The proposed five-year budget will apply to not only the proposed projects, but also the replacement projects when the initial projects are completed after two to three years.

Research Project Leaders that hold junior investigator status must make an initial minimum effort commitment of six person-months annually. Established investigators must make an initial effort commitment of at least three person-months annually. It is recognized that during the development of an investigator's career (for example, the acquisition of other research support), it may be necessary to reduce these levels of commitment. PD(s)/PI(s) should consult with NIGMS program staff regarding appropriate reductions, as reductions below the minimum effort required or a decrease of 25% or more from the approved level of effort will require prior NIGMS approval. Each Research Project Leader should indicate in the Biographical Sketch his/her current and previous history of peer-reviewed research support.

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)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed (but not required) for each component. The Introduction must include responses to the criticisms and issues raised in the prior Summary Statement and summarize the substantial additions, deletions, and changes.

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: The application should describe long-term goals and delineate the design principles supporting the research or the hypotheses to be tested. Preliminary studies are not required for COBRE applications, but they are encouraged. In the absence of preliminary results, applicants should describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project. Each research project should describe its relationship to the area of multidisciplinary research that is the focus of the COBRE. It should also critically assess the existing knowledge and approaches that have been, or are being, directed in the area with a specific emphasis on how the multidisciplinary COBRE approach will advance the field. Moreover, the importance and health relevance of the proposed research should be concisely stated.

Each individual Research Project description must be complete. The application must not include projects that are incomplete or have not yet been fully defined in terms of the proposed Research Project Leader and/or the research plan.

Letters of Support: The applicant institution must demonstrate, in a letter(s) from the appropriate senior institutional official(s), a clear commitment to support the faculty appointment independent of the outcome of the COBRE grant application.

Additional letters demonstrating state-level, regional, and/or local commitment and support to the proposed Research Projects 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 (Research Project )

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. 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. If human subjects research protocol(s) are used in multiple components or projects of the Center or if data and/or biospecimens from human subjects research protocol(s) are used in multiple components or projects of the Center, a Human Subjects Core should be proposed as one of the Research Cores. A study record(s) with sufficient information for all involved components and projects must be included in the Human Subjects Core.

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 and below.

• In addition to the materials listed in the Post Submission policy, updates on funding obtained (not applications submitted) by Research Project Leaders or Pilot Project Leaders who have participated in a previously awarded COBRE Phase 1 will also be accepted.

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 Center 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?

Program Accomplishments: Has previous support allowed the Center to achieve specific benchmarks, which include career progression of and obtaining independent funding by the junior investigators, including 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?

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 Center 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?

Has the PD(s)/PI(s) shown the ability to lead, develop, and direct the COBRE to establish thematic collaborative research efforts? Has the PD(s)/PI(s) shown effective leadership and judgment in the selection of Research Projects in terms of Research Projects being of high quality and significance? Has the PD(s)/PI(s) shown effective leadership in directing and managing the career guidance plan required to move the investigators toward independent status? Does the PD(s)/PI(s) present a plan for the continued development of investigators to independent status?

If a new PD(s)/PI(s) has been selected, has the new PD(s)/PI(s) provided evidence of successfully mentoring and guiding graduate students, postdoctoral fellows and junior investigators as well as leading a large research group?

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?

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 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 Center 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?

Overall Plan for the Center:

Does the overall plan provide confidence that a productive, thematic multidisciplinary center can (or will) continue for an additional five years?

Are the efforts and ongoing research of all Research Project Leaders described in the context of developing an independent and sustainable multidisciplinary program? Are the proposed projects related to and consistent with the overall goals of Center?

If the PD(s)/PI(s) plans to recruit new investigators in the future, are these plans consistent with the thematic focus of the Center? Are the senior investigators research projects related to, and do they advance, the thematic focus of the COBRE?

Are highly qualified senior faculty members assigned as Mentors to Research Project Leaders? Does the mentoring plan include clear strategies of Mentors providing advice and guidance to Research Project Leaders?

Are the role and continuance of the External Advisory Committee properly described? Is the proposed scientific expertise of EAC members adequate to critique the scientific progress of the Center and offer advice on scientific matters including the evaluation of Research Projects and Research Project Leaders to the PD(s)/PI(s)? Is the role of the External Advisory Committee in these matters properly described?

Milestones and Evaluation: Does the application include appropriate and suitable evaluation strategies? Does the development plan include both formative and summative evaluation strategies detailing specific milestones for the acquisition of independent status by the investigators, the Research Cores, and the overarching research infrastructure supported by the Center? Are specific milestones identified and supported to measure progress toward attaining long-range goals?

If support for instrumentation to augment existing or establish new core facilities is requested, does the application identify the needs of each component research project for the core(s) and how this instrumentation will facilitate the Center’s research?

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?

Does the application describe the institutional commitment to provide support for the continued development of a thematic multidisciplinary center? Has the applicant described the environment and resources available to investigators, and indicated how COBRE support has improved facilities or made available new and collaborative resources (e.g., laboratory facilities, patient populations, laboratory space and personnel)? Does the applicant detail the long-term goals as to how the institution intends to make the transition from the research support of the COBRE to competitive grant support?

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 (as applicable for the Overall, Core, and Projects proposed).

Administrative Core

Does the Administrative Core plan provide confidence that the Overall plans of the Center will be fully implemented?

Is there a coordinated plan to manage and coordinate the Cores, Projects, Advisory Committees, and Mentors to reach the Center's goals?

Is there a clear plan to carry out all responsibilities required of the COBRE (P20) 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 such as seminar series, workshops, and retreats?

Does the Administrative Core include a clear plan for the transition to and attainment of independent status for junior investigators and for the continued development of early career investigators and describe how the Center as a whole intends to make the transition from support of multidisciplinary COBRE research projects to competitive grant support?

Has the process of selecting candidate investigators and reviewing Research Projects by EAC for replacement/substitute project been appropriately described?

If a Pilot Project Program is proposed, is there an adequate plan to solicit proposals, prioritize the projects and review their methodology and research performance? Are plans adequate to assure compliance with applicable federal policies and guidelines for research and research protections?

Research Cores

Has the Core Director and/or the PD/PI (as appropriate) provided the necessary oversight to establish and maintain the necessary core resources and laboratory facilities to carry out the objectives of the application? In the case of new proposed Research Cores, has the application proposed an adequate oversight by the proposed Core Director and/or the PD/PI (as appropriate) to establish and maintain the proposed core resources and laboratory facilities to carry out the objectives described in the application?

Do the Core resources and facilities adequately serve the scientific needs of the individual Research Projects? In the case of new proposed Research Cores, will the proposed core resources and facilities adequately serve the scientific needs of the individual Research Projects?

Are the personnel who do or will direct the Core facility as well as the technical staff who operate the Core facility well qualified?

Has the Core Director and/or the PD/PI (as appropriate) obtained institutional commitments sufficient to ensure that the resources and facilities required to sustain the Center are present?

Are requests of new Core facilities justified, considering the institution's currently available facilities, to meet the needs of the COBRE thematic research focus?

For each Research Project, reviewers will consider each of the review criteria below in determination of scientific and technical merit and provide an overall impact score but will not give separate scores for the individual criteria.

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.

Significance

Does the project 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 project 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, for applications involving clinical trials: 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?

Investigator(s)

Are the Research Project Leader(s), collaborators, and other researchers well suited to the project? For Early Stage Investigators or those investigators in the early stages of independent careers, do they have appropriate experience and training? For established investigators, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Are the strengths, academic qualifications and biomedical expertise of the Research Project Leaders appropriate and sufficient for research productivity? Do the Research Project Leaders publish their work in a timely manner? Do the Research Project Leaders demonstrate the ability to compete successfully for investigator-initiated support? Do Research Project Leaders show career development potential and/or an ability to achieve independent status? For Research Project Leaders new to the COBRE, do they show career development potential and/or an ability to achieve independent status?

In addition, for applications involving clinical trials: With regard to the proposed leadership for the project, do the Research Project Leaders 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 multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating 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?

In addition, for applications involving clinical trials: 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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the Research Projects 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 Research Project Leaders presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? Can this project stand alone?

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) the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (exclusion) of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

If this project involves community engagement and outreach research, are there clear and detailed plans for identifying a health issue that fits community priorities and academic capacity to respond? Are there plans for developing a coalition of community and academic stakeholders and for implementing evaluation strategies for the proposed projects? Is the research characterized by substantial community input in the development of the proposed study? Are community members, persons affected by the health condition, disability or issue under study, or other key stakeholders in the community’s health, full participants in each phase of the research, including conception, design, conduct, analysis, interpretation, drawing of conclusions and communication of results?

In addition, for applications involving clinical trials: 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?

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

In addition, for applications involving clinical trials: 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 international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial? 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?

As applicable for the Overall, Core, 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 proposing 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)?

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 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.

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.

For Renewals, the committee will consider the progress made in the last funding period.

Not Applicable

As applicable for the project or core 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 to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• 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.

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/.

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 awardee 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).

Administrative Core

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

Research Projects

Research Project Leaders are named as key personnel on the Notice of Award. LOE reductions below the required minimum effort (six person-months for junior investigators and three person-months for established investigators) or a decrease of 25% or more from the approved LOE will require NIGMS prior approval.

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

If a Research Project Leader will be leaving the COBRE, the grantee must request approval for this change when it happens. The grantee should not wait until a replacement Project Leader has been identified to request approval for the change. The new COBRE Research Project that replaces the completed project must be reviewed by the PD(s)/PI(s) and the EAC. The PD(s)/PI(s) must communicate the EAC recommendation to the NIGMS for their programmatic and administrative review.

All Research Project Leaders, regardless of their career status, must submit independent investigator-initiated research project grant (RPG) applications by the end of two years of COBRE support. It is expected that a Research Project Leader will be supported by the COBRE for three years and move to independent research support. COBRE Research Project support beyond three years may be provided in circumstances where the PI and the EAC have carefully evaluated the progress and Research Project and concluded that continued support is justified. Support of a Research Project Leader by the COBRE mechanism beyond a total of five years is not allowed.

An investigator who has acquired independent RPG support may direct a COBRE core facility or serve as an advisor. In either case, investigators should not be excluded from Center activities and should be encouraged to participate in collaborative research efforts. In some instances, a Research Project Leader may be considered for removal from the COBRE program if a review by the EAC indicates a failure by the investigator to make significant progress toward achieving the specific aims of his/her project or, as noted above, failure to submit an investigator-initiated RPG application by the end of two years of COBRE support.

A junior investigator who has acquired independent status through the award of an RPG may continue to participate as a COBRE Research Project Leader to complete aims proposed in the COBRE Project that do not overlap with the new RPG. In this case, continued support for personnel (e.g., postdoctoral associates, graduate students, technicians, etc.) associated with the COBRE Project but also listed on the other award can be provided. However, the percent efforts of these individuals must be appropriately adjusted. In cases where the new award funding overlaps or is significantly similar to the work described in the COBRE Project, COBRE funding can be terminated.

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

Pilot Projects

If a Pilot Project Program is proposed, the Pilot Project(s) must be reviewed by EAC. It is strongly encouraged that junior investigators with tenure-, research-, or clinical -track faculty appointments are given the first priority for consideration for leading the Pilot Projects. However, individuals holding postdoctoral training positions are not eligible to lead COBRE Pilot Projects.

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

Pilot Project Leaders do not have a required minimum level of effort and are not named as key personnel. Any changes to their effort or removal from the COBRE does not require prior approval and can be reported in annual progress reports.

Awardee-selected projects require prior approval by NIH before the commencement of any Pilot or Replacement Research Projects, and the following documentation must be submitted to NIGMS staff for administrative review:

Replacement Research Projects:

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
• Updated Other Support (research project only)
• Biographical Sketch (research project only)
• Detailed budget and budget justification (research project only)
• Checklist Format Page with F&A cost breakdown (research project only)

External Advisory Committee approval - communication from the EAC chair (at a minimum) indicating that the EAC concurs with supporting the research or pilot project

If the proposed study involves human subjects:

• Current PHS Human Subjects and Clinical Trials Information Form https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general/g.500-phs-human-subjects-and-clinical-trials-information.htm
• Institutional Review Board (IRB) approval
• Human Subjects Education Certification (required even when research is exempt)

If the proposed project involves clinical trials:

• Current PHS Human Subjects and Clinical Trials Information Form https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general/g.500-phs-human-subjects-and-clinical-trials-information.htm
• 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: Within 30 days after receiving NIGMS approval, the grantee must enter study data in the Human Subjects System (HSS).

If the proposed project involves Vertebrate Animals:

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

Pilot Projects (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

External Advisory Committee approval - communication from the EAC chair (at a minimum) indicating that the EAC concurs with supporting the research or pilot project

If the proposed study involves human subjects:

• Current PHS Human Subjects and Clinical Trials Information Form https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general/g.500-phs-human-subjects-and-clinical-trials-information.htm
• Institutional Review Board (IRB) approval
• Human Subjects Education Certification (required even when research is exempt)

If the proposed project involves clinical trials:

• Current PHS Human Subjects and Clinical Trials Information Form https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general/g.500-phs-human-subjects-and-clinical-trials-information.htm
• 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: Within 30 days after receiving NIGMS approval, the grantee must enter study data in the Human Subjects System (HSS).

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. In the RPPR include progress towards the four program accomplishments listed in the description of the overall research program (research productivity, research grants submitted, improvement of infrastructure and increased critical mass of investigators, to assist in evaluating the program. 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.

In addition to submitting annual progress reports, COBRE awardees are also required to provide Supplemental Programmatic Data in the NIGMS Scientific Information Reporting System (SIRS). The SIRS system can be accessed at: https://sirs.nigms.nih.gov. Similar to the RPPR submission, SIRS submissions are due 60 days before the end of the active budget period. Approved research and pilot projects should be reported as separate components in the RPPR.

A summary of the issues discussed at each EAC meeting, recommendations made, and actions taken must be included in the yearly progress reports submitted to the NIGMS.

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]

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

Stephanie Constant, PhD.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Samantha Farrell, MHS
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.