NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

The Centers of Biomedical Research Excellence (COBRE) program seeks to promote the development or expansion of unique, innovative state-of-the-art biomedical and behavioral research centers at institutions in IDeA-eligible states. The COBRE program consists of three sequential five-year phases. Phase I focuses on developing research infrastructure and providing junior investigators with career guidance opportunities and research project funding to help them acquire preliminary data and successfully compete for independent research grant support. Phase II is intended to strengthen the center through further improvements in research infrastructure and to continue development and support of a critical mass of investigators with shared scientific interests. Phase III provides support for maintaining COBRE research cores developed during phases I and II. This funding opportunity announcement (FOA) focuses on COBRE phase II.

The objectives of COBRE phase II are the following:

• To further strengthen an institution's biomedical research infrastructure through continuing support of a thematic multi-disciplinary center established in COBRE phase 1.
• To enhance the ability of investigators to compete independently for individual research grants or center grants from NIH or other funding agencies.

Career guidance of investigators who are not yet established are significant parts of the creation and establishment of the critical mass of successful investigators necessary to make up a research center. The participation of junior investigators is integral to this concept. A junior investigator is defined as an individual who does not have, or has not previously had external, peer-reviewed Research Project Grant (RPG) or Program Project Grant (PPG) support from either Federal or non-Federal sources for which the individual is named as the PD/PI. This FOA also includes continued support for new and early career investigators to promote the success and integrity of the research center. Furthermore, this FOA allows the recruitment and/or support of established investigators to facilitate the growth and independence of the center. Investigators must demonstrate a record of productivity. Taken together, these efforts are intended to promote the development of an independent and successful research center. Although any investigator is eligible to participate as a research project investigator in the center, junior (new or early career investigators) must be given priority to lead research projects. It is expected that junior investigators will represent the majority of supported investigators.

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 in response to this FOA.

Only active COBRE Phase I awardees may 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) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 I PD(s)/PI(s) may continue to serve in this role or a new PD(s)/PI(s) may be appointed. In either case, the PD/PI must be an established biomedical or behavioral research scientist, who has an active research laboratory, and peer-reviewed funding (NIH, NSF or other Federal or non-Federal investigator-initiated support).

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).

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Component Types Available in ASSIST	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)	12

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

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

The application should consist of the following components:

• Overall: Required
• Administrative Core: Required
• Research Core(s): Optional
• Projects: Required, minimum of 3, maximum of 5

When preparing your application in ASSIST, 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. 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: Provide specific aims for the Center.

Research Strategy: Each application must describe program accomplishments and center organization and management plan. The important elements that need to be included in the section are the following:

A. Program Accomplishments

A description of the major progress and accomplishments made in COBRE Phase I in the following areas:

The purpose this FOA is to allow institutions holding COBRE Phase I grants to compete for continuation support of thematic, multi-disciplinary 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 made in COBRE phase I in the following areas:

• Research productivity: Number of scientific publications in peer reviewed journals from junior investigators (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 tabular form.;
• Transitioning of Junior investigators to independent status: Numbers of research grants submitted to and awarded by NIH or other funding agencies;
• 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 science faculty through COBRE support.

B. Center Organization and Management plan

An overall Center Organization and Management Plan must be provided in the following areas:

• Justification of a continued second five-year support for a thematic multidisciplinary COBRE Phase II program.
• Description of the unique research opportunities that have been and will continue to be provided to the investigators and to the institution. A research strategy that describes the organization and component functions of the COBRE. The plan should demonstrate the applicant's knowledge, ingenuity, practicality, and commitment to developing and maintaining a significant and productive research program.
• Sharing research resources among IDeA programs is strongly encouraged. Applicants should describe plans for utilizing equipment and instrumentation supported by existing COBRE or IDeA Networks of Biomedical Research Excellence (INBRE) awards.
• A description of and justification for the proposed individual research projects and core service facilities that collectively will contribute to the center.
• A description of how the efforts of each research project leader will contribute to the establishment of a multi-disciplinary research center.

Letters of Support: Matching funds are not required for these applications. However, evidence of institutional commitment must be included and explicitly described and/or documented. The level of institutional commitment may differ across applicant institutions because of the variability of resources available at those institutions. At a minimum, a letter of support from a senior institutional official (e.g., President or Dean) should outline the commitment of resources and facilities to sustain and support the COBRE throughout the funding period and plans to maintain these resources beyond the period of grant support.

Any additional letters of support for the proposed center should also be included.

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

Appendix: Do not use the Appendix to circumvent page limits. 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study
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 in ASSIST, use Component Type Admin Core.

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

Complete only the following fields:

Applicant Information

Type of Applicant (optional)

Descriptive Title of Applicant’s Project

Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

List all performance sites that apply to the specific component.

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

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

The PD(s)/PI(s) should clearly designate in the text the identity of the scientific advisors and describe their qualifications, both scientific and advisory, that make them appropriate to assist in the oversight of the project.

An applicant may request a budget for total direct costs of no more than $1.5 million per year excluding facilities and administrative (F&A) costs on consortium arrangement. If items are requested as direct costs that are normally treated as F&A costs (for example, general office supplies), the applicant must provide a strong justification for these items and demonstrated that the cost is commensurate with the benefit that particular item of cost will have on the associated project.

The PD(s)/PI(s) of the COBRE is not eligible for research project support from his/her COBRE or other COBRE (including all three phases) or INBRE awards. He/she may not use COBRE funds to supplement research activities within his/her laboratory. A minimum time commitment of 3 person months is required for PD(s)/PI(s). However, up to 6 person months will be supported for administrative oversight of the center. If multiple PDs/PIs are proposed, each PD/PI must devote 3-6 person months for administration of the center.

Each scientific advisor may be compensated for up to 1 person month of effort and should be listed in the Administrative Core's budget section of the application and not in the individual research projects' budget sections. Advisors from non-IDeA states can be compensated as a consultant or via a fee- for-service arrangement.

Funds may be used to recruit additional faculty who complement the scope of the proposed program. These funds are limited to $200,000 direct cost per year for each position and may be used to recruit either junior or established senior investigators. These funds may be used for salary, supplies, and/or equipment costs.

PD(s)/PIs of the Centers funded through this FOA should budget for attending biennial two-day meetings in Bethesda, Maryland with NIGMS staff.

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

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 in Administrative 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 Applicants must provide a clear and full explanation of the necessary administrative, fiscal and scientific aspects of the proposed COBRE. A detailed career guidance plan for the transition to and attainment of independent status for junior investigators and for the continued development of early career investigators must be included. This plan should also describe how the center as a whole intends to make the transition from support of multi-disciplinary COBRE research projects to competitive grant support obtained through applications submitted by its faculty members to relevant NIH Institutes and Centers or other appropriate Federal or non-Federal agencies or organizations.

The PD(s)/PI(s) should provide a brief summary of 3-5 standing alone research projects supervised by a single investigator who is responsible for ensuring that the specific aims of that project are met. The PD(s)/PI(s) should also indicate how the projects share a common thematic scientific focus, and explain the relationship between projects and research core(s).

Each junior investigator must have at least one scientific advisor. The advisor must be an established investigator who has demonstrated the ability to advise others on the acquisition of external support and the maintenance of an independent research laboratory. In some instances a suitable advisor may not be available within the applicant's institution and it is therefore acceptable to enlist appropriate advisors from outside institutions, including institutions in non-IDeA states.

The career guidance plan must include both formative and summative evaluation strategies detailing specific milestones, including, but not limited to, the acquisition of independent status by the investigators; competition for NIH, Federal or non-Federal external peer-reviewed research grant support; and publications in peer-reviewed journals.

Faculty development should include a strategy that involves oversight by established senior faculty members assigned as scientific advisors, constructive evaluations by members of the External Advisory Committee (EAC,.), and coordinated management of all of these individuals by the PD(s)/PI(s) of the COBRE program. Additional oversight may be augmented through the use of an internal advisory committee.

Each COBRE application must include a description of an EAC comprised of 3-5 scientists with national scientific reputations in their fields. Their expertise must be directly relevant to the scientific theme of the COBRE. The EAC critiques the scientific progress of the COBRE and also offers advice on scientific and administrative matters to the COBRE PD(s)/PI(s). Describe EAC activities including developing and planning concepts and programs, encouraging and assisting faculty development and mentoring, identifying resources, evaluating the development of the center, evaluating the progress of the individual research projects, and evaluating the junior investigators' progress toward acquiring independent status. The PD(s)/PI(s) should share the advice and critiques provided by the EAC with other COBRE investigators at the center. The EAC should also review and recommend candidate investigators for replacement/substitute projects, as required, before such requests are forwarded to the NIGMS for programmatic review. The EAC must meet at least twice per year. Video-, teleconferencing or other means may be used in situations where it would be difficult to hold an in-person meeting.

A Pilot project program, to support research proposals of up to 2 years duration with annual budget less than $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. Research plans for individual pilot research projects should not be included in the application.

Letters of Support: Letters indicating institutional commitment and any letter of support for the proposed administrative core should be included.

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

Appendix: Do not use the Appendix to circumvent page limits. 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: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Research Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Core)

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

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

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

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

List all performance sites that apply to the specific component.

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

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

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

Qualifications and Responsibilities of Core Director(s)

Director(s) of research core facilities must be experienced personnel with the requisite stature, knowledge, authority, leadership, and administrative skills and capabilities to direct the resource. The Core Director should describe expertise to 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.

Budget (Research Core)

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 (5 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 in 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 applicant must demonstrate that each core will serve the scientific needs of the individual research projects and must show how each core will impact the development and sustainability of the center. A clear description of how the cores will be operated must be provided. If support for instrumentation to augment existing or establish new core facilities is requested, the application should identify 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. Although the COBRE award is not intended to replace support for ongoing investigator-initiated research projects, plans may be described for all center participants, including the advisors, as well as other non-center investigators at the institution, to use these facilities. If a new core is proposed, justification must be provided by showing how a new core facility will benefit investigators and improve the research infrastructure of the institution.

It is expected that any proposed core should be unique and not duplicate services or facilities that already exist at the applicant institution. Utilization/modification/expansion of existing resources to accomplish the goals of proposed research is strongly encouraged. Extensive justification must be provided if proposed research cores that appear to replicate services already available at the applicant institution are described.

Each core description may include plans to recruit personnel to operate the core, if needed, and the proposed business plan for operation of the core including prioritization of the service requests.

Letters of Support: Letters indicating institutional commitment to support and maintain the proposed facilities should be included.

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

Appendix: Do not use the Appendix to circumvent page limits. 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: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, 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.

Investigators must hold a faculty appointment (or equivalent at research institutes) at the time the award is made. Individuals holding postdoctoral fellowships or other positions that lack independent faculty status are not eligible to lead COBRE research projects.

An investigator who is supported by IDeA Networks of Biomedical Research Excellence (INBRE) is not eligible to receive research support from COBRE. An investigator is not allowed to receive research support from multiple COBREs simultaneously.

Budget (Research Project)

The applicants should propose a 5-year budget for each research project (i.e. Research proposal of at least 2 years duration with annual budget more than $100,000). The proposed 5-year budget will apply to not only the proposed projects, but also the replacement projects when the initial projects are completed after 2-3 years.

Research project investigators must make an initial minimum commitment of 6 person months annually. Established investigators must make an initial commitment of at least 3 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. Each project investigator 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 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 the goals for the long term, 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 rationale and scientific basis for the proposed research. Each research project should describe its relationship to the area of multi-disciplinary 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 multi-disciplinary COBRE approach will advance the field. Moreover, the importance and health relevance of the proposed research should be concisely stated.

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.

Any letter of support for the proposed research project should be included.

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

Appendix: Do not use the Appendix to circumvent page limits. 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: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: 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: https://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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow our Post Submission Application Materials policy.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research 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 project that by its nature is not innovative may be essential to advance a field.

Does the program address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the program? If the aims of the program 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 the acquisition of independent status by the junior investigators, publishing data in peer-reviewed journals, and evidence that the competitiveness of these investigators for other NIH, Federal or non-Federal external peer-reviewed research grant support has been enhanced?

Is there evidence that a critical mass of investigators has been (or is being) established?

Have new investigators been recruited to the center and have these efforts been successful in increasing the biomedical or behavioral research capacity of the institution?

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

Does the PD(s)/PI(s) demonstrate leadership by showing that the infrastructure necessary for the continued functioning of the center (e.g., facility improvements, modernization/acquisition of equipment, implementation of administrative resources, etc.) is in place, and that the institution is committed to maintain the resources and infrastructure that have been established through prior COBRE support?

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

If the program 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 children, justified in terms of the scientific goals and research strategy proposed?

Center Organization and Management Plan: Does the overall plan provide confidence that a productive, thematic multi-disciplinary center can (or will) continue for an additional five years?

Are the efforts and ongoing research of all center investigators described in the context of developing an independent and sustainable multi-disciplinary 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?

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

Does the application 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)?

Reviewers will score each core based on the criteria provided

Administrative Core

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 multi-disciplinary COBRE research projects to competitive grant support?

Does the development plan include a career guidance plan that involves oversight by established senior faculty members assigned as advisors, and constructive evaluations by members of the External Advisory Committee? Is there coordinated management of all of these individuals by the PD(s)/PI(s) of the COBRE program?

Milestones and Evaluation: Has the PD(s)/PI(s) selected 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? Are specific milestones identified and supported to measure progress toward attaining long-range goals?

Has the PD(s)/PI(s) described the strategies and milestones that will be applied in the future, describing what has worked and what needs to be improved in terms of milestones?

Is the External Advisory Committee properly constituted with the scientific expertise to critique the scientific progress of the COBRE and offer advice on scientific matters to the COBRE PD(s)/PI(s)?

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 PD/PI provided the necessary oversight to establish and maintain the necessary core resources and laboratory facilities to carry out the objectives of the application?

Do the core resources and facilities serve the scientific needs of the individual research projects?

Are the personnel who direct the core facility as well as the technical staff who operate the core facility well qualified?

Has the PD/PI obtained institutional commitments sufficient to ensure that the resources and facilities required to sustain the center are present?

For requests of new core facilities: is the request justified in terms of the need for the core as it relates to 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.

For this particular announcement, note the following: 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 there a strong scientific premise for the project? 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 proposing 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 PD(s)/PIs, collaborators, and other researchers well suited to the project? 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)? 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 project investigator appropriate and sufficient for research productivity? Does the project investigator have the potential and ability to achieve independent status? Does the investigator demonstrate the ability to compete successfully for investigator-initiated support? Does the investigator publish his/her work in a timely manner? For project investigators new to the COBRE, do they show career development potential and/or an ability to achieve independent status?

In addition, for applications proposing clinical trials: With regard to the proposed leadership for the project, do the PD/PI(s) 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 proposing 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 presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, 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?

Can this project stand alone?

In addition, for applications proposing clinical trials: Does the application adequately address the following, if applicable:

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 scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? 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?

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

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 six 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 six 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 children 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 project.

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

Not Applicable

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

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 . Following initial peer review, recommended applications will receive a second level of review by the NIGMS Advisory Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

Additionally, ICs may specify any special reporting requirements for the proposed clinical trial to be included under IC-specific terms and conditions in the NoA. For example: If the proposed clinical trial has elevated risks, ICs may require closer programmatic monitoring and it may be necessary to require the awardee to provide more frequent information and data as a term of the award (e.g., to clarify issues, address and evaluate concerns, provide documentation). All additional communications and information related to programmatic monitoring must be documented and incorporated into the official project file. Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

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

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as 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

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.

New COBRE research project that replace 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. 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 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.

If Pilot Project Program is proposed, the pilot project(s) must be reviewed by EAC. The recommendation from EAC must be submitted to NIGMS for programmatic review as described below. It is strongly encouraged that junior investigators are given the first priority consideration for leading the pilot projects.

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

Research Core

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

Research Project

All research project investigators, regardless of their career status, must submit independent investigator-initiated research project grant (RPG) applications by the end of two years of COBRE phase II support. It is expected that a research project investigator will be supported by the COBRE for 3 years and move to independent research support. COBRE support beyond three years may be provided in circumstances where the PD/PI and the EAC have carefully evaluated the progress and research project and concluded that continued support is justified. Support of a research project investigator by the COBRE mechanism beyond a total of 5 years is not allowed.

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

An investigator who has acquired independent status through the award of an RPG may continue to participate as a COBRE research project investigator to complete aims proposed in the COBRE project that do not overlap with the new RPG. However, funding from the COBRE program will be adjusted or terminated when an investigator's new award overlaps or is significantly similar to the work described in the COBRE project.

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

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

• Using PHS398 forms and instructions, only the following sections need to be submitted:
  • Face page (signed by institutional signing official)
  • Project Summary (page 2)
  • Biographical Sketch (Research project only)
  • Updated Other Support
  • Detailed budget and budget justification (Research project only)
  • Research Strategy section
• External Advisory Committee (EAC) approval communication from the EAC chair (at a minimum) indicating that the EAC concurs with supporting the pilot project. If the proposed study involves human subjects, following documents must be submitted to NIH:
  • Written protocol addressing the risks and protections for human subjects, in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
  • Institutional Review Board (IRB) approval.
  • Create Inclusion Data Record (IDR) and enter inclusion data in Inclusion Management System (IMS).
• If the proposed project involves clinical trials, in addition to above documents, following documents must also be submitted to NIH:
  • Specific plans for data and safety monitoring.
• If the proposal involves Vertebrate Animal, IACUC approval and vertebrate Animal Section as described above must be submitted.

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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 http://www.hhs.gov/ocr/civilrights/understanding/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.

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.

A final progress report, 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.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Ming Lei, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3900
Email: [email protected]

Brian Pike, PhD.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3907
Email: [email protected]

Christy Leake
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-7706
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.