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 using ASSIST or an institutional system-to-system solution; 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.

It is critical that applicants follow the instructions in the Multi-Project Instructions for 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 COBRE program seeks to promote the initiation and development or expansion of unique, innovative state-of-the-art biomedical and behavioral research centers at institutions in IDeA-eligible states. Research supported by this program spans the full spectrum of basic and clinical sciences and encompasses all areas of health-related investigation. The NIH recognizes that contributions from institutions in IDeA-eligible states are important and essential in fulfilling the promise of the NIH research agenda. The intent of this FOA is to assist these institutions to implement and use the technologies and other resources needed to conduct state-of-the-art research.

The COBRE program consists of three sequential five-year phases. Phase 1, which is the focus of this FOA, aims to (1) strengthen an institution's biomedical research infrastructure through the establishment of a thematic multi-disciplinary center and (2) enhance the ability of investigators to compete independently for complementary NIH individual research grants or other external peer-reviewed support. Phase 2 is intended to strengthen the center through further improvements in research infrastructure and to continue development and support of a critical mass of investigators with shared scientific interests. Phase 3 provides support for maintaining COBRE research cores developed during phases 1 and 2.

Overall Center Organization and Management Plan: The application in response to this FOA must have a thematic scientific focus in a specific research area and may use basic, clinical, and/or translational research approaches, including community engagement and outreach research, to attain the goals of the proposed center. The center is intended to support investigators from several complementary disciplines. It will enable the institution to develop a critical mass of investigators and enhance their competitiveness in a specific research area that accelerates the rate at which those investigators compete for other complementary NIH, Federal or non-Federal external peer-reviewed research grant support. It is also anticipated that, in some instances, the support through this FOA will facilitate the development of new disease-specific research centers or augment the capability of existing centers.

Although the individual career development of the junior investigators is an important part of this program, the primary objective of the COBRE initiative is to build and develop thematic multi-disciplinary research centers. This is accomplished through the leadership of a peer-reviewed, funded investigator with expertise central to the research theme of the application. The scientific leadership provided by one or more established biomedical research faculty is critical to the success of this FOA, especially for the career guidance of promising junior investigators.

Although the individual career development of the junior investigators is an important part of this program, the primary objective of the COBRE initiative is to build and develop thematic multi-disciplinary research centers. This is accomplished through the leadership of a peer-reviewed, funded investigator with expertise central to the research theme of the application. The scientific leadership provided by one or more established biomedical research faculty is critical to the success of this FOA, especially for the career guidance of promising junior investigators.

Support for research core facilities necessary to carry out the objectives of the center may be proposed in the Overall Center Organization and Management Plan.

Administrative Core:

The administrative core will provide management in administrative, fiscal, and scientific aspects of the proposed COBRE center. The plans for the administrative core should identify established senior faculty members who will provide career guidance and oversight to the junior investigator; constructive evaluations by members of the External Advisory Committee (EAC, see details below); and how the COBRE PD/PI will coordinate the management of all of these individuals. An internal advisory committee may provide additional oversight and input, but this committee may not act as a substitute for the EAC.

Each junior investigator should have at least one scientific advisor. The advisor must be an established investigator who has demonstrated the ability to advise others through the acquisition of external support and the maintenance of an independent research laboratory. In some instance 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.

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 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.

The award of a RPG to a junior investigator should be viewed as a milestone and a criterion for changing the status of an investigator from mentored support via the COBRE to independent investigator. A junior investigator also may be considered for a status change if independence is indicated by the acquisition of sufficient skills and knowledge. However, it is stressed that the goal of the COBRE program is to promote the development of an independent and sustainable center.

External Advisory Committee: Each COBRE must be advised by 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 matters to the COBRE PD(s)/PI(s). The EAC will be involved in developing and planning concepts and programs, encouraging and assisting faculty development and career guidance, 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) will share the advice and critiques provided by the EAC with other COBRE investigators at the center. The EAC also will review and recommend candidate investigators for replacement/substitute projects, as required, before such requests are forwarded to the NIGMS for programmatic review. The EAC should 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. The applicant should not contact potential EAC members or provide the names of potential EAC members during the preparation or review of the application as this complicates the peer review process.

Research Core: Funds may be requested to establish core facilities. 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 core facilities.

Sharing research resources among COBRE and IDeA Networks of Biomedical Research Excellence (INBRE) investigators is strongly encouraged. As much as practicable, applicants should seek to utilize existing equipment and instrumentation supported by other COBRE or INBRE awards.

It is expected that 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. Proposed research cores that appear to replicate services already available at the applicant institution will not be allowed without extensive justification.

Research Projects: The individual research projects should stand alone, but share the COBRE’s common thematic scientific focus. Each research project should be led by a single junior investigator who is responsible for ensuring that the Specific Aims of that project are met.

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

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.

Higher Education Institutions

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

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

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Eligible IDeA states to participate in the COBRE competition

The following states/commonwealth are the IDeA states eligible to apply to this FOA:

Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Puerto Rico, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, Wyoming.

Eligible Institutions

An eligible institution must be within an eligible IDeA state with one of the following characteristics:

• A biomedical research institution that awards a doctoral degree in the health sciences or sciences related to health, or
• An independent biomedical research institute with ongoing biomedical research programs funded by the NIH or other federal agencies.

Applications will be accepted from eligible institutions that hold two or less active COBRE awards at the time of submission. Please note that applications will NOT be accepted from institutions that hold three active Phase 1 and/or Phase 2 COBRE awards. The COBRE Phase 3-Transition Centers award and the IDeA program for Clinical and Translational Research (IDeA-CTR) do not count into total number of COBRE awards.

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 PD(s)/PI(s) must be an established biomedical or behavioral research scientist, who has an active research laboratory, peer-reviewed funding (NIH, NSF or other Federal or non-Federal investigator-initiated support) that is relevant to the scientific theme of the proposed COBRE and administrative leadership to effectively carry out the objectives of the COBRE program and to meet its goals.

The PD(s)/PI(s) of a previous COBRE center that completed the 3 consecutive phases may not lead a new COBRE phase 1 application without compelling justification. . PD(s)/PI(s) may not simultaneously lead two or more IDeA program awards.

If the PD/PI is not in place at the institution at the time of review, that individual must be a full-time faculty member at the time of award. The application must be written by that proposed PD/PI.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) per fiscal year is allowed.

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).

A button to access the online ASSIST system 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.

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 Multi-Project Instructions for 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.

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

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

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

The letter of intent should be sent to:

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

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 (used for Research Project)	12
Alt and Renov (use for Alteration and Renovation)	12

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

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

The application should consist of the following components:

• Overall: required
• Administrative Core: required, maximum of 1
• Core(s): optional
• Projects: required, minimum of 3, maximum of 5
• Alteration and Renovation: optional

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.

Facility and other Resources: The institutional environment and resources that are available to investigators must be briefly described. Available resources (e.g., laboratory facilities, patient populations, geographic distributions of space and personnel) and collaborative resources should be described.

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 provide an overall center organization and management plan. The important elements that need to be included in the section are the following:

• Justification of a five-year support for a thematic multidisciplinary COBRE program.
• A description of the unique research opportunities that will be provided to junior 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.
• 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 junior investigator will contribute to the establishment of a multi-disciplinary research center.
• 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.

Each application must provide an overall center organization and management plan to justify support of a thematic multi-disciplinary COBRE program for five years. The plan should indicate the unique research opportunities that will be provided to the junior investigators and to the institution. If the proposed COBRE research is closely related to ongoing research or to an existing center, an explanation of how the research activities of the COBRE will complement but not overlap with existing research should be included. In addition, the application should describe how the efforts of each junior investigator will contribute to the establishment of a multi-disciplinary research center.

The Overall Center Organization and Management Plan should contain the overall descriptions of at least three and no more than five individual research projects. For applications that propose community engagement and outreach research, the applicants should have clear and 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.

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. In addition, any letter of support for the proposed center may 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.

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

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 career guidance and 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. Scientific advisors from non-IDeA states can be compensated as a consultant or via a fee- for-service arrangement.

Funds may be used to hire 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 hire either junior or established senior investigators. These funds may be used for salary, supplies, and/or equipment costs.

For those small and developing institutions where Offices of Sponsored Programs are not in place, funds may be used to develop Offices of Sponsored Programs.

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 at collaborative institutions in non-IDeA states via a subcontract/consortium arrangement. 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.

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

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 the Administrative Core component. The Introduction should 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 COBRE.
• A description of the research and career development goals and capabilities of the proposed COBRE.
• A career guidance plan addressing the development of junior investigators for their transition to and attainment of independent investigator status.
• A description of the identity of scientific advisors and their qualifications, both scientific and advisory, to assist in the oversight of the project.
• A detailed evaluation strategy with specific milestones.
• A description of how the EAC will be constituted, the expertise that will be expected of the members, and the role of the EAC in advising the PD/PI to conduct the activities of the COBRE (evaluation of the whole center and review of research/pilot projects).
• Since a junior investigator who has achieved independent status and no longer leads a research project may be replaced by a new junior investigator, describe the process of selecting candidate investigators and reviewing research projects by the EAC for replacement/substitute projects.
• If a pilot project program is proposed, a plan for the solicitation of proposals, their review 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 must be provided. Research plans for individual pilot projects should not be included in the application.

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 multi-disciplinary 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 annual budget less than $100,000 (direct cost) may be proposed and should include plans to solicit, evaluate, and select pilot project proposals.

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.

Facilities and Other Resources: The applicants should describe the scientific environment (e.g., institutional support, physical resources, and intellectual rapport) in which the research will be done.

Equipment: The applicants must provide a description of the existing equipment and instrumentation for conducting studies aimed at developing a nationally competitive biomedical research program.

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)

The Core Lead(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.

Budget (Research Core)

Funds may be requested to establish core facilities. In addition to personnel and supply costs, the acquisition of new equipment and modernization of instrumentation may be proposed.

A detailed budget for the entire proposed project period (5 years) must be proposed.

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 for the Research Core component. The Introduction should 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 the impact of proposed core on the development of the center and how they will serve the scientific needs of the individual research projects.
• A description of how the core will be operated.

The applicant must demonstrate that each proposed core will impact the development of the center and how it will serve the scientific needs of the individual research projects. Additional justification may be offered by showing how a core facility will benefit these individuals 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. If the core lead is not named at the time of submission, a plan to recruit personnel to operate the core should be described.

Letters of Support: Letters indicating institutional commitment and any letter of support for the proposed research 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 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.

Criteria for Eligibility of Research Project Leaders

The research project leader must be a junior investigator. The junior investigator is defined either as (1) an individual who does not have and has not previously had an external, peer-reviewed RPG or Program Project Grant (PPG) from either a Federal or non-Federal source that names that investigator as the PD/PI or (2) an established investigator who is making a significant change to his/her career. Senior, funded investigators who are not making a significant career change must not be proposed as leaders for individual research projects; if such a project is included, it will be deemed to be non-compliant it will not be reviewed or counted in the minimum required 3 projects.

With respect to item (1), grants that name an individual as a co-investigator, collaborator, consultant, or to a position other than PD/PI or PD/PI on research grants that allow multiple PD(s)/PIs, do not disqualify that investigator. 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 funding whose purpose is to provide preliminary support in anticipation of a RPG or PPG also do not disqualify the investigator. The intent of this FOA is to support and develop promising investigators whose early career support consists of awards geared toward initiating their intended area of research. However, investigators who have managed to obtain significant support in the form of a RPG or PPG (e.g., NIH R01, K99/R00, or P01, NSF, or other Federal or non-Federal agency awards) are not eligible. Each Project Lead should indicate in his/her Biographical Sketch their current and previous history of peer-reviewed research support.

A junior investigator must hold a faculty appointment (or equivalent at a research institute) at the time that the award is made. Postdoctoral fellows or other positions that do not carry independent faculty status at the applicant institution will disqualify that individual and his/her research project from further consideration and will not be reviewed or counted towards the minimum required 3 projects.

With respect to item (2) above, support may be provided to an established investigator who is making a significant change to his/her career goals by initiating a new line of research that is distinctly and significantly different from his/her current investigative program. The current or previous history of independent peer-reviewed research support, which should be indicated in the Biographical Sketch, in a different investigative area than that proposed in this application does not disqualify the investigator from serving as a Project Lead. Furthermore, this individual can be of any faculty rank. However, investigators whose current research is already supported by a RPG or PPG and who are not changing their current research program are not eligible. Investigators who propose to develop a new or alternate line of research, but whose intention is to maintain support of an active RPG or PPG in a different area of research are also not eligible.

Project Lead(s) should indicate in the Biographical Sketch his/her current and previous history of peer-reviewed research support.

The INBRE investigators are not eligible to receive simultaneous research funding as COBRE project investigators. Similarly, COBRE investigators may not receive simultaneous research project support from an INBRE or other COBRE award.

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 direct cost). 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. 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.

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

Specific Aims: Each individual research project should describe the Specific Aims in the selected area of research and the goals for the first year and for the long term. In addition, how the Specific Aims relate to the importance and health relevance of the proposed research to should be concisely stated.

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

• A detailed description of experimental design principles supporting the research or the hypothesis to be tested.
• Applicants should propose research projects of 2-3 year duration. The nature and scope of any scientific research collaborations within or cross institution should be described in the application.
• Preliminary data is not required, but should be included if the data is available.

The design principles supporting the research or the hypotheses to be tested should be delineated. Preliminary studies are not required for projects in a COBRE application, but applicants with preliminary results should describe them. In the absence of preliminary results, applicants should have a strong research plan that includes a description of the rationale and scientific basis for the proposed research. Furthermore, the research project should describe its relationship to the thematic area of multi-disciplinary research that is the focus of the COBRE and critically assess the existing knowledge and approaches that have been or are being directed in the area with an emphasis on specifically how the multi-disciplinary COBRE approach will advance the field.

Letters of Support: A clear commitment to support junior faculty appointment independent of the outcome of this application must be demonstrated from the institution by a letter(s) from the appropriate senior institutional official(s). Any other letter of support for the proposed research project 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, 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 Alt and Renov .

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

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

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Alteration and Renovation)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Alteration and Renovation)

Human Subjects: 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.

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

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

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

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Alteration and Renovation)

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

Budget (Alteration and Renovation)

Alteration and Renovation is allowed up to $300,000 in direct costs only in year one of the award as a one-time cost expenditure. Direct costs requested for A&R are not subject to facilities and administrative costs (F&A). This amount will be provided only in year one. It is expected that the funds be expended within 3 years of award.

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

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

PHS 398 Research Plan (Alteration and Renovation)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for Alteration and Renovation component. The Introduction should 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: A narrative summary as outlined below must be provided:

• A description of how proposed renovations relate to the research projects that will use the facility.
• If renovations to animal facilities are proposed, they should be related to the projected animal populations (by species) in the proposed projects. Applicants must include the lines of authority and responsibility for administering the institution's animal care and use program. The role and composition of the Institutional Animal Care and Use Committee (IACUC) and how compliance with relevant laws, policies, and guidelines are achieved should also be included.
• List the functional components, including the size (dimensions) and square footage of each component (room, alcove, or cubicle) that will be directly affected by the renovation project.
• List engineering criteria applicable to each component (mechanical, electrical, and utilities). Include information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam.
• List appropriate architectural criteria (such as width of corridors and doors, surface finishes).
• List and justify all fixed equipment items requested for the renovated area. A list of allowable fixed equipment can be found at http://dpcpsi.nih.gov/orip/diic/instru_fixed_equip_s10.aspx (refer to: Allowable as "Fixed Equipment" under C06/G20).
• Changes or additions to existing mechanical and electrical systems should be clearly described in notes made directly on the plan or attached to the plan.
• Indicate the type(s) of new finishes to be applied to room surfaces.

Line drawing should be included in Other Attachments in "Research & Related Other Project Information" form.

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

Resource Sharing Plan: Not Applicable

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.

PHS Human Subjects and Clinical Trials Information (Alteration and Renovation)

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.

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

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 project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a center that by its nature is not innovative may be essential to advance a field.

Does the center address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the center? 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?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the center? 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 center?

Do(es) the PD(s)/PI(s) have the qualifications and skills to provide scientific and administrative leadership in developing and directing the COBRE and establishing thematic collaborative research efforts? Do(es) the PD(s)/PI(s) have the experience and ability to implement and manage an effective career guidance plan to move investigators toward independent status?

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

If the center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of 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 will be developed?

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?

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?

Is the infrastructure necessary for the proposed center (e.g., facility improvements, modernization/acquisition of equipment, implementation of administrative resources, etc.) in place?

Does the application describe the institutional commitment to provide support for the development of a thematic multidisciplinary center? Has the applicant described the environment and resources available to investigators, and indicate how COBRE support will improve facilities or make 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, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the core proposed)

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 that involves oversight by established senior faculty members assigned as scientific advisors, and constructive evaluations by members of the External Advisory Committee? Is there coordinated management of all of these individuals by the PD/PI of the COBRE program?

Milestones and Evaluation: Has the PD/PI 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 constitution of the EAC been adequately described? Is the role of the EAC properly described for evaluating scientific progress of the COBRE and providing advice on scientific matters to the COBRE PD/PI?

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 Core Facilities

Has the Core Lead 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 Core Lead 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 in terms of the need related to the COBRE thematic research focus?

Review Criteria for Individual Research Projects

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 Project Lead(s), collaborators, and other researchers well suited to the project? Do they have appropriate experience and training? 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 investigator publish his/her work in a timely manner?

Do the project investigators demonstrate the ability to compete successfully for investigator-initiated support? Do project investigators 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?

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?

Review Criteria for Alteration and Renovation (If included)

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the component 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 component proposed):

Are requested alteration and renovation projects relevant to the scope of the proposed research? Are the costs and suitability of the project justified?

Do the proposed renovations relate to the research projects that will use the facility? If renovations to animal facilities are proposed, do the proposed renovations relate to the projected animal populations (by species)?

If renovations to animal facilities are proposed, are the lines of authority and responsibility for administering the institution's animal care and use program indicated?

Are there lists of the functional components, including the size (dimensions) and square footage of each component (room, alcove or cubicle) that will be directly affected by the renovation project? Are there appropriate descriptions of the engineering criteria applicable to each component (mechanical, electrical, and utilities) including information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam, as well as the appropriate architectural criteria (such as width of corridors and doors, surface finishes)? Is justification provided for all fixed equipment items requested for the renovated area?

Are legible line drawings provided for all floor plans with the scale clearly indicated? Are the line drawings of the proposed renovation drawn to a scale adequate to explain the project? Do the drawings indicate size (dimensions), function, and net and gross square feet of space for each room? Are the total net and gross square feet of space to be renovated provided? Does the plan indicate the location of the proposed renovation area in the building? Does the plan include the as-built drawings of the proposed renovation area and indicate any areas that will be demolished? Do the plans indicate changes or additions to existing mechanical and electrical systems in notes made directly on the plan or attached to the plan? Do the plans indicate the type(s) of new finishes to be applied to room surfaces?

As applicable for the overall application, core(s) and projects proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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 core and 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.

Not Applicable

Not Applicable

As applicable for the overall application, core and 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 the National Institute of General Medical Sciences (NIGMS) in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. 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).

It is emphasized that support cannot be provided in instances where a junior investigator's new award overlaps or is significantly similar to that described in the COBRE program. 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.

If the specific aims of the junior investigator's RPG are significantly different from the project described in the COBRE, then the junior investigator has an obligation to remain in the program to complete his/her COBRE project. In this latter 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.

Investigators who have acquired independent status or completed a research project should not be excluded from center activities. These investigators should be allowed access to core facilities and should be encouraged to participate in collaborative research efforts. If appropriate, an investigator who has acquired independent status may direct a COBRE core facility or serve as an advisor.

A junior investigator who has achieved independent status and no longer leads a research project may be replaced by a new junior investigator. Replacement junior investigators and new research projects may be selected by the PD(s)/PI(s) and reviewed by the EAC. In some instances, a junior investigator may be placed on probation or 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, to submit an investigator-initiated RPG application by the end of two years of COBRE support. Prior approval by the NIGMS is required for adding or removing junior investigators. The PD/PI must communicate the EAC's recommendation to the NIGMS for programmatic and administrative review.

If the COBRE center contains a Pilot Project Program, the scientific merit of pilot project(s) must be reviewed by EAC. The pilot project(s) and recommendation from EAC must be submitted to NIGMS for programmatic and administrative review. The pilot project must be led by a junior investigator.

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

Prior to the commencement of any pilot or research 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)
• Biographic 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 or research project.
• If 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.
• Human Subjects education certification.
• 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 describe 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.

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.

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.

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 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.

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 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
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
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, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3907
Email: [email protected]

Ms. 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.