Part 1. Overview Information

Key Dates

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review,

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Authorized by the U.S. Congress in 1993, the National Institutes of Health (NIH) established the Institutional Development Award (IDeA) program to enhance biomedical research activities in states and territories that had historically low NIH grant funding success rates. The IDeA program currently supports basic, translational, clinical, and behavioral research in 23 U.S. states and Puerto Rico through faculty development, student research, and infrastructure enhancement activities.

A key IDeA component is the Centers of Biomedical Research Excellence (COBRE) program that supports the establishment and development of innovative biomedical and behavioral research centers at institutions in IDeA-eligible states through awards for three sequential five-year phases. Phase 1 awards aim to enhance an institution's capacity in one area of biomedical research through the establishment of a thematic center that draws participation of faculty members with complementary scientific expertise and interests. This Funding Opportunity Announcement (FOA) supports COBRE Phase 2 awards, which are intended to strengthen the Center through further improvements in research infrastructure and the continued development of investigators with shared scientific interests. By the end of the Phase 2 award period, it is expected that a critical mass of investigators in the COBRE research area will be able to compete successfully for other sources of research funding. Phase 3 awards provide resources to transition COBREs to self-sustaining research programs.

COBRE Phase 2 Program: Structure and Components

To submit a Phase 2 application in response to this FOA, the applicant institution must have an active COBRE Phase 1 award. The Program Director/Principal Investigator (PD/PI) is expected to be an established biomedical or behavioral research scientist with mentoring and administrative experience necessary to lead the COBRE program, and who has a record of external research funding; see Section III. Eligibility Information for additional details.

Phase 2 Centers must include an Administrative Core and 2-5 scientifically independent Research Projects related to the Center’s scientific theme. Each Research Project should be led by a Research Project Leader (RPL) who is responsible for ensuring that the Specific Aims of that project are met. An RPL must hold an independent faculty appointment (or equivalent at a research institute) at the time the application is submitted, and must qualify either as an NIH Early Stage Investigator (ESI) or as a New Investigator (NI). See Section III. Eligibility Information for additional details. Applications proposing ESIs in the RPL role are of high programmatic priority and are strongly encouraged.

The application should demonstrate research capacity growth in Phase 1 and describe plans for further development in Phase 2, including enhancements to research facilities and resources, and the continued professional development of new investigators. Plans for organizational management and evaluation of the Center, faculty mentoring, and an Advisory Committee should be included. Funds may be requested to sustain Research Cores established in Phase 1 or to establish new ones that are essential to support the research of the Center. Applicants may also propose a Pilot Project Program.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Only institutions that hold an active COBRE Phase 1 award, including a Phase 1 award in no-cost-extension, are eligible to apply to advance the COBRE Center to Phase 2.

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

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

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

Applicant organizations

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

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
  • Dun and Bradstreet Universal Numbering System (DUNS) Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.

• eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from 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) is expected to be an established biomedical or behavioral research scientist with the mentoring and administrative experience necessary to lead the COBRE program. The PD(s)/PI(s) may be the current COBRE Phase 1 PD(s)/PI(s), or a replacement PD(s)/PI(s) for the Phase 2 application may be appointed by the institution.

At the time of submission, the PD/PI must also hold, as PD/PI, at least one active, qualifying research grant, defined here as an externally funded, peer-reviewed research grant from the NIH, NSF, or other Federal or non-Federal sources that is awarded to the applicant institution and related to the scientific theme of the COBRE. The COBRE PD/PI’s primary appointment must be at the applicant institution. If a COBRE PD/PI’s qualifying research grant is a multiple PD/PI award to a different institution, the funds provided to the COBRE PD/PI’s laboratory must be awarded via subcontract to the applicant institution.

For multiple PD/PI COBRE applications, the contact PD/PI must meet the requirements listed above. A non-contact PD/PI must also have at least one qualifying grant to the applicant institution or to the institution where they hold a primary appointment.

A PD/PI may not simultaneously lead more than one IDeA (INBRE, IDeA-CTR, or other COBRE) program award. Previous COBRE PD(s)/PI(s) of different COBRE Centers, except those who served in that capacity on an interim basis, are not eligible to lead a COBRE Phase 2 application. All investigators who intend to apply as PD(s)/PI(s) are encouraged to speak to the Scientific/Research Contact listed in Section VII prior to preparing an application.

Eligible Individuals (Research Project Leaders)

An RPL must hold an independent faculty appointment (or equivalent at a research institution) at the time the application is submitted and must qualify either as an NIH Early Stage Investigator (ESI) or as a New Investigator (NI). The primary appointments of more than half of the RPLs must be at the applicant institution. An RPL supported for less than five years on a COBRE award can also be proposed to lead a Research Project on a COBRE Phase 2 application; however, the RPL must meet all required milestones (see Post-Award Requirements in Section VI) based on the combined total years of COBRE RPL support. The five-year total limit on RPL support still applies. A COBRE RPL cannot receive additional simultaneous research support from any other IDeA award.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

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

Instructions for the Submission of Multi-Component Applications

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

Overall Component

When preparing your application, use Component Type Overall .

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

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

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

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

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

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

Specific Aims: Provide Specific Aims for the Center.

Research Strategy: This section must include the following elements:

A. Program Accomplishments

The purpose of this FOA is to allow institutions holding COBRE Phase 1 grants to compete for continuation support to advance the Center to Phase 2. Applicants must provide evidence that previous support has enabled the Center to achieve specific benchmarks in Phase 1 in the following areas (use tabular format where appropriate):

• Investigators and funding:
  • Efforts and outcomes of applying for independent funding by RPLs: number of research grants submitted to, and awarded by, NIH or other funding agencies (Federal and non-Federal).
  • Growth of a critical mass of investigators: list of investigators recruited to the institution in the Center’s research area during Phase 1; list of RPLs and, if applicable, Pilot Project Leaders (PPLs) supported by the Phase 1 award.
• Research productivity: number of scientific publications in peer-reviewed journals from RPLs, PPLs, and other investigators supported by COBRE core facilities; presentations by RPLs and PPLs at national and international scientific meetings and conferences.
• Development and usage of research infrastructure: establishment of core facilities, their use by COBRE and non-COBRE investigators, and their enhancement of institutional research capabilities.

B. Organization and Management Plan

The overall Organization and Management Plan for the Center should clearly convey a strategy for a successful Phase 2 Center that builds upon the Phase 1 efforts. This should include effective use of the available funding, configuration of the Center and its cores, and approaches for selecting research projects and supporting investigators. Important elements to include are:

• Justification of continued support via a second five-year phase for the enhancement and growth of an established, thematic biomedical research center.
• A description of the unique research opportunities that have been, and will continue to be, provided to the investigators and to the institution.
• A description of the organization and component functions of the COBRE that foster the productivity of the research Center.
• A description of how the components in the Center will interact with each other and with existing programs and resources in the institution, including equipment, instrumentation, and cores supported by current or prior COBRE, INBRE, or IDeA-CTR awards.
• A description of how each RPL will contribute to the continued growth of the Center. This should include descriptions of the proposed COBRE Research Projects for the Center, but not those for whom a Project Leader is yet to be selected. If recruitment for one or more additional RPL slots is proposed, provide a detailed description of the recruitment process and priority areas of scientific expertise.
• If the COBRE focuses on rural health and/or community-engaged research, detailed plans that outline stakeholder input, community outreach, and evaluation strategies for outcomes must be provided.

C. Plan for an Advisory Committee

An Advisory Committee (AC) composed of three external, nationally recognized scientists with expertise directly relevant to the scientific theme of the Center, one senior institutional official (e.g., Dean, Vice-President for Research), and one senior faculty member appointed by the senior institutional official must be assembled to advise the PD(s)/PI(s) after the proposed Center is funded. AC members who previously served as external advisors during Phase 1 may be appointed as Phase 2 AC members. Responsibilities of the AC include, but are not limited to, evaluating whether the goals of the Center remain well aligned with the institution’s strategic priorities, evaluating the scientific progress of the supported Research Projects and optional Research Cores and Pilot Program, evaluating RPL progress toward acquiring independent research funding, and reviewing/approving proposals for replacement Research Projects when such a need arises. Applications for replacement research projects and pilot projects must be evaluated by the AC. NIGMS will only review PD(s)/PI(s) requests to appoint replacement RPLs and PPLs if the AC’s recommendations are included. The AC should meet at least twice per year.

Plans for the AC should detail:

• The names and positions of the senior official and senior faculty member from the applicant institution.
• Name, position, and scientific expertise of external AC members who are continuing their Phase 1 advisory roles. For new external AC members, only provide a description of the qualities and scientific expertise desired without naming specific individuals or contacting them prior to receiving the Notice of Award (NoA) for the application.
• A description of the selection process for filling vacancies for external AC members.

D. Mentoring Plan

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

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

E. Evaluation Plan

The Center must provide an Evaluation Plan with clear timelines and milestones to monitor and evaluate the performance of all components of the Center and the progress of the RPLs it supports. Strategies to identify and remedy deficiencies such as poor performance and lack of progress should be described.

Letters of Support: A letter of support from a senior institutional official (e.g., President or Dean) must be included, outlining the institution’s strategic plan and how the COBRE aligns with the institution’s strategic priorities. The letter must describe 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. Additional letters demonstrating state-level, regional, and/or local support to the proposed Center may be included in this section only if they address a substantive and specific need.

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

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form (Overall)

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

Administrative Core

When preparing your application, use Component Type Admin Core.

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

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

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

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

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

List all performance sites that apply to the specific component.

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

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

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

Budget (Administrative Core)

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

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

Funds to compensate external members of the AC as consultants via a fee-for-service arrangement should be requested in the Administrative Core budget. Internal AC members may not receive compensation from the COBRE.

Funds to compensate mentors should be requested in the Administrative Core budget. Each mentor may be compensated for up to one person-month of effort and should be listed in the Administrative Core's budget section of the application and not in the budget sections of individual research projects. Mentors from non-IDeA states can be compensated as consultants or via a fee-for-service arrangement.

Funds may be used to assist the institution's recruitment of additional faculty who complement the scope of the proposed program. These funds are limited to $400,000 in annual direct costs and may be used to recruit investigators at any career stage. These funds may be used for salary, supplies, and/or equipment costs.

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

Funds cannot be used by or for collaborators at institutions in non-IDeA states or at foreign sites. However, funds may be used in other IDeA and non-IDeA states and foreign sites for fee-for-service activities, such as learning new techniques, sample and data analysis, attending workshops, or obtaining scientific advising/consulting/mentoring (as described above).

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

Other Expenses: If the application proposes a Pilot Project Program, costs should be a line item under "Other Direct Costs". Each individual Pilot Project may have a duration of up to one year with a maximum budget of $100,000 in direct costs. An investigator may receive support for up to two distinct one-year Pilot Projects during Phase 2. The budget should only include a placeholder for the Pilot Projects, as prior approval is required before starting any Pilot Projects; see Post-Award Program Requirements under Section VI of this FOA. A COBRE PPL cannot receive simultaneous support from any IDeA award as an RPL or PPL.

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

PHS 398 Research Plan (Administrative Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component. The Introduction must include responses to the criticisms and issues raised in the prior Summary Statement and summarize the substantial additions, deletions, and changes.

Specific Aims: The SF424 application Guide must be followed.

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

• A clear and full explanation of the necessary administrative, fiscal, and scientific aspects of the proposed Phase 2 COBRE.
• A description of the research and career development goals and capabilities of the proposed Phase 2 COBRE.
• An RPL Development Plan addressing the development and transition of RPLs to independent research funding. This Plan should include details of how the Center, together with the institution, will assist its COBRE-supported investigators to transition to competitive grant support through applications submitted to relevant NIH Institutes and Centers or to other appropriate Federal or non-Federal agencies or organizations. The Plan should also describe strategies for the continued engagement of these investigators in the COBRE after their RPL support has ended. The Plan must also include both formative and summative evaluation strategies with specific milestones, including, but not limited to, acquisition of independent NIH, Federal or non-Federal external peer-reviewed research grant support and publication in peer-reviewed journals.
• A description of the process for selecting replacement Research Projects and their review by the AC.
• An optional Pilot Project Program may be proposed to support one or more projects of up to one year in duration and $100,000 in direct costs. The description of a Pilot Project Program must include a plan for the solicitation of proposals, their review by the AC and funding prioritization, oversight and evaluation procedures, and assurance of full compliance with all applicable Federal policies, rules, and guidelines for research involving human subjects, vertebrate animals, and/or biohazards. Complete eligibility information for Pilot Project Leaders is found in Post-Award Program Requirements under Section VI of this FOA. Research plans for individual Pilot Projects should not be included in the application.

Letters of Support: Letter(s) from institutional leader(s) demonstrating support for the proposed Administrative Core may be included but should not duplicate letters found elsewhere in the application.

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

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

Do not complete. Human subjects research is not allowed in the Administrative Core.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Research Core

When preparing your application, use Component Type Core .

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

SF424 (R&R) Cover (Research Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Core)

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

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

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

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

List all performance sites that apply to the specific component.

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

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

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

The Director(s) of a research core facility must be experienced personnel with the requisite stature, knowledge, authority, leadership, and administrative skills and capabilities to direct the resource. The Core Director will lead a team that provides services to: (1) develop or improve plans for standard operating procedures governing the utilization and management of core expertise and resources; (2) develop or improve plans for disseminating information, training, and serving as subject matter experts to investigators; (3) maintain state-of-the-art technologies and knowledge capabilities; and (4) recommend to the COBRE PD(s)/PI(s) any updates and/or replacement of equipment.

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

Budget (Research Core)

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

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

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

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

PHS 398 Research Plan (Research Core)

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

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: The important elements to include in this section are:

• A description of how the Core will impact the development of the Center and how the core will serve the scientific needs of the individual Research Projects.
• A description of how the Core will operate.
• A description of a Core's userbase that was established in Phase 1 and any plans to expand it.
• A description and justification for any support for instrumentation to augment existing or establish new Core facilities, including the needs of each research project for the Core(s) and how this instrumentation will benefit investigators and improve the research infrastructure of the institution.
• A description and justification for any proposed new Cores, including how new Core facilities will benefit investigators and improve the research infrastructure of the institution.
• A description of the proposed business plan for operation of the Core, including prioritization of the service requests, user fee structure, and maintenance costs.

It is expected that every Core should be unique. Cores that duplicate services already available at the applicant institution are not allowed. Utilization, modification, or expansion of existing Core resources supported by institutional funds or other IDeA programs to accomplish the goals of proposed COBRE research is strongly encouraged.

Letters of Support: Letter(s) from an institutional leader(s) demonstrating commitment to support and maintain the proposed facilities can be included but should not duplicate letters included elsewhere in the application. Letters from leaders of established Cores that will be leveraged for the COBRE research 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: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Research Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Research Project

When preparing your application, use Component Type Project

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

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

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

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

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

List all performance sites that apply to the specific component.

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

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

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

Additional instructions:

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

RPL Eligibility: An RPL must hold an independent faculty appointment (or equivalent at a research institute) at the time the application is submitted and must qualify either as an NIH Early Stage Investigator (ESI) or as a New Investigator (NI). See Section III for details.

Budget (Research Project)

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

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

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

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

PHS 398 Research Plan (Research Project)

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

Specific Aims: The SF424 application Guide must be followed.

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

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

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

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

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

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Research Project)

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and NIGMS. Applications that are incomplete or non-compliant will not be reviewed.

Post Submission Materials

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

• In addition to the materials listed in the Post Submission policy, updates on funding obtained (not applications submitted) by RPLs or PPLs who participated in Phase 1 of the COBRE Center will also be accepted.

Section V. Application Review Information

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

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 components proposed).

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

Significance

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

Program Accomplishments: Has the Center brought together a scientifically complementary cadre of investigators working in the Center's research area? Has the institution invested in the recruitment of investigators with expertise in the scientific area of the Center? Have recruitment efforts increased the biomedical or behavioral research capacity of the institution? Has previous support allowed the Center to achieve specific benchmarks, which, for RPLs include career progression, attainment of independent research funding, and publishing their results in peer-reviewed journals? Is there evidence that the competitiveness of these investigators for other NIH, Federal or non-Federal external peer-reviewed research grant support has been enhanced through COBRE support?

Investigator(s)

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

Has the PD(s)/PI(s) shown the ability to lead, develop, and direct the COBRE to enhance research capacity at the institution in a biomedical scientific area? Has the PD(s)/PI(s) shown effective leadership in directing and managing the Phase 1 COBRE?

If a new PD(s)/PI(s) has been appointed, has the new PD(s)/PI(s) provided evidence of successfully mentoring and guiding trainees and early career research investigators as well as leading a productive research group?

Innovation

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

Approach

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

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

Does the overall plan for the Center support the need for continuation of funding into Phase 2?

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

If the PD(s)/PI(s) plans to recruit new investigators in the future, are these plans consistent with the goals of strengthening biomedical research capacity in the scientific area of the Center?

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

Is the proposed composition of the Advisory Committee appropriate? Is the proposed scientific and administrative expertise of AC members adequate to critique the scientific progress of the Center and offer advice on scientific and career development matters, including the evaluation of new Research Projects and RPLs to the PD(s)/PI(s)? Is the role of the AC in these matters adequately described? Is there evidence that the Center is well-aligned with the institution's strategic goals?

Milestones and Evaluation: Does the application include appropriate and suitable evaluation strategies? Does the Mentoring Plan include both formative and summative evaluation strategies? Does the application address the development of strong user and funding bases for its Research Cores and for the overarching research infrastructure supported by the Center?

If support for instrumentation to augment existing or new core facilities is requested, are the needs for such instrumentation scientifically justified by the Research Projects? Will the instrumentation enhance the productivity of the Center’s research?

Environment

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

Does the application demonstrate the institutional commitment to support the goal of strengthening the biomedical research capacity in the scientific area of the Center? Are the institution's strategic priorities in alignment with the proposed plans for a Phase 2 Center? Do the environment and resources available at the institution meet the needs of the Research Cores and the RPLs? Has prior COBRE support improved facilities or made available new and collaborative resources (e.g., laboratory facilities, patient populations, laboratory space and personnel)?

Review Criteria for Cores

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Core to exert a sustained impact on the research field(s) involved, in consideration of the following review criteria and additional review criteria .

Administrative Core

Do the plans for the Administrative Core provide confidence that the Overall goals of the Center will be fully implemented?

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

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

Does the Administrative Core include a clear RPL Development Plan for continued professional development of RPLs and their attainment of independent, peer-reviewed research funding? Does the Plan provide specific milestones for the acquisition of independent funding by the investigators?

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

If a Pilot Project Program is proposed, are there well developed plans for proposal solicitation, reviewing, award selection, and performance evaluation? Are plans adequate to assure compliance with applicable federal policies and guidelines for research and research protections?

Research Cores

Does the Core Director have the expertise to provide the necessary oversight to administer the maintenance and growth of existing core resources and laboratory facilities to carry out the scientific objectives outlined in the application? Has the Core Director and/or the PD(s)/PI(s) (as appropriate) obtained sufficient institutional commitments to ensure that the resources and facilities required to sustain the Core are present? Are requests for new instruments and Cores well-justified, considering the institution's currently available facilities, to meet the needs of the RPLs and other investigators working in the COBRE’s scientific area?

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 (as applicable for the proposed project).

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

Significance

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

In addition, for applications involving clinical trials: Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is the trial needed to advance scientific understanding?

Investigator(s)

Is the RPL well suited to the project? For Early Stage Investigators or those investigators in the early stages of independent careers, do they have appropriate experience and training? Does the proposed RPL possess complementary expertise that will contribute to a collaborative environment of the Center?

Does the RPL have the necessary qualifications and scientific expertise to lead the proposed Research Project? Does the RPL publish their work in a timely manner? Does the RPL demonstrate the potential to compete successfully for investigator-initiated support? Do RPLs that are new to the COBRE show career development potential?

In addition, for applications involving clinical trials: With regard to the proposed leadership for the project, do the RPL and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

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

In addition, for applications involving clinical trials: Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the Specific Aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Has the Research Project 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? Has the RPL presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? Is the Research Project scientifically independent from other proposed Research Projects? Does the Project generate synergy with other Center research? Do the assigned Mentors have the scientific expertise and experience to provide appropriate career advice to the RPLs?

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

If this project involves rural health and/or community-engaged 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?

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

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the prior preclinical and/or clinical research that serves as the key support for the proposed project rigorous? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

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

In addition, for applications involving clinical trials: If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate? If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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

Study Timeline

Specific to applications involving clinical trials

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

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented.

Renewals

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

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIGMS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. Applications will compete for available funds with all other recommended applications.The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Inclusion of Early Stage Investigators as Research Project Leaders.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

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

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

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Post-Award Program Requirements

Administrative Core

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

Research Projects

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

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

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

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

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

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

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

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

Pilot Projects

If a Pilot Project Program is proposed, the Pilot Project(s) must be reviewed by the AC. It is strongly encouraged that Early Stage and New Investigators be given priority for leading a Pilot Project, but independent investigators of all ranks are eligible. Individuals holding postdoctoral, trainee, or similar non-independent positions are not eligible to lead COBRE Pilot Projects.

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

PPLs do not have a required minimum level of effort and are not named as key personnel. Changes to their effort or removal from the COBRE does not require prior approval but must be reported in annual Research Performance Progress Reports.

Prior Approval of Pilot and Replacement Research Projects

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

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

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

If the proposed study involves human biospecimens or data, include:

• Current PHS Human Subjects and Clinical Trials Information Form

If the proposed study involves Human Subjects, include:

• Current PHS Human Subjects and Clinical Trials Information Form
• Institutional Review Board (IRB) approval
• Human Subjects Education Certification (required even when research is exempt)

If the proposed project involves Clinical Trials, include:

• Current PHS Human Subjects and Clinical Trials Information Form
• Institutional Review Board (IRB) approval
• Documentation of Investigational New Drug (IND)/Investigational Device Exemption (IDE) status for studies that are subject to FDA regulation
• Human Subjects Education Certification and Good Clinical Practice (GCP) Training Certification
• For all clinical trials, in addition to the information requested in Section 3.3 of the PHS Human Subjects and Clinical Trials Information form, the awardee institution will provide NIGMS with a statement detailing the risks to study participants, the frequency of monitoring of clinical trial data and participant safety, and the name(s) of the responsible party/parties for regulatory and legal compliance, adverse event reporting, and clinicaltrials.gov registration and results reporting.

Note: For Human Subjects or Clinical Trials, the grantee must enter study data in the Human Subjects System (HSS) before requesting NIGMS approval.

If the proposed project involves Vertebrate Animals, include:

• IACUC approval
• Vertebrate Animal Section

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

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

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

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

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

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

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

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

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

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

Not Applicable

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

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

4. Evaluation

In carrying out the stewardship of grant programs, NIGMS will periodically evaluate the COBRE program employing the representative measures identified below. In assessing the effectiveness of research capacity building investments, NIGMS may use information from progress reports and public databases, PDs/PIs, and from participants themselves. Where necessary, PDs/PIs and participants may be contacted after the completion of the grant period for updates on participants subsequent outcomes, as appropriate. The overall evaluation of the program will be based on metrics that may include, but are not limited to, the following:

• Indicators of institutional and investigator capacity building, such as
  • Recruitment and development of faculty
  • Progression through program phases and sustainability
  • Improved access to scientific research infrastructure
  • Subsequent submission of peer-reviewed grant proposals
  • Subsequent external funding obtained by participants in the program
• Characteristics of the applicant and awardee pool for the program, such as:
  • Geographic distribution
  • Investigator demographics
  • Institution types
  • Scientific areas of focus
• Indicators of scientific productivity and impact among grantees, such as:
  • Peer-reviewed research publications and citations
  • Conference presentations

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

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

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

Stephanie Constant, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: stephanie.constant@nih.gov

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

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.