Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title

Limited Competition: Centers of Biomedical Research Excellence (COBRE) Phase III - Transitional Centers (P30)

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of PAR-13-238

Related Notices
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number

PAR-14-178

Companion Funding Opportunity

None  

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.859

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to transition the core resources and biomedical research activities of Centers of Biomedical Research Excellence (COBRE) into independence and sustainability.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

May 30, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

June 30, 2014; May 26, 2015; and May 26, 2016, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October/November 2014, October/November 2015, October/November 2016

Advisory Council Review

January 2015, January 2016, January 2017

Earliest Start Date

April 2015, April 2016, April 2017

Expiration Date

May 27, 2016

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

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

Required Application Instructions

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

You will be sent to ASSIST to prepare and submit your application. Problems accessing or using ASSIST should be directed to the eRA Commons Help Desk.
Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

The Institutional Development Award (IDeA) Program endeavors to stimulate research at institutions in states that have not traditionally received significant levels of research funding from the NIH. Created through congressional mandate, the IDeA Program broadens the geographic distribution of NIH funding for competitive biomedical and behavioral research by enhancing the research capabilities of institutions in eligible states. The IDeA Program aims to achieve this goal through 2 major initiatives: (1) the IDeA Networks of Biomedical Research Excellence (INBRE), and (2) the Centers of Biomedical Research Excellence (COBRE).

The COBRE initiative seeks to develop unique, innovative, multidisciplinary, and collaborative state-of-the-art biomedical and behavioral research centers focused on a scientific theme that is nascent or only minimally developed at applicant institutions. This is accomplished by nurturing and expanding a critical mass of competitive biomedical research investigators through intensive mentoring of emerging research faculty and aggressive recruitment of seasoned investigators, and by enhancing the research environment and infrastructure through the establishment of critical core resources.

COBRE support consists of three sequential five-year phases. Phase I focuses on the development of requisite research resources and infrastructure, and the provision of formal research mentoring and research project funding to junior investigators to facilitate their acquisition of preliminary data and successful competition for independent research grant support. Phase II is intended to further strengthen the center through the support and enhancement of the growing research infrastructure and continuing the development and expansion of a critical mass of investigators with shared scientific interests. After ten years of COBRE support, the centers and their aligned investigators are expected to be able to compete successfully for other sources of research funding, including individual and/or program project or center grants from other NIH Institutes and Centers or other Federal and non-Federal entities.

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

Applications for the COBRE Phase III Transitional Centers can only be submitted by active COBRE Phase II awardees. The application must include infrastructure and/or activities that will support the following components:

Section II. Award Information
Funding Instrument

Grant: a support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission (from PAR-13-238)

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

The annual budgets must not exceed $750,000 in direct costs.

Award Project Period

The scope of the proposed project should determine the project period.  The maximum project period is 5 years.

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Limited Competition: Eligibility is restricted to COBRE Phase II award recipients that are active on the application due date.

Foreign Institutions

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.

Required Registrations

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.

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.

Eligible Individuals (Program Director/Principal Investigator)

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.

Limited Competition: Eligibility is restricted to COBRE Phase II award recipients that are active on the application due date.

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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

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

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

2. Content and Form of Application Submission

It is critical that applicants follow the 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.

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

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12

Admin Core

12

Core (use for each Scientific/Technical Core)

12

Project (use for Pilot Projects Program)

12


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

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.

The application should consist of the following components:

Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

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

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.

Other Attachments: All publications produced in COBRE Phases I and II must be included here.

Project/Performance Site Location(s) (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 & 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.

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

Specific Aims: Provide the Specific Aims for the Center.  

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

Letters of Support:  Applicants must provide letters from the appropriate high-ranking institutional official(s) that defines the financial and other resource support for the COBRE that will be provided by the institution. There are no dollar requirements, but specific commitment is required.

While non-Federal matching funds are not required, the application must show clear evidence of strong and specific institutional commitment for the overall center and each center component. It is recognized that the availability of resources is variable among institutions. Consequently, the level of institutional commitment will differ among applicant institutions. At a minimum, the application should include a letter from a senior institutional official (e.g., President or Dean) outlining the resources and facilities that will be committed by the institution to support and sustain the COBRE throughout the period of funding and the commitment to maintain these resources that will be made beyond the period of grant support. Some examples of institutional commitments that may be documented include financial support, adequate space, release time agreements, tenured or tenure-track positions for faculty, FTEs for core facility personnel, and core consolidation and maintenance.

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Administrative Core

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

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

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)

Budget (Administrative Core)

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

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

The COBRE PD/PI must devote a minimum time commitment of 1.2 person months for the administrative oversight of the COBRE, serving as the Administrative Core Lead. A maximum of 2.4 person months effort may be supported.  Each individual named as a Program Coordinator (PC) may devote 1.2 to 2.4 person months. The levels of effort specified for the PD/PI and the PC(s) are required whether or not salary support is requested.

The Administrative Core Lead (PD/PI) of the COBRE is not eligible for research support from the COBRE award, nor can he/she use COBRE funds to supplement research activities within his/her laboratory. Mentors may be compensated for up to 1 person month of effort.  Mentors from non-IDeA states can be compensated as a consultant or fee for service.

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

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

The application should budget for a biennial one-day meeting in Bethesda, Maryland, with NIGMS staff.

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

PHS 398 Research Plan          (Administrative Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is required.

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

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

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

Leadership and Governance Plan:  The Administrative Core oversees the overall governance and organizational structure of the COBRE, including the functional relationships between the PD/PI, PC, and the Directors of Core Resources, and between the COBRE leadership and advisory committees. The efficient management of institutional resources, the various cores and proposed center activities will depend on a strong Administrative Core.

Program Director/Principal Investigator (PD/PI) and Program Coordinator(s) (PC) of the COBRE: The implementation of the activities detailed in the application is the ultimate responsibility of the COBRE PD/PI. The PD/PI must be an established biomedical or behavioral research scientist with demonstrated administrative leadership skills. As the director of the COBRE, the PD/PI will establish the overall direction and appropriate administrative structure of the center to support research efforts, including the efficient management of component facilities and resources, staffing and resource allocation, and for administering the award in accordance with NIH policies. The PD/PI will be responsible for developing a pilot grants program, selecting the core directors, resolving disputes arising in the usage of the core facilities, and for final budget decisions.

The PD/PI may be assisted by Program Coordinator(s) with administrative skills and experience that complement those of the PD/PI. The PC(s) will provide day-to-day oversight of center operations and administration, including assisting core directors to set work priorities, coordinating recommendations for major purchases of supplies and equipment upgrades, recruitment of technical support staff, and assisting in the resolution of other budget issues with the core directors and the PD/PI. The PD/PI and the PC(s) are expected to attend a two-day biennial meeting in Bethesda, Maryland with NIGMS staff.

Steering Committee:  Each Center will be directed by a Steering Committee chaired by the PD/PI of the Center Grant. Members of the committee will include the PC(s), directors of the individual Cores, and a senior institutional official. Representation in the Steering Committee should also come from the PD/PI(s) of research projects that utilize core resources. The Steering Committee will establish guidelines to determine the most appropriate methods for providing access to the Core facilities and services. The Steering Committee will also advise the Center PD/PI on strategic and operational issues, to maximize the impact of the Center on biomedical research at the institution.

External Advisory Committee:  The COBRE is required to establish an External Advisory Committee (EAC) of 3-5 members that will meet at least annually to review the structure and progress of the COBRE and to offer recommendations to the PD/PI. An annual EAC report that summarizes discussions at EAC meetings, recommendations made, and actions taken by the COBRE leadership will be provided in yearly progress reports submitted to NIH.  The EAC report must not be submitted separately to NIH Program staff.

Evaluation Plan:  The Administrative Core is tasked with overseeing an internal evaluation plan for monitoring and documenting progress towards achieving target goals and timelines. The Steering Committee is expected to provide ongoing assessment and evaluation of the progress of the center. Annual evaluation reports, including plans for any corrective actions, must be provided to the EAC, Core Directors, other key personnel, institutional stakeholders, and NIH Program Staff.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report  (Administrative Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Scientific/Technical Core

When preparing your application in ASSIST, use Component Type ‘Core’ for each proposed scientific/technical core.

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

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

Complete only the following fields:

PHS 398 Cover Page Supplement (Scientific/Technical Core)

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

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

Project /Performance Site Location(s) (Scientific/Technical Core)

List all performance sites that apply to the specific component.

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

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

Budget (Scientific/Technical Core)

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

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

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

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

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

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

PHS 398 Research Plan          (Scientific/Technical Core)

Introduction to Application: For resubmission applications, an Introduction to Application is required.

Specific Aims: The SF424 Application Guide must be followed.

Research Strategy:

The Research Strategy section for each proposed scientific or technical core must provide details of the following:

Income Source

Current Support ($)

Percent  of Current Total Budget

Proposed Support for Year 1 ($)

Percent of Proposed Total Budget (Y1)

Proposed Support for Year 5 ($)

Percent of Proposed Total Budget (Y5)

COBRE

           

Fee for Service/ Chargebacks

           

Other (specify sources, add additional lines as needed)

           

TOTAL Operating Budget

           

When completing the research strategy section, the following elements must be considered for each proposed scientific/technical core:

Resources and services:  The applicant may support already existing and/or new research core facilities. Each proposed core must be well-justified and shown to be essential in meeting the scientific requirements of projected users. Consequently, the resources and services offered by each proposed core facility must be adequate and appropriate in supporting ongoing and planned research projects. Essential services for each core will include dissemination of core capabilities, mentoring and training in new technology and modern instrumentation, and providing scientific guidance in the design of research proposals and experiments. Other essential components of each proposed core are project prioritization and evaluation plans. Equally important are sustainability plans for each proposed core beyond COBRE III.

Leveraging: Sharing research resources among IDeA programs is strongly encouraged.  Applicants should seek to utilize existing equipment and instrumentation supported by other COBRE or INBRE awards. Requests that appear to be duplicative of existing equipment or instrumentation, including computational facilities and related bioinformatics resources, must be appropriately justified. Core facilities supported through this FOA must not duplicate currently available facilities at the institution. Co-funding by the applicant organization or by outside sources is encouraged.

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

Core Revenue:  It is expected that the Cores will generate revenue via fee-for-service arrangements whenever possible, in order to optimize efficient resource usage and enhance resource sustainability.

Letters of Support: Applicants must provide letters from the appropriate high-ranking institutional official(s) that indicates the financial and other resource that will be provided by the institution specifically for the core. There are no dollar requirements, but specific commitment is required.

While non-Federal matching funds are not required, the application must show clear evidence of strong and specific institutional commitment for the proposed scientific/technical core.  At a minimum, the application should include communication from a senior institutional official (e.g., President or Dean) outlining the resources and facilities that will be committed by the institution to support and sustain the core throughout the period of funding and the commitment to maintain these resources that will be made beyond the period of grant support. Some examples of institutional commitments that may be documented include financial support, adequate space, FTEs for core facility personnel, and core consolidation and maintenance.

As appropriate, letters from the Program Directors/Principal Investigators of other awardees of NIH and other Federal and non-Federal entities (e.g., INBREs, COBREs, CTSAs) may be included indicating their program’s role in supporting the core. When applicable, applicants should include letters which indicate how the core will leverage, complement, or interact with existing institutional resources funded by NIH or other Federal or non-Federal entities.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (Scientific/Technical Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Scientific/Technical Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Pilot Projects Program

When preparing your application in ASSIST, use Component Type ‘Project’

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

SF424 (R&R) Cover (Pilot Grants Program)

Complete only the following fields:

PHS 398 Cover Page Supplement (Pilot Projects Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot Projects Program)Facilities and Other Resources: Summary of specific institutional commitments to support the pilot grants program.

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

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

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

Project /Performance Site Location(s) (Pilot Projects Program)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Pilot Projects Program)

Budget (Pilot Projects Program)

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

Up to $250,000 annually can be used to support the pilot projects program.  Pilot projects cannot overlap with ongoing funded projects.  Funds cannot be used for graduate student stipend, postdoctoral training, or alterations and renovations.  The PD/PI of the COBRE is not eligible for pilot project funding.

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

PHS 398 Research Plan          (Pilot Grants Program)

Introduction to Application: For resubmission applications, an Introduction to Application is required.

Specific Aims: The SF424 Application Guide must be followed.

Research Strategy:

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

Letters of Support: Applicants must provide letters from the appropriate high-ranking institutional official(s) that specifies the financial and other resources that will be provided by the institution for the COBRE's Pilot Projects Program. There are no dollar requirements, but specific commitment is required.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report  (Pilot Projects Program)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Pilot Projects Program)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. 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 Applying Electronically.

Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

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

Scored Review Criteria - Overall Center Application

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

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Are the Center's vision and strategy adequate to facilitate and sustain high-caliber research in the institution?

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

Investigator(s)

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

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

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

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?

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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? 

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

Is the management plan appropriate for fiscal administration, resource procurement, property and personnel management, planning, and budgeting? Has the PD/PI presented a well-thought out plan for achieving sustainability of the cores beyond COBRE III?

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?

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

Additional Review Criteria for Components

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

Administrative Core

Reviewers will consider the following criteria in the determination of an impact score for the Administrative Core, although scores for the individual criteria will not be provided.

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

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

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

Scientific/Technical Cores

Reviewers will consider the following criteria in the determination of an impact score for each proposed Scientific/Technical Core, although scores for the individual criteria will not be provided.

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

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

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

Evaluation: Is there an adequate plan in place to evaluate core performance?

Pilot Projects Program

Reviewers will consider the following criteria in the determination of an impact score for the Pilot Projects Program, although scores for the individual criteria will not be provided.

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

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

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

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

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

Additional Review Criteria - Overall Application and Components, as applicable

As applicable for the overall application and each component 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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall Application and Components, as 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) Genome Wide Association Studies (GWAS).

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:

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

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

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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Prior Approval of Pilot Projects

Awardee-selected projects require approval by NIH prior to initiation.  The awardee institution will provide NIH with the following documents for review:

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: http://grants.nih.gov/support/index.html

TTY: 301-451-5939
Email: commons@od.nih.gov

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

J. Rafael Gorospe, M.D., Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone : 301-435-0832
Email: gorospejr@mail.nih.gov

Peer Review Contact(s)

Helen R. Sunshine, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-435-0815
Email: sunshinh@nigms.nih.gov

Financial/Grants Management Contact(s)

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

Authority and Regulations

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 Parts 74 and 92.


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