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: Renewal of Centers of Biomedical Research Excellence (COBRE)[P20]

Activity Code

P20 Exploratory Grants

Announcement Type

Reissue of PAR-09-180

Related Notices
  • June 7, 2013 - This PAR has been expired and reissued as PAR-13-243.
  • September 28, 2012 – See Notice NOT-OD-12-161. NIH Announces Plans to Transition to Electronic Submission of Multi-Project Applications
Funding Opportunity Announcement (FOA) Number

PAR-12-224

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 National Institute of General Medical Sciences (NIGMS) of the NIH invites applications for competing continuation of eligible Centers of Biomedical Research Excellence (COBRE) grants. The objective of the COBRE initiative is to strengthen an institution's biomedical research infrastructure through the establishment of a thematic, multi-disciplinary center and to enhance the ability of investigators to compete independently for National Institutes of Health (NIH) individual research grants or other external peer-reviewed support. COBRE awards are supported through the Institutional Development Award (IDeA) Program, which aims to foster health-related research by increasing the competitiveness of investigators at institutions located in states with historically low aggregate success rates for grant awards from the NIH.

Key Dates
Posted Date

July 10, 2012

Letter of Intent Due Date

Not Applicable.

Application Due Date(s)

September 25 2012, September 25 2013, and September 25 2014

AIDS Application Due Date(s)

Not Applicable. 

Scientific Merit Review

January/February 2013, January/February 2014, and January/February, 2015   

Advisory Council Review

May 2013, May 2014, and May 2015

Earliest Start Date(s)

July 2013, July 2014, and July 1015

Expiration Date

(Now Expired June 8, 2013 per issuance of PAR-13-243), Originally September 26, 2014

Due Dates for E.O. 12372

Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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

Program Description:  The goals of the Centers of Biomedical Research Excellence (COBRE) program are (1) to strengthen an institution's biomedical research infrastructure through the establishment of a thematic multi-disciplinary center and (2) to enhance the ability of investigators to compete independently for NIH individual research grants or other external peer-reviewed support. It is emphasized that a significant part of the COBRE program is to build and develop thematic multi-disciplinary research centers. COBRE support consists of three sequential five-year phases.  Phase I focuses on developing research infrastructure and providing junior investigators with formal mentoring and research project funding to help them acquire preliminary data and successfully compete for independent research grant support.  Phase II, which is the focus of this FOA, is intended to strengthen the center through further improvements in research infrastructure and to continue development and support of a critical mass of investigators with shared scientific interests.  It is therefore expected that progress will have been made toward establishing centers that can compete independently for external peer-reviewed center or program project grant support. In some instances centers may be more effectively maintained by the centers’ investigators competing for individual investigator-initiated research support.  Phase III provides support for maintaining COBRE research cores developed during phases I and II.

Objectives:   The purpose of this FOA is to allow institutions holding COBRE Phase I grants to compete for continuation support to promote the development of thematic, multi-disciplinary centers. Progress must be commensurate with previous support and must substantiate the merit of continued NIH research funding. It must be demonstrated that previous support has allowed the center to achieve specific benchmarks, which include the acquisition of independent status by the junior investigators and evidence that the competitiveness of these investigators for other NIH, Federal or non-Federal external peer-reviewed research grant support has been enhanced. Furthermore, evidence that a critical mass of investigators has been (or is being) established must be shown.  These benchmarks are a measure of successful mentoring and scientific leadership by the PD/PI and the established biomedical research faculty. Leadership is also demonstrated by showing that the infrastructure necessary for the continued functioning of the center (facility improvements, modernization/acquisition of equipment, implementation of administrative resources, etc.) is in place, and that the institution is committed to maintain the resources and infrastructure that have been established through prior COBRE support.

Overall Center Organization and Management plan:  Applications must describe an overall center organization and management plan that justifies continued support of a thematic multi-disciplinary center for COBRE Phase II, and a description of the unique research opportunities that have been and will continue to be provided to the investigators and to the institution. The efforts and ongoing research of all center investigators should be described in the context of developing an independent and sustainable multi-disciplinary program. The research plan must contain the descriptions of at least three and no more than five individual research projects. An administrative core with a detailed development and mentoring plan must be included.  In addition, support for research core facilities necessary to carry out the objectives of the center may be proposed.

The leadership and direction of the COBRE are provided by the Program Director/Principal Investigator (PD/PI). He/she has the primary responsibility for administering the program and overseeing the development of the center and its associated core facilities. The current PD/PI may continue to serve in this role or a new PD/PI may be appointed. In either case, the PD/PI must be an established biomedical or behavioral research scientist who will ensure that high-quality research is performed, and who has the experience and qualifications to effectively administer and integrate all program components of the program. A minimum time commitment of 3 person months is required for this individual. However, up to 6 person months will be supported for mentoring and administrative oversight of the center.

No non-Federal matching funds are required for these applications. However, evidence of institutional commitment must be included and explicitly described and/or documented. The level of institutional commitment will differ across applicant institutions because of the variability of resources available at those institutions. At a minimum, a letter of support from a senior institutional official (e.g., President or Dean) should outline the commitment of resources and facilities to sustain and support the COBRE throughout the funding period and plans to maintain these resources beyond the period of grant support.

Applications must briefly describe the institutional environment and resources available to investigators, and indicate how prior COBRE support has improved facilities or made available new and collaborative resources (e.g., laboratory facilities, patient populations, laboratory space and personnel). If support for instrumentation to augment existing or establish new core facilities is requested, the application should identify the needs of each component research project for the core(s) and how this instrumentation will facilitate the center’s research.

Administrative Core:   A clear plan for the transition to and attainment of independent status for junior investigators and for the continued development of early career investigators must be included. This plan should also describe how the center as a whole intends to make the transition from support of multi-disciplinary COBRE research projects to competitive grant support obtained through applications submitted by its faculty members to relevant NIH Institutes and Centers or other appropriate Federal or non-Federal agencies or organizations. All project investigators, regardless of their career status, must submit independent investigator-initiated RPG applications by the end of two years of COBRE support to be eligible for continued COBRE funding.

The development plan must include both formative and summative evaluation strategies detailing specific milestones, including, but not limited to, the acquisition of independent status by the investigators; competition for NIH, Federal or non-Federal external peer-reviewed research grant support; and publications in peer-reviewed journals.  Faculty development should include a mentoring plan that involves oversight by established senior faculty members assigned as mentors, constructive evaluations by members of the External Advisory Committee (EAC), and coordinated management of all of these individuals by the PD/PI of the COBRE program. Additional oversight may be augmented through the use of an internal advisory committee, but this committee should not act as a substitute for the EAC.

Each junior investigator must have at least one mentor. The mentor must be an established investigator who has demonstrated the ability to advise others on the acquisition of external support and the maintenance of an independent research laboratory. In some instances a suitable mentor may not be available within the applicant's institution and it is therefore acceptable to enlist appropriate mentors from outside institutions. Mentors may be compensated for up to 1.8 person months of effort and should be listed in the Administrative Core's budget section of the application and not in the individual research projects' budget sections. Investigators should clearly designate in the text the identity of their mentors and describe their qualifications, both scientific and advisory, that make them appropriate to assist in the oversight of the project.

An investigator who has acquired independent status through the award of an RPG may continue to participate as a COBRE research project investigator by proposing a new project that does not overlap with his/her other award(s). New COBRE projects must be reviewed by the PD/PI and the EAC. The PD/PI must communicate the EAC recommendation to the NIGMS for their programmatic and administrative review. An investigator who has acquired independent RPG support may direct a COBRE core facility or serve as a mentor. In either case, investigators should not be excluded from center activities and should be encouraged to participate in collaborative research efforts. In some instances, a project leader may be considered for removal from the COBRE program if a review by the EAC indicates a failure by the investigator to make significant progress toward achieving the specific aims of his/her project or, as noted above, failure to submit an investigator-initiated RPG application by the end of two years of COBRE support.

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

A pilot project program may be proposed.  The description of a pilot project must include a plan for the solicitation of applications, their review and funding prioritization, oversight and evaluation procedures, and assurance of full compliance with all applicable federal policies, rules, and guidelines for research involving human subjects, vertebrate animals, and/or biohazards. The pilot project(s) must be reviewed by EAC. The recommendation from EAC must be submitted to NIGMS for programmatic review. Research plans for individual pilot research projects should not be included in the application.  

Research Core Facilities:   Funds may be requested to maintain 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. The applicant must demonstrate that each core will serve the scientific needs of the individual research projects and must show how each core will impact the development and sustainability of the center. Although the COBRE award is not intended to replace support for ongoing investigator-initiated research projects, all center participants, including the mentors, as well as other non-center investigators at the institution, may use these facilities. Additional justification may be offered by showing how a core facility will benefit these individuals and improve the research infrastructure of the institution. Each core description should indicate the qualifications of personnel selected to manage the facility and/or plans to recruit personnel to operate the core, if needed, and the proposed business plan for operation of the core including prioritization of the service requests, charge back fees for non-COBRE users. Furthermore, the PD/PI should indicate any institutional commitment to support and maintain the proposed facilities.

Individual Research Projects:   The COBRE center must contain at least three and up to five individual research projects.  The individual research projects should stand alone but share a common thematic scientific focus.  Each research project should be supervised by a single investigator who is responsible for ensuring that the specific aims of that project are met. Each individual research project should describe the specific aims in the selected area of research and the goals for the long term, and delineate the design principles supporting the research or the hypotheses to be tested. Preliminary studies are not required for COBRE applications, but applicants with preliminary results should describe them. In the absence of preliminary results, applicants should describe the rationale and scientific basis for the proposed research. Each research project should describe its relationship to the area of multi-disciplinary research that is the focus of the COBRE.  It should also critically assess the existing knowledge and approaches that have been, or are being, directed in the area with a specific emphasis on how the multi-disciplinary COBRE approach will advance the field. Moreover, the importance and health relevance of the proposed research should be concisely stated.

Mentoring and development of investigators who are not yet established are a significant part of the creation and establishment of the critical mass of successful investigators necessary to make up a research center. The participation of junior investigators is integral to this concept and is strongly encouraged. A junior investigator is defined as an individual who does not have, or has not previously had external, peer-reviewed Research Project Grant (RPG) or Program Project Grant (PPG) support from either Federal or non-Federal sources for which the individual is named as the PD/PI. A junior investigator who is supported by IDeA Networks of Biomedical Research Excellence (INBRE) is not eligible to receive research support from COBRE.  This FOA also includes continued mentoring of and support for qualified early career investigators to promote the success and integrity of the research center. Furthermore, this FOA encourages the recruitment and/or support of qualified, more senior investigators to facilitate the growth and independence of the center. Qualified investigators must demonstrate a record of productivity. Taken together, these efforts are intended to promote the development of an independent and successful research center. To this end, any qualified investigator is eligible to participate as a project investigator in the center.

Junior investigators must make an initial minimum commitment of 6 person months annually. Established investigators must make an initial commitment of at least 3 person months annually. It is recognized that during the development of an investigator's career (for example, the acquisition of other research support) it may be necessary to reduce these levels of commitment. PD/PIs should consult with NIGMS program staff regarding appropriate reductions. Each project investigator should indicate in the Biographical Sketch his/her current and previous history of peer-reviewed research support.

Investigators must hold a faculty appointment (or equivalent at research institutes) at the time the award is made. Moreover, the applicant institution must demonstrate, in a letter(s) from the appropriate senior institutional official(s), a clear commitment to support this faculty appointment independent of the outcome of the COBRE grant application. Individuals holding postdoctoral fellowships or other positions that lack independent faculty status are not eligible to lead COBRE research projects. The PD/PI of the COBRE is not eligible for research project support nor can he/she use COBRE funds to supplement research activities within his/her laboratory.

COBRE support cannot be provided for a project that overlaps with or is significantly similar to an investigator-initiated research program that is already funded from another source. Furthermore, if a COBRE supported investigator obtains additional external support, COBRE support of the project must be discontinued if it is significantly similar to, or overlaps with, the newly funded project. Conversely, COBRE support can be continued if there are sufficient differences between the COBRE and non-COBRE supported projects, since the investigator is obligated to complete his/her COBRE project.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

Renewal
Resubmission

The OER Glossary and the PHS398 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 $1.5 million in direct costs. .

Award Project Period

Five 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

Applications will only be accepted from institutions that are in IDeA states and currently hold a Phase I COBRE award.

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 theNIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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.

Multiple PD(s)/PI(s) are not allowed for this FOA.

The NIH recognizes a compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their trainee and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/ .  Nationally, groups found to be underrepresented in biomedical and behavioral research include, but are not limited to, African Americans, Hispanic Americans, Native Americans (including Alaska Natives), and natives of the U.S. Pacific Islands.  In addition, it is recognized that underrepresentation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.

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

Applications will be accepted from institutions that are in IDeA states and currently hold a Phase I COBRE award.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. 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.

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Helen R. Sunshine, PhD
Office of Scientific Review
National Institute of General Medical Sciences
National Institutes of Health
45 Center Drive, Room 3An.12F, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 435-0815
E-mail: sunshinh@nigms.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following requirements:

The application should be organized and assembled in the order as follows:

Face Page

Use Form 1 of the PHS 398.  On Line 1, include the title that best represents the nature of the COBRE Program.  On Line 2, provide the FOA number  PAR-12-224 and the FOA title “Limited Competition: Renewal of Centers of Biomedical Research Excellence”.  Information for the PD/PI should be entered on the PHS398 face page.  Please remember that the PD/PI must be registered in the eRA Commons prior to application submission. The budget figures should be taken from the consolidated program budget (see below).

Description Page

Use Form 2 of the PHS 398. An abstract describing proposed COBRE center is required and should be placed in the Project Summary area. The length of abstract must not exceed the space provided. 

Key Personnel including the PD/PI, core directors, research project leaders, and other key professional and administrative members of this Program should be placed in the area of Performance Sites and Key Personnel. Do not separate key personnel into each project section.

Table of Contents

Applicant must customize the PHS 398 Table of Contents to specifically identify the section of the application. All sections including the content each core and research project must be separately identified in the customized table of contents.

Detailed Budget Pages for Initial Budget Period and Entire Proposed Period of Support

Use Form 4 and 5 of the PHS 398. A summary or composite budget page should be provided for the Center which should preceed all other individual and entire proposed project period budget pages. A detailed budget for the initial budget period (form page 4) and the budget for the entire proposed project period (form page 5) must be provided for each core and individual research project. Each budget page should be clearly labeled with the name of the core or research project. A detailed justification for each item requested, including supply costs and other expenses, must be provided. The justification should be placed immediately after each budget section.  Do not separate the individual budgets into each core or research project section.

An applicant may request a budget for direct costs no more than $1.5 million per year, excluding facilities and administrative (F&A) costs on consortium arrangements.  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 project .

The PD/PI of the COBRE is not eligible for research project support, nor can he/she use COBRE funds to supplement research activities within his/her laboratory.

Core facilities and individual research projects that are proposed to begin in the first year should have a detailed budget for the initial budget period (form page 4) and a corresponding budget for the entire proposed project period (form page 5). Although the applicant can propose research projects and/or support for core facilities to begin in later years, each year's budget should include costs for only those projects or cores that will be active in that year.

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

PD(s)/PI(s) of the Centers funded through this FOA should budget for and will be expected to attend an annual two-day meeting in Bethesda, Maryland with NIGMS staff.

Funds for alteration & renovation of laboratory facilities should not be proposed and will not be supported.

When a grant application includes research activities that involve institutions other than the grantee institution, it is considered a consortium effort. Such activities may be included in the COBRE grant application, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. In addition, the thematic scientific focus of the COBRE must be evident in applications that include consortia arrangements. Applicants for COBRE grants should exercise great diligence in preserving the interactions of the participants and the integration of the consortium project(s) with those of the parent institution because synergism and cohesiveness can be diminished when projects are located outside of the parent institution.

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.

Biographical Sketches

All Biographical Sketches should be grouped together with the PD/PI's biographical sketch presented first followed by all other sketches in alphabetical order. Do not separate the biographical sketches into each project section.

Resources

Resources including existing equipment, instrumentation and laboratory space for cores and research projects should be described using the PHS398 Resources form page and instructions.  Although there is no page limit for resource section, it should be concise and contain only information that is not included in the Research Strategy section for that corresponding core or research project.  Do not include information required by the FOA, such as methods, that belongs in the page-limited Research Strategy sections. Resources section may be divided into resources available for each core/and or project but all sections should appear together.  Do not include Resources form in individual projects and cores.

If you do not want the applicants to deviate from the Application Guide for any of the Components listed above, then you must DELETE ALL headings listed above. Otherwise, keep ONLY the headings in which you are adding information about the content and form of the above listed sections, and describe each section separately, with its own heading. Include ONLY instructional information that is different from the application guide.  Do NOT include any sections that are part of the Research Plan Component (which should be placed below).

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

The Research Plan for each section consists of the following components, as applicable.  All page limits include all tables and figures.  Do not use components without page limits (1, 2, and 6 to 15) to circumvent the page limits of the Research Strategy.

1.  Cover page

2.  Description page

3.  Introduction (1 page, Resubmission Applications only)

4.  Specific Aims (1 page)

5.  Research Strategy (12 pages)

6.  Bibliography and References Cited

7.  Protection of Human Subjects

8.  Inclusion of Women and Minorities

9.  Targeted/Planned Enrollment Table

10. Inclusion of Children

11. Vertebrate Animals

12. Consortium/Contractual Arrangements

13. Letters of Support

14. Resource Sharing Plan

15. Check List

Specific Requirements for Individual Sections:

Cover page (Do NOT use PHS 398 face page)

For each individual core and research project, a cover page should be included that indicates the project title, the name of the investigator supervising the project, the name of the mentor(s) if applicable, whether human subject/human subject materials will be used in the project, and whether vertebrate animals will be used in the project.

Description page (PHS 398 Form 2)

An Abstract of the proposed core or project is required.  The length of the abstract must not exceed the space provided. Do not include a key personnel list in individual core or project section. 

Introduction (Resubmission Application only, 1 page for each section)

The Introduction must include responses to the criticisms and issues raised in the prior Summary Statement, which summarizes the substantial additions, deletions, and changes. Insert the Introduction before the Research Strategy of each section, identifying within the Research Strategy the changes made by clearly bracketing, indenting, or changing typography, unless the changes are so extensive as to include most of the text. This exception should be explained in the Introduction. Do not underline or shade changes.

Progress and Accomplishments (6 pages)

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

Overall Center Organization and Management Plan

Administrative Core

Research Cores

Research Projects

Letters indicating institutional commitment and any letter of support for the proposed center and research core (if applicable) should be placed immediately after the Research Strategy of the overall center organization and management plan and corresponding core, respectively.  As necessary, each project section can be concluded with letters of commitment from mentors and, as needed, letters of commitment from collaborators and/or consultants.

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 PHS398 Application Guide, with the following modification:

Appendix

No appendix material is allowed. 

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 theNIH 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 postmarked on or before the due dates in Part I. Overview Information.

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-10-115.

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/priority score to reflect their assessment of the likelihood for the COBRE 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 COBRE center proposed). The overall impact/priority score will also take into consideration the extent to which the individual cores and projects enhance the strength of the overall center and the importance of the individual cores and projects to the success of the center.

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 program address an important problem or a critical barrier to progress in the field? If the aims of the program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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?

Investigator(s)

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

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

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

If a new PD/PI has been selected, has the new PD/PI provided evidence of successfully mentoring graduate students, postdoctoral fellows and junior investigators as well as leading a large 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 project? 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 clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Center Organization and Management Plan

Will the proposed organization and management plan provide appropriate support for a thematic, multi-disciplinary center durning the next five-year period? Does the overall plan justify continued support of a thematic multi-disciplinary center for an additional five years?

Are the efforts and ongoing research of all center investigators described in the context of developing an independent and sustainable multi-disciplinary program? Are the proposed projects related to and consistent with the overall goals of center?

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

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

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?

Does the application describe the institutional environment and resources available to investigators, and indicate how prior COBRE support has improved facilities or made available new and collaborative resources (e.g., laboratory facilities, patient populations, laboratory space and personnel)?

Review Criteria for Cores

       Reviewers will score each core based on the criteria provided.

Administrative Core

Does the administrative core include a clear plan for the transition to and attainment of independent status for junior investigators and for the continued development of early career investigators and describe how the center as a whole intends to make the transition from support of multi-disciplinary COBRE research projects to competitive grant support?

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

Milestones and Evaluation: Has the PD/PI selected appropriate and suitable evaluation strategies? Does the development plan include both formative and summative evaluation strategies detailing specific milestones for the acquisition of independent status by the investigators? Are specific milestones identified and supported to measure progress toward attaining long-range goals?

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

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

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

Research Core Facilities

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

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

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

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

For requests of new core facilities: is the request justified in terms of the need for the core as it is related to the COBRE thematic research focus?

Review Criteria for Individual Research Projects

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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?   

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? 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)? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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

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 project? 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 clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

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

Can this project stand alone?

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?

Additional Review Criteria - Overall

As applicable for the cores and projects proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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

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

Revisions

Not Applicable

Additional Review Considerations - Overall

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/priority 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. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) 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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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) 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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Yanping Liu, MD., PhD.
National Institute of General Medical Sciences
National Institutes of Health
6701 Democracy Boulevard, Room 930
Bethesda, MD 20892-4874
Telephone: (301) 451-4217
FAX: (301) 480-3770
E-mail: liuyanp@mail.nih.gov

Peer Review Contact(s)

Helen R. Sunshine, PhD
Office of Scientific Review
National Institute of General Medical Sciences
National Institutes of Health
45 Center Drive, Room 3An.12F, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
E-mail: sunshinh@nigms.nih.gov

Financial/Grants Management Contact(s)

Ms. Courtney Tardd-Wright
Grants Management Specialist
Grants Management Branch
National Institute of General Medical Sciences
National Institutes of Health
45 Center Drive, Room 2AN32C
Bethesda, MD  20892
Telephone:  (301) 594-3918
Email:  tarddwrightc@mail.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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