Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov/)

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


Announcement Type
This is a reissue of RFA-RR-07-001.

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-RR-08-007

Catalog of Federal Domestic Assistance Number(s)
93.389

Key Dates
Release Date: May 8, 2008
Letters of Intent Receipt Date: Not applicable.  
Application Receipt Date: October 22, 2008
Peer Review Date(s): February – March 2009.
Council Review Date: May 2009.
Earliest Anticipated Start Date: July 2009
Additional Information To Be Available Date (Url Activation Date): Not applicable.
Expiration Date: October 23, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The purpose of this Funding Opportunity Announcements (FOA) is to allow institutions holding eligible Centers of Biomedical Research Excellence (COBRE) 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 PI and the established biomedical research faculty. Leadership also is demonstrated by showing that the infrastructure necessary for the continued functioning of the center (e.g., facility improvements, modernization/acquisition of equipment, implementation of administrative resources, etc.) is in place, and that the institution is committed to maintain the resources and infrastructure that have been established through prior COBRE support.

The objectives of the 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. 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.

Overall Research Plan

Each application must describe an overall research plan that justifies continued support of a thematic multi-disciplinary center for an additional five years. A description of the unique research opportunities that have been and will continue to be provided to the investigators and to the institution must be provided. The efforts and ongoing research of all center investigators should be described in the context of developing an independent and sustainable multi-disciplinary program. Ideally, it is recommended that the research plan contain the descriptions of at least three and up to five individual research projects. However, the research plan cannot contain fewer than three individual research projects. An administrative core with detailed development and mentoring plan must be included.  In addition, support for core facilities necessary to carry out the objectives of the center may be proposed.

The leadership and direction of the COBRE is provided by the Principal Investigator (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 PI may continue to serve in this role or a new PI may be appointed. In either case, the 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 a given institution. 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 period of funding and plans to maintain these resources beyond the period of grant support.

The institutional environment and resources that are available to investigators must be briefly described. Evidence of how prior support has improved facilities or made available new and collaborative resources (e.g., laboratory facilities, patient populations, geographic distribution of space and personnel) should be indicated. If support for instrumentation either to augment current or establish new core facilities is requested, the need of each component research project to the core(s) should be identified or how this instrumentation would facilitate center research plans should be described.

Individual Research Projects

Each COBRE program should ideally include three to five individual research projects that stand alone, but share a common thematic scientific focus. Each program must propose a minimum of three individual research projects. 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. The design principles supporting the research or the hypotheses to be tested should be delineated. 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. Furthermore, each research project should describe the area of multi-disciplinary research that is the focus of the COBRE and critically assess the existing knowledge and approaches that have been or are being directed in the area with an emphasis on specifically how the multi-disciplinary COBRE approach will advance the field. Moreover, the importance and health relevance of the proposed research to the specific aims should be concisely stated.

Mentoring and development of investigators who are not yet established is 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 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. Established investigators must make an initial commitment of at least 3 person months. 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. PIs should consult with NCRR 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 that the award is made. Moreover, a clear commitment to support this faculty appointment independent of the outcome of this application must be demonstrated by the institution in a letter(s) from the appropriate senior institutional official(s). Postdoctoral fellows or other positions that do not carry independent faculty status will disqualify those individuals and their research projects from further consideration. The 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.

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 detail the long-term goals regarding how the institution intends to make the transition from the research support of multi-disciplinary COBRE projects to competitive grant support through applications submitted by its faculty members to relevant NIH Institutes and Centers or to other appropriate Federal or non-Federal agencies or organizations. All project investigators, regardless of their career status, must submit investigator-initiated RPG applications by the end of two years of support to maintain continued funding through the COBRE award.

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; see Other-Special Eligibility Criteria below), and coordinated management of all of these individuals by the 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. Additionally, mentoring of early career investigators is strongly encouraged. 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 up to 1.2 – 1.8 person months and should be listed in the Administrative Core's budget section of the application and not in the individual 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 project investigator by proposing a new research project that does not overlap with his/her new award. New projects must be reviewed by the PI and the EAC. The PI must communicate the EAC recommendation to the NCRR for their Programmatic Review. An investigator who has acquired an RPG may direct a 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.

A project leader who no longer supervises a research project may be replaced by a new investigator. Replacement research projects and new investigators must be reviewed by the PI and the EAC. The PI must communicate the EAC's recommendation to the NCRR for Programmatic Review.

In some instances, a project leader may be placed on probation or considered for removal from the COBRE program if a review by the EAC indicates a failure by the investigator to make significant progress toward achieving the specific aims of his/her project or, as noted above, to submit an investigator-initiated RPG application by the end of two years of COBRE support.

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. Furthermore, the PI should indicate any institutional commitment to support and maintain the proposed facilities.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the P20 award mechanism(s).

The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

2. Funds Available

The NCRR intends to commit approximately $18 million dollars in FY 2009 to fund up to nine renewal grants in response to this FOA. An applicant must request a project period of five years and a budget for direct costs up to $1.5 million dollars per year.

Individual research projects and core facilities that are proposed to begin in the first year should have corresponding individual budgets. 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. The PI must communicate plans for the expenditure of funds for recruitment purposes to the NCRR for Programmatic Review.

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.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

NIH grants policies as described in the http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-03-014.html ); RR-02-007; (http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-02-007.html ), and RR-02-003, (http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-02-003.html ),

Eligibility is also opened to Institutions who submitted but were not awarded a competitive continuation in response to RFA-RR-07-001, (http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-07-001.html ).

1.B. Eligible Individuals

Either the current PI or a new PI with the skills, knowledge, and resources necessary to carry out the proposed research may be selected by the institution to develop an application for continuation support. The PI of the COBRE application must be an established biomedical or behavioral research scientist who has demonstrated the administrative abilities to effectively carry out the objectives of the COBRE program and meet its goals. The qualifications of the PI have been previously described.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Investigators may submit only one application in response to this FOA.

Resubmission of renewal applications will be accepted; however, such applications must include an Introduction addressing the previous peer review critiques (Summary Statement).

Renewal applications are permitted in response to this FOA.

Annual Meetings for Principal Investigators

PIs 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 NCRR staff.

External Advisory Committees

Each COBRE application must include an External Advisory Committee (EAC) comprised of scientists with national scientific reputations in their field; their expertise must be directly relevant to the scientific theme of the COBRE. The PI must name in the application all EAC members and must confirm their participation in the EAC by including a letter of acceptance and a current biographical sketch of each member. Ideally, an EAC consists of at least three, but no more than five scientists, although it is understood that in some cases additional members may have been added after the original award was made to reflect the development of the center. The PI may recruit additional members or remove members to the EAC after an award is made. The PI must communicate the selection of additional EAC members or removal of members to the NCRR for Programmatic Review.

The EAC critiques the scientific progress of the COBRE and also offers advice on scientific matters to the COBRE 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 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 candidates for replacement/substitute projects and investigators, as required, before such requests are forwarded to the NCRR 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 NCRR.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A).

Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: Not applicable.
Application Receipt Date: October 22, 2008
Peer Review Date(s): February – March 2009
Council Review Date: May 2009
Earliest Anticipated Start Date: July 2009.

3.A.1. Letter of Intent

Not applicable.

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard
Bethesda, MD  20892-4874
Bethesda, MD  20817-4874 (for express/courier service)
Telephone: (301) 435-0811
FAX: (301) 480-3660

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-019.html.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

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. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements and Information

An application for a COBRE award must include the following:

A clear and full explanation of the necessary administrative, fiscal, and scientific aspects of the proposed COBRE.

A research plan for five years that describes the organization and component functions of the COBRE. The plan should demonstrate the applicant's knowledge, ingenuity, practicality, and commitment to developing and maintaining a significant and productive research program.

A description of and justification for the proposed individual research projects and core service facilities that collectively will contribute to the center. Applicants should propose at least three and up to five individual research projects and must describe the nature and scope of the scientific research collaborations.

A description of the research and research training or career development goals and capabilities of the proposed COBRE.

A description of the infrastructure for conducting studies aimed at developing a nationally competitive biomedical research program.

Applicants should follow the order of content described in the PHS 398 document instructions and indicated on the Table of Contents page; a customized Table of Contents page is encouraged to indicate the start pages for major sections of the application. With respect to specific sections, the Budget section should begin with the summary or composite budget for the center, followed by the individual budgets for all projects, cores, consortia and contractual arrangements. Do not separate the individual project budgets into each project section. All Biographical Sketches should be grouped together with the PI's biographical sketch presented first followed by all other sketches in alphabetical order. Do not separate the biographical sketches into each project section. The Research Plan for the center should be followed with letters indicating institutional commitment and any letters of support for the proposed center (if applicable). Do not place these letters in the Appendix. The Research Plan for the center (including letters) should be followed by the core descriptions and individual investigator Research Plans. Although a PHS 398 face page should not be used for each individual research project, a cover page should be included that indicates the project title, the name of the project investigator, the name of the mentor(s) and/or collaborators, as applicable, whether human subjects/human subject materials will be used in the project, and whether vertebrate animals will be used in the project. A Description page that provides an Abstract of the proposed project is required and should immediately precede each project's Research Plan. 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. Do not place these letters in the Appendix. Consecutively number the pages throughout the application. Do not include unnumbered pages and do not use suffixes, such as 5a, 5b, etc. Adhere to NIH format described in the PHS 398 instructions for font, line spacing and margins.

The Preliminary Studies/Progress Report sections for the overall center and for revised individual projects should incorporate any work done since the prior version was submitted.

Research Plan Page Limitations

The Research Plan section of the application describing the center, but not including the individual investigators' research projects and core facilities, is limited to no more than 25 pages, including all text, tables, graphs, figures, diagrams, and charts. The Research Plans for the investigators' research projects and core facilities descriptions are limited to no more than 10 pages each. These limitations do not include the sections describing Human Subject Research, Vertebrate Animals, Literature Cited, Consortium/Contractual Arrangements, Consultants, and/or supporting letters. Each Biographical Sketch is limited to no more than four pages, using the NIH format. If not specifically cited in the PHS 398 document instructions, no page limit is in place for any other section. However, applicants are strongly urged to be succinct.

Resubmission Applications:

Applicants submitting a resubmission, (those who applied but were not funded under RFA- RR-07-001) application should follow the instructions for resubmission applications described in the PHS 398 document instructions. The resubmission must include an Introduction of not more than three pages that summarizes the substantial additions, deletions, and changes. The Introduction must include responses to the criticisms and issues raised in the Summary Statement. Insert the Introduction just before the very beginning of the Research Plan. Identify within the Research Plan 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.

Individual projects and core descriptions that are retained in the resubmission may each include a separate section of not more than one page titled Response to Previous Review that summarizes the substantial additions, deletions, and changes from the project that was originally submitted with the prior COBRE application. Insert the Response to Previous Review just before the very beginning of the individual project’s Research Plan section. Changed text should be marked as described above.

Appendix Materials

All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application.  Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.  Only one appendix for the entire application is allowed; do not attach an appendix to each project or other sections of the application.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

In addition, the final selection of awards will depend upon recommendation of the National Advisory Research Resources Council, geographic distribution, program balance, and the enhancement of the research competitiveness of the institution.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCRR and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Review of a COBRE application involves an evaluation of the qualifications of the PI; the COBRE milestones and evaluation; investigator research projects; and core facilities:

Principal Investigator: Has the PI demonstrated effective administrative leadership in developing and sustaining an independent, multi-disciplinary center?

Has he/she shown the ability to lead, develop, and direct the COBRE to establish thematic collaborative research efforts?

Has the PI shown effective leadership and judgment in the selection of research projects? Are these projects related to and consistent with the overall goals of center?

Does the PI provide evidence that he/she can continue to provide effective leadership?

If a new PI has been selected, has the new PI provided evidence of successfully mentoring graduate students, postdoctoral fellows and junior investigators and leading a large research group?

Milestones and Evaluation: Has the PI selected appropriate and suitable evaluation strategies?

Are specific milestones identified and supported to measure progress toward attaining long-range goals?

Has the PI demonstrated how prior support has helped achieve these milestones, such as junior investigators reaching independent status, successfully obtaining complementary NIH, Federal or non-Federal external peer-reviewed research grant support, and publishing data in peer-reviewed journals?     

Has the 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?

Has the PI selected a suitable External Advisory Committee and has he/she made effective use of this committee to achieve the objectives of the center?

COBRE Research Projects: Note: The projects themselves are reviewed using the standard NIH review criteria provided in the prior section, Significance, Approach, Innovation, Investigator, and Environment. For the COBRE as a whole, please review the following in relation to the research projects:

Has the PI shown effective leadership in directing and managing the mentoring plan required to move the investigators toward independent status?

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

Are all research projects of high quality and significance?

Do project investigators publish their work in a timely manner?

Does the PI present a plan for the continued development of investigators to independent status?

Has the PI demonstrated that critical mass of investigators has been (is being) established?  Has the PI recruited new investigators to the center and have these efforts been successful in increasing the biomedical research capacity of the institution?

If the 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 advance the thematic focus of the COBRE?

For project investigators new to the COBRE, do they show career development potential and/or an ability to achieve independent status?

Core Facilities: Has the 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 manage the core facility well qualified?

Has the 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 related to the COBRE thematic research focus?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information


1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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. See Also Section IV.5. Funding Restrictions.

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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

3. Reporting

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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Yanping Liu, MD, PhD.
Division of Research Infrastructure
National Center for Research Resources
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

2. Peer Review Contacts:

Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard
Bethesda, MD  20892-4874
Bethesda, MD  20817-4874 (for express/courier service)
Telephone: (301) 435-0811
FAX: (301) 480-3660

3. Financial or Grants Management Contacts:

Ms. Vicki Maurer
Office of Grants Management
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard, Room 1047
Bethesda, MD  20892-4874
Telephone: (301) 435-0837
FAX: (301) 480-3777
E-mail: maurervl@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


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NIH Funding Opportunities and Notices


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