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EXPIRED

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: Centers of Biomedical Research Excellence (COBRE) (P20)

Announcement Type
This is a reissue of PAR-07-229.

Update: The following updates relating to this announcement have been issued:

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-09-079

Catalog of Federal Domestic Assistance Number(s)
93.389

Key Dates - New Dates
Letters of Intent Receipt Date(s): January 2, 2011
Application Receipt Dates(s): February 1, 2011
Peer Review Date(s): May/June 2011
Council Review Date(s): September 2011
Earliest Anticipated Start Date: February 2012
Expiration Date: February 2, 2011

Key Dates - Old Dates
Release Date: January 16, 2009
Letters of Intent Receipt Date(s): March 28, 2009; March 28, 2010, and March 28, 2011
Application Receipt Dates(s): April 28, 2009 and April 28, 2011
Peer Review Date(s): September/October 2009, September/October 2010, and September/October 2011.
Council Review Date(s): January 2010, January 2011, and January 2012
Earliest Anticipated Start Date: May 2010, May 2011, and May 2012
Expiration Date: April 29, 2011

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 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 and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
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

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

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

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

Collaboration with other non-doctoral degree-granting and research-performing institutes or institutions is encouraged. Funds for research activities 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 type of activities that include activities associated with collaborative projects, attending instructional activities and learning new techniques, sample and data analysis, and workshops etc. It is the responsibility of the PI to define an effective partnership and collaboration.

These centers are expected to engage in future growth through the promotion of collaborative interactive efforts among researchers with complementary backgrounds, skills and expertise and to compete independently for external peer-reviewed center or program project grant support. This goal is accomplished through the direction provided by a PI, who provides leadership to junior investigators (defined below) and has the primary responsibility for administering the program and for overseeing the development of the center and its associated core facilities.

Qualifications and Responsibilities of the PI: The PI must be an established biomedical or behavioral research scientist, who has an active research laboratory, peer-reviewed funding (NIH, NSF or other Federal or non-Federal investigator-initiated support) that is relevant to the scientific theme of the proposed COBRE, and administrative leadership and mentoring experience to effectively carry out the objectives of the COBRE program and to meet its goals. A minimum time commitment of 3 person months is required for the PI. However, up to 6 person months will be supported for mentoring and administrative oversight of the COBRE. If community based participatory research (CBPR) is proposed, the community partner(s) should serve as co-investigator(s). Multiple PIs are not allowed.

If the PI is not in place at the institution at the time of review or award, a plan to recruit such an individual must be included in the application that will result in having that individual on the full-time faculty within one year of the peer-review of the institution's application. An award will not be made until the institution has appointed a permanent COBRE PI.

Overall Center Organization and Management Plan: Each application must describe an overall center organization and management plan to justify support of a thematic multi-disciplinary COBRE program for five years. Ideally, the center will contain three to five individual research projects. Pilot project(s) may be proposed, but they will not be subjejct to peer review. In addition, applications must describe an administrative core that includes a detailed plan for development and mentoring junior investigators. The establishment of research core facilities necessary to carry out the objectives of a multi-disciplinary, collaborative research program may be included in the proposal as well.

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

For applications that propose Community Based Participatory Research (CBPR) (defined below), clear and detailed plans for identifying a health issue that fits community priorities and academic capacity to respond, for developing a coalition of community and academic stakeholders, and for implementing evaluation strategies for the proposed projects must be included.

CBPR is defined as scientific inquiry conducted in communities in partnership with researchers, and is characterized by substantial community input in the development of the proposed study. The process of scientific inquiry is such that community members, persons affected by the health condition, disability or issue under study, or other key stakeholders in the communitys health, are full participants in each phase of the research, including conception, design, conduct, analysis, interpretation, drawing of conclusions and communication of results.

The community refers to populations defined by: geography, race, ethnicity, gender, illness or other health condition, or to groups that have a common interest or cause, such as health or service agencies and organizations, health care or public health practitioners or providers, policy makers, or lay public groups with public health concerns. Community-based organizations refer to organizations involved in the research process as members or representatives of the community.

Although no non-Federal matching funds are required for these applications, clear evidence of institutional commitment must be included with the application. The level of institutional commitment will differ among applicant institutions because of the variability of resources available among institutions. At a minimum, a letter of support from a senior institutional official (e.g., President or Dean) must outline the commitment of resources and facilities to sustain and support the COBRE throughout the period of funding and to maintain these resources beyond the period of grant support.

The institutional environment and resources that are available to investigators must be briefly described. Available resources (e.g., laboratory facilities, patient populations, geographic distributions of space and personnel) and collaborative resources should be described. If core facilities are included for support, the relationship of each component research project to the core(s) should be described.

Individual Research Projects: The individual research projects should stand alone, but share the COBREs common thematic scientific focus. Each research project should be led by a single junior investigator who is responsible for ensuring that the Specific Aims of that project are met. An initial minimum commitment of 6 person months is required for this individual. It is recognized that during the development of a junior investigator's career (for example, the acquisition of other research support) it may be necessary to reduce this effort. Each individual research project should describe the Specific Aims in the selected area of research and the goals for the first year and for the long term. The design principles supporting the research or the hypotheses to be tested should be delineated. Preliminary studies are not required for projects in a COBRE application, but applicants with preliminary results should describe them. In the absence of preliminary results, applicants should have a strong research plan that includes a description of the rationale and scientific basis for the proposed research. Furthermore, each research project should describe its relationship to the thematic area of multi-disciplinary research that is the focus of the COBRE and critically assess the existing knowledge and approaches that have been or are being directed in the area with an emphasis on specifically how the multi-disciplinary COBRE approach will advance the field. In addition, how the Specific Aims relate to the importance and health relevance of the proposed research to should be concisely stated.

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

With respect to item (1), grants that name an individual as a co-investigator, collaborator, consultant, or to a position other than PI or co-PI on research grants that allow multiple PIs, do not disqualify that investigator. Starter grants (such as NIH's FIRST award mechanism, R29), Academic Research Enhancement Award grants (AREA, R15), exploratory/pilot project grants (such as NIH R03 and R21 awards), mentored career development awards (such as NIH K01 and K08 awards), or other Federal or non-Federal funding whose purpose is to provide preliminary support in anticipation of a RPG or PPG also do not disqualify the investigator. The intent of this FOA is to allow promising investigators whose early career support consists of awards geared toward initiating their intended area of research. However, investigators who have managed to obtain significant support in the form of a RPG or PPG (e.g., NIH R01 or P01, NSF, or other Federal or non-Federal agency awards) are not eligible. Each project Investigator should indicate in his/her Biographical Sketch their current and previous history of peer-reviewed research support.

A junior investigator must hold a faculty appointment (or equivalent at a research institute) at the time that the award is made. Moreover, a clear commitment to support this appointment independent of the outcome of this application must be demonstrated from the institution by a letter(s) from the appropriate senior institutional official(s). Postdoctoral fellows or other positions that do not carry independent faculty status at the applicant institution will disqualify that individual and his/her research project from further consideration and will not be reviewed or counted towards the minimum required 3 projects.

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

This FOA is not intended to replace support for ongoing investigator-initiated research programs of established investigators. Instead, established investigators should serve as mentors to advance the junior investigators' careers.

Administrative Core: A clear plan addressing the development of junior investigators and for their transition to and attainment of independent investigator status must be included. This plan should detail the long-term goals as to how the institution intends to make the transition from the research support of multi-disciplinary COBRE projects to competitive grant support through applications submitted by its faculty members to relevant NIH Institutes and Centers or to other appropriate Federal or non-Federal agencies or organizations. Each junior investigator must submit an investigator-initiated RPG application by the end of two years of COBRE support in order to be eligible to receive continued funding through the COBRE award.

The faculty development plan must include both formative and summative evaluation strategies with specific milestones, including, but not limited to, acquisition of independent status by the junior investigators, competition for complementary NIH, Federal or non-Federal external peer-reviewed research grant support, and publication in peer-reviewed journals. Plans for faculty development should include the mentoring plan that identifies established senior faculty members who will provide mentoring and oversight to the junior investigator; constructive evaluations by members of the External Advisory Committee (EAC); and how the COBRE PI will coordinate the management of all of these individuals. An internal advisory committee may provide additional oversight and input, but this committee should not act as a substitute for the EAC.

Each junior investigator should have at least one mentor. The mentor must be an established investigator who has demonstrated the ability to advise others through the acquisition of external support and the maintenance of an independent research laboratory. In some 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 receive up to 1.8 person months of salary support, which should be listed in the Administrative Core's budget section of the application and not in the individual projects' budget sections. Mentored junior investigators should clearly designate in the text of their individual research plans the identity of their mentors and describe the mentors qualifications, both scientific and advisory, to assist in the oversight of the project.

The award of a Research Project Grant (RPG) to a junior investigator should be viewed as a milestone and a criterion for changing the status of an investigator from mentored support via the COBRE to independent investigator. A junior investigator also may be considered for a status change if independence is indicated by the acquisition of sufficient skills and knowledge. However, it is stressed that the goal of the COBRE program is to promote the development of an independent and sustainable center. Investigators who have acquired independent status or completed a research project should not be excluded from center activities. These investigators should be allowed access to core facilities and should be encouraged to participate in collaborative research efforts. If appropriate, an investigator who has acquired independent status may direct a COBRE core facility or serve as a mentor.

It is emphasized that COBRE support cannot be provided in instances where a junior investigator's new award overlaps or is significantly similar to that described in the COBRE program. However, if the specific aims of the junior investigator's RPG are significantly different from the project described in the COBRE, then the junior investigator has an obligation to remain in the program to complete his/her COBRE project. In this latter case, continued support for personnel (e.g., postdoctoral associates, graduate students, technicians, etc.) associated with the COBRE project but also listed on the other award can be provided. However, the percent efforts of these individuals must be appropriately adjusted. Under this FOA, IDeA Networks of Biomedical Research Excellence (INBRE) investigators are not eligible to receive simultaneous research funding as COBRE project investigators. Similarly, COBRE investigators may not receive simultaneous research project support from an INBRE award.

A junior investigator who has achieved independent status and no longer leads a research project may be replaced by a new junior investigator. Replacement junior investigators and new research projects may be substituted following review by the PI and the EAC. The PI must communicate the EAC's recommendation to the NCRR for Programmatic Review.

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

Each COBRE application must include an External Advisory Committee (EAC) comprised of scientists with national scientific reputations in their fields; their expertise must be directly relevant to the scientific theme of the COBRE. The PI must select and name in the application at least three, but no more than five scientists who will serve as EAC members. Furthermore, the participation of each member in the EAC must be confirmed by inclusion in the application of a letter of acceptance and a current biographical sketch of each proposed member. 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 the removal of EAC 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 candidate investigators for replacement/substitute projects, 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.

The COBRE PI should budget for a biannual two-day meeting in Bethesda, Maryland, with NCRR staff.

Research Core Facilities: Funds may be requested to establish core facilities. The applicant must demonstrate that each proposed core will impact the development of the center and how it will serve the scientific needs of the individual research projects. . Although the COBRE award is not intended to replace support for ongoing, investigator-initiated research projects of established investigators, mentors and other 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.

Sharing research resources among COBRE and INBRE investigators is strongly encouraged. As much as practicable, applicants should seek to utilize existing equipment and instrumentation supported by other COBRE or INBRE awards. Requests for duplicative equipment or instrumentation, including computational facilities and related bioinformatics resources, must be appropriately justified.

Alteration and Renovation: Alteration and Renovation (A&R) costs to improve existing research laboratories or animal facilities are allowed. This PA will provide up to $500,000 in direct costs only in year one of the award as a one-time cost expenditure. Direct costs requested for A&R are not subject to facilities and administrative costs (F&A). Although this amount will be provided only in year one, the proposed A&R work does not have to be completed in year one. However, PIs are strongly encouraged to complete all A&R work in an expeditious manner and all A&R work must be completed before expiration of the award. Alteration and Renovation projects must be relevant to the scope of the proposed research. Sufficient detail must be provided to estimate the cost and suitability of the project. Failure to adequately justify an A&R request will likely result in its deletion from the requested budget. Funds designated for A&R under this FOA cannot support new construction, including completion of shell space, or the purchase of movable research equipment/instrumentation or equipment intended for teaching or other non-research related purposes. Please note that A&R costs will be approved only for facilities improvements at the applicant organization. Proposed improvements at consortia sites are disallowed.

The expenditure of funds for all A&R projects in excess of $300,000 or funds that support the installation of fixed equipment or other structural alterations is restricted until the project documentation/architectural drawings have been reviewed and approved by NIH staff.

For any proposed A&R, a narrative summary (as outlined below), line drawings, and cost estimates must be provided. The following sample format is suggested:

Narrative Summary

(1) Relate the proposed renovations to the research projects that will use the facility. If renovations to animal facilities are proposed, relate the proposed renovations to the projected animal populations (by species). If renovations to animal facilities are proposed, include the lines of authority and responsibility for administering the institution's animal care and use program. The role and composition of the Institutional Animal Care and Use Committee (IACUC) and how compliance with relevant laws, policies, and guidelines are achieved should also be included.

(2) List the functional components, including the size (dimensions) and square footage of each component (room, alcove, cubicle) that will be directly affected by the renovation project.

(3) List engineering criteria applicable to each component (mechanical, electrical, and utilities). Include information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam.

(4) List appropriate architectural criteria (such as width of corridors and doors, surface finishes).

(5) List and justify all fixed equipment items requested for the renovated area.

Line Drawings

(1) Submit line drawings on 8-1/2" x 11" paper only. (DO NOT SUBMIT BLUEPRINTS.) These drawings will not be counted against the page limit. All floor plans must be legible, with the scale clearly indicated.

(2) The line drawings of the proposed renovation must be at a scale adequate to explain the project. The drawings should indicate size (dimensions), function, and net and gross square feet of space for each room. The total net and gross square feet of space to be renovated should also be given.

(3) The plan should indicate the location of the proposed renovation area in the building.

(4) Include the as-built drawings of the proposed renovation area and indicate any areas that will be demolished.

(5) Changes or additions to existing mechanical and electrical systems should be clearly described in notes made directly on the plan or attached to the plan.

(6) Indicate the type(s) of new finishes to be applied to room surfaces.

Cost Estimates

Detailed cost estimates must be included. Provide vendor quotes when available.

Those individuals interested in seeking additional funds for facilities improvements are referred to the NCRR Research Facilities Improvement and Animal Facilities Improvement Programs, which accept applications for construction and for extensive renovation. Please refer to the NCRR Website: http://www.ncrr.nih.gov/.

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 announcement (FOA) will use the P20 award mechanism. The applicant 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 $22 million to fund up to 10 awards in response to this FOA contingent upon the availability of funds. An applicant must request a project period of five years and may request a budget for direct costs of up to and no more than $1.5 million per year, excluding facilities and administrative (F&A) costs on consortium arrangements. The applicant may also request additional direct costs in year one only of up to $500,000 as a one-time expenditure for Alteration and Renovation of laboratory or animal facilities. If Alteration and Renovation costs are requested, then the total budget request for year one must not exceed $2 million in direct costs, excluding F&A costs on consortium arrangements. Regardless whether Alteration and Renovation costs are requested, budget requests for years two through five cannot exceed $1.5 million per year, excluding F&A costs on consortium arrangements.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Individual research projects and core facilities that are proposed to begin in year one should have corresponding 5-year individual budgets. Individual project and core facility budgets should be grouped together with justifications and prefaced by a summary or composite budget for the entire center.

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.

For those small and developing institutions where Offices of Sponsored Programs are not in placed, funds may be used to develop Offices of Sponsored Programs or to recruit additional faculty who complement the scope of the proposed program. Recruitment funds are limited to $200,000 per year for each position. 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.

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

Consortium Arrangements: When a grant application includes research activities that involve institutions or communities 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 group at 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 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

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Criteria for Eligibility of an IDeA State to participate in this COBRE competition: In making its assessment for eligibility, NCRR included all states/commonwealths with a success rate for obtaining NIH grant awards (number of applications awarded vs. number of applications approved) of less than 20 percent over the period of 2001-2005 or received less than an average of $120 million per year during that time period. Under these criteria, the following states/commonwealth are the IDeA states eligible to respond to this solicitation:

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

Criteria for Institutional Eligibility: An eligible institution must be within an IDeA state. An eligible institution must either be (1) a domestic, public or private, or non-profit research institution that awards doctoral degrees in health sciences or sciences related to health, or (2) an independent biomedical research institute.

Applications will be accepted from eligible institutions that hold two or less active COBRE awards. Eligible institutions that do not hold a current COBRE award are encouraged to apply. Please note that applications will NOT be accepted from institutions that hold three or more active COBRE awards (excluding COBRE Phase 3: Transition Center awards). These institutions cannot submit new applications.

Restrictions for Submitting an Application: No eligible institution can submit more than one application per fiscal year in response to this FOA. Multiple applications received from these institutions or applications received from ineligible institutions (those that hold three or more active COBRE awards) will not be reviewed. If an institution is planning more than one application, it is the responsibility of that institution to appoint a steering or selection committee to decide which single application to submit in response to this FOA.

Special Consideration: Special consideration will be given to eligible small and developing institutions, minority serving institutions and applications with strong collaborations to such institutions in IDeA states. Special consideration will also be made based upon geographic distribution throughout IDeA eligible states.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution 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.

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

Applications submitted in response to previous COBRE RFAs or PA (RFA-RR-00-003, http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-00-003.html; RFA-RR-00-006, http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-00-006.html; RFA-RR-02-003, http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-02-003.html; RFA-RR-02-007, http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-02-007.html; RFA-RR-03-014, http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-03-014.html; RFA-RR-04-007, http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-04-007.html; RFA-RR-06-002, http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-06-002.html; PAR-07-229, http://grants1.nih.gov/grants/guide/pa-files/PAR-07-229.html) and resubmitted in response to this FOA will be treated as amended applications. However, no resubmissions of unfunded applications that were submitted two or more times in response to previous COBRE RFAs or PA will be accepted in response to this FOA. This does not preclude the submission of a new application where the focus and scientific theme of the center are significantly different from any prior submission. Resubmission must include an Introduction addressing the previous peer review critiques (Summary Statement)

Renewals will not be accepted.

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) 710-0267, Email: [email protected].

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

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): March 28, 2009; March 28, 2010, and March 28, 2011.
Application Receipt Dates(s): April 28, 2009, April 28, 2010, and April 28, 2011
Peer Review Date(s): September/October 2009, September/October 2010, and September/October 2011.
Council Review Date(s): January 2010, January 2011, and January 2012.
Earliest Anticipated Start Date: May 2010, May 2011, and May 2012.

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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

The letter of intent is to be sent by the date listed in Section IV.3.A.

Steven Birken, PhD
Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard, Room 1078
Bethesda, MD 20892-4874
Bethesda, MD 20817-4874 (for express/courier service)
Telephone: (301) 435-0815
FAX: (301) 480-3660
E-mail: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application 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 CDs of the appendix materials must be sent to:

Steven Birken, PhD
Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard, Room 1078
Bethesda, MD 20892-4874
Bethesda, MD 20817-4874 (for express/courier service)
Telephone: (301) 435-0815
FAX: (301) 480-3660
E-mail: [email protected]

3.C. Application Processing

Applications must be received on or before the application receipt/ date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete 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 merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

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.

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 new 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 new 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/grants/policy/nihgps_2003/NIHGPS_Part6.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 ideally propose at least three and up to five meritorious individual research projects and must describe the nature and scope of any 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. 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 by 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 must not be used for each individual 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. 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.

The main body of the application should be self contained and the Appendix must not be used to circumvent page limitations. Applicants must adhere to the guidelines described in the PHS 398 document instructions regarding the preparation and presentation of materials that can be included in the Appendix.

Applicants submitting a revised application should follow the instructions for revised applications described in the PHS 398 document instructions. The revision must include an Introduction of not more than one page that summarizes the substantial additions, deletions, and changes. The Introduction must include responses to the criticisms and issues raised in the prior Summary Statement. Insert the Introduction just before the very beginning of the overall COBRE 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 revision must 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 or core to what was originally submitted with the prior COBRE application. Insert the Response to Previous Review just before the very beginning of the individual projects Research Plan section. Revised text should be marked as described above.

Page Limitations

The Overall Center Organization and Management Plan of the application describing the center, but not including the individual investigators' research projects and core facilities, is limited to no more than 30 pages, including all text, tables, graphs, figures, diagrams and charts. The Research Plans for the investigators' research projects, core descriptions, and alteration and renovation are limited to no more than 12 pages each. These limitations do not include the sections describing Human Subjects Research, Vertebrate Animals, Literature Cited, Consortium/Contractual Arrangements, Consultants, and/or supporting letters. Each Biographical Sketch is limited to no more than four pages. 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.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

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.

2. Review and Selection Process

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by (Enter CSR or IC name here) 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:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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 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/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, 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? Are the strengths, academic qualifications and biomedical expertise of the project investigators appropriate and sufficient for research productivity?

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) Protections for Human Subjects, 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?

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

In addition to the above review criteria, which will be used to evaluate each scientific project, the following criteria will be addressed and considered in the determination of scientific merit and the rating.

The review of a COBRE application is not only based on the traditional review criteria (Significance, Approach, Innovation, Investigator, Environment), but also on the qualifications of the PI to provide both scientific and administrative leadership and on the feasibility and potential for investigators to become competitive for independent funding. Specifically, the Scientific Review Group should evaluate the 1) administrative leadership and overall potential for enriching the intellectual milieu for doing research, 2) effectiveness in training and promoting junior investigators, and 3) scientific merit of the individual biomedical research projects .

Administrative Leadership and Overall Potential for Enriching the Intellectual Milieu for Doing Research:

Principal Investigator

Does the PI have the qualifications to provide scientific and administrative leadership in developing and directing the COBRE, and establishing thematic collaborative research efforts? As noted previously, the PI must demonstrate that he/she is an established biomedical or behavioral research scientist, that he/she has an active research laboratory, that he/she has relevant peer-reviewed funding (either NIH, NSF or other Federal or non-Federal investigator-initiated support), and that he/she has shown administrative leadership and mentoring experience.

Biomedical Research Capacity

Does the application describe how the institutional biomedical research capacity will be augmented and strengthened? How will basic and/or clinical research be encouraged? How will a scientific thematic focus be established and maintained?

Are the nature, scope, and effectiveness of the plans for coordination and cooperation among research project investigators appropriate and will they contribute to the establishment of the center?

Institutional Support

Is the level of institutional commitment sufficient to provide support for the development of a thematic multidisciplinary center? Has the applicant demonstrated that the resources and facilities to sustain the COBRE program are present, including, but not restricted to, existing relevant equipment, animal, and/or computer resources, and departmental or interdepartmental cooperation? Does the applicant detail the long-term goals as to how the institution intends to make the transition from the research support of the COBRE to competitive grant support?

Core Facilities

Has the applicant demonstrated the need for the proposed core facilities and the effectiveness of these facilities to enhance the research effort? Has the applicant demonstrated that each proposed core will serve the scientific needs of the individual research projects and has he/she shown how each core will impact the development of the center? Has the applicant selected qualified personnel to manage and operate the core facilities? Does the applicant indicate any institutional commitment to support and maintain the proposed core facilities?

External Advisory Committee and Evaluation of Progress

Has the PI selected a suitable External Advisory Committee with expertise relevant to the theme of the COBRE and does he/she describe plans to make effective use of this committee to achieve the objectives of the center? Has the PI selected appropriate and suitable evaluation strategies and specific milestones to measure progress, not only of the junior investigators, but of the center as a whole, toward attaining its long-range goals? ? Have appropriate and suitable evaluation strategies and specific milestones to measure progress toward attaining long-range goals been selected and how will these be employed?

Effectiveness in Training and Promoting Junior Investigators

Are plans to direct and manage the research training, career development and mentoring of junior investigators well-described and will these plans be effective in transitioning these investigators toward independent status? If the PI plans to recruit new faculty to the center, are these plans suitable and consistent with the effective growth and development of the center?

Scientific Merit of the Individual Biomedical Research Projects: In addition to the traditional review criteria: Has the PI shown effective judgment in the selection of research projects? Are the projects related to and consistent with the overall goals of the center? Can the individual projects stand alone? Although the Scientific Review Group will evaluate the qualifications of each junior investigator using the traditional criteria and considerations indicated in this PA, do the junior investigators have the potential and ability to achieve independent status?

Community Based Participatory Research, CBPR, (If included)

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 CBPR 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 communitys health, full participants in each phase of the research, including conception, design, conduct, analysis, interpretation, drawing of conclusions and communication of results?

Alteration and Renovation

Are requested alteration and renovation projects relevant to the scope of the proposed research? Are the costs and suitability of the project justified? Do the proposed renovations relate to the research projects that will use the facility? If renovations to animal facilities are proposed, do the proposed renovations relate to the projected animal populations (by species)? If renovations to animal facilities are proposed, are the lines of authority and responsibility for administering the institution's animal care and use program indicated? Is the role and composition of the Institutional Animal Care and Use Committee (IACUC) and how compliance with relevant laws, policies, and guidelines are achieved described? Are there lists of the functional components, including the size (dimensions) and square footage of each component (room, alcove, cubicle) that will be directly affected by the renovation project. Are there appropriate descriptions of the engineering criteria applicable to each component (mechanical, electrical, and utilities) including information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam, as well as the appropriate architectural criteria (such as width of corridors and doors, surface finishes)? Is justification provided for all fixed equipment items requested for the renovated area?

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

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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.

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.

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.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), 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.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Do individual projects and core descriptions that are retained in the revision 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?

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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.

Additional Review Considerations

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

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

Select Agents 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).

Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or impact/priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

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.

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 they are considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

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.

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/grants/policy/nihgps_2003/NIHGPS_Part4.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/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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 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: [email protected]

2. Peer Review Contacts:

Steven Birken, PhD
Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard, Room 1078
Bethesda, MD 20892-4874
Bethesda, MD 20817-4874 (for express/courier service)
Telephone: (301) 435-0815
FAX: (301) 480-3660
E-mail: [email protected]

3. Financial or Grants Management Contacts:

Mr Gavin Wilkom
Office of Grants Management
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard, Room 1048
Bethesda, MD 20892-4874
Telephone: (301) 435-0964
FAX: (301) 480-3777
E-mail: [email protected]

Section VIII. Other Information

Required Federal Citations

Vertebrate Animals:
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 impact/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/

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/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.

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.

Inclusion of Women, Minorities, and Children:
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-09-116.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.

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 investigators 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. 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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