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 modification of RFA-RR-04-007, which was previously released June 24, 2004.

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

• February 22, 2007 - This RFA has been reissued as (PAR-07-229).

Request For Applications (RFA) Number: RFA-RR-06-002

Catalog of Federal Domestic Assistance Number(s)
93.389

Key Dates
Release Date: June 1, 2006
Letters of Intent Receipt Date(s): September 25, 2006 (for both receipt dates)
Application Receipt Date(s): October 23, 2006 and February 26, 2007
Peer Review Date(s): February/March 2007 and June/July 2007
Council Review Date(s): May 17, 2007 and September 6, 2007
Earliest Anticipated Start Date(s): September 30, 2007
Expiration Date: February 22, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• The National Center for Research Resources (NCRR) of the NIH invites applications for Centers of Biomedical Research Excellence (COBRE) from investigators at biomedical research institutions that award doctoral degrees in the health sciences or sciences related to health or at independent biomedical research institutes within IDeA-eligible states. The objective of COBRE initiative is to strengthen an institution's biomedical research infrastructure through the establishment of a thematic multi-disciplinary center and to enhance the ability of investigators to compete independently for complementary National Institutes of Health (NIH) individual research grant or other external peer-reviewed support. COBRE awards are supported through the Institutional Development Award (IDeA) Program, which aims to foster health-related research by increasing the competitiveness of investigators at institutions located in states with historically low aggregate success rates for grant awards from the NIH.
• The NCRR intends to commit approximately $12 million in FY 2007 to support this initiative. It is anticipated that up to five applications will be funded in response to this RFA. 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 and the receipt of a sufficient number of meritorious applications.
• This Request for Applications (RFA) will use the NIH exploratory grant mechanism (P20).
• In making its assessment for eligibility, NCRR includes all states/commonwealths with success rates for obtaining NIH grant awards (number of applications awarded vs. number of applications approved) of less than 20 percent over the period of 2000-2004. Also included are those states that had higher success rates, but received less than $120 million average NIH funding over the five-year period. Under these criteria, the following states/commonwealth are eligible IDeA states: 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, and Wyoming.
• 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. Applications will NOT be accepted from institutions that hold three or more active COBRE awards; these institutions cannot submit applications.
• No eligible institution can submit more than one application in response to this RFA. 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 RFA.
• Applications are encouraged from veterinary and dental schools in IDeA states. For purposes of this RFA, veterinary and dental school components of institutions will be treated as separate eligible entities and will be allowed to submit applications in addition to the parent institution.
• The Principal Investigator of the COBRE application must be an established biomedical or behavioral research scientist, who has an active research laboratory, relevant peer-reviewed funding (either NIH, NSF or other Federal or non-Federal investigator-initiated support), and administrative leadership and mentoring experience to effectively carry out the objectives of the COBRE program and to meet its goals.
• See Section IV.1 for application materials.
• Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

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 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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
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 Centers of Biomedical Research Excellence (COBRE) program seeks to promote the initiation and development or expansion of unique, innovative state-of-the-art biomedical and behavioral research at institutions in IDeA-eligible states. The research focus of this program encompasses the full spectrum of the basic and clinical sciences and also includes cellular and molecular biology, biophysics and biotechnology, genetics and developmental biology, pharmacology and other biomedical research areas. The NIH recognizes that the contributions from the institutions in IDeA-eligible states are important and essential in fulfilling the promise of the NIH research agenda. The intent of this announcement is to assist these institutions to implement and use the technologies and other resources needed to conduct state-of-the-art biomedical 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. Although the individual career development of the junior investigators is an important and significant part of this program, the primary objective of the COBRE initiative is to build and develop thematic multi-disciplinary research centers.

The establishment of a thematic multi-disciplinary center is accomplished through the leadership of a peer-reviewed, funded investigator with expertise central to the research theme of the proposal. The application must have a thematic scientific focus in a specific research area and may use basic, clinical, translational or any combination of research approaches to attain the goals of the proposed center. The scientific leadership provided by one or more established biomedical research faculty is critical to the success of this initiative, especially for the mentoring of promising junior investigators. 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 initiative will facilitate the development of new disease-specific research centers or augment the capability of existing centers.

Collaboration with other non-doctoral degree-granting and research-performing institutes or institutions is encouraged. However, funds for research activities cannot be used at collaborative institutions in non-IDeA states.

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

Qualifications and Responsibilities of the PI: 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 Principal Investigator (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. The PI must be an established biomedical or behavioral research scientist, who has an active research laboratory, relevant peer-reviewed funding (either NIH, NSF or other Federal or non-Federal investigator-initiated support), 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 25-percent is required for the PI. However, up to 50-percent effort will be supported for mentoring and administrative oversight of the COBRE.

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 Research Plan: Each application must describe an overall research plan to justify support of a thematic multi-disciplinary COBRE program for five years. 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. In addition, the establishment of core facilities necessary to carry out the objectives of a multi-disciplinary, collaborative program may be proposed.

The overall research 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 an existing center, an explanation how the research activities of the COBRE will complement but not overlap with existing research should be described. In addition, the application should describe how the efforts of each junior investigator will assist in the establishment of a multi-disciplinary research center.

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) should 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: 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 junior investigator who is responsible for ensuring that the Specific Aims of that project are met. An initial minimum commitment of 50-percent effort 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. Investigators should consult with NCRR Program staff regarding appropriate reductions. 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 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.

Criteria for Eligibility of Junior Investigators: 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.

With respect to item (1), grants that name an individual as a co-investigator, collaborator, consultant, or to a position other than Principal Investigator 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), 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 initiative is not to disallow 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. Investigators who propose to develop a new or alternate line of research, but whose intention is to maintain support through an active RPG or PPG in a different area of research are also not eligible. Investigators should indicate in the 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 will disqualify that individual and his/her research project from further consideration.

With respect to item (2), 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 than his/her current investigative program. The current or previous history of independent peer-reviewed research support, which may 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. Please note that the intent of this initiative is to allow established investigators the opportunity to initiate and develop a new line or 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.

This initiative 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.

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.

Development and Mentoring Plan for Junior Investigators: A clear plan for the development of junior investigators and for their transition to and attainment of independent 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 support to maintain continued funding through the COBRE award.

The development plan must include both formative and summative evaluation strategies with specific milestones. 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 below under SPECIAL REQUIREMENTS), 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 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 be provided 10 to 15-percent effort and should be listed in the Administrative Core's budget section of the application and not in the individual projects' budget sections. The junior 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.

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 to independent investigator. A junior investigator may also 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 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.

A junior investigator who has achieved independent status and no longer supervises a research project may be replaced by a new investigator. Replacement 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.

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

Alteration and Renovation: Alteration and Renovation (A&R) costs to improve existing research laboratories or animal facilities are allowed. This RFA 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. This RFA will not provide support for new construction, including the completion of shell space, or for movable research equipment/instrumentation or for equipment intended for teaching or other non-research related purposes. Please note that Alteration and Renovation costs will be approved only for facilities improvements at the applicant's organization. Proposed improvements at consortia sites are disallowed.

The expenditure of funds for all A&R projects in excess of $300,000 is restricted until project documentation/architectural drawings have been reviewed and approved by NIH staff. A&R projects of less than $300,000 that support the installation of fixed equipment or other structural alterations should not be initiated 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 25-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/.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the P20 award mechanism.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

The NCRR intends to commit approximately $12 million per fiscal year to fund up to five new grants in response to this RFA 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 and the receipt of a sufficient number of meritorious applications.

Individual research projects and core facilities that are proposed to begin in year one should have corresponding individual budgets. Although the applicant can propose research projects and/or core facilities to begin in later years, each year's budget should include costs for those projects or cores that will be active in that year only. Individual project and core facility budgets should be grouped together with justifications and prefaced by a summary or composite budget for the entire center.

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.

Consortium Arrangements: 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 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.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Units of State government
• Units of local government
• Domestic Institutions

Criteria for Eligibility of an IDeA State: 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 2000-2004. Also included are those states that had higher success rates, but received less than $120 million average NIH funding over the five-year period. Under these criteria, the following states/commonwealth are eligible IDeA states:

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; these institutions cannot submit applications.

Applications are encouraged from veterinary and dental schools in IDeA states. For purposes of this RFA, veterinary and dental school components of institutions will be treated as separate eligible entities and will be allowed to submit applications in addition to the parent institution.

Restrictions for Submitting an Application: No eligible institution, including veterinary and dental schools, can submit more than one application per fiscal year in response to this RFA. 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 RFA.

Applications submitted in response to previous solicitations of COBRE RFAs (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) and revised in response to this announcement will be treated as amended applications. However, no resubmissions of unfunded applications that were submitted three or more times in response to previous solicitations of COBRE RFAs will be accepted in response to this announcement. 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.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their 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 Principal Investigator 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 Principal Investigator 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. The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

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 respective COBRE. The PI must select and name in the application at least three, but no more that 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 an annual two-day meeting in Bethesda, Maryland, with NCRR staff.

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: 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 on line 2 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 dates described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): September 25, 2006 (for both receipt dates)
ApplicationReceipt Date(s): October 23, 2006 and February 26, 2007
Peer Review Date(s): February/March 2007 and June/July 2007
Council Review Date(s): May 17, 2007 and September 6, 2007
Earliest Anticipated Start Date(s): September 30, 2007

3.A.1. Letter of Intent

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

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

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 at the beginning of this document. This RFA has two receipt dates. The letter of intent should indicate the intended receipt date to which the application will be submitted.

The letter of intent should be sent to:

Dr. Mahadev Murthy
Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard, Room 1070
Bethesda, MD 20892-4874
Bethesda, MD 20817-4874 (for express/courier service)
Telephone: (301) 435-0811
FAX: (301) 480-3660
E-mail: mmurthy@mail.nih.gov

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 copies of the appendix material must be sent to:

Dr. Mahadev Murthy
Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard, Room 1070
Bethesda, MD 20892-4874
Bethesda, MD 20817-4874 (for express/courier service)
Telephone: (301) 435-0811
FAX: (301) 480-3660
E-mail: mmurthy@mail.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

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 the CSR and responsiveness by the NCRR. Incomplete and 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. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed in response to previous solicitations of COBRE RFAs (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). Such applications will be treated as amended applications and must include an Introduction addressing the previous critique. However, no resubmissions of unfunded applications that were submitted three or more times in response to previous solicitations of COBRE RFAs will be accepted in response to this announcement.

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 http://grants.nih.gov/grants/policy/policy.htm.

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 or competing continuation award if such costs: are necessary to conduct the project, and 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 or competing continuation 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

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.

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 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. 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.

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 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 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 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 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 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. Revised text should be marked as described above.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

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

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of program priorities

In addition, the final selection of awards will depend upon 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 RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCRR in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique
• Receive a second level of review by the National Advisory Research Resources Council (NARRC).

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 high 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?

2.A. Additional Review Criteria:

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: Does the Principal Investigator 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.

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

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? Are the strengths, academic qualifications and biomedical expertise of the project investigators appropriate and sufficient for research productivity?

Is the level of institutional commitment sufficient to provide support for the development of a thematic multidisciplinary center? Has the application 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? 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 PI selected a suitable External Advisory Committee 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?

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: 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? Although the Scientific Review Group will evaluate the qualifications of each junior investigator using the traditional criteria and considerations indicated in this RFA, do the junior investigators have the potential and ability to achieve independent status?

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

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 E on Human Subjects in the PHS Form 398).

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 E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions 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.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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/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

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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:

Dr. Lawrence N. Yager
Division of Research Infrastructure
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard, Room 930
Bethesda, MD 20892-4874
Telephone: (301) 435-0760
FAX: (301) 480-3770
E-mail: yagerL@mail.nih.gov

2. Peer Review Contacts:

Dr. Mahadev Murthy
Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard, Room 1070
Bethesda, MD 20892-4874
Bethesda, MD 20817-4874 (for express/courier service)
Telephone: (301) 435-0811
FAX: (301) 480-3660
E-mail: mmurthy@mail.nih.gov

3. Financial or Grants Management Contacts:

Ms. Alice Chi
Office of Grants Management
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard, Room 1040
Bethesda, MD 20892-4874
Telephone: (301) 435-0844
FAX: (301) 480-3777
E-mail: chia@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.

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/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:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 RFA 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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