CENTERS OF BIOMEDICAL RESEARCH EXCELLENCE (COBRE)

RELEASE DATE:  September 24, 2002 

RFA: RR-02-007

National Center for Research Resources (NCRR)
 (http://www.ncrr.nih.gov)

LETTER OF INTENT RECEIPT DATE: December 18, 2002

APPLICATION RECEIPT DATE: January 22, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations:

PURPOSE OF THIS RFA

The purpose of the Institutional Development Award (IDeA) Program is to 
foster health-related research and increase the competitiveness of 
investigators at institutions located in states with historically low 
aggregate success rates for grant awards from the National Institutes of 
Health (NIH). To provide flexible support to build research capacity, the 
National Center for Research Resources (NCRR) of the National Institutes of 
Health invites applications for Centers of Biomedical Research Excellence 
(COBRE) from investigators at independent biomedical research institutions or 
biomedical research institutions that award doctoral degrees in the health 
sciences or sciences related to health within IDeA eligible states. 
Collaboration with other non-doctoral degree granting and research performing 
institutes or institutions is encouraged.

The purpose of this Request for Applications (RFA) is to augment and 
strengthen the institutional biomedical research capacity through flexible 
support to expand and develop biomedical faculty research capability and 
enhance research infrastructure through support of a multi-disciplinary 
center, led by 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, such as neuroscience, cancer, 
structural biology, immunology, or bioengineering, and may use basic, 
clinical or both 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 
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.

RESEARCH OBJECTIVES

This 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 others. 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 RFA 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 enhance the ability of 
investigators to compete independently for complementary NIH individual 
research grant or other external peer-reviewed support and (2) to strengthen 
an institution's biomedical research infrastructure through the establishment 
of a multi-disciplinary center. 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 of the COBRE application 
must be an established biomedical or behavioral research scientist who will 
ensure that high quality research be performed and who has the experience to 
effectively administer and integrate all components of the program. The PI 
must have an active biomedical or behavioral research program that receives 
NIH, NSF or other peer-reviewed support in the scientific area of the center 
and have the requisite administrative experience to direct the program. A 
minimum time commitment of 25 percent is required for this individual; 
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. An award pursuant to this RFA 
will not be made until and unless the institution has appointed a permanent 
COBRE PI.

Each COBRE program should include three to five research projects that stand 
alone, but share a common thematic scientific focus. Each research project 
should be supervised by a single junior investigator who is responsible for 
insuring that the specific aims of that project are met. 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 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. 

With respect to the item (1), grants that name an individual as a co-
investigator, collaborator or consultant do not disqualify that investigator. 
Starter grants (such as NIH's FIRST award mechanism, R29), Academic Research 
Enhancement Award grants (AREA, R15), or exploratory/pilot project grants 
(such as NIH R03 or R21 awards) also do not disqualify the investigator. The 
investigator must hold either a tenure track or non-tenure track faculty 
appointment of any rank at the time that the award is made. Furthermore, a 
clear commitment to support this faculty appointment 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 the item (2), support may be provided to an individual 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. In this case a current or previous history of 
independent peer-reviewed research support in a different investigative area 
from that proposed in this application does not disqualify the investigator. 
Moreover, this individual can be of any faculty rank.

This initiative is not intended to replace support for ongoing investigator-
initiated research programs of established investigators, nor are established 
investigators eligible for support. Instead, established investigators should 
serve as mentors to advance the junior investigators' careers.

RESEARCH PLAN: Each application should describe an overall research plan to 
justify support of a multi-disciplinary COBRE program for five years. It is 
recommended that the research plan contain the descriptions of at least three 
and up to five research projects. In addition, the establishment of core 
facilities necessary to carry out the objectives of a multi-disciplinary, 
collaborative program may be proposed.

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.

With respect to the overall COBRE program the PI 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 PI should describe how the 
efforts of each junior investigator will assist in the establishment of a 
multi-disciplinary research center.

The qualifications of the COBRE PI selected for this effort should be clearly 
described. If that individual is not a member of the faculty at the time of 
review of the application, include a detailed plan that will result in having 
that individual on the full-time faculty within one year from the date of 
peer-review of the institution's application.

Although no non-federal matching funds are required for these applications, 
clear evidence of institutional commitment should 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.

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.

A clear plan for the development and graduation of investigators who are 
provided research support from the COBRE program should 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. This 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 substitute for the EAC.

Each junior investigator should be assigned to at least one mentor. The 
mentor is an established faculty member 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 request between 10 and 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 the 
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 basis for graduation of that investigator from 
the COBRE program. In addition, a junior investigator may be graduated from 
the COBRE program if the PI and/or the EAC deem that the investigator has 
achieved independent status.

The receipt of an award that overlaps or is significantly similar to that 
described in the COBRE program is sufficient justification to graduate a 
junior investigator from the 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. 

Following the graduation of a junior investigator from the COBRE program, the 
PI can appoint another investigator to assume the vacated slot. The 
appointment of a replacement investigator should involve review and 
recommendation of that investigator's project by the EAC. The PI should 
communicate the EAC's recommendations to NCRR Program staff to review and 
approve the appointment of new investigators (and possibly new mentors) to 
the program.

BIOGRAPHICAL SKETCHES: The Principal Investigator, co-investigator(s), junior 
investigators, and mentors must provide a biographical sketch as initiated in 
the PHS 398 instructions. This section must not exceed four pages per person.

RESOURCES: The application must describe the equipment and facilities 
available to the proposed COBRE.

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 in year one only of the award as 
a one-time cost expenditure. Alteration and renovation projects must be 
relevant to the scope of the proposed research and at the institution. 
Sufficient detail must be provided to estimate the cost and suitability of 
the project. Failure to adequately justify A&R requests will likely result in 
its deletion from the requested budget. Proposed renovations in successful 
applications will subsequently require the submission of design documents for 
review and approval before the renovation project may commence. 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 only be approved for facilities 
improvements at the applicant's organization. Proposed improvements at 
consortia sites is disallowed.

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:

o 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, please 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 is 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, 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.

o 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 which 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.

o 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 
Program, that accepts applications for construction and for extensive 
renovation. Please refer to the NCRR Website: http://www.ncrr.nih.gov/.

MECHANISM OF SUPPORT

This RFA will use the NIH exploratory grant award mechanism (P20). The 
applicant will be solely responsible for planning, directing, and executing 
the proposed project. This RFA is a one-time solicitation. The anticipated 
award date is September 2003.

All budget requests should be submitted in non-modular format. Individual 
project and core facility budgets should be grouped together with 
justifications and prefaced by a summary budget for the entire program.

FUNDS AVAILABLE

The NCRR intends to commit approximately $35 million in FY03 to fund 15 to 20 
new grants in response to this RFA. An applicant must request a project 
period of 5 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.

Funds may be used to develop Offices of Sponsored Programs and for faculty 
expansion (i.e., recruitment of additional faculty who complement the scope 
of the proposed program) up to $100,000 per year for each position. These 
funds may be used for salary, supplies and equipment costs.

Because the nature and scope of the proposed research will vary from 
application to application, it is anticipated that the size of each award 
will also vary. Although the financial plans of the NCRR provide support for 
this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of meritorious 
applications. At this time, it is not known if this RFA will be reissued.

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 COBRE's thematic 
scientific focus 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.

For the purposes of this RFA, F&A costs for the consortium organization(s) 
are excluded from the limit on the amount of direct costs that can be 
requested for the entire application. Applicants are encouraged to review the 
NIH policy and procedures applicable to consortium agreements, which are 
published as part of the NIH Grants Policy Statement, Part III, available on 
the NIH homepage at 
http://grants.nih.gov/grants/policy/nihgps_2001/index.htm. 
Questions may be directed to the fiscal contact identified below under Inquiries.

ELIGIBLE INSTITUTIONS

o 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 1997-2001. Also included are those states 
that had higher success rates, but received less than $75 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

o 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 institutions that do not currently hold a 
COBRE award. Applications will also be accepted from institutions that hold 
one active COBRE award. However, applications will NOT be accepted from 
institutions that hold two or more active COBRE awards. These institutions 
are disqualified from this competition and cannot submit applications. 

Applications are encouraged from veterinary and dental schools in IDeA 
states. Applications will be accepted from veterinary and dental schools 
regardless of the number of active COBRE awards held by that institution.
 
Applications are also encouraged from eligible institutions in IDeA states 
that propose research that relates to the scope and mission of the National 
Institute on Deafness and Other Communication Disorders (NIDCD).

o RESTRICTIONS FOR SUBMITTING AN APPLICATION

No eligible institution, including veterinary and dental schools, can submit 
more than one application in response to this RFA. Multiple applications 
received from these institutions or applications received from disqualified 
institutions (those that hold two or more active COBRE awards) will be 
returned without further consideration. If an institution is writing 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.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

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 programs. 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.

SPECIAL REQUIREMENTS

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

Each COBRE application must include an External Advisory Committee (EAC), 
comprised of at least three to five scientists, with national scientific 
reputations in their field; their expertise must be directly relevant to the 
scientific theme of the COBRE. The EAC critiques scientific progress of the 
COBRE and also offers advice on scientific matters to the COBRE PI. The EAC 
activities include concept development, program planning, encouraging and 
assisting with faculty development and mentoring, identifying resources, and 
evaluating progress toward stated goals. The PI will share the advice and 
critiques provided by the EAC with other investigators at the center. The EAC 
will also review and approve candidates for replacement/substitute projects 
and investigators as required, before such requests are forwarded to NCRR for 
confirmation and approval. The EAC must meet at least twice per year on 
average. Minutes are to be recorded and made available for review by NCRR 
program staff responsible for the COBRE. 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.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA 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:

o Direct your questions about scientific/research issues to:

Dr. Lawrence N. Yager
Division of Research Infrastructure
National Center for Research Resources
National Institutes of Health
6705 Rockledge Drive, Suite 6030
Bethesda, MD  20892-7965
Telephone: (301) 435-0760
FAX: (301) 480-3770
E-mail: lawrencey@ncrr.nih.gov

o Direct your questions about peer review issues to:

Dr. Sheryl K. Brining
Office of Review
National Center for Research Resources
National Institutes of Health
6705 Rockledge Drive, Room 6018
Bethesda, MD  20892
Telephone: (301) 435-0809
FAX: (301) 480-3660
E-mail: sb44k@nih.gov

o Direct your questions about financial or grants management matters to:

Ms. Irene Grissom
Office of Grants Management
National Center for Research Resources
National Institutes of Health
6705 Rockledge Drive, Room 6086
Bethesda, MD  20892
Telephone: (301) 435-0844
FAX: (301) 480-3777
E-mail: grissomi@ncrr.nih.gov

LETTER OF INTENT

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

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

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. The letter of intent should be sent to:

Dr. Sheryl K. Brining
Office of Review
National Center for Research Resources
National Institutes of Health
6705 Rockledge Drive, Room 6018
Bethesda, MD  20892
Telephone: (301) 435-0809
FAX: (301) 480-3660
E-mail: sb44k@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

SUPPLEMENTAL INSTRUCTIONS: An application for a COBRE award must include the 
following:

o  A clear definition of the nature and extent of research collaboration, 
including a full explanation of the necessary administrative, fiscal, and 
scientific aspects of the proposed COBRE.

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

o  A description of and justification for the proposed individual research 
projects (a ten-page limitation for the Research Plan Section for each 
project) and core service facilities that collectively will contribute to the 
center. Applicants are required to propose at least three and up to five 
meritorious research projects and must describe the nature and scope of any 
scientific research collaborations.

o  A description of the research and research training or career development 
goals and capabilities of the proposed COBRE. The PI must establish a time 
line for supported applicant investigators to prepare and submit proposals 
for traditional research grant review during the performance period of the 
COBRE award.

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

o  A narrative summary, line drawings and cost estimates must be provided for 
any proposed alteration and renovation project. An itemized budget and 
justification of the impact that this alteration and renovation would have on 
the COBRE activities must also be provided.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form 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/label-bk.pdf.

SENDING AN APPLICATION TO THE NIH: 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
Bethesda, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application and five 
copies of any appendices must be sent to:

Dr. Sheryl K. Brining
Office of Review
National Center for Research Resources
National Institutes of Health
6705 Rockledge Drive, Room 6018
Bethesda, MD  20892
Telephone: (301) 435-0809
FAX: (301) 480-3660
E-mail: sb44k@nih.gov

APPLICATION PROCESSING: Applications must be received by the application 
receipt date listed in the heading of this RFA. If an application is received 
after that date, it will be returned to the applicant without review.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NCRR. Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration. Applications 
that exceed the maximum allowable first year direct cost limit of $1.5 
million (or $2 million, if requesting first year alteration and renovation 
costs), excluding F&A costs for consortium budgets, will be returned to the 
applicant without further consideration.

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 Office of Review, NCRR in accordance with the review criteria 
stated below.

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

o receive a written critique,

o 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,

o receive a second level review by the National Advisory Research Resources 
Council.

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health. In 
the written comments, reviewers are asked to discuss the following aspects of 
an application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals:

o Significance
o Approach
o Innovation
o Investigator
o Environment

The review of the COBRE application is additionally based not only on these 
traditional review criteria, but also on the qualification and stature of the 
Principal Investigator to provide both scientific and administrative 
leadership and on the feasibility and potential for investigators to become 
competitive for independent funding. Senior, funded investigators must not be 
proposed as subproject leaders.

The following criteria will be used to evaluate the 1) administrative 
leadership and overall potential for enriching the intellectual milieu for 
doing research, 2) scientific merit of the individual biomedical research 
projects, and 3) effectiveness in training and promoting junior 
investigators:

ADMINISTRATIVE LEADERSHIP AND OVERALL POTENTIAL FOR ENRICHING THE 
INTELLECTUAL MILIEU FOR DOING RESEARCH: Reviewers will be asked to consider 
the following:

o The qualifications of the Principal Investigator to provide scientific and 
administrative leadership in developing and directing the COBRE, and 
establishing thematic collaborative research efforts. The Principal 
Investigator must be an established biomedical or behavioral research 
scientist. He/she should be supervising an active research laboratory that is 
supported by relevant, peer-reviewed, research grants (NIH, NSF or other 
peer-reviewed research awards).

o The significance, approach, and innovation of the proposed research 
projects and of the COBRE as a whole.

o The nature, scope, and effectiveness of the plans for coordination and 
cooperation among research project investigators.

o The strengths of the applicant investigators and the collaborating 
researchers, if involved, particularly their academic qualifications, 
biomedical expertise and research productivity.

o The level of institutional commitment with regard to assuring 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.

o The need for the proposed core facilities and the effectiveness of these 
facilities to enhance the research effort.

o The ability to augment and strengthen the institutional biomedical research 
capability.

o The ability to provide support for the development of a multidisciplinary 
center.

o The means by which basic or clinical research is encouraged.

o The establishment and maintenance of a scientific thematic focus.

o The suitability of the External Advisory Committee.

o The appropriateness and suitability of evaluation strategies and specific 
milestones necessary to measure progress toward attaining long-range goals.

SCIENTIFIC MERIT OF THE INDIVIDUAL BIOMEDICAL RESEARCH PROJECTS: The 
scientific review group will address and consider each of the below criteria 
in assigning the project's overall merit and weighting them as appropriate 
for each project. The project does not need to be strong in all categories to 
be judged likely to have major scientific impact. For example, important work 
may be proposed that by its nature is not innovative but is essential to move 
a field forward.

o SIGNIFICANCE: Does the study address an important problem? If the aims of 
the application are achieved, how do they advance scientific knowledge? What 
will be the effect of these studies on the concepts or methods that drive 
this field?

o APPROACH: Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project? Are potential problem areas acknowledged and alternative tactics 
considered?

o INNOVATION: Does the project employ novel concepts, approaches or methods? 
Are the aims original and innovative? Does the project challenge existing 
paradigms or develop new methodologies or technologies?

o INVESTIGATOR: Is the investigator appropriately trained and well suited to 
carry out this work? Is the work proposed appropriate to the experience level 
of the investigator and to that of other researchers (if any)?

o ENVIRONMENT: Does the scientific environment in which the work will be done 
contribute to the probability of success? Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements? Is there evidence of institutional support?

EFFECTIVENESS IN TRAINING AND PROMOTING JUNIOR INVESTIGATORS: The reviewers 
will be asked to use the following criteria in evaluating this criterion:

o The quality of the research training, career development and mentoring plan 
for junior investigators of the center.

o The plan for development and graduation of junior investigators.

o The suitability of the plan for recruiting new faculty.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the 
application will also be reviewed with respect to the following:

o PROTECTIONS: The adequacy of the proposed protection for humans, animals, 
or the environment, to the extent they may be adversely affected by the 
project proposed in the application.

o INCLUSION: 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. Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below.)

o DATA SHARING: The adequacy of the proposed plan to share data.

o BUDGET: The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: December 18, 2002

Application Receipt Date: January 22, 2003

Peer Review Date: June 16, 2003 (subject to change)

Council Review: September 11, 2003

Earliest Anticipated Start Date: September 30, 2003

AWARD CRITERIA

Funding decisions will be based on scientific and technical merit as 
determined by the Initial Review Group, the National Advisory Research 
Resources Council, geographic distribution, program balance, the enhancement 
of the research competitiveness of the institution, and the availability of 
funds.

REQUIRED FEDERAL CITATIONS

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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 AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

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 that is available at 
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 proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, 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://grants.nih.gov/grants/stem_cells.htm 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 (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide 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.

PUBLIC 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 public 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 RFA 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.

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 No. 93.389. Awards are made under authorization 
of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as 
amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH 
grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and 92 
and are not subject to the intergovernmental review requirements of Executive 
Order 12372 or Health Systems Agency review. Awards made under these 
authorizations are administered under NIH grants policies described 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.

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