CENTERS OF EXCELLENCE IN COMPLEX BIOMEDICAL SYSTEMS RESEARCH

Release Date:  January 26, 2001

RFA:  RFA-GM-01-001

National Institute of General Medical Sciences
 (http://www.nigms.nih.gov/)

Letter of Intent Receipt Dates For Planning Grants (P20) and Specialized 
Center Grants (P50):  September 1, 2001

Application Receipt Dates For Planning Grants (P20) and Specialized Center 
Grants (P50):         October 11, 2001

PURPOSE

The National Institute of General Medical Sciences (NIGMS) will provide 
funding for the establishment of new academic Centers of Excellence in 
Complex Biomedical Systems Research (CE/CBSR). This program is responsive to 
the Biomedical Information Science and Technology Initiative (BISTI) and its 
call for National Programs of Excellence in Biomedical Computing (NPEBC). The 
CE/CBSR goal is to promote the analysis of the organization and dynamic 
behaviors of complex biological systems. The Center Grant mechanism (P50), 
together with the Planning Grant mechanism (P20), will support the 
development of multi-investigator teams capable of engaging biomedical 
complexity with a scope of activities not possible with other funding 
mechanisms. Activities will encompass research and training, as well as 
workshops, symposia, and other forms of outreach. Centers will support 
research activities that may include the development of new instrumentation 
and methods, bioinformatics infrastructure, and new theoretical frameworks to 
advance knowledge of life processes at the system level.  Training activities 
may include programs in computational and information sciences.  Workshops 
and symposia are encouraged, as well as partnering with undergraduate 
institutions, especially those with substantial numbers of underrepresented 
minority students.  Typical areas of NIGMS interest include computationally-
based modeling of processes such as the cell cycle, pattern formation during 
embryogenesis, the flux of substrates and intermediates in metabolism, and 
the application of network analysis to understanding the integrated systemic 
host responses to trauma, burn, or other injury. 

NIGMS recognizes that biomedical research is entering an era in which 
computational approaches will be used to deepen our understanding of 
biological behavior.  Building upon mechanistic descriptions of individual 
biological constituents there will be an increasing emphasis on concepts and 
methods that target systems and their integrated behavior. Multicomponent, 
interactive processes at the subcellular, cellular, tissue, and organ levels 
will be amenable to modeling and simulation in ways previously limited by the 
lack of adequate data. Traditional molecular and genetic approaches will be 
augmented with concepts and methods requiring new areas of expertise, 
particularly from the computational disciplines of engineering, physics, and 
computer science.  The need for quantitative data will likely call for the 
development of new instrumentation and methods.  The organization and 
representation of these data streams and their relation to preexisting 
knowledge will require bioinformatics advances, and the development of 
computer based hypotheses and simulations will require mathematical 
expertise, as will the development of new theoretical frameworks.

The organization of projects incorporating these approaches, and the 
recruitment of personnel, is not a simple undertaking, and these Centers 
grants are designed to support these activities.  In addition to research 
contributions, successful Centers will provide their home institutions with 
the means to implement organizational and professional changes that will make 
interdisciplinary research in complex biological systems and bioinformatics 
attractive career options for both established and entry level investigators.  
The institutions will receive the resources to recruit new investigators who 
have the skills needed to develop new methods and tools, and to develop 
appropriate training programs in computational and information sciences.  In 
addition, the Centers will disseminate expertise and knowledge through 
workshops and symposia, and, because the Centers will be pioneering a new era 
in biological sciences, they will provide outreach activities to 
undergraduate institutions, including minority-serving institutions.  

Current initiatives related to CE/CBSR can be found in prior NIGMS program 
announcements: http://www.nigms.nih.gov/funding/complex_systems.html.

Some groups interested in the scope of this RFA might find the P01 mechanism 
more suited to the scale of their efforts, they should consult the prior 
announcement at the URL: 
http://grants.nih.gov/grants/guide/pa-files/PA-98-077.html.

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, Centers of 
Excellence in Complex Biomedical Systems Research, 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.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic non-profit organizations, public 
and private, such as universities, colleges, hospitals, laboratories, units 
of State and local governments, and eligible agencies of the Federal 
government. Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators. Applications 
from foreign institutions and for-profit organizations will not be accepted, 
however, subcontracts to foreign institutions and for-profit organizations 
may be included. 

MECHANISM OF SUPPORT

Support of this program will be through the National Institutes of Health 
(NIH) P50 Specialized Center Grant and P20 Exploratory Grant mechanisms. 
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.

A P50 Center grant application may request up to five years of support. The 
length of award will be determined through the peer review and Council 
advisory processes.  Most projects that can be initiated now are likely to 
have a limited lifetime during which support from the NIGMS will be 
appropriate, either because the project goals will have been accomplished or 
the Center will have developed to the point that support from other sources 
will be more appropriate.  Therefore, the total length of support for any P50 
Center under this program will be limited to no more than ten years.  The 
anticipated award date is July 1, 2002.

Centers will receive an administrative site visit during the third year of 
the first grant cycle. The fifth year of funding will depend on the outcome 
of that administrative review, and the Principal Investigator (PI) will 
receive advice about NIGMS interest in accepting a competing renewal 
application to extend the initial award.

The requested budget for a Center may be up to $2 million direct costs per 
year (including F&A costs for subcontracts) for continuing operations (e.g., 
personnel, supplies, travel, and other expenses).  Funds for initial large 
equipment may be requested in excess of this $2 million limit if well 
justified. It is anticipated that the size of the awards will vary because 
the nature and scope of research programs proposed will vary.  NIGMS 
anticipates establishing two or three such Centers in fiscal year 2002. The 
actual number of awards and level of support will depend upon receipt of a 
sufficient number of applications of high scientific merit and availability 
of funds. 

The Principal Investigator of Center Grant must commit a minimum effort of 
30%. 

NIGMS expects to reannounce this RFA. Revised applications will be accepted 
at that time.

At some institutions, the nucleus of a research group that could conduct the 
research described in this RFA may already exist, and such groups will be 
able to submit suitable applications for this program directly. However, some 
groups of investigators may need an opportunity to establish themselves and 
formulate plans in preparation for submitting a Center application.  The 
Exploratory Grant (P20) mechanism can be used when the applicant wishes to 
request a period of planning and preliminary investigation prior to preparing 
a P50 Center application. The planning grant budget may request funds for 
partial salary of key investigators, travel, and some supplies and equipment. 
Planning grants will be awarded for up to three years at a direct cost not to 
exceed $150,000 per year. 

While there is no minimum effort requirement for the Principal Investigator 
of a Planning Grant, an appropriate commitment must be made.  A planning 
grant is not required as a precursor to a P50 Center application. Funding of 
a planning grant does not obligate NIGMS to fund a subsequent P50 Center 
grant.

FUNDS AVAILABLE

For FY 2002, a minimum of $5 million will be committed to fund P50 Center 
applications submitted in response to this RFA. It is anticipated that about 
2-3 Centers will be funded, however, this funding level is dependent upon the 
receipt of a sufficient number of applications of high scientific merit. 
Although this program is provided for in the financial plans of NIGMS, the 
award of grants pursuant to this RFA is also contingent upon the availability 
of funds for this purpose. 

RESEARCH OBJECTIVES

Background

The biomedical sciences have undergone a fundamental shift in both the 
conceptual and technical approaches that can be brought to bear on certain 
problems of profound importance.  These problems center on the understanding 
of the behavior of biological systems whose function is the product of 
spatial and temporal ordering of myriad interacting components.  Examples of 
first attempts to understand these phenomena can be found at all levels of 
biological organization, including the modeling of the circuitry of 
bacteriophage lambda regulation, the modeling of the yeast cell division 
cycle, and the quantitation of cellular processes such as metabolic flux and 
response to stress.  At higher levels of organization, modeling approaches 
are being used to understand the orderly development of biological pattern in 
model organisms such as Drosophila.  At the clinical level, new approaches 
are being explored to understand the integrated activity of tissues and 
organs.  Part of the impetus for systems-scale approaches rests on recent 
advances in acquiring data of the necessary quality and quantity to permit 
computer based modeling.  Among the most striking recent examples is the 
availability of complete DNA sequences for a number of organisms, including 
humans.  This advance has made it feasible to generate a truly comprehensive 
 parts list  for any organism.  Potentially, the enumeration of all the 
informational units of the genomes (protein coding regions, regulatory 
elements), their processed forms, and their positional significance, should 
be possible and, for some microorganisms, close at hand. 

However, the task of assigning functions to all these elements is formidable.  
Currently, 30-40% of newly identified coding regions have no known relatives 
in existing indices of function, and the identification of regulatory 
elements presents a substantial informatics challenge. Much progress is being 
made in adapting existing methods (such as gene inactivation) to high-
throughput functional analysis, and developing newer computational approaches 
grounded in evolutionary theory.  A higher order problem presents itself in 
understanding how the genome-encoded components and the  stuff  of the living 
state (metabolites, ions, water) are constituted in networks of interacting 
molecules with particular distributions in time and space.  Advances in 
imaging techniques and analytic methods promise to yield copious quantitative 
and spatial data on specific molecules in biological systems.  Knowledge of 
the network and changes in its components over time, and the local rules by 
which the individual components distribute material and information will 
substantially advance our knowledge, however, a further hurdle must be 
cleared. The medical, biotechnological, and other usefulness of this 
information rests on our ability to understand the principles and dynamics 
that explain the behavior of the system as a whole. Whether the goal is to 
understand the consequences of disease or injury, or to identify particular 
molecular targets for drug interventions, or to modify the metabolism of 
microorganisms to produce medicines, the challenge is  predictability.   
Predicting how the system of interest will respond to an intervention is a 
computational problem.  For biological systems this challenge is daunting.  

NIGMS currently is committed to supporting the analysis of complex biological 
systems through investigator-initiated research project grants, using the 
R01, P01, R21, and other appropriate grant mechanisms. However, the resources 
needed to conduct the multi-faceted, multi-disciplinary projects that may be 
required to achieve significant advances in these complex areas may be beyond 
the scope of the typical R01 or P01 grant. Therefore, this RFA presents an 
opportunity for applicants to assemble large teams of investigators from 
diverse disciplines that are not possible with other funding mechanisms. High 
priority will be given to projects that integrate multi-investigator, multi-
disciplinary approaches with a high degree of interplay between computational 
and experimental approaches. A variety of organizational models are possible, 
and it is not the purpose of this announcement to prescribe any particular 
one.

Scope of Research

The NIGMS intends to support Centers of Excellence in Complex Biomedical 
Systems for research areas that 1) are central to its mission, and 2) focus 
on developing new computational approaches to biomedical complexity.  
Research areas that historically have been computationally based (e.g., 
population genetics, molecular structure) are excluded as a focus of this 
Center program. Research projects focusing on disease processes and their 
specific organ systems are not eligible. An example of particular interest to 
NIGMS has been articulated in the planning document,  A Vision for the 
Future: A Complete Picture of the Healthy Cell.  [URL: 
http://www.nigms.nih.gov/news/reports/planning.html]  This goal includes all 
the aspects of complex systems research previously listed - the catalog of 
structure and function, the understanding of intermolecular linkages that 
lead to a wiring diagram, and ultimately the understanding of intracellular 
behavior and intercellular interactions in time and space. 

NIGMS mission areas for which Centers of Excellence in Complex Biomedical 
Systems Research would be particularly appropriate include the following: 

o  Pattern formation and developmental processes in model systems (e.g., 
Drosophila, C. elegans, etc.)
o  Metabolic networks and the control of the flux of substrates, 
intermediates, and products in cell physiology
o  Signaling networks and the regulatory dynamics of cellular processes such 
as cell cycle and apoptosis, and response to environmental stress
o  Supramolecular machines, such as the replisome, spliceosome, molecular 
motor assemblies in cell division and motility
o  Organ system networks involved in multi-organ failure in shock, trauma, 
and burn injury

NIGMS strongly encourages investigators who propose to develop applications 
to discuss their ideas with NIGMS program staff prior to submission, to 
ensure that applications will be responsive to the NIGMS mission and intent 
for this program.

Center Developmental Activities

Centers will likely support the development of new mathematical tools, 
theory, and technologies that foster computational solutions.  Examples are 
network theoretical structures for understanding genetic and physiological 
regulatory circuitry, systems of equations allowing the description of 
signaling dynamics, and computer models of morphological changes during 
development.  The substantial bioinformatics challenge of such work has been 
highlighted in the BISTI report 
(http://www.nih.gov/about/director/060399.htm): "To make optimal use of 
information technology, biomedical researchers need, first of all, the 
expertise to marry information technology to biology in a productive way. New 
hardware and software will be needed, together with deepened support and 
collaboration from experts in allied fields. Inevitably, those needs will 
grow as biology moves increasingly from a bench-based to a computer-based 
science, as models replace some experiments and complement others, as lone 
researchers are supplemented by interdisciplinary teams. The overarching need 
is for an intellectual fusion of biomedicine and information technology."  To 
this end, Centers may include bioinformatics tool development that could 
include DNA sequence feature search programs, specialized databases, 
development of data sharing and representation formats, and data mining 
algorithms.  The plan may also include the design of new instrumentation that 
may be required, for example, to obtain time series measurements of multiple 
parameters of cell and tissue function, including spatial information by 
imaging technologies.  

Centers will also be expected to support training in this emerging 
discipline.  One reason for the current lack of adequately qualified 
personnel is that there are too few appropriate environments available to 
support this kind of training. The establishment of Centers under this 
program is intended to help to alleviate this shortage by serving as an 
academic focus for systems approaches. To maximize their impact, Centers 
should integrate the training of young investigators and broaden the training 
of established investigators. Graduate students and postdoctoral fellows 
should participate in the research. Additional training activities that 
leverage strengths of the institution and the research program of the Center 
are encouraged. Such training could be at the undergraduate, graduate, or 
professional levels.  The NIGMS strongly urges the inclusion of partnering 
programs that will help minority-serving institutions to develop capabilities 
in these new arenas.  

Workshops and courses that may develop from Center activities will serve the 
wider community of investigators and their institutions by disseminating 
scientific knowledge and organizational information, and are encouraged under 
this program.

Center Directors may be asked to join a committee to provide feedback on this 
Centers program.  

GUIDANCE FOR APPLICANTS FOR P50 CENTER GRANTS

The applicant should identify clearly in the abstract and more fully in the 
research plan the new approaches and collaborations, and the specific 
biological questions that are to be explored as a result of the establishment 
of the Center. The synergies to be achieved through the establishment of 
multi-disciplinary teams and novel collaborations should be fully described. 

The P50 grant application should specify the administrative and 
organizational structure(s) that will be used to support the research. It is 
anticipated that these projects will be multi-disciplinary and will draw on a 
variety of resources. Thus, a well thought out and carefully described 
organization will be required. The PI is responsible for ensuring that 
scientific goals are met, and for developing and managing a decision-making 
structure and process that will allow resources to be allocated (and 
reallocated, if necessary) to meet those goals. Projects of the complexity, 
both scientific and managerial, that NIGMS anticipates will characterize 
these Centers require a substantial amount of the PI"s effort to achieve 
success. Therefore, the PI will be required to devote at least 30% effort to 
the leadership and implementation of the Center. If core facilities or shared 
resources are required, these should be described, as should their management 
and service to the research projects. The proposal should explain how 
different components of the organization, including key personnel, will 
interact, why they are essential to accomplishing the research, and how the 
combined resources create capabilities that are more than the sum of the 
parts. "Centers-without-walls" are welcome under this solicitation. If any of 
the components are physically separated from each other (i.e., located in 
different departments or institutions), the applicant should address how 
interactions will be facilitated.  NIGMS is not specifying a specific 
organizational structure (e.g., specific numbers of projects and cores) in 
this RFA, preferring that applicants develop the structure that would best 
promote the research. However, applicants should note that the effectiveness 
of the proposed structure will be a criterion of the evaluation prior to an 
award and will be monitored after an award is made. 

A timeline for the project should be presented. This timeline should outline 
how the project"s goals can be met within the time frame of a CE/CBSR grant. 
The timeline also will assist the investigators, NIGMS, and its advisors in 
evaluating progress toward the project"s goals. For those projects for which 
the investigator deems it appropriate to do so, NIGMS encourages applicants 
to present explicit, quantitative milestones.

NIGMS encourages applicants to devise a strategy for the Center"s training 
component that best takes advantage of the research program, the 
investigators" talents, and other institutional resources, to offer unique 
and substantial training opportunities for students and other investigators. 
The CE/CBSR will therefore augment programs previously developed by NIGMS 
(see http://grants.nih.gov/grants/guide/pa-files/PAR-99-146.html, 
http://grants.nih.gov/grants/guide/pa-files/PA-98-082.html) for expanding the 
cadre of investigators working in computational biology. 

The Center will be expected to have a Board of Advisors, drawn from experts 
outside the project. These advisors will meet annually to review and provide 
guidance on Center activities.  While a description of the Board’s activities 
should be included in the application, potential members of the Board should 
not be named, contacted, or selected until an award has been made.  This 
stipulation will allow a wider pool of potential reviewers of the 
application.
  
GUIDANCE FOR APPLICANTS FOR P20 PLANNING GRANTS

Appropriate activities under the P20 Planning Grant include the establishment 
of new multi-investigator or interdisciplinary relationships, exploration of 
organizational concepts, development of the rationale and research design for 
the subsequent Center, and the collection of preliminary data. 

DATA AND MATERIALS DISSEMINATION

The NIH is interested in ensuring that the information about new methods, 
technologies, computer software, and high-throughput functional data that are 
developed through this program become readily available to the research 
community for further research and development.  Such sharing will eventually 
lead to information and products that improve the health of the public. For 
this reason, applicants should develop and propose specific plans for sharing 
of data, materials, and software generated through the grant, taking into 
consideration the recent Guidance issued by NIH 
(http://www.nih.gov/od/ott/RTguide_final.htm). To the extent that established 
public databases have the capability for collecting and disseminating the 
data that would be collected under the grant, it is NIGMS"s strong preference 
that a plan for the rapid deposition of data into such public databases be 
described in the application.

The scientific review group will comment on the proposed plan for sharing and 
data release. The adequacy of the plan will also be considered by NIH staff 
as one of the criteria for award. The proposed sharing plan, after 
negotiation with the applicant when necessary, will be made a condition of 
the award. Evaluation of renewal applications will include assessment of the 
effectiveness of data, materials, and software release.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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 biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are 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 research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), 
a complete copy of the updated Guidelines are available at:  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to 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) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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 was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

LETTER OF INTENT 

Prospective applicants are encouraged to submit a letter of intent that 
includes a descriptive title of the proposed research, the name, address, 
telephone number, and e-mail address of the PI, names of other key personnel 
and, if applicable, participating institutions, and the number and title of 
this RFA. The letter of intent is not binding, and does not enter into the 
review of subsequent applications.  However, the information that it contains 
allows NIGMS staff to estimate the potential review workload and to plan the 
review. 

The letter of intent is to be sent by September 1, 2001, to: 

James J. Anderson, Ph.D.
Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
Bldg. 45, Room 2AS-25A
Bethesda, MD 20892-6200
TEL: (301) 594-0943
FAX: (301) 480-2228
Email: andersoj@nigms.nih.gov

APPLICATION PROCEDURES (P50 AND P20)

Applications are to be submitted on the grant application form PHS 398 (for 
newly revised version see: 
http://grants.nih.gov/grants/funding/phs398/phs398.html)
and must be received by the application deadlines indicated on the first page 
of this RFA. Application kits are available at most institutional offices of 
sponsored research and may be obtained from:

Division of Extramural Outreach and Information Resources
National Institutes of Health
6701 Rockledge Drive, MSC 7910
Bethesda, MD 20892-7910
TEL: (301) 710-0267
Email: GrantsInfo@nih.gov

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application.  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 
title and number of the RFA must be typed on line 2 of the face page of the 
application form and the YES box must be marked.

The sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change.  Please note this is in pdf format.

Submit a signed 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, 
including all appendices, must be sent to: 

Helen R.Sunshine, Ph.D.
Office of Scientific Review 
National Institute of General Medical Sciences
Bldg. 45, Room 1AS-13F
Bethesda, MD 20892-6200

ADDITIONAL APPLICATION PROCEDURES FOR P50 CENTER GRANTS

If the Center is to be organized into projects, then the page limits 
specified in the PHS 398 form for sections a-d of the Research Plan will 
apply for each project. If, however, the Center is to integrate its 
activities in such a way that describing individual projects would not be 
helpful, then the limit for the narrative section (a-d) is 40 pages. Please 
note that there is no requirement to submit this maximum number of pages, 
instead, concise, articulate applications are desired.

ADDITIONAL APPLICATION PROCEDURES FOR P20 PLANNING GRANTS

The planning activities to be carried out, and the justification for their 
necessity, should be described in the context of the anticipated P50 Center 
grant application. 

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and for 
responsiveness by the NIGMS. Incomplete applications 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 NIGMS in accordance with 
the standard NIH peer review procedures. The applications will receive a 
second-level review by the National Advisory Council, General Medical 
Sciences. 

Review Criteria 

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health. To 
ensure that applications for this CE/CBSR program are evaluated 
appropriately, the standard NIH review criteria have been adapted to be more 
appropriate for proposals of the scope described in this RFA. In the written 
comments reviewers will be asked to discuss the following aspects of the 
overall application 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 considered in assigning the overall score, 
weighting them as appropriate for each application.  If the Center grant 
application includes distinct subprojects, the scientific merit of each 
project will be assessed, based on its merit as an independent effort and its 
potential importance/contribution to the success of the overall effort.  Core 
facilities and resources will be assessed for their quality, cost-
effectiveness, and utility to the overall effort.

Overall Review Criteria for P50 Centers 

(1) Significance: Importance of the proposed research areas and topics being 
explored, and their relevance to the objective of understanding the 
organization and dynamics of one or more biomedically important systems.  
Utility to researchers of any technology, research tools, software, 
scientific approaches, etc., that are proposed to be developed. Likely effect 
of the proposed research on the field, and likely impact on the larger 
biological community.

(2) Approach: Quality of the scientific research plan. Likelihood that the 
proposed research plan will achieve the aims of the proposed research. 
Appropriateness of the proposed experimental approach, conceptual framework, 
design, methods, analyses, techniques, and technologies to the proposed 
research. Acknowledgement of potential problems and consideration of 
alternative approaches. For proposed multi-component centers, the scientific 
gain from combining the research components in a center, i.e., the degree of 
interrelatedness and synergy among the components. 

(3) Management: Appropriateness and quality of the management plan, including 
the effectiveness of the management structure. Quality of the plan for 
deployment of equipment and human resources to attain the research aims and 
overall Center goals. Organization and coordination of personnel. Quality of 
the plans for making critical decisions or choices about overall research 
direction during the project. Where appropriate the cost-effectiveness of 
approaches used or under development. Adequacy of plans for a Board of 
Advisors to provide scientific and managerial oversight.   

(4) Innovation: Novelty or originality of approach, method, technology, 
experimental design (including presentation, organization, analysis or 
application of data), conceptual framework, or the insight provided into 
complex systems.

(5) Investigators: Appropriateness of the scientific training, background, 
and expertise of the Principal Investigator and key personnel to achieving 
the specific aims and overall goals of the proposed research. Contribution 
that the individual and combined scientific expertise of the key personnel 
will make to the achievement of the overall goals of the proposed research. 
Adequacy of the PI"s ability to lead and coordinate the activities, and 
develop and implement the management plan, as required for the project"s 
success. Adequacy of the level of effort of key personnel. 

(6) Environment: Adequacy of the scientific environment and resources 
available, including space, equipment, services, infrastructure, and 
facilities. Degree to which the proposed research plan, experiments, or 
organization takes advantage of unique features of the scientific 
environment. Degree of institutional commitment, including any needed 
expansion of facilities, improvement of infrastructure, and relief from other 
academic duties where necessary. Environment for training or educational 
activities, especially for under-represented minorities.

(7) Data release and distribution of research tools: Adequacy of plans for 
dissemination to the scientific community of research tools or research 
resources (e.g., data sets, computer modeling and simulation software, mutant 
stocks, DNA libraries) that are proposed to be developed. 

(8) Training: Quality of the proposed training plan and its likely 
effectiveness in meeting community needs. Plans to integrate the training 
components of the Center with other on-going or planned training.

Overall Review Criteria for P20 Planning Grants

(1) Significance: Importance of the proposed research areas and topics being 
explored, and their relevance to the objective of understanding the 
organization and dynamics of one or more biomedical systems.  Effect of the 
proposed areas of research on the field, and the likely impact on the larger 
biological community. 

(2) Approach: Quality of the scientific research plan. Likelihood that the 
proposed planning grant will culminate in the ability of the participants to 
form an on-going collaboration, generate relevant preliminary data, if 
appropriate, and submit a competitive application for a CE/CBSR award. 

(3) Management: Quality of the plan for acquisition, organization, and 
deployment of equipment and human resources to attain the goals of the 
exploratory research. Potential success of the proposed exploratory 
components. Adequacy of the level of effort of key personnel. 

(4) Innovation: Novelty or originality of the research area being 
investigated or the methods to be developed.

(5) Investigators: Appropriateness of the training, background, and expertise 
of the P.I. and key personnel to achieving the specific aims and overall 
goals of the proposed research. 

(6) Environment: Adequacy of the scientific environment and resources 
available, including space, equipment, services, infrastructure, and 
facilities. Degree to which the proposed research plan, experiments, or 
organization takes advantage of unique features of the scientific 
environment. Degree of institutional commitment, including any needed 
expansion of facilities, improvement of infrastructure, and relief from other 
academic duties where necessary. The environment for training and educational 
activities. 

(7) Data release and distribution of research tools: Adequacy of plan to 
develop a responsive data and tools distribution plan.

(8) Training: Adequacy of plan to develop an effective training component 
that will include under-represented minorities. 

Additional Review Criteria for P50 and P20 Applications

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  If the application proposes to involve human subjects, then the adequacy 
of plans to include both genders, minorities and their subgroups, and 
children as appropriate for the scientific goals of the research will be 
evaluated. Plans for the recruitment and retention of subjects will also be 
evaluated. 
o  The reasonableness of the proposed budget and duration in relation to the 
proposed research. 
o  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.

SCHEDULE

Letter of Intent Receipt Dates:   September 1, 2001
Application Receipt Dates:        October 11, 2001
Peer Review Date:                 February-March, 2002
Council Review:                   May, 2002
Earliest Anticipated Start Date:  July 1, 2002

AWARD CRITERIA 

The following will be considered in making funding decisions:

o  Quality of the proposed project as determined by peer review
o  Appropriateness of data, materials, and technology sharing plan
o  Availability of funds
o  Program priority. 

INQUIRIES 

Inquiries are strongly encouraged. The opportunity to clarify any issues or 
questions from potential applicants is welcome. 

Direct inquiries regarding programmatic issues to: 

James J. Anderson, Ph.D.
Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
Bldg. 45, Room 2AS-25A
Bethesda, MD 20892-6200
TEL: (301) 594-0943
FAX: (301) 480-2228
Email: andersoj@nigms.nih.gov

Direct inquiries regarding review issues to: 

Helen R. Sunshine, Ph.D.
Office of Scientific Review 
National Institute of General Medical Sciences, NIH
Bldg. 45, Room 1AS-13F
Bethesda, MD 20892-6200 
TEL: (301) 594-2881
FAX: (301) 480-8506
Email: sunshinh@nigms.nih.gov

Direct inquiries regarding fiscal matters to:

Joseph Ellis 
Grants Administration Branch 
National Institute of General Medical Sciences, NIH 
Bldg. 45, Room 2AN-32C
Bethesda, MD 20892-6200 
TEL: (301) 594-5135
FAX: (301) 480-1969
E-mail: ellisj@nigms.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos. 
93.821, 93.859, 93.862. Awards are made under authorization of sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies and Federal Regulations 42 CFR 52 and 
45 CFR Parts 74 and 92. This program is not subject to the intergovernmental 
review requirements of Executive Order 12372 or Health Systems Agency review. 

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-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, and 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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