CENTERS OF EXCELLENCE IN GENOMIC SCIENCE (Modified and reissued, see PAR-05-163)
                                         (superceded by PAR-02-021)

Release Date:  May 30, 2000

PA NUMBER:  PAR-00-101

National Human Genome Research Institute

Letter of Intent Receipt Dates:
For Exploratory Grants (P20):  May 1, September 1, January 1 annually  
For Specialized Center (P50):  August 1, 2000,  April 1 annually thereafter

Application Receipt Dates:
For Exploratory Grants (P20):  June 1, October 1, February 1 annually
For Specialized Center (P50):  October 1, 2000, June 1 annually thereafter

PURPOSE

The National Human Genome Research Institute (NHGRI) is initiating a program 
to establish new academic Centers for advanced genome research.  These Centers 
of Excellence in Genomic Science (CEGS) grants (P50) will support multi-
investigator, interdisciplinary teams to develop innovative genomic approaches 
to address biological problems.  The scope of the CEGS program is intended to 
be broad with a simple unifying theme that the Centers will address important 
biological problems on a “genomic scale.”  A CEGS may focus, for example, on a 
particular genome-scale biological problem, on the development of novel 
technological and computational methods for the production and analysis of 
comprehensive data sets, or on other ways to develop and use genomic 
approaches for understanding biological systems.  In addition to pursuing 
research activities, a Center should help to nurture genomic science at its 
institution, for example, by facilitating the interaction of investigators 
from different disciplines and by providing training. 

The NHGRI particularly encourages the formation of new groups of investigators 
to conduct genomic research.  As some newly formed groups may require 
substantial time and support for development and planning before being in a 
position to submit a high quality Center grant application, a CEGS Planning 
Grant (P20) is being offered to facilitate this planning.  Applicants 
intending to focus their Center on bioinformatics approaches may also use the 
BISTI planning grant (available at:
http://grants.nih.gov/grants/guide/pa-files/PAR-00-102.html) in preparation 
for the CEGS P50 Center grant application.

RESEARCH OBJECTIVES

Background

The NHGRI is currently engaged, along with several other federal, private, and 
international organizations, in a multi-year research program called the Human 
Genome Project (HGP).  Most of the initial goals of the HGP, including genetic 
and physical maps of the mouse and human, and the DNA sequences of E. coli, S. 
cerevisiae, C. elegans, and D. melanogaster have been realized.  Others will 
be met imminently, including the complete human sequence.  As of April 2000, 
more than three-quarters of the human sequence, either in finished or working 
draft form, has been deposited in the public sequence databases.  After 
generation of a working draft version of at least 90% of the genome, 
completion of the high quality sequence will follow no later than 2003.  Mouse 
genome sequencing has also begun, with completion of that sequence anticipated 
no later than 2005.

The HGP has been characterized by a focus on large, comprehensive genomic data 
sets, such as complete DNA sequences and genomic maps, efficient data 
production, and the development of new technologies.  Once the DNA sequence of 
an organism becomes available, many new avenues to studying its biology are 
opened.  However, new and improved research tools, approaches, and 
capabilities are needed to discover and use the vast amount of biological 
information in complete genomic DNA sequences.  In 1998, a set of new goals 
was adopted for the U.S. Human Genome Program (see Goals at 
http://www.nhgri.nih.gov/98plan/).  In addition to completing the human and 
mouse maps and sequences, the aim of the HGP was extended to developing some 
of the new data sets and technological approaches that will be necessary to 
understand and use genomic DNA sequence.  The purpose of this new solicitation 
is to stimulate the development of such new approaches, which are likely to 
involve computational, instrumental, biochemical, genetic, and analytical 
technologies.  These approaches are likely to require the expertise of teams 
of investigators from different fields as well as substantial infrastructure.

This Program Announcement (PA) signals an augmentation of the NHGRI Center 
grant program.  Previous NHGRI solicitations for Center grants have had as 
their purpose the production of large data sets, such as genetic maps, physical 
maps, or DNA sequences, and were derived from the quantitative resource-
generation goals of the HGP five-year plans.  While such programs continue, 
this new program is intended to provide support for novel basic genomics 
research projects.  These new Centers will conduct research into biological 
problems at a genomic scale, or develop new methods, approaches, tools, or 
technologies to make possible novel analyses of biological questions from a 
genomic perspective.  Some projects may result in new analyses of existing 
data sets.  Other projects may result in technologies and methods that provide 
the ability to collect, analyze, and present effectively new types of genomic 
data sets.

The NHGRI is committed to continuing to support basic genomic research through 
investigator-initiated, single-laboratory project grants, using the R01, R21, 
and other appropriate grant mechanisms, under existing and future programs.  
However, the resources needed to conduct the multi-faceted, multi-disciplinary 
projects that may be required to achieve significant advances in these complex 
problems are sometimes beyond the scope of the typical R01 grant.  Therefore, 
this PA presents an opportunity for applicants to assemble the teams of 
investigators from diverse disciplines that will be required to approach 
biological problems using genomics tools in ways that are not possible today.  
High priority will be given to projects that integrate multi-investigator,".,
 multi-disciplinary approaches to a scientific problem, especially those that 
 can meld computational and experimental approaches.

Scope of Research

The U.S. HGP goals for 1998-2003 (Science, Vol. 282, pp. 682–689, 23 Oct. 
1998, see http://www.nhgri.nih.gov/98plan/) articulated several areas of 
genomics for which substantial research opportunities exist.  The more recent 
publication of the Biomedical Information Science and Technology Initiative 
(BISTI) (http://www.nih.gov/welcome/director/060399.htm) lays out additional 
challenges, many of which are complementary to those of the HGP.  The 
following excerpts from these reports exemplify the challenges and 
opportunities that lie ahead:

o  Sequencing Technology:  “In the future, de novo sequencing of additional 
genomes, comparative sequencing of closely related genomes, and sequencing to 
assess variation within genomes will become increasingly indispensable tools 
for biological and medical research....[R]esearch must be supported on new 
technologies that will make even higher throughput DNA sequencing efficient, 
accurate, and cost-effective, thus providing the foundation for other advanced 
genomic analysis tools.”  (HGP goals)

o  Human Genome Sequence Variation:  “Natural sequence variation is a 
fundamental property of all genomes....Basic information about the types, 
frequencies, and distribution of polymorphisms in the human genome and in 
human populations is critical for progress in human genetics.  Better high-
throughput methods for using such information in the study of human disease 
are also needed.”  (HGP goals)

o  Technology for Functional Genomics:  “The availability of entire genome 
sequences is enabling a new approach to biology often called functional 
genomics – the interpretation of the function of DNA sequence on a genomic 
scale....Many genes and other functional elements of the genome are discovered 
only when the full DNA sequence is known....However, knowing the structure of 
a gene or other element is only part of the answer.  The next step is to 
elucidate function, which results from the interaction of genomes with their 
environment....Large-scale characterization of the gene transcripts and their 
protein products underpins functional analysis....Improved technologies are 
[also] needed for global approaches to the study of non-protein-coding 
sequences....”  (HGP goals)

o  Comparative Genomics:  “Because all organisms are related through a common 
evolutionary tree, the study of one organism can provide valuable information 
about others.  Much of the power of molecular genetics arises from the ability 
to isolate and understand genes from one species based on knowledge about 
related genes in another species.  Comparisons between genomes....provide insight 
into the universality of biologic mechanisms and....into the details of gene 
structure and function.”  (HGP goals)

o  Bioinformatics and Computational Biology:  “Bioinformatics support is 
essential to the implementation of genome projects and for public access to 
their output....Collection, analysis, annotation, and storage of the ever 
increasing amounts of mapping, sequencing, and expression data in publicly 
accessible, user-friendly databases is critical to the project"s success.  In 
addition, the community needs computational methods that will allow scientists 
to extract, view, annotate, and analyze genomic information efficiently.”  
(HGP goals)

o  “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.”  (BISTI goals)

o  “The information that biomedical researchers are amassing in profuse 
quantities today...creates enormous digital repositories of information.  The 
scale of those databases swamps all the information collected before....In 
order to be useful, the data must be indexed and stored, and the challenges 
for data analysis and abstraction are formidable.”  (BISTI goals)

The passages quoted above from the U.S. HGP five-year plan and the BISTI 
report are intended to convey the kinds of subjects and scope of projects that 
may be appropriate under this Centers program.  This PA does not provide a 
list of examples of possible Center themes because of the NHGRI’s desire not 
to limit applicants’ imaginations and to solicit truly new ideas for genomic 
approaches to biological problems, related to the goals discussed above.  The 
NHGRI strongly encourages investigators who propose to develop such novel 
approaches to discuss their ideas with NHGRI program staff prior to submitting 
an application, to ensure that applications will be responsive to the CEGS 
program.

Biomedical research has entered an era in which the solutions to many 
important problems will require the collection and analysis of large data 
sets, such as an entire genome, an entire set of expressed RNAs or proteins, 
an entire gene family from a large number of species, the variation among 
individuals for a genomic region of substantial size, or a class of gene 
regulatory or chromatin organizational elements.  Therefore, the unifying 
theme for this program will be that the Centers will address important 
biological problems on a “genomic scale.”  Preference will be given to 
approaches and technologies that are applicable to a wide variety of cell 
types or organisms and that are usable in a high-throughput, cost-effective, 
comprehensive manner, i.e., are “genomic technologies.”  Similarly, preference 
will be given to approaches designed to be generally applicable at large 
scale, for example, not limited to any one genetic locus, specific disease, or 
organ system.
 
Preference will be given to the development of genomic methods for eukaryotes 
where genome sequence is available.  Methods development or pilot studies 
using other systems (e.g., eukaryotes whose genomes have not been sequenced, 
or prokaryotes for which the genomic sequence is known) will be considered 
with adequate justification, direct applicability to the analysis of 
eukaryotic genomes must be evident.  Where appropriate, integration with other 
NIH genomics initiatives (e.g., NHLBI genomics program 
[http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-99-024.html], full-length 
cDNA [http://www.ncbi.nlm.nih.gov/MGC/], and
SNPs [http://www.nhgri.nih.gov:80/About_NHGRI/Der/SNPawardees.htm]) will be 
considered advantageous.

It is anticipated that these Centers may employ large amounts of data to 
accomplish their goals.  However, the application of genomic technologies for 
data production per se is not the purpose of these Centers.  Instead, these 
Centers may generate data sets to address a biological problem, or may develop 
tools.  The generation of test data sets may be appropriate for developing the 
methods and technologies, or demonstrating the feasibility of methods under 
investigation.  The cost-effectiveness of the project plan will be a review 
criterion.  Decisions by NHGRI to embark on the large-scale implementation of 
any new tools developed by these Centers to generate large data sets, 
particularly when such projects are expensive, will require careful 
consideration, with advice from the scientific community.

Additional Objectives - Training 

There is a widely recognized shortage of investigators who have the 
interdisciplinary skills needed to conduct most effectively the types of 
research described in this PA.

o  “The HGP has created the need for new kinds of scientific specialists who 
can be creative at the interface of biology and other disciplines, such as 
computer science, engineering, mathematics, physics, chemistry, and the social 
sciences.  As the popularity of genomic research increases, the demand for 
these specialists greatly exceeds the supply.  In the past, the genome project 
has benefited immensely from the talents of non-biological scientists, and 
their participation in the future is likely to be even more crucial.  There is 
an urgent need to train more scientists in interdisciplinary areas that can 
contribute to genomics.  Programs must be developed that will encourage 
training of both biological and non-biological scientists for careers in 
genomics....[A] stable academic environment for genomic science must be 
created so that innovative research can be nurtured and training of new 
individuals can be assured.”  (HGP goals) 

o  “Strong action by the NIH is required because the existing biomedical 
research and teaching structures of the universities and research institutions 
of this country inadequately value interdisciplinary efforts generally, and 
computation in particular.  Few grant programs and fewer academic departments 
foster the kind of interdisciplinary work required to meet biomedical 
challenges, let alone educate students about them.  National Programs 
specifically would include formal and informal instruction from the 
undergraduate through post-graduate levels, and incorporate a range of 
opportunities for scholars and researchers to participate.”  (BISTI goals)

One reason for the 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 the CEGS program is intended to help to 
alleviate this shortage by serving as an academic focus for genomic research 
approaches.  To maximize the impact of these Centers, they should integrate 
the training of young investigators and broadening 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 level.

Additional Objectives – ELSI

In the case of projects that raise ethical, legal, or social concerns (e.g., 
the study of sequence variation), a component of the Center focusing on 
analysis of such concerns as they relate to the particular research proposed 
is encouraged.

MECHANISM OF SUPPORT

Support of this program will be through the National Institutes of Health 
(NIH) P50 Specialized Center 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.  Genomics is a rapidly changing field, and it is 
anticipated that most projects that can be initiated now are likely to have a 
limited lifetime during which support from the NHGRI will be appropriate, 
either because the project goals will have been accomplished or the Center 
will have developed to the point that support from another source 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.

In general, Centers will receive an administrative site visit during the third 
year of each competing cycle.  The fifth year of funding will depend on the 
outcome of that administrative review, and the Principal Investigator (P.I.) 
will receive advice about the NHGRI"s 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 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.  Under this cap, it is anticipated 
that the size of the awards will vary because the nature and scope of research 
programs proposed will vary.  The NHGRI anticipates establishing ten or more 
such Centers over the next few years, and therefore expects that two to four 
P50 awards will be made per year.  The actual number of awards and level of 
support will depend on receipt of a sufficient number of applications of high 
scientific merit and availability of funds.

A high priority under this program is the establishment of new academic 
Centers in which state-of-the-art genomics research can be conducted.  At some 
institutions, the nucleus of a research group that could conduct the research 
described in this PA 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 will be used when the applicant wishes to request a 
period of planning and preliminary investigation prior to preparing a P50 
Center application.  Appropriate activities under the CEGS 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.  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.  A planning grant is not required as a precursor to 
a P50 Center application.  Funding of a planning grant does not obligate NHGRI 
to fund a subsequent P50 Center grant.

Applicants anticipating the submission of projects that are largely or 
exclusively computational should be aware that an additional planning grant 
opportunity for entry into the CEGS P50 program described here is available. 
Information on the Planning Grants: National Program for Excellence in 
Biomedical Computing (Pre-NPEBC) program is available at 
http://grants.nih.gov/grants/guide/pa-files/PAR-00-102.html.

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 will be 
considered.

GUIDANCE FOR APPLICANTS FOR P50 CENTER GRANTS

The applicant should identify clearly in the abstract and more fully in the 
research plan the new capabilities that are proposed to be developed, or what 
specific biological question is to be studied, as a result of the 
establishment of the Center.  The synergies achieved through the establishment 
of multi-disciplinary teams and novel collaborations should be fully 
described.  

The P50 grant application should specify the specific administrative and 
organizational structure(s) that will be used to support the research, and the 
synergies enabled by those structures.  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 
P.I. 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 NHGRI 
anticipates will characterize these Centers require a substantial amount of 
the P.I.’s effort to achieve success.  Therefore, the P.I. 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 is physically separated 
from each other (i.e., different departments or institutions), the proposal 
should address how that separation will be managed.  The NHGRI is not 
specifying a specific organizational structure (e.g., specific numbers of 
projects and cores) in this PA, 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 CEGS grant.  The 
timeline will also assist the investigators, NHGRI, and its advisors in 
evaluating progress toward the project"s goals.  For those projects for which 
the investigator deems it appropriate to do so, NHGRI encourages applicants to 
present explicit, quantitative milestones.

The NHGRI 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 
CEGS will therefore become an additional mechanism, to those previously 
developed by NHGRI (see 
http://www.nhgri.nih.gov/Grant_info/Funding/Training/), for expanding the 
cadre of investigators working in the field of genomics.  Training of 
racial/ethnic minority individuals, women, and persons with disabilities is a 
particularly high priority.

Data and Materials Dissemination

The sharing of materials, data, and software in a timely manner has been an 
essential element in the rapid progress that has been made in genome research.  
While Public Health Service (PHS) policy requires that investigators make 
unique research resources, including DNA sequences and mapping information, 
readily available when they have been published (NIH Grants Policy Statement, 
October 1, 1998, p. II-62), the advisors to the NIH and the Department of 
Energy (DOE) genome programs have encouraged more rapid sharing 
(http://www.nhgri.nih.gov:80/Grant_info/Funding/Statements/data_release.html).  
This has become the norm in the genome community.

The NIH is interested in ensuring that the information about new methods, 
technologies, computer software, and genomic biology data that is developed 
through this program becomes readily available to the research community for 
further research and development, with the expectation that this 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 the data, materials, and software generated through the grant, 
taking into consideration the recent Guidance issued by NIH 
(http://www.ott.nih.gov/policy/rt_guide_final.html).  To the extent that established 
public databases (e.g., GenBank or dbSNP) have the capability for collecting 
and disseminating the data that would be collected under the grant, it is the 
NHGRI’s strong preference that a plan for the rapid deposition of data into 
such public databases be described in the application.

The initial 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.

LETTER OF INTENT 

Prospective applicants are asked 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 P.I., names of other key personnel and, if 
applicable, participating institutions, and the number and title of this PA. 
Although a letter of intent is not required, is not binding, and does not 
enter into the review of subsequent applications, the information that it 
contains allows NHGRI staff to estimate the potential review workload and to 
avoid possible conflict of interest in the review.  Please note that 
applicants planning to request $500,000 or more in direct costs for any year 
must contact NHGRI program staff before submitting the application (see 
ADDITIONAL APPLICATION PROCEDURES FOR P50 CENTER GRANTS, below).

The letter of intent is to be sent to: 

Jeffery A. Schloss, Ph.D. 
Division of Extramural Research
National Human Genome Research Institute, NIH
Bldg. 31, Room B2-B07
Bethesda, MD 20892-2033
TEL: (301) 496-7531
FAX: (301) 480-2770
Email:  jeff_schloss@nih.gov

APPLICATION PROCEDURES (P50 AND P20)

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) and will be accepted at the application deadlines indicated on the first 
page of this PA.  Application kits are available at most institutional offices 
of sponsored research and may be obtained from the Division of Extramural 
Outreach and Information Resources, National Institutes of Health, 6701 
Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, 
email: GrantsInfo@nih.gov.

The title and number of the PA must be typed on line 2 of the face page of the 
application form and the YES box must be marked.

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: 

Scientific Review Branch
National Human Genome Research Institute, NIH
Bldg. 31, Room B2-B37
Bethesda, MD 20892-2032 
TEL: (301) 402-0838 
FAX: (301) 435-1580

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.

In accordance with NIH policy (NIH Guide for Grants and Contracts, March 20, 
1998, available at http://grants.nih.gov/grants/guide/notice-files/not98-030.html), 
an applicant planning to submit an application requesting $500,000 
or more in direct costs for any year MUST contact NHGRI program staff before 
submitting the application, as plans for the study are being developed, to 
obtain agreement that NHGRI will accept the application for review.  The 
applicant must identify, in a cover letter sent with the application, the 
NHGRI staff member who agreed to accept assignment of the application.  The 
NHGRI is not obligated to accept applications requesting more than $500,000 in 
the absence of such staff agreement.  This policy requires an applicant to 
obtain agreement for acceptance of both any such application and any 
subsequent amendment. 

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 NHGRI.  Incomplete applications will be returned to the 
applicant without further consideration.  Applications that are complete and 
responsive to the PA will be evaluated for scientific and technical merit by 
an appropriate peer review group, convened by the NHGRI in accordance with the 
standard NIH peer review procedures.  The applications will receive a second-
level review by the National Advisory Council for Human Genome Research. 

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 CEGS program are evaluated appropriately, 
the standard NIH review criteria have been adapted to be more appropriate for 
proposals of the scope described in this PA.  In the written comments 
reviewers will be asked to discuss the following aspects of the 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.  Note that the 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 is not innovative but is essential to move a 
field forward.

Review Criteria for P50 Centers 

(1) Significance:  Importance of the proposed research areas and topics being 
explored, and their relevance to investigation of a biological problem, 
particularly one that is amenable to genomic approaches.  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 the 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.

(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 a 
genomic or biological problem.

(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 P.I.’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 take 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.

(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 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.

Review Criteria for P20 Planning Grants

(1) Significance:  Importance of the proposed research areas and topics being 
explored, and their relevance to elucidating a biological problem, 
particularly one that is amenable to genomic approaches.  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 CEGS.

(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 take 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.

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.

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications received through this and other NHGRI programs.  The following 
will be considered in making funding decisions:  Quality of the proposed 
project as determined by peer review, appropriateness of data, materials, and 
technology sharing plan, availability of funds, and program priority.

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 subpopulations 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 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 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research" that were published in the Federal Register of March 28, 1994 (FR 59 
14508-14513), and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, 
March 18, 1994, and are available on the web at the following URL address:  
http://grants.nih.gov/grants/guide/notice-files/not94-100.html.
 
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 were published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and are 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.

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 PA, Centers of Excellence in 
Genomic Science, 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.

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 connect to an Internet site.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Jeffery A. Schloss, Ph.D. 
Division of Extramural Research
National Human Genome Research Institute, NIH
Bldg. 31, Room B2-B07
Bethesda, MD 20892-2033
TEL: (301) 496-7531
FAX: (301) 480-2770
Email:  jeff_schloss@nih.gov

Direct inquiries regarding review issues to:  

Scientific Review Branch
National Human Genome Research Institute, NIH
Bldg. 31, Room B2-B37
Bethesda, MD 20892-2032 
TEL: (301) 402-0838 
FAX: (301) 435-1580

Direct inquiries regarding fiscal matters to:

Jean Cahill
Grants Administration Branch
National Human Genome Research Institute, NIH
Bldg. 31, Room B2-B34 
Bethesda, MD 20892-2031 
TEL: (301) 402-0733 
FAX: (301) 402-1951
E-mail:  jc166o@nih.gov

AUTHORITY AND REGULATIONS 

This program is described in the Catalog of Federal Domestic Assistance No. 
93.172.  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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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