Release Date:  November 14, 2000

RFA NUMBER: DK-01-023 

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date: March 9, 2001
Application Receipt Date: April 10, 2001


This initiative is designed to stimulate and solicit studies on 
gastrointestinal tract, liver and exocrine pancreas development and stem 
cells.  Key research issues to be addressed will be (1) how the developing 
endoderm gives rise to heterogeneous populations of cells in these developing 
and adult tissues, and (2) the molecular characterization of stem cells and 
their immediate descendants.  Interdisciplinary projects that focus on basic 
developmental biology, stem cell biology and relevant clinical conditions 
associated with the GI tract, liver and pancreas are encouraged.  In addition 
to hypothesis-driven R01 projects, this initiative will encourage development 
of new research tools through Exploratory/Developmental Grants (R21).


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 Request for 
Applications (RFA),”Development of the Gut, Liver, and Exocrine Pancreas,” is 
related to one or more of the priority areas.  Potential applicants may 
obtain a copy of "Healthy People 2010" at


Applications may be submitted by domestic and foreign, for-profit and 
nonprofit 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 


This RFA will use the National Institutes of Health (NIH) research project 
grant (R01) and exploratory research grant (R21) mechanisms.  Except as 
otherwise noted in this announcement, awards will be administered under 
policies as stated in the NIH Grants Policy Statement. R01 applications 
submitted in response to this RFA may not request a total project period of 
more than five years.  In general, the maximum budget request for R01 
applications should be limited to $250,000 in direct costs, including 
facilities and administrative (F&A) costs on consortium arrangements, for 
each budget year.  Exploratory research grant (R21) applications may not 
exceed two years for the total project period.  The maximum budget request 
for R21 applications may not exceed $100,000 in direct costs for each budget 
year.  The R21 grant mechanism may be used by new investigators or 
experienced investigators to develop pilot and feasibility studies for new 
and innovative approaches.  R21 applications generally are expected to have 
little preliminary data and are reviewed based on the development of 
hypotheses and supporting literature.

Applicants from institutions that have a General Clinical Research Center 
(GCRC) funded by the NIH's National Center for Research Resources may wish to 
identify the GCRC as a resource for conducting the proposed research. In such 
a case, a letter of agreement from either the GCRC Program Director or 
principal investigator should be included with the application.  

This RFA is a one-time solicitation.  Future unsolicited competing 
continuation applications will compete with all investigator-initiated 
applications and be reviewed according to customary peer review procedures.  
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  The anticipated award date is 
September 30, 2001.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.  
Complete and detailed instructions and information on Modular Grants can be 
found at

The NIDDK intends to commit approximately $3 million in FY 2001 to fund six 
to eight new research project grants (R01) and six to eight new exploratory 
research grants (R21) in response to this RFA.  Although the financial plans 
of the NIDDK 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 applications of outstanding scientific and technical merit. 



The GI tract and related organs share common embryological origin from the 
endoderm.  Cross talk between endoderm and mesoderm plays an important role 
in specifying different components of the gut.  The endoderm gives rise to 
gastrointestinal organs that branch from the main tube (liver, gallbladder, 
pancreas and cecum).  Several genes have been found to be required for bud 
formation (e.g., Pdx1, Hlx9, Pax4, Pax6, for pancreas and Hex for liver).  
Subsequent expansion of cellular populations in developing organs is 
orchestrated by a number of mesenchymal signals, such as Hlx (liver, 
intestinal epithelium), Pdx1 (pancreas), Cdx1 (intestinal crypts) and NKx2.3 
(mid-gut epithelium).  Terminal differentiation results from the interplay of 
both mesenchyme (genes of the Notch/Delta pathway) and epithelium (Shh).

Although genes critical for patterning of the early endoderm and 
organogenesis have been identified, much remains to be understood about these 
processes.  One area that needs considerable attention is the 
characterization of the stem cell populations in these developing organs.  
This requires a number of technical advances including identification of 
surface markers, methods for recovering these cells, clonigenic assays, and 
implementation of “genome anatomy projects” that will allow searchable 
databases of expressed genes to be developed and annotated. 

Knowledge of the molecular regulation of organogenesis and cell renewal 
should provide new strategies for treating or preventing a variety of 
diseases that affect the gastrointestinal tract, exocrine pancreas and liver.  
For example, the loss, or disruption, of intestinal absorptive function that 
occurs with inflammatory bowel disease, intestinal resection secondary to 
vascular disease, trauma, various congenital and neonatal disorders, AIDS 
enteropathy, and chemo- or radiation-therapy represent major causes of 
morbidity and impaired quality of life. Currently, the only option for some 
of these patients is lifelong parenteral nutrition.  While further research 
on small bowel transplantation is encouraged, and may soon provide a 
therapeutic option for selected patients, research underlying possible 
strategies to increase the absorptive function of the intestine is needed.  
Following loss of small bowel surface area, the intestine undergoes an 
adaptive response that includes increases in the number of proliferative 
units (crypts), and lengthening of villi.  The molecular mechanisms that 
regulate epithelial cell census and regional differentiation remain poorly 
defined.  One goal of future research in this area will be to use well 
defined model systems to decipher the complex interplay between 
“environmental” factors (e.g., nutrients, the microflora) and intrinsic 
cellular factors that normally serve to regulate epithelial cell renewal in 
the intestine.  An additional goal will be to develop markers (including 
surrogate markers) that can be used to monitor various elements of the 
renewal process.  Yet another component will be an assessment of stem cell 
“plasticity” as it pertains to the gut.  The results of this effort should 
facilitate development of new means for accurately classifying disease 
states, new and rational nutritional and pharmacological strategies for 
preserving the absorptive surface area of the intestine when it is 
jeopardized, and for restoring it when loss has occurred, and new means for 
defining the effectiveness of various therapeutic interventions.

This need for molecular definition of cellular differentiation and renewal 
also applies to the liver and pancreas.  In recognition of this need, the 
current RFA includes an extension of a previous initiative (PA-96-079) that 
encourages research applications for identification and characterization of 
factors regulating specification and differentiation of cell lineages in the 
developing and adult liver and biliary tree.  The liver has a unique capacity 
to regenerate after injury.  The process begins with proliferation of 
“mature” hepatocytes; other cell lineages including biliary epithelial cells 
(BEC) and sinusoidal cells proliferate somewhat later.  When the hepatocytes 
are prevented from entering the growth cycle by exposure to hepatotoxins or 
carcinogens, activation of a liver stem cell population is postulated to 
occur.  While the debate on the source and location of hepatic stem cells is 
ongoing, two recent studies offer a hypothesis to explain the origin of the 
bipotential oval cell.  A number of surface determinants are shared between 
bone-marrow derived progenitor cells and hepatic oval cells (c-kit,CD34, and 
Thy-1 in rodents, and c-kit and CD34 in humans).  These observations suggest 
that a population of hematopoietic stem cells originating in the bone marrow 
may give rise to oval cells in the liver, which in turn, have the potential 
to further differentiate into hepatocytes and/or ductal cells.  Such a 
concept could have important clinical implications for gene therapy and 
hepatocyte transplantation, two innovative approaches to the treatment of 
fulminant hepatic failure and genetic metabolic disorders of the liver. 

As in the liver, the adult pancreas appears to harbor stem cells that may be 
induced to proliferate in response to injury.  The identification and 
characterization of progenitor cells that can support expansion of 
ductal/exocrine cell populations destroyed during acute or chronic 
pancreatitis, or pancreatic cancer, and factors that control differentiation 
of the descendants of these progenitors, may provide entirely new approaches 
for treating these diseases.  

Research Scope

This initiative encourages development of innovative models, approaches and 
reagents for characterizing the molecular properties of gastrointestinal stem 
cells and their differentiated descendants, as well as mesenchymal cell 
populations that may serve to regulate epithelial cell renewal in the 
developing and adult GI tract, liver and exocrine pancreas.  The long-term 
goal of this effort is to provide a broader conceptual and experimental 
foundation for understanding the regulation of epithelial renewal in the 
normal gut and associated organs, characterizing the epithelial-mesenchymal 
cross-talk that underlies normal development, and for understanding the 
pathogenesis of disease states affecting the gut, liver, and pancreas.  The 
initiative encourages development of new surrogate markers for identifying 
and classifying patient populations at risk for development of diseases 
affecting these organs, for following disease progression, and for 
characterizing therapeutic responses to existing treatment regimens.  
Finally, studies supported under this initiative could provide new ways for 
identifying therapeutic targets and strategies for disease prevention and 

Areas of particular focus for R01 grant applications include, but are not 
limited to:

o Analysis of steps in development and maturation of the gastrointestinal 
tract as well as characterization of gene expression and protein synthesis at 
the different stages and steps in this orderly development.

o Analysis of steps in development and maturation of the liver including 
hepatocyte and sinusoidal populations.

o Analysis of regeneration and growth in the mature gastrointestinal tract, 
liver and exocrine pancreas.

o Identification and functional characterization of the stem cell populations 
in gut, liver and exocrine pancreas.

o Development and/or use of model systems for studies of intestinal, liver 
and exocrine pancreas regeneration/restitution/adaptation.

o Genetic screens for identifying endodermal and mesodermal mutations that 
influence intestine, liver and exocrine pancreas development.

o Growth requirements necessary for expansion of hepatic, pancreatic or gut 
stem cells in culture and their differentiation.

o Regulation of endoderm and mesoderm specification by transcription factors 
and signaling factors.

o Cellular interactions, motility and apoptosis in development and 
differentiation of intestine, liver and exocrine pancreas.

o Role of stem cells in epithelial renewal and how renewal is perturbed in a 
variety of pathologic states.

o Characterization of epithelial-mesenchymal cross-talk that underlies normal 
development as well as homeostatic mechanisms that operate in adult stem cell 

In addition to hypothesis-driven studies, this initiative will support 
exploratory/developmental efforts that seek to develop new resources for the 
research community.  As discussed above, these resources include new methods 
for rapid recovery of specific cell lineages in both developing and adult GI, 
liver and pancreas; methods for amplifying and/or retrieving normally rare 
epithelial lineage progenitors from genetically defined models and the 
development of clonigenic assays for lineage progenitors; new and broadly 
applicable methods for amplifying mRNA isolated from single or small numbers 
of recovered cells so that gene expression profiling can be conducted; and 
development of systems for inducible expression of gene products in specified 
cell populations at specified times during development, or in adult animals.

Examples of research areas for R21 Exploratory projects on liver, intestine 
and exocrine pancreas would include, but are not limited to:

o Generation of panels of markers for stem cell characteristics that are 
common across species, for isolation and characterization of stem cells in 
relevant tissues.

o Development of reliable and convenient clonigenic assays for lineage 

o Creation and/or use of new and broadly applicable methods for amplifying 
mRNA isolated from single or small numbers of recovered epithelial cells so 
that gene expression profiling can be done.

o Development and/or use of innovative and broadly applicable, invasive or 
non-invasive methods for monitoring gene expression in vivo.

o Use and/or identification of cell lines and ex vivo culture conditions that 
provide useful representations of cell lineages in vivo.

o Development and/or use of systems where recombination of target
genes can be induced at any time during or after completion of morphogenesis, 
under selected physiologic or pathologic conditions.

o Development of new bioinformatic and computational tools for compiling, 
annotating, searching and  comparing databases of genes expressed in various 
normal and diseased cell populations in the intestine, liver and exocrine 


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 (
048.html); a complete copy of the updated Guidelines are available at 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.


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 

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


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.


Prospective applicants are asked to submit, by March 9, 2001, a letter of 
intent that includes a descriptive title of the proposed research; the name, 
address, and telephone number of the Principal Investigator; the identities 
of other key personnel and participating institutions; and the number and 
title of the RFA in response to which the application may be submitted.

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 NIDDK staff to estimate the potential review workload and 
plan the review.

The letter of intent is to be sent to:

Chief, Review Branch 
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 653 MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone:  (301) 594-8885
FAX:  (301) 480-3505


Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) no later than April 10, 2001.  Application kits are available at most 
institutional offices of sponsored research, or 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 301-710-0267, email:

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach.  The just-in-
time concept allows applicants to submit certain information only when there 
is a possibility for an award.  It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers, and Institute 
staff.  The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants, with the modifications noted below.

Budget Instructions

Modular Grant applications will request direct costs in $25,000 modules, up 
to a total direct cost request of $100,000 per year for R21 exploratory grant 
applications and $250,000 per year for R01 regular research grants 
applications. The total direct costs must be requested in accordance with the 
program guidelines and the modifications made to the standard PHS 398 
application instructions described below:

PHS 398

o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in 
$25,000 increments) and Total Costs [Modular Total Direct plus Facilities and 
Administrative (F&A) costs] for the initial budget period.  Items 8a and 8b 
should be completed indicating the Direct and Total Costs for the entire 
proposed period of support.

of the PHS 398. It is not required and will not be accepted with the 

categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION:  Prepare a Modular Grant Budget Narrative 
page. (See
for sample pages.)  At the top of the page, enter the total direct costs 
requested for each year.  This is not a Form page.

o Under Personnel, list all project personnel, including their names, percent 
of effort, and roles on the project. No individual salary information should 
be provided. However, the applicant should use the NIH appropriation language 
salary cap and the NIH policy for graduate student compensation in developing 
the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the 
nearest $1,000.  List the individuals/organizations with whom consortium or 
contractual arrangements have been made, the percent effort of all personnel, 
and the role on the project.  Indicate whether the collaborating institution 
is foreign or domestic.  The total cost for a consortium/contractual 
arrangement is included in the overall requested modular direct cost amount.  
Include the Letter of Intent to establish a consortium.  Indirect costs for 
subcontracts are included in the total cost budget for the R21 applications 
submitted in response to this RFA. The subcontract costs should not be in 
modular format but should be rounded to the nearest $1000. 

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o BIOGRAPHICAL SKETCH:  The Biographical Sketch provides information used by 
reviewers in the assessment of each individual's qualifications for a 
specific role in the proposed project, as well as to evaluate the overall 
qualifications of the research team. A biographical sketch is required for 
all key personnel, following the instructions below.  No more than three 
pages may be used for each person. A sample biographical sketch may be viewed 

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
  research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;

o CHECKLIST:  This page should be completed and submitted with the 
application. If the F&A rate agreement has been established, indicate the 
type of agreement and the date. All appropriate exclusions must be applied in 
the calculation of the F&A costs for the initial budget period and all future 
budget years.

o The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review.  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 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.
The sample RFA label available at: has been modified to 
allow for this change. Please note this is in pdf format.
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 time of submission, two additional copies of the application must be sent 

Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 653 MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)

Applications must be received by the application receipt date listed in the 
heading of the RFA.  If an application is received after that date, it will 
be returned to the applicant without review. Supplemental documents 
containing significant revision or additions will not be accepted, unless 
applicants are notified by the Scientific Review Administrator.  

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications previously reviewed, but such applications must 
include an introduction addressing the previous critique.


Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIDDK.  Incomplete and/or non-responsive 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 NIDDK in accordance with review criteria stated below.  As 
part of the initial merit review, all applications will receive a written 
critique and undergo a process in which only those applications deemed to 
have the highest scientific merit, generally the top half of the applications 
under review, will be discussed, assigned a priority score, and receive a 
second level review by The National Diabetes and Digestive and Kidney 
Diseases Advisory 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 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 addressed and 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 by its 
nature is not innovative but is essential to move a field forward.

o Significance:  Does this study address an important problem?  If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
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?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

o Innovation:  Does the applicant employ novel tools, 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 principal investigator and 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 

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

o Adequacy of plans to include both genders, minorities and their subgroups, 
and children as appropriate for the scientific goals of the research.  Plans 
for the recruitment and retention of subjects will also be evaluated.  The 
reasonableness of the proposed budget and duration to the proposed research 
will also be reviewed.

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

O Availability of special opportunities for furthering research programs 
through the use of unusual talent resources, populations, or environmental 
conditions in other countries which are not readily available in the United 
States or which provide augmentation of existing U.S. resources.


The following will be considered in making funding decisions:

o Quality of the proposed project as determined by peer review;
o Availability of funds;
o Program priorities.


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

Direct inquiries regarding programmatic issues to:

Michael K. May, Ph.D.
6707 Democracy Boulevard, Room 663
Bethesda, MD 20892-5458
Telephone:  (301) 594-8884
FAX:  (301)480-8300 

Direct inquiries regarding NIDDK fiscal and administrative matters to:

Mrs. Sharon Bourque
Division of Extramural Activities
6707 Democracy Blvd, Room 612
Bethesda, MD 20892
Telephone:  (301) 594-8846
FAX: (301) 480-3504


This program is described in the Catalog of Federal Domestic Assistance No. 
93. 93.848.  Awards are 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 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, 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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