Full Text DK-93-024


NIH GUIDE, Volume 22, Number 20, June 4, 1993

RFA:  DK-93-024

P.T. 04

  Digestive Diseases & Disorders 
  Biomedical Research, Multidiscipl 
  Gene Therapy+ 

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  October 15, 1993
Application Receipt Date:  November 18, 1993


The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) invites applications for Silvio O. Conte Digestive Diseases
Core Center grants.  The NIDDK anticipates the award of four
competitive Digestive Diseases Core Center Grants (P30s) in Fiscal Year

The Silvio O. Conte Digestive Diseases Research Core Centers are part
of an integrated program of digestive diseases-related research support
provided by the NIDDK.  The Centers currently funded in this program
have provided a focus for increasing collaboration and improving the
cost-effectiveness of supported research among groups of successful
investigators at institutions with an established comprehensive
digestive diseases research base.


The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS led national activity for setting priority areas.  This Request
for Applications (RFA), Digestive Diseases Research Core Centers, is
related to the priority area of diabetes and chronic disabling
conditions.  Potential applicants may obtain a copy of "Healthy People
2000" (Full Report:  Stock No. 017-001-00474-0) or Healthy People 2000"
(Summary Report:  Stock No. 017-001-00473-1) through the Superintendent
of Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202-783-3238).


Applications may be submitted by domestic (not foreign) for-profit and
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.  Minority
individuals and women are encouraged to submit as Principal

Applicant institutions must have an adequate base of established
programs of high quality in laboratory and/or clinical digestive
diseases-related research.  The quality of the programs must be evident
from the fact that they have been awarded support through peer reviewed
competition, such as NIDDK research project grants (R01), program
project grants (P01), FIRST (R29) awards, cooperative agreements, and
contracts or peer reviewed and funded through other Federal Agencies or
non-federal groups.


Support of this program will be through the NIH core center (P30)
award.  Responsibility for the planning, direction, and execution of
the proposed center will be solely that of the applicant.  Awards will
be administered under PHS grants policy as stated in the Public Health
Service Grants Policy Statement.

This RFA is a one-time solicitation.  The receipt of four competing
continuation applications is anticipated.  These applications will
compete for the awards along with other applications received in
response to this RFA.  The total project period for applications
submitted in response to the present RFA may not exceed five years.
The earliest possible award dates will be December 1994 for three
center grants and January 1995 for the other grant.  Applicants must
limit their requests to not more than $700,000 direct costs for the
initial budget period.  Included in this $700,000 may be funds with a
limit of $100,000 for the pilot and feasibility program.  Future budget
period escalations may not exceed a four percent increase over the
previous budget period.

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the proposed
research.  If so, a letter of agreement from either the GCRC program
director or a Principal Investigator must be included with the


For FY 1995, up to $3,000,000 in total costs will be committed to fund
applications submitted in response to this RFA.  It is anticipated that
four awards will be made with an average size of approximately $750,000
per year, total costs; 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
the NIDDK, the award of grants pursuant to this RFA is also contingent
upon the availability of funds for this purpose.


The objective of the Core Centers is to bring together investigators
from relevant disciplines to enhance and extend the effectiveness of
research related to digestive diseases and their complications.  A Core
Center must be an identifiable unit within a single university medical
center or a consortium of cooperating institutions, including an
affiliated university.  The overall goal of the Core Center is to bring
together clinical and basic science investigators in a manner that will
enrich the effectiveness of digestive diseases research.  An existing
program of excellence in biomedical research in the area of digestive
diseases disorders is required.  This research must be in the form of
NIH funded research projects, program projects, or other peer reviewed
research that is already funded at the time of submission of a Center
grant application.  Close cooperation, communication, and collaboration
among all involved personnel of all professional disciplines are
ultimate objectives.

The Core Centers must have a central focus of research investigation.
The central focus must be a digestive disease, group of diseases or
functional studies relating to digestive diseases; at least half of the
research must relate to this central focus.  Examples of a
gastrointestinal disease-related central focus of research
investigation include (but are not restricted to) inflammatory bowel
disease, peptic ulcer disease, pancreatic disease, liver disease,
pediatric gastrointestinal disease and AIDS in gastrointestinal
disease.  Examples of functional studies as the central focus include
(but are not restricted to) gastrointestinal motility, gastrointestinal
hormones, or gene therapy for digestive diseases.  Applicants should
consult with NIDDK staff concerning plans for the development of the
Center and the organization of the application.

Silvio O. Conte Digestive Diseases Research Core Centers are based on
the core concept.  Five or six cores are usually included in a Center.
Cores are defined as shared resources that enhance productivity or in
other ways benefit a group of investigators working in digestive
diseases centers to accomplish the stated goals of the Center.
Examples of such resources include electron microscope, tissue culture,
and radioimmunoassay facilities.

Centers are encouraged to include a clinical component or core that
deals with patients.  This clinical component can exist as a stand
alone core or part of another core such as the administrative core.
Besides leading to a better understanding of disease etiology and
natural history of disease, such cores might provide biostatistical
support, enhance clinical study design, enhance collaboration among
researchers and recruitment of subjects for clinical studies, provide
for epidemiological studies in areas of digestive diseases or provide
modest funding for tissue, DNA, or serum storage. In addition, a
clinical or epidemiology core may more effectively address NIH policies
concerning issues of women and ethnic minority participation in
clinical studies.

Two other types of activities may also be supported with Center
funding:  a pilot and feasibility (P/F) program and an enrichment
program.  The P/F program provides modest support for new initiatives
or feasibility research studies.  This program is directed at new
investigators, at investigators established in other research
disciplines with expertise that may be applied to digestive disease
research, and, occasionally, at investigators already working in
digestive diseases but who wish to make a substantial change in the
direction of their research.  In addition, temporary salary support for
one Named New Investigator in a specified area of research with a
defined P/F study may be requested for up to 24 months, with subsequent
individuals to be named by the Center Director and approved by the
Center's External Advisory Board and the NIDDK.  The Core Center grant
may include limited funds for program enrichment such as seminars,
visiting scientists, consultants, and workshops.


At least 50 percent of the already funded research base in a new
application must be supported by the NIDDK.  In competing continuation
applications the percent may be less than 50 percent due to, for
example, a growing research base of investigators entering digestive
diseases from other fields.  The significance of the research base will
be determined by the initial review group.



NIH policy is that applicants for NIH clinical research grants and
cooperative agreements will be required to include minorities and women
in study populations so that research findings can be of benefit to all
persons at risk of the disease, disorder or condition under study;
special emphasis should be placed on the need for inclusion of
minorities and women in studies of diseases, disorders and conditions
which disproportionately affect them.  This policy is intended to apply
to males and females of all ages.  If women or minorities are excluded
or inadequately represented in clinical research, particularly in
proposed population-based studies, a clear compelling rationale should
be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of the
study.  This information should be included in the form PHS 398 in
Sections 1-4 of the Research Plan AND summarized in Section 5, Human

Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However, NIH
recognizes that it may not be feasible or appropriate in all research
projects to include representation of the full array of United States
racial/ethnic minority populations (i.e., Native Americans (including
American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks,

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology, prevention
(and preventive strategies), diagnosis, or treatment of diseases,
disorders or conditions, including but not limited to clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the selected
study population is inadequate, it will be considered a scientific
weakness or deficiency in the study design and will be reflected in
assigning the priority score to the application.

All applications for clinical research submitted to NIH are required to
address these policies.  NIH funding components will not award grants
or cooperative agreements that do not comply with these policies.


Prospective applicants are asked to submit, by October 15, 1993, 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 this RFA.

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 is helpful in planning for the review of applications.
It allows NIDDK staff to estimate the potential review workload and to
avoid possible conflict of interest in the review.

The letter of intent is to be sent to:

Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
Bethesda, MD  20892
Telephone:  (301) 594-7515
FAX:  (301) 594-7503


Applications are to be submitted on form PHS 398 (rev. 9/91), available
in the office of sponsored research of most academic or research
institutions and from the Office of Grants Inquiries, Division of
Research Grants, National Institutes of Health, 5333 Westbard Avenue,
Room 449, Bethesda, MD 20892, telephone (301) 710-0267.

Administrative Guidelines for Silvio O. Conte Digestive Diseases
Research Core Centers may be requested from the NIDDK program staff
listed under INQUIRIES below.

The RFA label available in the application form must be affixed to the
bottom of the face page.  Failure to use this label could result in
delayed processing of the application such that it may not reach the
review committee in time for review.  In addition, the RFA title and
number must be typed on line 2a of the face page of the application
form and check the YES box.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed, exact photocopies, in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At time of submission, two additional copies of the application must
also be sent under separate cover to:

Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
Bethesda, MD  20892

Applications must be received by November 18, 1993.  If an application
is received after that date, it will be returned to the applicant.  The
Division of Research Grants (DRG) will not accept any application in
response to this announcement that is essentially the same as one
currently pending initial review, unless the applicant withdraws the
pending application.  The DRG 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.  Such applications must not only include an introduction
addressing the previous critique but also be responsive to this RFA.


Upon receipt, applications will be initially reviewed by the DRG for
completeness.  Incomplete applications will be returned to the
applicant without further consideration.  Evaluation for responsiveness
to the program requirements and criteria stated in the RFA is an NIDDK
staff function.  If the application is not responsive to the RFA, NIDDK
staff will contact the applicant to determine whether it should be
returned to the applicant.

Those applications that are complete and responsive will be evaluated
in accordance with the criteria stated below for scientific/technical
merit by an appropriate peer review group convened by the NIDDK.  If
the number of applications is large compared to the number of awards to
be made, a preliminary scientific peer review may be conducted to
withdraw applications from further competition if they are not
competitive for the award.  The NIDDK will notify the applicant and
institutional official of this action.

Those applications judged to be competitive will be reviewed for
scientific and technical merit in accordance with the usual NIH peer
review procedures by an initial review group specifically convened for
this RFA.  Applications are unlikely to be reviewed by a site visit
team; therefore, the written application must be complete to facilitate
review without a site visit.  Following this review, the applications
will be given a second level review by the National Diabetes and
Digestive and Kidney Diseases Advisory Council unless not recommended
for further consideration by the initial review group.

Review criteria for RFAs generally include those for unsolicited
research grant applications:

o  scientific, technical, or medical significance and originality of
proposed research;

o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  qualifications and research experience of the Principal Investigator
and staff, particularly, but not exclusively, in the area of the
proposed research;

o  availability of resources necessary to perform the research;

o  appropriateness of the proposed budget and duration in relation to
the proposed research; and

o  if an application involves activities that could have an adverse
effect upon humans, animals, or the environment, the adequacy of the
proposed means for protecting against or minimizing such effects.

Specific review criteria for Digestive Diseases Core Centers include:

o  The scientific excellence of the Center's research base (its
strengths, its breadth and depth) as well as the relevance and
interrelation of these separately funded research projects to the
central theme(s) or focus of the Center and the likelihood for
meaningful collaboration among Center investigators.  The existence of
a base of established, independently supported biomedical research of
high quality is a prerequisite for the establishment of a Digestive
Diseases Core Center and is the most important component of the review.
(The results of previous peer reviews of its content will weigh heavily
in the application's overall strength as a potential recipient of an

o  The qualifications, experience, and commitment of the Center
investigators responsible for the individual research projects, and
their willingness to interrelate with each other and contribute to the
overall objectives of the Digestive Diseases Core Center.

o  The appropriateness and relevance of the proposed Cores and their
modes of operation (such as how usage will be prioritized), facilities,
and potential for contribution to ongoing research. Competing
continuation applications must document the use, utility, quality
control and cost effectiveness of each Core requested to continue as
part of the Center.  Progress will be judged in part on the list of
publications arising from the cores.  At least two users are required
to establish a core.  However, a greater number of users generally can
be evaluated as more cost effective.

o  For new and competing continuation applications, four or five P/F
studies may be submitted for evaluation as part of the review of the
P/F program.

o  In general for new applications, the proposed P/F projects will be
examined to assess:  the eligibility of the P/F applicant, i.e.,
whether they fit the three eligibility categories (1) new investigator,
(2) an investigator bringing a different expertise into digestive
diseases, or (3) an established investigator making a substantial
change in direction in digestive diseases; the reasonableness of the
hypothesis; and scientific and technical feasibility of projects for
which funds are requested.  The P/F program also will be judged as a

o  In addition, in the case of new applications, the P/F studies should
be presented as the Centers' best selection.  The internal selection
process should be described.  In competitive continuation applications,
the P/F studies should have been selected by using the existing
internal evaluation mechanisms.

o  For competing continuation applications, the P/F program also will
be assessed as a whole, including past accomplishments indicated by
publications arising from P/F studies, peer reviewed funded grants
arising from P/F studies, and investigators remaining in academic
research even if they have moved to another research or academic
environment; management of the program; and the general scientific
merit of past, ongoing, and proposed P/F studies as a group.  The
quality of these P/F studies is an indication of how well the internal
selection mechanism has been working.

o  In each case (new and competing continuation), the effectiveness of
the proposed P/F program will be evaluated.  However, in the case of
the competing continuation, the progress of the established program
will also serve as a basis for recommendations concerning the level at
which P/F studies will be supported throughout the grant award period.

o  The Named New Investigator, when identified in the application, must
be reviewed separately.  The associated pilot study must be evaluated
in a manner similar to the P/F studies in general.  In a competing
continuation application only, the progress of previous Named New
Investigators should also be evaluated:  whether or not their P/F
projects led to publications, grant awards, and whether or not the
investigator has remained in digestive diseases related research in
that research environment or elsewhere.

o  Efficient and effective use and/or planned use of the limited
enrichment funds, including the contribution of these activities in
enhancing the objectives of the Center.

o  The scientific and administrative leadership abilities of the
proposed Center Director and Associate Director and their commitment
and ability to devote adequate time to the effective management of the

o  The administrative organization proposed for the following:

(a) Coordination of ongoing research between the separately funded
projects and the Center, including mechanisms for internal monitoring.

(b) Establishment and maintenance of internal communication and
cooperation among the Center investigators.

(c) Mechanism for selecting and replacing professional or technical
personnel within the Core Center.

(d) Mechanism for reviewing the use of and administering funds for the
P/F program.  The general quality of P/F studies selected for the
application.  These funds are restricted and thus can only be used for
this program.

(e) Management capabilities that include fiscal administration,
procurement, property and personnel management, planning, budgeting,
and other appropriate capabilities.

o  The institutional commitment to the program, including lines of
accountability regarding management of the Center grant and the
institution's contribution to the management capabilities of the

o  The academic environment and resources in which the activities will
be conducted, including the availability of space, equipment,
facilities, and the potential for interaction with scientists from
other departments and institutions.

o  The institutional commitment to new individuals responsible for
conducting essential Center functions.

o  The institutional commitment to establishing new positions
specifically designed to enhance the operation of the Center.

o  The appropriateness of the budgets for the proposed and approved
work to be done in Core facilities, for P/F studies (these are
restricted funds and are capped at $100,000), and for enrichment in
relation to the total Center program.  Total Direct Costs are limited
to $700,000 (including the P/F program).  In competing continuation
applications, consideration must be taken for reductions instituted in
FY 1987 in accordance with NIDDK administrative policy.  Ongoing Center
grants incurred negotiated budget reductions averaging approximately 20
to 25 percent per year in addition to the Initial Review Group
recommended reductions indicated in the summary statements.


The anticipated date of award is December 1994 for three center grants
and January 1995 for one additional center grant.

Applications recommended for further consideration by the National
Diabetes and Digestive and Kidney Diseases Advisory Council will be
considered for funding on the basis of overall scientific and technical
merit of the research as determined by peer review, program needs and
balance, and availability of funds.


Written and telephone inquiries concerning this RFA are encouraged.  It
is strongly suggested that the pamphlet "Administrative Guidelines for
Silvio O. Conte Digestive Diseases Research Core Centers" be obtained
before an application is prepared.  Inquiries regarding programmatic
issues and requests for the Administrative Guidelines may be directed

Dr. Judith M. Podskalny
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A15
Bethesda, MD  20892
Telephone:  (301) 594-7539

Inquiries regarding fiscal matters may be directed to:

Ms. Nancy Dixon
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 637A
Bethesda, MD  20892
Telephone:  (301) 594-7543


Letter of Intent Receipt Date:  October 15, 1993
Application Receipt Date:       November 18, 1993
Initial Review:                 March 1994
Second Level Review:            May 1994
Anticipated Date of Awards:     December 1994 and January 1995


This program is described in the Catalog of Federal Domestic Assistance
No. 93.848.  Awards are made under authorization of the Public Health
Service Act, Title IV, Part A (Public Law 78-410, as amended by Public
Law 99-158, 42 USC 241 and 285) and administered under PHS grants
policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74.  This
program is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.


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