Full Text DK-94-021

SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTERS

NIH GUIDE, Volume 23, Number 18, May 13, 1994

RFA:  DK-94-021

P.T. 04

Keywords: 
  Digestive Diseases & Disorders 
  Etiology 
  Pathophysiology 
  Treatment, Medical+ 


National Institute of Diabetes and Digestive and Kidney
Diseases

Letter of Intent Receipt Date:  October 18, 1994
Application Receipt Date:  November 15, 1994

PURPOSE

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 1996.  At least one of these awards will be to a center with a
research emphasis on the etiology, pathology, and treatment of
inflammatory bowel disease.

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.

HEALTHY PEOPLE 2000

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).

ELIGIBILITY REQUIREMENTS

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
Investigators.

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 support has been awarded through peer
reviewed competition, such as NIDDK research project grants (R01),
program project grants (P01), First Independent Research Support and
Transition (FIRST) (R29) awards, cooperative agreements, and
contracts or through other Federal agencies or non-federal groups.
It is required that at least fifty percent of the digestive
diseases-related research being conducted at the applicant
institution be supported by the NIDDK.

MECHANISM OF SUPPORT

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.

This RFA is a one-time solicitation.  The receipt of four competing
continuation applications is anticipated.  These applications will
compete for four awards along with other applications received in
response to this RFA.  The total project period for each application
submitted in response to the present RFA may not exceed five years.
The earliest possible award dates will be December 1995 for three
center grants and January 1996 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 a maximum of
$100,000 for a 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 at the National Center for Research Resources
or a Principal Investigator must be included with the application.

FUNDS AVAILABLE

For FY 1996, up to $3,265,000 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.

RESEARCH OBJECTIVES

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 and 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 Center 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
biostatistics 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.

SPECIAL REQUIREMENTS

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.

STUDY POPULATIONS

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 is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 9, 1994 (FR 59 11146-11151) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.

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

LETTER OF INTENT

Prospective applicants are asked to submit, by October 18, 1994, 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

APPLICATION PROCEDURES

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 Information,
Division of Research Grants, National Institutes of Health, 5333
Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301)
435-0714.

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 15, 1994.  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.

REVIEW CONSIDERATIONS

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 to return the application to the applicant or submit it for
review in competition with unsolicited applications at the next
review cycle.

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.

The most important component of a DDRCC is an ongoing, strong base of
digestive disease-related research.  Specific review criteria for
Digestive Diseases Core Centers are:

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 award.)

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 all applications, four P/F studies should be submitted for
evaluation as part of the review of the P/F program.  In general for
new applications, the proposed P/F projects will be examined to
assess the eligibility of the P/F applicant and the adequacy of the
selection process by which the individual studies were selected.
Applicants should refer to the Administrative Guidelines for DDRCCs
for specific details regarding the P/F program and its review by the
IRG.

o  The Named New Investigator, if requested, will be considered
separately.

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 program.

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.

(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
Center.

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  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 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 requested Direct Costs
are limited to $700,000 (including the P/F program).  For competing
continuation application, total requested Direct Costs should not
exceed the $700,000 cap or be 10% greater that the amount recommended
in the last funding period, whichever is lower.

Also in competing continuation applications, consideration must be
taken for reductions instituted in FY 87 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.  Applicants should address how
these cuts affected their Center.

AWARD CRITERIA

The anticipated date of award is December 1995 for three center
grants and January 1996 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.

INQUIRIES

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 to:

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
FAX:  (301) 594-7504

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
FAX:  (301) 594-7594

Schedule

Letter of Intent Receipt Date:  October 18, 1994
Application Receipt Date:       November 15, 1994
Initial Review:                 March 1995
Second Level Review:            May 1995
Anticipated Date of Awards:     December 1995 and January 1996

AUTHORITY AND REGULATIONS

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.

The Public Health Service (PHS) strongly encourages all grant
recipients to provide a smoke-free workplace and promote the non-use
of all tobacco products.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American
people.

.

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