SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTERS

Release Date:  May 4, 1999

RFA:  DK-99-017

P.T.

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  October 15, 1999
Application Receipt Date:       November 16, 1999

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 (P30) in Fiscal Year 2001.

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
established, comprehensive digestive diseases research bases.

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 RFA, Silvio O. Conte Digestive Diseases
Research Core Centers, is related to the priority area of chronic disabling
conditions.  Potential applicants may obtain a copy of "Healthy People 2000"
(Full Report:  Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-
00473-1) through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone: 202-512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit
organizations, public or 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.  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,
R03, R21), program project grants (P01), any of the K-series of Career
Development Awards (K01, K02, K08, K23, K24, K25), cooperative agreements, and
contracts, or through other Federal agencies or non-federal groups.  It is
required that at least 50 percent of the digestive diseases-related research
being conducted at a new 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.  Awards will be administered under NIH
grants policy as stated in the NIH Grants Policy Statement.

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.  It is
anticipated that at least one of the awards issued will be for a center whose
primary area of research focus is the study of inflammatory bowel disease.

The total project period for each application submitted in response to the
present RFA may not exceed five years.  The earliest possible award date will be
December 2000. 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 3 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 principal investigator should
be included with the application.

FUNDS AVAILABLE

For FY 2001, up to $4 million will be committed to fund applications submitted
in response to this RFA.  It is anticipated that four awards will be made. 
However, this funding level is dependent upon the receipt of a sufficient number
of applications of high scientific merit. First-time applicants must limit their
requests to not more than $700,000 direct costs for the initial budget period.
Competing applicants must limit their requests to not more than a 10% increase
over their last year's awarded budget, or $700,000, whichever is less.  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.  Three to 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 a center to accomplish the stated goals of the
Center.  Examples of such resources include electron microscope, transgenic
animal, and membrane preparation 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 as a 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; foster
collaboration among researchers; aid in recruitment of subjects for clinical
studies; support 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 population 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 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.  Subsequent individuals for this slot will 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.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH supported biomedical and behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification 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 20, 1994
(FR 59 14508-14513), and reprinted in the NIH Guide For Grants and Contracts,
Volume 23, Number 11, March 18, 1994.

Investigators may also obtain copies from these sources or from the program staff
or contact person listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them.  This
policy applies to all initial (Type 1) applications submitted for receipt dates
after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for Grants
and Contracts, March 6, 1998, and is available at the following URL address:
https://grants.nih.gov/grants/guide/notice-files/not98-024.html.

LETTER OF INTENT

Prospective applicants are asked to submit, by October 15, 1999, 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 avoid conflict
of interest in the review.

The letter of intent is to be sent to:

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AS-37F, MSC 6600
Bethesda, MD  20892-6600
Telephone: (301) 594-8885
FAX:  (301) 480-3505

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in applying
for these grants.  These forms 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 301-710-0267, email:
GrantsInfo@nih.gov.

Administrative Guidelines for Silvio O. Conte Digestive Diseases Research Core
Centers may be requested from the NIDDK program staff listed under INQUIRIES
below or obtained on the internet at
http://www.niddk.nih.gov/fund/fund.htm.

The RFA label available in the PHS 398 (rev. 4/98) application form must be
affixed to the bottom of the face page of the application. Failure to use this
label could result in delayed processing of the application such that it may not
reach the review committee in time for review.  In addition, the 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.

Submit a signed, typewritten original of the application, including the
Checklist, plus 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 to:

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AS-37F, MSC 6600
Bethesda, MD  20892-6600

Applications must be received by November 16, 1999.  If an application is
received after that date, it will be returned to the applicant without review. 
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.

REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIDDK.  Applications that are complete and are 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 NIH peer review
procedures.  Applications will not be reviewed by a site visit team; therefore,
the written application must be complete to facilitate review without a site
visit.  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 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 most important component of a DDRCC is an ongoing, strong base of digestive
disease-related research.

Specific review criteria for Digestive Diseases Research 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 collaborations 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
Research 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
assessment of 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 by
the list of publications arising from the cores.  At least two users are required
to establish a core.  However, a greater number of users will be considered to
be 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 applications, total requested Direct Costs should not
exceed the $700,000 cap or be 10% greater than the amount recommended in the last
funding period, whichever is lower.

Also, for competing continuation applications, the budget reductions instituted
in accordance with NIDDK administrative policy are taken into consideration. 
Ongoing Center grants have incurred negotiated budget reductions averaging
approximately 10 to 20 percent per year in addition to the budget reductions
recommended by the Initial Review Group as indicated in the summary statements. 
The applicant should address how these reductions affected their Center.

As part of the scientific and technical merit evaluation of the research plan,
reviewers will be instructed to address the adequacy of plans for including
children as appropriate for the scientific goals of the research, or
justification for exclusion.

AWARD CRITERIA

The earliest anticipated date of award is December 2000/January 2001 for the four
centers.

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

Inquiries concerning this RFA are encouraged. The opportunity to clarify any
issues or questions from potential applicants is welcome. 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.  These are available at:
http://www.niddk.nih.gov/fund/fund.htm

Inquiries regarding programmatic issues and requests for the Administrative
Guidelines may be directed to:

Judith M. Podskalny, Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AN-12E, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8876
FAX:  (301) 480-8300
Email:  jp53s@nih.gov

Direct inquiries regarding fiscal matters to:

George Tucker, M.B.A
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AN-49B, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8853
FAX:  (301) 480-3504
Email:  tuckerg@extra.niddk.nih.gov

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 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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