SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTERS

Release Date:  February 2, 2001

RFA:  RFA-DK-01-027

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  June 29, 2001
Application Receipt Date:       July 26, 2001

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 two competitive 
Digestive Diseases Core Center Grants (P30) in fiscal year 2002.

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 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a 
PHS-led national activity for setting priority areas.  Potential 
applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople. 

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and nonprofit 
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

This RFA will use the National Institutes of Health (NIH) Center Core 
Grant (P30) award mechanism.  Responsibility for the planning, 
direction, and execution of the proposed center will be solely that of 
the applicant.  The total project period for an application submitted 
in response to this RFA may not exceed 5 years.  This RFA is a one-time 
solicitation.  The receipt of one competing continuation application is 
anticipated.  This application will compete for two awards along with 
other applications received in response to this RFA.   

The earliest possible award date will be June 2002. Applicants must 
limit their requests to no 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 three 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. In such a case, a letter of agreement from either the GCRC 
program director or principal investigator should be included with the 
application. 

FUNDS AVAILABLE

For FY 2002, up to $2 million will be committed to fund applications 
submitted in response to this RFA. It is anticipated that one or two 
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 years 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 imaging resources, 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, children, 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 initial review group will determine 
the significance of the research base.

Center Principal Investigators are required, and their administrators 
encouraged, to attend a once a year meeting to be held at a location to 
be determined by the NIDDK.  Funds for travel to this meeting should be 
included in the budget for the Administrative Core of the Center.

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 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 Contract on August 2, 2000 
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines is available at 
https://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  
The revisions relate tot 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.

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 

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

URLS in NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained 
within specified page limitations.  Unless otherwise specified in an 
NIH solicitation, Internet addresses (URLs) should not be used to 
provide information necessary to the review because reviewers are under 
no obligation to view the Internet sites.  Reviewers are cautioned that 
their anonymity may be compromised when they directly access an 
Internet site.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that 
includes a descriptive title of the proposed research, the name, 
address, 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 is 
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 Institute staff to 
estimate the potential review workload and plan the review.

The letter of intent is to be sent to the program staff listed under 
INQUIRIES by the letter of intent receipt date listed.

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 Grants Information Office, Division of Extramural Outreach and 
Information Resources, National Institutes of Health, 6701 Rockledge 
Drive, Suite 6095, 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/other/centers/ddrcguidetoc.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 your 
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.

The sample RFA label available at: 
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf 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, 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, NIDDK
6707 Democracy Blvd., MSC 5452
Bethesda, MD 20892-5452

Applications must be received by the application receipt date listed in 
the heading of this RFA. 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.  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 the review 
criteria stated below. As part of the initial merit review, all 
applications will receive a written critique, be 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. 

Schedule

Letter of Intent Receipt Date:    June 29, 2001
Application Receipt Date:         July 26, 2001
Peer Review Date:                 October/November 2001
Council Review:                   January, 2002
Earliest Anticipated Start Date:  June, 2002

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o scientific merit (as determined by peer review)
o availability of funds
o programmatic priorities
o geographic distribution.

INQUIRIES

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

Direct inquiries regarding programmatic issues and requests for the 
Administrative Guidelines to:

Judith M. Podskalny, Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., MSC 5450
Bethesda MD  20892-5450
Telephone:  (301) 594-8876
FAX:  (301) 480-8300
Email:  jp53s@nih.gov  

Direct inquiries regarding review issues to:

Francisco Calvo, Ph.D.
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., MSC 5452
Bethesda MD  20892-5452
Telephone:  (301) 594-8897
FAX:  (301) 480-3505
Email: fc15y@nih.gov

Direct inquiries regarding fiscal matters to:

Teresa Farris
Grants Management Branch, Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., MSC 5456
Bethesda MD  20892-5456
Telephone:  (301) 594-7682
FAX:  (301) 480-3504
Email:  tf102y@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance 
No. 93.3848.  Awards are made under authorization of Sections 301 and 
405 of the Public Health Service Act as amended (USC 241 and 284) and 
administered under NIH grants policies and Federal Regulations 42 CFR 
52 and 45 CFR Parts 74 and 92.  This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review.

The PHS strongly encourages all grant 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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