DIGESTIVE DISEASES RESEARCH DEVELOPMENT CENTERS

Release Date:  April 26, 2001

RFA:  RFA-DK-01-030 (November 27, 2006 (RFA-DK-06-018) - 
This RFA has been reissued as RFA-DK-06-018. 

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  September 26, 2001
Application Receipt Date:       October 29, 2001

PURPOSE

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
invites applications for Digestive Diseases Research Development Centers 
(DDRDCs).  These Research Development Centers will support shared research 
resources, or cores, to be used by groups of NIDDK-funded investigators pursuing 
research that can be enhanced by the use of those shared resources, but who do 
not currently have access to a  Silvio O. Conte Digestive Diseases Research Core 
Center.  DDRDCs will enhance capabilities for conducting basic, clinical, and/or 
translational digestive diseases research relevant to the mission of the 
Division of Digestive Diseases and Nutrition (DDDN), NIDDK.  The major purpose 
of this initiative is to increase the availability of core resources, with the 
goal of fostering research, collaborations, and new directions in digestive and 
liver disease research.

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 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.  Foreign institutions are not eligible for resource-related 
research project (R24) grants.  Racial/ethnic minority individuals, women, and 
persons with disabilities are encouraged to apply as DDRDC Directors and/or 
core directors.

Each application for a DDRDC must propose to serve a minimum of six NIH Research 
Project (R01), Exploratory/Development (R21), MERIT (R37), and/or Program 
Project (P01) grants, with no less than 10 grant-years collectively remaining in 
the council-recommended project periods of those grants at the time of the start 
date for the DDRDC. A minimum of three of these grants must be supported by the 
NIDDK. This cohort of funded grants will be known collectively as the 
‘base grants’ for the DDRDC. Every grant counted in the base must have more than 
one year remaining in the council-recommended project period at the requested 
start date for the DDRDC.  No other mechanism or source of support will be 
considered in determining eligibility.  While only three NIDDK grants are 
required, it is anticipated that the composition of the base grant portfolio 
will strongly influence funding decisions by the NIDDK.

Only one DDRDC will be awarded to any single applicant organization.  Principal 
Investigators of the base grants, however, may be located at several affiliated, 
or closely aligned, institutions provided a clear plan of operation is provided 
describing administration structure and current interactions among the 
investigators.  Each NIDDK base grant may only serve that purpose for one DDRDC.  
If well justified, supported core activities and core-related research may be 
located at sites and institutions other than that/those of the base grants and 
the DDRDC.  This could be justified, for example, when the applicant institution 
is located in close proximity to a research institution with a well-established 
gnotobiotic animal facility, when it would not be logical or cost effective to 
duplicate the facility at the DDRDC institution.

Each DDRDC will support one to three cores.  Each core must be used by at least 
three of the base grants, and, in general, should serve as many base grants 
as possible.

Direct costs requested on each DDRDC application may not exceed 25 percent of 
the annual direct costs awarded to the base grants at the anticipated start date 
for the DDRDC.  Maximum allowable direct costs may not exceed $350,000 per year.

MECHANISM OF SUPPORT

DDRDCs will be supported by the resource-related research project grant (R24) 
mechanism.  Each of the cores comprising a DDRDC should provide services, 
equipment, and/or other research resources to the base grants.  Research related 
to the cores, in turn, will enhance the capabilities of those cores.  The 
coordinated use of shared resources should increase the efficiency of digestive 
diseases research, facilitate the use of new technologies and the pursuit of new 
lines of investigation, and promote interdisciplinary and collaborative research.  
Up to five years of support may be requested.

DDRDCs will be eligible for one competing renewal, making 10 years the maximum 
support period for a DDRDC.  Former DDRDCs may apply, after a hiatus of at least 
two years, and in response to a Request for Applications, for a new DDRDC.  
Alternatively, former DDRDC awardees may wish to compete for a Silvio O. Conte 
Digestive Diseases Research Core Center (P30) grant.  The latter compete for 
funding in response to periodic Requests for Applications.

This RFA is a one-time solicitation.  The anticipated award date is 
December, 2002.

FUNDS AVAILABLE

The NIDDK will commit $1.5 million in FY 2003 to fund 3 to 5 new R24 grants in 
response to this RFA. An applicant may request a project period of up to 5 years 
and a budget for direct costs of up to $350,000 per year, excluding facilities 
and administrative (F&A) costs on consortium arrangements.  Although the 
financial plans of the NIDDK provide support for this program, awards pursuant 
to this RFA are contingent upon the availability of funds and the receipt of a 
sufficient number of applications of outstanding scientific and technical merit.

RESEARCH OBJECTIVES

Background

The NIDDK recognizes that a critical mass of funded investigators is needed to 
provide the research base for a large core grant, such as a Silvio O. Conte 
Digestive Diseases Research Core Center, but that many sites around the country 
support smaller groups of NIDDK-funded investigators whose research would be 
enhanced, and could be extended, by the existence of shared core facilities. The 
DDRDC award is designed to allow groups of investigators already engaged in 
common thematic areas of digestive diseases research to benefit from shared 
research resources on a smaller scale than our P30 centers program.  The use of 
such shared resources is expected to increase efficiency and cost-effectiveness 
by eliminating unnecessary duplication of effort and by supporting resources 
(e.g., costly equipment) that might be needed by, but not fully utilized by, any 
one research grant or investigator.

Objectives and Scope

The primary purpose of each DDRDC is to support shared research resources to 
enhance the capabilities of NIDDK-supported investigators who are pursuing 
research in areas of interest to the DDDN. A DDRDC will support cores and 
core-related research representing shared research resources and activities that 
can include services (e.g., cell isolations, patient recruitment, statistical 
support), equipment (e.g., confocal microscope, scanning electron microscope), 
or other resources (e.g., use of transgenic facilities, access to batch 
preparation of reagents, clinical research resources).  The DDRDC must benefit 
the base grants that it serves and should increase efficiency, promote new 
research directions, and foster interactions and collaborations among the base 
grant researchers.

Cores can also promote new research directions and innovative uses of technology 
by providing access to techniques, equipment, services, and expertise that might 
not otherwise be available.  DDRDC cores may not be used to fund pilot projects, 
per se, but can help investigators validate novel hypotheses and generate 
sufficient preliminary data for the submission of a research project grant. It 
is anticipated that the proper use and management of the cores in the DDRDC will 
promote interactions, collaborations, and new projects that will in turn advance 
the field of digestive diseases research.

Cores may also be used judiciously by investigators not directly supported by 
base grants, as long as the core usage provides opportunities for new 
investigators, for minority investigators, and for investigators wishing to 
become involved in the research base of the DDRDC.

The proposed Director of the DDRDC must have a demonstrated ability to organize, 
administer, and direct the DDRDC, must be the Principal Investigator on one of 
the base grants, and may also serve as the head of a core.

Research Topics

The following are examples of the research supported by the NIDDK which would be 
eligible to apply for DDRDCs: pediatric liver disease, pediatric 
gastroenterology, celiac disease, inflammatory bowel disease, motility 
disorders/irritable bowel syndrome, diarrheal diseases, pancreatitis/pancreatic 
disease, peptic ulcer disease/Helicobacter pylori, gene therapy of liver or 
digestive disorders, gastroesophageal reflux disease/Barrett’s esophagus, and 
gastrointestinal aspects of AIDS. This list is neither inclusive, nor exclusive, 
and consultation with program staff is advisable to determine the programmatic 
suitability of a research focus for a DDRDC.

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 are provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research.  This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

All investigators proposing research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on August 
2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender and/or 
racial/ethnic groups, including subgroups if applicable, and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

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: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained. 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, by September 26, 2001, a letter of 
intent that includes a descriptive title of the proposed research, the name, 
address, and telephone number of the Principal Investigator, the identities of 
other key personnel and participating institutions, and the number and title of 
this RFA-DK-01-030.

Although a letter of intent is not required, is not binding, and does not enter 
into the review of a subsequent application, the information that it contains 
allows NIDDK staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent or e-mailed to:

Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD  20892-5452
(for express/courier service:  Bethesda, MD  20817)
Telephone:  (301) 594-8885
FAX:  (301) 480-3505
E-mail:  fc15y@nih.gov

APPLICATION PROCEDURES

Applicants are strongly encouraged to call NIDDK program staff with any 
questions regarding the responsiveness of their proposed application to the 
goals of this RFA.

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) and will be accepted only on or before the receipt date for this RFA, 
October 29, 2001. Application kits 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) 435-0714, 
fax:  (301) 480-0525 Email:  . The application is also 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html

The title and number of this RFA, DK-01-030, must be typed in Section 2 on the 
face page of the application.

The DDRDCs are intended to enhance the capabilities of NIDDK-supported 
investigators to pursue digestive diseases research.  The manner in which the 
proposed DDRDC will do this must be evident from the information provided in the 
application.  The following sections should replace the Specific Aims, 
Background and Significance, Preliminary Studies/Progress Report, and the 
Research Design and Methods sections of the traditional Research Plan in form 
PHS 398 (Rev. 4/98):

o  General Description of the Base Grants. Each base grant should be described 
in no more than two pages, one page is preferred. The following must be provided 
for each base grant:  the grant number, title, name of the PI, grantee 
organization, the project period end date, and the direct cost budget for the 
year on which the budget of the DDRDC application is based. In addition, the 
single page per grant must include a description providing an overview of the 
research goals and approaches used in the grant and the manner in which the 
DDRDC award will enhance, complement, or expedite the research activities of the 
research supported by the base grant.

In addition, the specific ways in which the DDRDC will increase efficiency, 
promote new research directions, and foster collaborations should be described 
in the context of all the base grants in another section, not to exceed 4 pages.

o  Core Descriptions.  These should not exceed 5 pages for any one core and 
should detail the purpose of the core, any anticipated core-related research, 
including the manner in which the research is expected to enhance the 
capabilities of the core, and must clearly delineate the space, facilities, 
resources, services, technical and professional expertise and support that the 
core will provide. If a fee-for-service is anticipated, this must be described.

The specific manner in which each core will relate to base grants must also be 
described as well as how each base grant will benefit from the core. For each 
core, describe the degree of use by the relevant base grants, and the 
investigators supported by the base grants, keeping in mind that each core must 
be used by at least three of the base grants. It is not sufficient for a single 
investigator, holding three grants, to be the sole user of a core.  Also, 
describe any anticipated use of the core facility by non-base grant 
investigators and the rationale for and extent of such use, if appropriate.

o  Operational Plan.  This should not exceed the equivalent of 2 pages per core, 
and may be included as a sub-section of each of the core descriptions, or as an 
overarching plan for the operation of the DDRDC.  The operational plan should 
describe arrangements required to manage the DDRDC, including the manner in 
which priority for core access and use is determined, the operational and 
administrative role of the director of each core, and plans for upgrades, 
enhancements, and modifications of core offerings as well as the plans for 
quality control.  Any committee structure developed for managing the center 
should be described here, also.

In exceptional circumstances, a core may be located at a site other than that of 
the DDRDC.  For those applications proposing an offsite core, clear 
justification for this arrangement must be included.

Budget

The maximum direct costs requested may not exceed 25% of the direct costs for 
the base grants for the year in which the DDRDC would begin, up to a maximum of 
$350,000 per year in direct costs.  The requested budget should include the 
costs of travel for the DDRDC Director to attend the yearly Digestive Diseases 
Centers Directors’ meeting in the budget.

Other

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 title of this 
RFA (Digestive Diseases Research Development Centers) and number (DK-01-030) 
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 and appendices, and three signed photocopies, in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

At time of submission, two additional copies of the application and appendices 
must be sent to:

Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD  20892-5452
(for express/courier service:  Bethesda, MD  20817)

Applications must be received by October 29, 2001.  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 
also 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.

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 this 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 and 
undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, will 
be discussed, assigned a priority score, and receive a second level review by 
the National Diabetes and Digestive and Kidney Diseases Advisory Council.

Review Criteria

Criteria for scientific/technical review of DDRDC grant applications will 
include the following:

o  Approach:  Is the research development center grant approach appropriate?  
The need for and suitability of the DDRDC approach will be assessed as well as 
whether this support will significantly enhance the capabilities of base grant 
investigators to pursue digestive diseases research. In addition, the likelihood 
that the DDRDC will increase efficiency, promote new research directions, 
facilitate interactions and collaborations among DK-funded investigators, and 
prove cost-effective will be evaluated.

o  Innovation:  Is it likely that the proposed resources, in support of the base 
grants, will lead to fundamental advances within the field, to new discoveries, 
and/or to new technological, clinical, or scientific developments? The overall 
quality, scientific merit, and suitability of the activities to be supported as 
well as the likelihood that the cores will significantly enhance the research of 
the individual investigators will be evaluated.

o Investigators:  The capability and scientific credentials of the Director of 
the DDRDC, the core directors, and other participating investigators will 
be assessed.

o  Significance:  Will the existence of the DDRDC grant significantly enhance 
the funded research, provide opportunities not otherwise available to the 
investigators, represent an appropriate cost savings/cost sharing advantage, and 
stimulate the development of new approaches? Are the operational plans and core 
structure appropriate? Is the organizational and administrative structure, 
oversight, and contingency plans for the management of the DDRDC adequate?

o Environment:  What is the nature and level of resource commitment from the 
applicant institution and from any other participating institutions? Do the 
proposed cores appear to complement or to enhance what is already available at 
the institution?

The initial review group will also examine: the appropriateness of proposed 
project budget and duration. For applications requesting support for cores 
dealing with human subjects or animals, the initial review group will examine:  
the adequacy of plans to include both genders, minorities and their subgroups, 
and children, plans for the recruitment and retention of subjects, the 
provisions for the protection of human and animal subjects, and the safety of 
the research environment.

The initial review group will make an overall recommendation to score (by 
assigning a priority score) or not to score the entire DDRDC application.  Under 
some circumstances, it may be appropriate for the initial review group to 
recommend that one or more core(s) not be recommended for further consideration.

Schedule
Letter of Intent Receipt Date:    September 26, 2001
Application Receipt Date:         October 29, 2001
Peer Review Date:                 March, 2002
Council Review:                   May, 2002
Earliest Anticipated Start Date:  December, 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 or review issues to:

Judith Podskalny, Ph.D.
Division of Digestive Diseases and Nutrition
NIDDK
6707 Democracy Boulevard, Rm. 667 MSC 5450
Bethesda, MD  20892-5450
Telephone:  (301) 594-8876
FAX:  (301) 480-8300
E-mail:  jp53s@nih.gov

Direct inquiries regarding fiscal matters to:

Teresa Farris
Division of Extramural Activities
NIDDK
6707 Democracy Boulevard, Rm. 728 MSC 5456
Bethesda, MD  20892-5456
Telephone:  (301) 594-7682
FAX:  (301) 480-3504
E-mail:  tf102y@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.848. Awards are under authorization of the Public Health Service Act, Title 
IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 
285) and administered under NIH grants policies and Federal Regulations 42 CFR 
52 and 45 CFR Parts 74 and 92.  This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health Systems 
Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care or early childhood 
development services are provided to children.   This is consistent with the PHS 
mission to protect and advance the physical and mental health of the 
American people.



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