Release Date:  February 22, 2001

RFA:  RFA-DK-01-001

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  May 10, 2001
Application Receipt Date:       June 12, 2001


The National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK) invites applications for Diabetes Research Center Grants to 
support research on diabetes mellitus and its complications, and 
related areas of endocrinology and metabolism.  The NIDDK anticipates 
the award of two Diabetes Endocrinology Research Centers (DERCs) and 
one Diabetes Research and Training Center (DRTC) from applications 
submitted in response to this solicitation.
Both DERCs and DRTCs are intended to facilitate progress in research 
with the goal of developing new methods to treat, prevent and 
ultimately cure diabetes mellitus and its complications. Both DERCs and 
DTRCs support research cores that provide shared resources to enhance 
the efficiency of biomedical research and foster collaborations within 
and among institutions with established, comprehensive bases of 
research relevant to diabetes mellitus.  Both types of center also 
support a Pilot and Feasibility Program and an Enrichment Program.  

The following additional requirements for DRTCs should be noted.  DRTCs 
must request substantial support for cores and pilot and feasibility 
projects directed at prevention and control of diabetes.  The cores and 
pilot and feasibility projects directed at prevention and control of 
diabetes should focus on translation of research advances into clinical 
practice.  This includes the identification of barriers to widespread 
adoption of new science and the development and testing of 
interventions to overcome these barriers under real world conditions.  
Applicants are encouraged to focus on underserved populations 
disproportionately affected by diabetes in the cores and pilot and 
feasibility projects directed at prevention and control of diabetes.   
All other features of the two grant mechanisms are identical.


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.  This Request for 
Applications (RFA), Diabetes Research Centers, is related to the 
priority area of chronic diseases.  Potential applicants may obtain a 
copy of "Healthy People 2010" at http://www.health.gov/healthypeople/.


Applications may be submitted by domestic nonprofit 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 center grants.  Racial/ethnic minority individuals, women, 
and persons with disabilities are encouraged to apply as principal 

Applicant institutions must have a strong existing base of high quality 
basic and/or clinical research relevant to diabetes mellitus, including 
substantial diabetes research support awarded through peer reviewed 


This RFA will use the National Institutes of Health (NIH) core centers 
grant (P30 DERC and P60 DRTC) award mechanisms.  Responsibility for the 
planning, direction, and execution of the proposed project will be 
solely that of the applicant.  

Applicants from institutions which 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 

This RFA is a one-time solicitation.  The NIDDK accepts P30 and P60 
applications only when submitted in response to an RFA.  The receipt of 
competing continuation applications from two P30 DERC centers and one 
P60 DRTC center is anticipated.  These applications will compete for 
the three anticipated awards along with other applications received in 
response to this RFA.   

The total requested project period for applications submitted in 
response to this RFA may not exceed five years.  The maximum dollar 
request in any budget period is limited to $1,250,000 in direct costs 
for DRTC (P60) and $1,000,000 in direct costs for DERC (P30) 
applications with the following exceptions.  Not included in these 
direct cost limits are: 1) requests for equipment in the first year of 
a competitive award; 2) direct costs on subcontracts for the purpose of 
establishing collaborations and providing access to the research 
infrastructure to investigators at historically black colleges and 
universities (HBCU’s), health departments, community health centers or 
other agencies that focus on underserved populations and offer special 
opportunities to foster research to reduce or eliminate health 
disparities in populations disproportionately affected by diabetes; and 
3) Facilities and Administrative (F&A) Costs associated with any 
subcontract. Approximately 20-25% of the direct costs requested in P30 
and P60 applications, exclusive of equipment, should be for support of 
a Pilot and Feasibility program.  Future budget period escalations may 
not exceed a 3 percent increase over the previous budget period. The 
anticipated award date is 04/01/02.


The NIDDK intends to commit approximately $4.5 million in FY 2002 to 
fund two new and/or competing continuation P30s and one new or 
competing continuation P60 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 $1.25 million (P60) or $1.0 million (P30) per year, excluding 
F&A costs on consortium arrangements, first year equipment and direct 
and F&A costs on subcontracts directed at underserved populations.  
Because the nature and scope of the research proposed may vary, it is 
anticipated that the size of each award will also vary. 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.  


The Diabetes Endocrinology Research Centers (DERCs) and Diabetes 
Research and Training Centers (DRTCs) are part of an integrated program 
of support provided by the NIDDK for research in diabetes and related 
areas of endocrinology and metabolism.  Development of new methods to 
prevent, treat or cure diabetes and its complications will depend on 
multidisciplinary collaborations among clinical and basic scientists.  
DERCs and DRTCs provide a focus for enhancing such collaborations among 
investigators at institutions with an established, comprehensive, 
federally supported diabetes research base.   DERCs and DRTCs are 
intended to improve the quality and multidisciplinary nature of 
diabetes research by providing shared access to specialized technical 
resources and expertise.  The overall goal of the DERC or DRTC is to 
bring together clinical and basic science investigators, from relevant 
disciplines, in a manner that will enhance and extend the effectiveness 
of research related to diabetes and its complications.   

A DERC or DRTC must be an identifiable unit within a single institution 
such as a university medical center or a consortium of cooperating 
institutions, including an affiliated university.  Both DERC and DRTC 
applications require an existing program of excellence in biomedical 
research in the area of diabetes and related areas of metabolism and 
endocrinology.  In addition to the DERC requirements, DRTC applications 
also require an existing program of excellence in translational 
research directed at prevention and control of diabetes.  This research 
should be in the form of NIH-funded research projects, program 
projects, or other peer-reviewed research that is in existence at the 
time of submission of a center application.  Close cooperation, 
communication, and collaboration among all involved personnel of all 
professional disciplines are essential to the success of a DERC or 
DRTC.  Accordingly, the applicant must clearly state the considerations 
for center membership.  It is also appropriate and beneficial to define 
one or more central themes around which DERC or DRTC investigators are 

Diabetes research involves many specialized technologies and other 
resources, which must be integrated into a cohesive research program.  
The objectives of the DERC and DRTC are to make these technologies and 
resources available to many investigators and to promote a multifaceted 
approach to diabetes research by providing shared resources to 
investigators with a wide variety of expertise.  These centers are 
based on the core concept.  Cores are defined as shared specialized 
technical resources and/or expertise that enhance efficiency, 
productivity, multi-disciplinary collaboration, or in other ways 
benefit a group of investigators working in diabetes or diabetes-
related areas to accomplish the stated goals of the center.   

For both DERC and DRTC applications, examples of possible biomedical 
core resources that would be considered responsive to this Request for 
Applications include: molecular biology, islet isolation, cell and 
tissue culture, transgenic, animal models, genetics, gene transfer, 
immunology, protein chemistry and macromolecular structure, analytical 
biochemistry, cytohistochemistry, protein expression, metabolism, mass 
spectrometry, immunoassay, morphology and image analysis, monoclonal 
antibody/hybridoma, computer resource, bioinformatics, biostatistics, 
and clinical research.  In addition to the biomedical core resources 
common to DERCs an DRTCs, DRTCs must propose specialized cores to 
develop and provide tools and technologies for intervention, 
measurement and evaluation to support an ongoing translation research.  
Such cores could provide access to telemedicine, behavioral or 
psychological assessment, nutrition or physical fitness assessment, 
patient identification and characterization, expertise and techniques 
for developing and conducting interventions, data management, study 
design and analysis, and other cores to support population based 
multidisciplinary research.  These possible cores are not listed in any 
particular order nor do they represent a comprehensive list of cores 
that could be supported under this Request for Applications.  
Applicants are encouraged to propose other cores that address the 
program objectives as stated above, based on the requirements of the 
investigators at the applicant institution.  

In addition to biomedical cores, DERC and DRTC applications must 
include an administrative core that will be responsible for allocation 
of resources within the Center and distribution of resources to Center 
participants.  The Administrative core will also be responsible for 
planning an enrichment program and convening a committee to oversee the 
solicitation, review and selection of the pilot projects.  

The DERCs and DRTCs also support a pilot and feasibility program.  The 
pilot and feasibility program provides modest support (up to $100,000 
direct costs per year for up to two years for each project) for new 
diabetes initiatives or feasibility studies. This program is directed 
at new investigators or established investigators in other research 
disciplines whose expertise may be applied to diabetes research.  
Established diabetes investigators exploring a new research direction 
related to diabetes are also eligible, but the great majority of Pilot 
and Feasibility project support should be directed at new investigators 
or investigators new to diabetes research.  Both DERCs and DRTCs should 
include pilot and feasibility projects directed at basic biomedical or 
clinical research relevant to diabetes and its complications.  In 
addition, DRTCs should propose one or more pilot and feasibility 
projects directed at translational research, such as studies of 
interventions in health care settings and communities.  These pilot and 
feasibility projects may subsequently be extended as R18s (See TPA-01-

Both DERCs and DRTCs may also include limited funds for an enrichment 
program to facilitate the exchange of information between investigators 
who have research interests in the areas of diabetes, endocrinology and 
metabolism.  The enrichment program can support activities such as 
seminars, guest speakers, visiting scientists, consultants, and 
workshops.  Although funds are not provided directly for training 
purposes, applicants may wish to describe how the core laboratories and 
program enrichment activities will provide training opportunities for 
center members.

DERC and DRTC applicants are encouraged to consult with NIDDK staff 
concerning plans for the development of a Diabetes Research Center and 
to request the NIDDK Administrative Guidelines for preparing a Diabetes 
Research Center application (See Application Procedures.)


For both DERC and DRTC applications an existing program of excellence 
of biomedical research in the area of diabetes and related 
endocrinology and metabolism research is required.  In addition to 
these requirements common to both mechanisms, applicants for DRTCs 
should also have an existing program of excellence in translational 
research relevant to diabetes and its complications.  For both DERC and 
DRTC applications a substantial research base, consisting of NIH and 
other peer-reviewed funded research projects, is required to justify 
the requested Center support.  Suggestions for describing and 
presenting this research base in the application are included in the 
Administrative Guidelines for NIDDK Diabetes Research Centers (See 
Application Procedures).

For both DERC and DRTC applications the proposed budget should include 
travel for the Principal Investigator and the Associate Director, or 
another key personnel, for an annual one-day meeting in Bethesda.  The 
application should include a statement of willingness to attend an 
annual meeting of Diabetes Research Center Directors.   

The DERC and DRTC grants provide support for enrichment activities to 
foster multi-disciplinary approaches to diabetes research and to 
attract new investigators or investigators with relevant expertise to 
diabetes research.  While many of these activities occur at the grantee 
institution, applicants are encouraged to suggest coordinated efforts, 
such as educational activities, that might involve multiple Diabetes 
Research Centers.  The application should include a statement regarding 
willingness to participate in such activities.  


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 

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 
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a 
complete copy of the updated Guidelines are available at 
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.


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: 

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


Prospective applicants are asked to submit, by May 10, 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 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 plan the review.

The letter of intent is to be sent to:

Chief, Review Branch 
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 653 MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone:  (301) 594-8885
FAX:  (301) 480-3505


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.

Applicants should request a copy of Administrative Guidelines for NIDDK 
Diabetes Research Centers.  These guidelines contain important 
additional suggestions and information on the format, content, and 
review of applications and review criteria.  Prospective applicants may 
obtain guidelines from staff listed under INQUIRIES or at 

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 
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, 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 must be 
sent to:

Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 653 MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)

Applications must be received by the application receipt date listed in 
the heading of the RFA.  If an application is received after that date, 
it will be returned to the applicant without review. Supplemental 
documents containing significant revision or additions will not be 
accepted, unless applicants are notified by the Scientific 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.


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 

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 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 

Review Criteria

The goals of the DERCs and DRTCs are to advance our understanding of 
biological systems relevant to diabetes and its complications, and to 
facilitate development of new methods to treat, prevent and ultimately 
cure diabetes and its complications.  DRTCs have the additional goal of 
improving the control and prevention of diabetes and its complications 
and enhancing health by facilitating translational research, 
particularly in underserved populations and populations 
disproportionately affected by diabetes.  In the written comments, 
reviewers will be asked to discuss the following aspects of the 
application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  Each of 
these criteria will be addressed and considered in assigning the 
overall score, weighting them as appropriate for each application.   
The most important component of both DERCs and DRTCs is the quality 
(strengths, breadth and depth) of its established, independently 
supported, ongoing base of diabetes research at the institution(s) to 
be served by the center.  For the DRTC this research base must include 
translational research in addition to the biomedical research base 
required for DERCs.

Specific review criteria are:
o   Scientific excellence of the Center's research base that must have 
a broad and central focus in diabetes and may extend to related 
research in metabolism and endocrinology.  The relevance of the 
separately funded research to the Center objectives (see above) and the 
likelihood for meaningful collaboration among Center investigators must 
be demonstrated.
o  Potential of the cores for contribution to ongoing research, 
including their appropriateness, impact, relevance, uniqueness, modes 
of operation, and suitability of facilities.  Renewal applications must 
document the use, impact, quality control, and cost effectiveness of 
each core, and demonstrate progress of any developmental research in 
the cores.  Progress will be judged in part by the publications 
supported by the cores.  While a minimum of two users (exclusive
of Pilot and Feasibility projects) are required to establish a core, a 
greater number of users will be considered to be more cost effective.
o  Scientific and administrative abilities of the Center Director and 
Associate Director and their commitment and ability to devote adequate 
time to the effective management of the  Diabetes Research Center.
o  The qualifications, experience, accomplishments, and commitment of 
the Center investigators and their inter-relatedness and 

o   For new applications, the pilot and feasibility program is judged 
on the basis of:  (1) scientific merit of the studies as submitted and 
(2) the merit of the administrative process for selecting subsequent 
studies.   The scientific merit of the submitted pilot and feasibility 
studies will be evaluated for:

(1) Significance:  Does this study address an important problem?  If 
the aims of the application are achieved, how will scientific knowledge 
be advanced?  What will be the effect of these studies on the concepts 
or methods that drive this field?

(2) Approach:  Are the conceptual framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the 
aims of the project?  Does the applicant acknowledge potential problem 
areas and consider alternative tactics?

(3) Innovation:  Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does the project 
challenge existing paradigms or develop new methodologies or 

(4) Investigator:  Is the investigator appropriately trained and well 
suited to carry out this work?  Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers 
(if any)?

(5) Environment:  Does the scientific environment in which the work 
will be done contribute to the probability of success?  Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements?  Is there 
evidence of institutional support?

In competing renewal applications, emphasis is placed on the pilot and 
feasibility program as a whole, including past track record and 
management of the program.
o   The Administrative organization proposed, including: coordination 
of ongoing research; establishment and maintenance of internal 
communication and cooperation among DERC or DRTC investigators; 
mechanisms for prioritizing usage of shares resources; mechanisms of 
selecting and replacing essential personnel within the Center; 
mechanisms for reviewing the use of and administering funds for the 
pilot and feasibility program, and management capabilities.
o   The appropriateness of the DERC or DRTC budgets for the proposed 
and approved work to be done in core facilities, for pilot and 
feasibility studies, and for enrichment in relation to the total Center 
o   Institutional commitment to the program, including lines of 
accountability regarding management of the DERC or DRTC grant and a 
commitment  to establish new positions as necessary.
o  Although the DERCs and DRTCs do not specifically support research 
training, demonstration of accomplishments and future plans related to 
the training of investigators necessary to conduct research in diabetes 
and related metabolic and endocrine disorders will be considered in 
assessing the potential to meet Center objectives.  The integration of 
these efforts into the overall Center, including core facilities is of 
particular importance.  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 will also be 
In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  Adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will 
also be evaluated.  

o  The reasonableness of the proposed budget and duration to the 
proposed research.

o  The adequacy of the proposed protection of humans, animals, or the 
environment, to the extent that they may be adversely affected by the 
project proposed in the application.

o The adequacy of the proposed plan to share data.  

Letter of Intent Receipt Date:    May 10, 2001
Application Receipt Date:         June 12, 2001
Peer Review Date:                 October, 2001
Council Review:                   February, 2002
Earliest Anticipated Start Date:  April 1, 2002


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.


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

Direct inquiries regarding programmatic issues to:

Judith Fradkin, M.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
6707 Democracy Boulevard, Rm. 689 MSC 5460
Bethesda, MD 20892-5460
Telephone:  (301) 594-8814
FAX:  (301) 480-3503
E-mail:  jf58s@nih.gov

Direct inquiries regarding fiscal matters to:

Kieran Kelley
Division of Extramural Activities 
6707 Democracy Boulevard, Rm. 636 MSC 5460
Bethesda, MD 20892-5460
Telephone:  (301) 594-0417 
FAX: (301) 480-3504
E-mail:  kelleyk@extra.niddk.nih.gov


This program is described in the Catalog of Federal Domestic Assistance 
No. 93.847.  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 

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