Release Date:  September 10, 2001

RFA:  RFA-DK-02-004

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  February 19, 2002
Application Receipt Date:       March 19, 2002


The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
invites applications for Diabetes Endocrinology Research Center (DERC) grants 
to support research on diabetes mellitus and its complications, and related 
areas of endocrinology and metabolism.  The NIDDK anticipates the award of 
three or four DERCs from applications submitted in response to this 
DERCs 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. DERCs 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; a Pilot and Feasibility 
Program; and an Enrichment Program.  

A separate RFA, DK-02-005, is being issued simultaneously inviting 
applications for Diabetes Research and Training Center (DRTC) grant awards.  
DRTCs also support Research Cores, a Pilot and Feasibility Program and an 
Enrichment Program.  In addition to the requirements for a DERC, DRTCs must 
have a substantial base of research on translation of research advances into 
clinical practice and must request substantial support for cores and pilot 
and feasibility projects directed at translational research for the 
prevention and control of diabetes.  

Institutions cannot apply for both a DERC under this RFA and a DRTC under RFA 
DK-02-005.  Since an application for DRTC support includes all the elements 
of a DERC, applicants responding to DK-02-005 will be given priority scores 
for both the DRTC and the subset of DRTC components required for a DERC.  
Applications that are not competitive for a DRTC award will also be 
considered for a DERC award under RFA DK02-004 based on the scientific merit 
of the components of the DRTC application that are also components of the 
DERC application.     


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 investigators.

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 competition.


This RFA will use the National Institutes of Health (NIH) core centers grant 
(P30) award mechanism.  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 application.  

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 three P30 centers is anticipated.  
These applications will compete for the three to four 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 $1,000,000 in direct costs for the DERC 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, 
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 
September, 2002.


The NIDDK intends to commit up to $5 million in FY 2002 to fund three to four 
new and/or competing continuation P30s 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 $1.0 million 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) 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 
provide a focus for enhancing such collaborations among investigators at 
institutions with an established, comprehensive, federally supported diabetes 
research base.   DERCs 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 
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 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.  DERC applications require an existing 
program of excellence in biomedical research in the area of diabetes and 
related areas of metabolism and endocrinology.  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.  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 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 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.   

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.  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 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 also support a pilot and feasibility program.  The pilot and 
feasibility program provides modest support (up to $50,000 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.  
DERCs should include pilot and feasibility projects directed at basic 
biomedical and/or clinical research relevant to diabetes and its 

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


For DERC applications an existing program of excellence of biomedical 
research in the area of diabetes and related endocrinology and metabolism 
research is required.  DERC applications require a substantial research base, 
consisting of NIH and other peer-reviewed funded research projects, 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).

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 

The DERC provides 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 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 
a complete copy of the updated Guidelines are available at 
https://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.


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 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 investigators proposing research involving human subjects should read the 
policy that was published in the NIH Guide for Grants an Contracts, June 5, 
2000 (Revised August 25, 2000), and is available at the following URL address 


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.


The Office of Management and Budget (OMB) Circular A-110 has been  revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances. Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA. It is important for applicants to understand the basic scope of 
this amendment. NIH has provided guidance at: 

Applicants may wish to place data collected under this RFA (PA) in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time. If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.


Prospective applicants are asked to submit, by February 19, 2002, 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. 752 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. 5/01) 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. 5/2001) application form must be 
affixed to the bottom of the face page of the application.  Type the RFA 
number on the label.  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. The RFA label is also available at: 

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 

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 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 Administrator.  

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 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 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

The goals of the DERCs 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.  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, weighing them as appropriate for each 
application.   The most important component of the DERCs 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 

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 collaborations.

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 technologies? 

(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 

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 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 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 program.
Institutional commitment to the program, including lines of accountability 
regarding management of the DERC grant and a commitment  to establish new 
positions as necessary.

o  Although the DERCs 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 considered.
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 

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:    February 19, 2002
Application Receipt Date:         March 19, 2002
Peer Review Date:                 July, 2002
Council Review:                   September, 2002
Earliest Anticipated Start Date:  September, 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
National Institute of Diabetes and Digestive and Kidney 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 
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 636 MSC 5460
Bethesda, MD  20892-5460
Telephone:  (301) 594-0417 
FAX:  (301) 480-3504
E-mail:  kk27g@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 people.

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