DIABETES ENDOCRINOLOGY RESEARCH CENTERS
 
RELEASE DATE:  February 12, 2004
 
RFA Number:  RFA-DK-04-007 (This RFA has been renewed, see RFA-DK-06-012
and RFA-DK-06-014)

EXPIRATION DATE:  July 14, 2004, unless reissued.

Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.847
 
LETTER OF INTENT RECEIPT DATE: June 15, 2004
APPLICATION RECEIPT DATE: July 14, 2004
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA 

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
invites applications for Diabetes Endocrinology Research Center (DERC) grants 
to support research in diabetes mellitus and its complications, and in 
related areas of endocrinology and metabolism. 

The Diabetes Endocrinology Research Center program is intended to facilitate 
progress in basic and clinical research with the goal of translating basic 
research findings into new methods to treat, prevent and ultimately cure 
diabetes mellitus and its complications. DERCs support three primary 
research-related activities: (1) Biomedical Research Cores that provide 
resources to enhance the efficiency, productivity, and multidisciplinary 
nature of research in designated topic areas; (2) a Pilot and Feasibility 
Program designed to foster development of new investigators and to provide 
seed-support for innovative high-risk projects; and (3) an Enrichment Program 
to promote interdisciplinary interaction and training of investigators in 
areas of NIDDK interest.  
 
RESEARCH OBJECTIVES

The DERCs are part of an integrated program of support provided by the NIDDK 
to enhance multidisciplinary research in diabetes and in related areas of 
endocrinology and metabolism. DERCs are intended to improve the efficiency 
and collaborative nature of diabetes research by providing shared access to 
specialized technical resources and expertise. In addition, DERCs provide a 
framework for fostering synergy between basic scientists and clinical 
investigators to promote rapid progress toward a treatment or cure for 
diabetes and its complications. 

A DERC must be an identifiable unit within a single institution such as a 
university medical center, or within a consortium of cooperating 
institutions. In either case, DERC applications require an associated program 
of excellence in biomedical research in diabetes and related areas of 
metabolism and endocrinology. This program of excellence should be evident in 
a consistent record of active NIH-funded research projects, program projects, 
or other peer-reviewed research. A high level of integration and close 
collaboration among center personnel from diverse scientific disciplines is 
an important feature of a successful DERC. Accordingly, the applicant should 
clearly state considerations for center membership with specific reference to 
the potential of members to form interactive, collaborative relationships. 
Center applicants should identify one or more central themes around which 
DERC investigators may be focused.

Diabetes research often requires the use of specialized technologies and 
resources to support a cohesive research effort. The goal of the DERC program 
is to make state-of-the art technologies and resources readily accessible to 
a broad spectrum of investigators who are pursuing studies in relevant topic 
areas. 

DERCs are designed around the core concept. Cores are defined as shared 
specialized technical resources and/or expertise that enhance the efficiency, 
productivity, and multidisciplinary research activities of investigators. In 
a DERC, cores are designed to facilitate the progress of investigators 
working in diabetes or diabetes-related areas to accomplish the stated goals 
of the center.    

Each core should provide state-of-the art services to multiple funded research 
projects. A Center may support research at a single or set of cooperating 
institutions through an Institutional Core, or may serve a wider scientific 
community on a geographic or national level through the establishment of a 
Regional/National Shared Resource Core. With a regional or national core the 
centers will service a specific research base that is expanded beyond DERC 
investigators who access Institutional Cores. Examples of DERC biomedical 
cores that would be considered responsive to this Request for Applications 
include:
 
o   gene expression 
o   islet isolation and function 
o   transgenic and ES-cell
o   genetics
o   immunology 
o   protein chemistry and macromolecular structure 
o   analytical biochemistry 
o   pathology
o   monoclonal antibody production 
o   proteomics 
o   metabolism  
o   imaging  
o   bioinformatics 
o   biostatistics 
o   clinical research  

These cores are not listed in any particular order, nor do they represent a 
comprehensive list of possibilities. In responding to this RFA, applicants 
are encouraged to propose cores that address specific objectives based on the 
unique requirements of investigators at the applicant institution.  

In addition to biomedical cores, DERC applications must include an 
administrative core that will be responsible for oversight and allocation of 
Center resources. The Administrative core will also be responsible for 
planning an enrichment program and for implementing a process for 
solicitation, review and selection of projects for the DERC Pilot and 
Feasibility Program.  

The DERC enrichment program should be designed to promote scientific exchange 
among investigators who have research interests in diabetes, endocrinology 
and metabolism, and between diabetes researchers and investigators from other 
fields with relevant expertise. 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.

The DERC Pilot and Feasibility (P&F) program provides seed support for new 
and innovative research projects directed at basic biomedical and/or clinical 
questions relevant to diabetes and its complications. To be considered a 
viable P&F program, the center must support a minimum of two pilot projects 
and direct no more than 25% of the center direct costs, exclusive of 
equipment, into P&F projects. Up to $50,000 in direct costs per year for up 
to two years can be provided for each approved P&F project. This program is 
particularly directed at new investigators and established investigators new 
to diabetes research. Established diabetes investigators pursuing high 
impact/high risk projects or projects that are a significant departure from 
their usual work are also eligible for support under the DERC P&F program.
 
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).

MECHANISM OF SUPPORT
 
This RFA will use the NIH Core Centers grant (P30) award mechanism.  As an 
applicant you will be solely responsible for planning, directing, and 
executing the proposed project.  This RFA is a one-time solicitation. The 
NIDDK accepts P30 applications only when submitted in response to an RFA. The 
receipt of competing continuation applications from three P30 DERC centers is 
anticipated in response to this solicitation. These applications will compete 
for the three anticipated awards along with other applications received in 
response to this RFA. The anticipated award date is April 01, 2005.  

This RFA uses just-in-time concepts and non-modular budgets.  Follow the 
instructions for non-modular budget research grant applications.  This 
program does not require cost sharing as defined in the current NIH Grants 
Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.  

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 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 (HBCUs), traditionally Hispanic institutions, 
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. 

FUNDS AVAILABLE 
 
The NIDDK intends to commit approximately $4,000,000 in FY 2005 to fund three 
new and/or competitive continuation grants in response to this RFA. An 
applicant may request a project period of up to five years and a budget for 
direct costs of up to $1,000,000 per year. Because the nature and scope of 
the proposed research will vary from application to application, it is 
anticipated that the size and duration 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 meritorious applications.  
 
ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics: 
   
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges,             
hospitals, and laboratories 
o Units of State and local governments
o Faith-based or community-based organizations 
o Eligible agencies of the Federal government  
o Foreign institutions are not eligible to apply as the primary institution, 
however, subcontracts to foreign institutions are permitted

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed program is invited to work with their institution to develop 
an application for support.  Individuals from underrepresented racial and 
ethnic groups as well as individuals with disabilities are always encouraged 
to apply for NIH programs. Because a DERC has a large and complex 
administrative structure, the principal investigator must have strong 
leadership abilities and demonstrated proficiency in managing a large, 
multicomponent project. 
 
SPECIAL REQUIREMENTS 

Successful DERC applications require an existing program of excellence in 
biomedical research in the area of diabetes, its complications, and in 
related endocrinology and metabolism research. To justify Center support, the 
DERC must serve a large research base that has a consistent and outstanding 
record of NIH and other peer-reviewed funding. 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).

Applicants from institutions with a General Clinical Research Center (GCRC) 
funded by the NIH National Center for Research Resources 
(http://www.ncrr.nih.gov/clinical/cr_gcrc.asp) are strongly encouraged to 
utilize the GCRC as a resource for enhancing clinical research programs 
within the DERC. In such a case, a letter of agreement from the GCRC program 
director or principal investigator should be included with the application. 
In addition, applicants should address the potential for integration, 
harmonization, and enhancement of DERC activities through cooperation with 
other core facilities existing at the applicant institution. Assurances 
should be provided that overlap or redundancy in core services will be 
avoided unless expressly required to fulfill the mission of the DERC.

Core resources must precisely define issues regarding access to core 
services, including investigator eligibility requirements for services, and 
policies and procedures for prioritization of services when demand exceeds 
capacity. Financial considerations such as calculations that justify 
investment of funds in core services and policies for cost recovery from 
investigators for use of services should also be included. 

Cores also need to develop policies and procedures for implementing change. 
New technologies or services might appear that should be supported, existing 
technologies might become less important, or economic changes might obviate 
the need for core services, such as the availability of cost-effective 
commercial services or core services provided by the research institution. 
Cores should address the issue of allocation of resources to development of 
new technologies versus provision of services with existing technologies. In 
addition, cores must have well-defined policies to insure that intellectual 
property is identified and appropriately protected, but that IP issues do not 
impede sharing of resources. 

The DERC must provide support for enrichment activities to foster 
multidisciplinary 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 operate on a regional or national level and involve 
multiple Diabetes Research Centers (including other DERCs as well as Diabetes 
Research Training Centers, DRTCs).  The application should include a 
statement regarding willingness to participate in such activities.  

The proposed budget should include travel for the Principal Investigator and 
Associate Center Director, or other 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.   
 
WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:

Kristin M. Abraham, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 607 
Bethesda, MD  20892-5460
Telephone:  (301) 451-8048
FAX: (301) 480-3503
Email: ka136s@nih.gov

o Direct your questions about peer review issues to:

Francisco O. Calvo, Ph.D.
Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD  20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone:  (301) 594-8897
FAX:  (301) 480-3505
E-mail: fc15y@nih.gov 

o Direct your questions about financial or grants management matters to:

Mary K. Rosenberg
Grants Management
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 722 
Bethesda, MD 20892-5456
Telephone: 301-594-8891
Fax: 301-480-3504
E-mail: mr239s@nih.gov
 
LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

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 by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Chief, Review Branch 
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD  20892-5452
(For express/courier service: Bethesda, MD  20817)
Telephone:  (301) 594-8897
FAX:  (301) 480-3505

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a DUN and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 document is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

SUPPLEMENTARY INSTRUCTIONS:  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: 
http://www.niddk.nih.gov/fund/other/guidelines.doc  

USING THE RFA LABEL: 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: 
http://grants.nih.gov/grants/funding/phs398/labels.pdf.
 
SENDING AN APPLICATION TO THE NIH: 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
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application and all 
copies of the appendix material must be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752 
Bethesda, MD  20892-5452
(Courier use ZIP 20817)
 
APPLICATION PROCESSING: Applications must be received on or before 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. 

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.
 
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.  
However, when a previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, 
it is to be prepared as a NEW application.  That is, the application for the 
RFA must not include an Introduction describing the changes and improvements 
made, and the text must not be marked to indicate the changes from the 
previous unfunded version of the application.  

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIDDK. Incomplete applications will not be reviewed.  
Incomplete and/or non-responsive applications will be returned to the 
applicant without further review.  

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:

o Undergo a process in which only those application deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Diabetes and Digestive and 
Kidney Diseases Advisory Council 
 
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to evaluate the application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals. The scientific review group 
will address and consider each of the following criteria in assigning the 
application’s overall score, weighting them as appropriate for each 
application. 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The application does not need to be strong in all categories to be judged 
likely to have major scientific impact and thus deserve a high priority 
score.  For example, an investigator may propose to carry out important work 
that by its nature is not innovative but is essential to move a field 
forward.

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?

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?

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?

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)?

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?  

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

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 
aspects of the application listed below 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 Center.  

Specific review criteria are:
 
o  Scientific excellence of the research base served by the Center 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, modes of operation, suitability of 
facilities, and ability to provide unique services.  Renewal applications 
must document the use, impact, quality control, and cost effectiveness of 
each core, demonstrate progress of developmental research in the cores, and 
show evidence of consistent evaluation and evolution of cores to meet 
changing needs. Progress will be judged in part by 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 submitted pilot and feasibility studies will be evaluated 
using NIH review criteria and prioritized on the basis of Significance, 
Approach, Innovation, Investigator and Environment. 

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. Quality of the P&F program will be assessed on the basis of: (1) 
the proportion of projects successfully converted to external funding 
sources, (2) use of the program to support high impact or paradigm-shifting 
research, and (3) the extent of support provided for bench to bedside and 
other clinical research efforts.  
 
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 and 
for systematic evaluation of needs for existing or new shared resources; 
mechanisms for 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.
 
o  Institutional commitment to the program, including lines of accountability 
for 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.
 
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See criteria included in the 
section on Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups 
(and subgroups), and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated. (See Inclusion Criteria in the sections on Federal Citations, 
below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL REVIEW CONSIDERATIONS

Sharing Research Data 

Applicants requesting more than $500,000 in direct costs in any year of the 
proposed research must include a data sharing plan in their application. The 
reasonableness of the data sharing plan or the rationale for not sharing 
research data will be assessed by the reviewers. However, reviewers will not 
factor the proposed data sharing plan into the determination of scientific 
merit or priority score. 

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:          June 15, 2004 
Application Receipt Date:               July 14, 2004
Peer Review Date:                       October, 2004
Council Review:                         February, 2005
Earliest Anticipated Start Date:        April 01, 2005

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.
 
REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II); efficacy, 
effectiveness and comparative trials (phase III).  The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking $500,000 or more in 
direct costs in any single year are expected to include a plan for data 
sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing  Investigators should seek 
guidance from their institutions, on issues related to institutional 
policies, local IRB rules, as well as local, state and Federal laws and 
regulations, including the Privacy Rule. Reviewers will consider the data 
sharing plan but will not factor the plan into the determination of the 
scientific merit or the priority score.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a 
clear and compelling justification is 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 clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm    
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy 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 is available at 
http://grants.nih.gov/grants/funding/children/children.htm

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: (if 
applicable) NIH policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for research 
involving human subjects.  You will find this policy announcement in the NIH 
Guide for Grants and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).  
It is the responsibility of the applicant to provide, in the project 
description and elsewhere in the application as appropriate, the official NIH 
identifier(s) for the hESC line(s) to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 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 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this 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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the “Standards for Privacy of Individually Identifiable Health Information”, 
the “Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as “covered entities”) must do so by April 14, 2003 (with the 
exception of small health plans, which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on “Am I a covered 
entity?”  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

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. This RFA is 
related to one or more of the priority areas. Potential applicants may obtain 
a copy of "Healthy People 2010" at http://www.healthypeople.gov/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 
284)and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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