MURINE ATLAS OF GENITOURINARY DEVELOPMENT - DATABASE
 
RELEASE DATE:  December 22, 2003
 
RFA Number:  RFA-DK-04-006  

Update: The following update relating to this announcement has been issued:

August 26, 2010 - This RFA has been reissued as (RFA-DK-10-005).

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: 93.849
 
LETTER OF INTENT RECEIPT DATE: February 18, 2004 
APPLICATION RECEIPT DATE: March 18, 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 genitourinary tract (GU) is the organ system most commonly affected by 
congenital birth defects, and many reports suggest that some of these birth 
defects (i.e. hypospadias and cryptorchidism) are increasing.  Many signaling 
cascades key to normal embryonic development also play key regulatory roles 
in adult diseases. In addition, developmental factors are likely to be 
important in regenerative processes. Thus, investigations defining normal 
embryonic development have significant clinical relevance, given the 
significant health impact of congenital and acquired diseases of the 
genitourinary organs. Currently, genitourinary developmental research is 
limited by a paucity of cell specific markers for key lineages within the 
developing GU tract, incomplete understanding of the normal three dimensional 
cellular structure of the major organs of the GU tract (kidney, ureter, 
bladder, urethra, prostate, testis, epididymis, vas, penis, ovary, uterus, 
and vagina), incomplete understanding of the morphogenetic events that occur 
during organogenesis, and the lack of a detailed integrative database to 
assimilate complex temporal and spatial expression data. 

To address these issues, the National Institute of Diabetes, Digestive, and 
Kidney Diseases (NIDDK) invites Cooperative Agreement Applications through 
this RFA and a companion Program Announcement (TPA-04-009) for projects 
that will contribute to an anatomical and gene expression atlas of the 
developing murine GU tract (Murine Atlas of GU Development, MAGUD). The 
specific goals of the MAGUD Projects will be:

1) to develop a low resolution gene expression atlas of all genes expressed 
within the developing murine GU tract, 
2) to perform high resolution anatomic gene expression studies using 
available or newly generated molecular tools, and 
3) to produce an integrated, continuously updated database that will provide 
the entire research community with access to the data as it is generated. 

This RFA invites applications for the database; applications for the first 
two of the above goals are invited through the companion PAR (TPA-04-009). 
The components of the atlas project will work together as a consortium. It is 
expected that the consortium will serve as a resource to provide reagents and 
data to the research community.   
  
RESEARCH OBJECTIVES
 
Background: In September, 2001, NIDDK convened a working group of its 
National Advisory Council to develop strategic plans for several cross-
cutting areas of research, including Stem Cells and Developmental Biology. 
The working group made several recommendations, with the overall goals of 
providing new strategies for repairing or replacing damaged organs and 
generating new insights into pathologic processes underlying developmental 
defects and disease. Similar goals were also voiced by the Bladder Research 
Progress Review Group, convened by NIDDK in 2002, which emphasized the need 
for a more thorough understanding of organogenesis so that tissue 
degeneration, neural dysfunction, and congenital malformations might be 
prevented and treated. 

A fundamental contribution to these overall goals is a solid understanding of 
how organs develop in the embryo. It is from such an understanding that 
experimentally manipulated development or regeneration can be evaluated. If 
cell therapies are to be developed to replace or repair damaged tissue, we 
must know the catalog of cell types for each organ, the genes that mark these 
cells as well as those that are required for their function, the regulatory 
factors that induce or maintain the various cell types, and the developmental 
and anatomic relationships of each cell type to its neighbor. For certain 
tissues, for example the hematopoietic lineages, a substantial literature 
exists which provides this fundamental knowledge. However, for the kidney and 
the genitourinary (GU) tract, markers are lacking for several physiologically 
or anatomically defined cell types, the developmental processes that 
establish functional domains is not described, and the genesis of organ 
anatomy at the molecular/cellular level is not understood. This lack of 
fundamental description of these organs is a major obstacle to the pursuit of 
stem cell research and the design of novel therapies: without knowledge of 
the cell types within an organ, it is impossible to determine whether 
putative therapies are effective at regenerating them or restoring their 
functionality.

For these reasons, the NIDDK asked a panel of advisors in January, 2003, to 
articulate the needs for fundamental description of the developing kidney and 
GU tract. The panel recommended that the following three objectives be 
combined to form a Murine Atlas of Genitourinary Development (MAGUD):

o High throughput in situ hybridization analyses to define the expression 
pattern of genes expressed in the developing kidney and GU tract
o High resolution gene expression analyses to define gene expression during 
developmental time, the overlap in gene expression patterns, and the 
correlation between boundaries of gene expression and boundaries of anatomic 
or functional domains
o Development of a database to house and annotate the above data and to 
provide rapid access of this data to the entire research community

SPECIFIC OBJECTIVES: This RFA requests applications for the database. The 
database will be crucial to maximize the utility of this type of descriptive 
research. Key features of the database are expected to include:

o Accommodation of multiple types of image files, including relatively low 
resolution images as well as high resolution, three dimensional images and 
movies
o Three dimensional displays of expression patterns derived from serial 
sections, confocal images, or other types of data
o Annotation of images and standard vocabularies developed in collaboration 
with consortium members
o User-friendly search tools with links to other sources of information for a 
given gene or cell type
o Rapid integration of data from consortium members 
o Information pertaining to experimental protocols
o Plans to expand data acquisition to accommodate data generated by 
investigators outside the consortium

This database is expected to be a continuing resource for the kidney/GU 
research communities. The plans for the database should therefore be 
expandable so that future studies of mutant mouse strains or gene 
expression/anatomical studies of other organ systems or of other organisms 
could be added.

MECHANISM OF SUPPORT
 
This RFA will use the NIH U01 award mechanism. This RFA is a one-time 
solicitation, but support for the database may be continued beyond the 
initial five year period following favorable review of a competing-
continuation application. The anticipated award date is September 30, 2004.

This RFA uses just-in-time concepts.  It also uses the modular budgeting as 
well as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular budget format.  Otherwise, 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 NIH U01 is a cooperative agreement award mechanism. In the cooperative 
agreement mechanism, the Principal Investigator retains the primary 
responsibility and dominant role for planning, directing, and executing the 
proposed project, with NIH staff being substantially involved as a partner 
with the Principal Investigator, as described under the section "Cooperative 
Agreement Terms and Conditions of Award."  

FUNDS AVAILABLE
 
The NIDDK intends to commit approximately $750,000 in FY 2004 to fund one new 
grant in response to this RFA. An applicant may request a project period of 
up to five years and a budget for total costs of up to $750,000 per year. 
Although the financial plans of the NIDDK provides 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 Domestic or foreign institutions/organizations
 
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research 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.  
 
SPECIAL REQUIREMENTS 

Applicants must indicate their willingness to be part of a MAGUD consortium 
consisting of representatives from projects funded through this initiative, 
PAR-04-042 (http://grants.nih.gov/grants/guide/pa-files/PAR-04-042.html), 
and NIH staff. Applicants must be willing to participate in the steering 
committee for this consortium, which will meet semi-annually and may meet 
additionally in subcommittees or through telephone conference calls. A major 
goal of these meetings will be to facilitate progress by establishing 
communication between the participating labs so that skills, ideas, 
technology, data, and reagents are exchanged. The participants at the meeting 
will work together to establish database vocabularies and annotation criteria 
and to provide feedback regarding ease of use and database utility. 
Participants will discuss progress toward each project, quality assurance, 
coordination of projects, data and reagent sharing, and means of informing 
the research community of progress. This consortium is expected to serve as a 
genuine resource to the community, so the investigators must be willing to 
think of themselves as resource-generating.

Throughout the funding period, input will be sought from experts within the 
MAGUD consortium, other NIH-sponsored initiatives, and from the broader 
research community.

During the course of the funding period, technologies will improve, and the 
rate of progress and focus of work supported by the cooperative agreement may 
change. It is expected that the Principal Investigator(s), in consultation 
with NIH program staff, the Steering Committee, and the External Advisory 
Board (see below) will make any necessary adjustments to accommodate the 
changing research environment, to remain focused on appropriate goals, to 
maintain excellent coordination with the other projects, and to incorporate 
new technological advances. 

Data and Reagent Sharing: 

All applications to the NIH requesting more than $500,000 in direct costs in 
any year of the proposed research must include a data sharing plan in their 
application. In addition, this RFA and its companion PAR have special 
requirements for sharing. All applications submitted through these 
announcements must include sharing plans for both data and unique research 
resources that are generated by the projects. Applicants must indicate their 
willingness to distribute research tools to the wider community, including 
probe sets, antibody libraries, transgenic or knock-in mouse strains, cell 
lines, and other reagents. Likewise the applicants must describe their 
willingness to submit data generated through this project to the MAGUD 
database. It is expected that data will be released to the database as soon 
as they are validated.

This RFA and its companion PAR have two special requirements regarding 
research resources produced in proposed projects:

(1) Applicants are required to include in their application a specific plan by 
which they will share research resources with the wider scientific community, 
as well as copies of all Material Transfer Agreements used by all institutions 
involved in the application. 

(2) Applicants are required to include a plan addressing if, or how, they will 
exercise their intellectual property rights while making available to the 
broader scientific community patentable research resources. These plans must 
be consistent with the policies of their institutional offices of technology 
transfer.

The scientific review group will evaluate the adequacy of the proposed plans 
for sharing and data access. Comments on the plan and any concerns will be 
presented in an administrative note in the Summary Statement. The adequacy of 
the plan will be considered by NIH program staff and will be important in 
determining whether the grant application will be awarded. The sharing plan as 
approved, after negotiation with the applicant when necessary, will be a 
condition of the award. Evaluation of non-competing continuation applications 
will include assessment of the effectiveness of research resource release.

TERMS AND CONDITIONS OF AWARD

The following terms and conditions will be incorporated into the award 
statement and provided to the Principal Investigator(s) and to the 
institutional official at the time of award. These special Terms of Award are 
in addition to and not in lieu of otherwise applicable OMB administrative 
guidelines; HHS Grant Administration Regulations at 45 CFR Parts 74 and 92; 
and other HHS, PHS, and NIH Grant Administration policy statements.

The administrative and funding instrument used for this program is the 
cooperative agreement (U01), an "assistance", rather than an "acquisition", 
mechanism, in which substantial NIH scientific and/or programmatic 
involvement with the awardee is anticipated during the performance of the 
activity. Under the cooperative agreement, the NIH purpose is to support 
and/or stimulate the recipient's activity by involvement in and otherwise 
working jointly with the award recipient in a partner role, but it is not to 
assume direction, prime responsibility, or a dominant role in the activity. 
Consistent with this concept, the dominant role and prime responsibility for 
the activity resides with the awardees for the project as a whole, although 
specific tasks and activities in carrying out the research will be shared 
among the awardees and the NIDDK Project Scientist.

1. Awardee Rights and Responsibilities

o The awardee will have primary authority and responsibility to define 
objectives and approaches and to plan, conduct, analyze, and publish results, 
interpretations, and conclusions of studies conducted under the terms and 
conditions of the cooperative agreement award.

o The PI will assume responsibility and accountability to the applicant 
organization officials and to the NIDDK for the performance and proper 
conduct of the research supported by the project in accordance with the terms 
and conditions of the award.

o The PI will serve, as a voting member of the Steering Committee, will 
attend the Planning Meeting and a Steering Committee meeting in the first 
year, and two Steering Committee meetings a year in subsequent years.

o The awardee will be responsible for accepting and implementing the goals, 
priorities, procedures, protocols, and policies agreed upon by the Steering 
Committee and subcommittees.

o The PI will be responsible for close coordination and cooperation with the 
other MAGUD projects and with NIH staff.

o Awardees will retain custody of, and have primary rights to, the data 
developed under these awards, subject to Government rights of access 
consistent with current HHS and NIH policies. However, all awardees must 
adhere to PHS policy for the distribution of unique research resources 
produced with PHS funding as described under Special Requirements. The NIH 
Project Scientist, on behalf of the NIH, will have the same access, 
privileges and responsibilities regarding the collaborative data as the other 
members of the Steering Committee.

o NIH reserves the right to require the transfer of appropriate cell lines, 
reagents, tools and pertinent data that are generated as the result of 
participation in research supported under these awards to an eligible third 
party, in order to preserve these materials and data about them and/or to 
continue the research. Third parties supported under these awards must be 
informed of this right.

o Within the first three months of the award period, the awardee will be 
responsible for establishing written milestones for the project, in 
negotiation with NIDDK Project Staff.

o Support or other involvement of industry or any other third party in any 
study performed by the project-- e.g., participation by the third party; 
involvement of project resources or citing the name of the project or the 
NIDDK support; or special access to project results, data, findings or 
resources -- may be advantageous and appropriate.  However, except for 
licensing of patents or copyrights, support or involvement of any third party 
will occur only following notification to, and concurrence by, NIDDK.

o Upon completion of the MAGUD projects, the awardees are expected to put all 
study design materials and procedure manuals into the public domain and/or 
make them available to other investigators, according to the approved plan 
for making data and materials available to the scientific community and the 
NIDDK, for the conduct of research at no charge other than the costs of 
reproduction and distribution.

2. NIH Staff Responsibilities

The NIDDK Project Scientist will have substantial scientific-programmatic 
involvement during conduct of this activity, through technical assistance, 
advice and coordination above and beyond normal program stewardship for 
grants, as described below.  The dominant role and prime responsibility for 
the project as a whole resides with the awardees, although specific tasks and 
activities in carrying out the studies will be shared by awardees and the 
NIDDK.

o NIDDK will designate a Project Officer and a Grants Management 
Specialist to provide normal program stewardship and administrative oversight 
of the cooperative agreement.

o NIDDK will form an External Advisory Committee, comprised of NIDDK Project 
Staff and other NIH extramural staff with relevant scientific expertise or 
who manage research grant programs that relate scientifically to the goals of 
the MAGUD projects, and outside advisors selected by the NIDDK. The External 
Advisory Committee will meet regularly to review the progress of the atlas 
projects and to advise NIDDK Project Staff of scientific developments and 
opportunities that may enhance the achievement of the MAGUD goals.

o The NIDDK Project Scientist will be a member of the Steering Committee and, 
as determined by that committee, its subcommittees.

o The NIDDK Project Scientist will coordinate and facilitate the MAGUD 
projects, attend and participate as a voting member in all meetings of the 
Steering Committee, and provide liaison between the Steering Committee and 
the External Advisory Committee.

o The NIDDK Project Scientist will help the Steering Committee develop and 
draft operating policies.

o The NIDDK Project Scientist will review the scientific progress of the 
individual MAGUD projects, review projects for compliance with operating 
policies developed by the Steering Committee, and may recommend to the NIDDK 
to withhold support, suspend, or terminate an award for lack of scientific 
progress or failure to adhere to policies established by the Steering 
Committee.

3. Collaborative Responsibilities

Steering Committee - The NIH Project Scientist and PIs of the atlas projects 
funded under this RFA and PAR TPA-04-009 will be responsible for forming a 
Steering Committee as defined below. An arbitration system, as detailed 
below, will be available to resolve disagreements among members of the 
Steering Committee. The Steering Committee will be the main governing board 
of the MAGUD projects. It will develop collaborative protocols, identify 
technological impediments to success and strategies to overcome them, develop 
shared software tools for disseminating information about the projects, and 
identify opportunities for sharing techniques and tools developed within each 
individual project.

o The Steering Committee will be composed of the PI from each atlas project 
funded through this RFA and PAR TPA-04-009, and the NIDDK Project Scientist. 
The PI from each project will have one vote. The NIDDK Project Scientist for 
this project and others that may be involved in the projects funded through 
the PAR will each have one vote. The Steering Committee will select a 
chairperson who will be someone other than an NIH staff member.

o The Steering Committee may, as it deems necessary, invite additional, non-
voting scientific advisors to meetings at which research priorities and 
opportunities are discussed. The NIH reserves the right to augment the 
scientific or consumer expertise of the Steering Committee when necessary.

o There will be two Steering Committee meetings annually, both in the 
Washington, DC, area at times agreed upon by the Steering Committee and the 
NIDDK.

o The first meeting of the PIs from atlas projects funded under this RFA and 
TPA-04-009 will be a Planning Meeting in the Washington, DC, area December 8-
10, 2004. At the Planning Meeting, the Steering Committee will be formed and 
select a chairperson from among the members who represent the awardees. At 
the Planning Meeting, the Steering Committee may: (a) draft a charter to 
detail policies and procedures, a process for monitoring compliance with the 
policies and procedures, and a process for recommending that the NIH Project 
Administrators act on evidence of non-compliance of any Consortium component 
with Steering Committee policies; (b) agree upon the terms of the charter; 
(c) discuss the approaches that were proposed in the project applications and 
any relevant new information, and set initial priorities for the projects to 
be pursued and for new technologies to be developed; (d) devise a plan for 
working with the MAGUD database developers to establish annotation criteria 
and to provide ongoing input into database design.

o At the second and subsequent meetings, the Steering Committee will refine 
the MAGUD scientific objectives and implementation as necessary, consistent 
with progress in the individual projects and other laboratories.

o The Steering Committee will plan workshops to which non-MAGUD participants 
will also be invited to (a) enable the atlas projects to explore scientific 
or technologic innovation that occurs during the course of the project, (b) 
inform the research community of the progress made toward development of the 
atlas, and (c) inform the research community of any technological advances 
related to implementation of an MAGUD project.  The NIDDK Project 
Scientist, the External Advisory Committee, and other NIH staff will provide 
the Steering Committee with advice on participants for the workshops and 
symposia. 

o The Steering Committee may establish subcommittees as it deems appropriate; 
the NIH Project Scientist and other NIH staff who are Steering Committee 
members will serve on subcommittees as they deem appropriate.
 
4.  Arbitration
 
Any disagreement that may arise on scientific and programmatic matters within 
the scope of the cooperative agreement and between award recipients and NIDDK 
may be brought to arbitration. An arbitration panel will be composed of three 
members: one selected by the MAGUD Principal Investigators; a second member 
selected by NIDDK; and the third member selected by the two prior selected 
members. This special arbitration procedure in no way affects the awardee's 
right to appeal an adverse action that is appealable in accordance with PHS 
regulations at 42 CFR Part 50, Subpart D, and HHS regulation at 45 CFR Part 
16.

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:

Betsy Wilder, Ph.D.
Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Rm. 623
Bethesda, MD  20892-5457
Phone: (301)594-7717
FAX: (301) 480-3510
Email: ew136e@nih.gov 

o Direct your questions about peer review issues to:

Francisco O. Calvo, Ph.D. 
Chief, Director, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Rm. 752
Bethesda, MD  20892-5452
Phone: (301) 594-8897
FAX: (301)480-3505
Email: fc15y@nih.gov 

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

Carolyn Kofa
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Rm. 727   
Bethesda, MD  20892-5456
Phone: (301)594-7687
FAX:  (301)480-3504
Email: ck104i@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, Rm. 752
Bethesda, MD  20892-5452
(for express/courier service: Bethesda, MD  20817)
Telephone:  (301) 594-8885
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) 710-0267, 
Email: GrantsInfo@nih.gov.

SUPPLEMENTARY INSTRUCTIONS:

The PHS Form 398 should be modified as follows. Response to the requirements 
described in the  Special Requirements  section should be appended to the 
 Research Plan  section of PHS Form 398 and will not be included within the 
25 page limit for that section.
 
Budget Instructions:
Applicants who have additional funds to support ( leverage ) the 
application should indicate the source of funds (institutional, R01, 
P01, P30, etc.) that permits them to accomplish the project goals. 
Subcontract direct and indirect costs should be calculated and listed as 
consortium/contractual costs, which are considered  direct costs of the 
applicant organization.  Additionally, subcontracts require a separate 
detailed budget.

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.

APPLICATION RECEIPT DATE: Applications must be received on or before the 
application receipt date, March 18, 2004 .  If an application is received 
after that date, it will be returned to the applicant without review.   
 
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, Rm. 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:

Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 752 
Bethesda, MD 20892-5452
(for express/courier service:  Bethesda, MD 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 and/or nonresponsive applications 
will not be reviewed.

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 selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of 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 Disease 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: The application should address the problem outlined in 
the RFA.  The application should demonstrate how the study would advance 
scientific and/or medical knowledge. Will the tools to be generated be 
generally useful by the community?

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:

INTERACTIONS: Are there adequate plans for effective interaction and 
coordination among Consortium components and the NIH? Are the proposed plans 
to share data and tools adequate? Do the investigators state their 
willingness to collaborate extensively and share information fully? Are the 
Material Transfer Agreements straightforward? Do the investigators state 
their willingness to abide by the priorities and policies agreed upon by the 
Steering Committee? Have the applicants proposed sound strategies for 
communication with the other MAGUD projects and with the NIH?    

All applications will be judged on the basis of the scientific merit of the 
proposed project and the documented ability of the investigators to meet the 
RESEARCH OBJECTIVES of the RFA. Although the technical merit of the proposed 
protocol is important, it will not be the sole criterion for evaluation of a 
study. Other factors considered to be important for review include 
demonstrated expertise in relevant technologies; demonstration of appropriate 
facilities and resources; willingness to share data and reagents freely.

Applicants are encouraged to submit and describe their own ideas about how 
best to meet the goals of the cooperative study, and they are expected to 
address issues identified under  SPECIAL REQUIREMENTS,   TERMS AND CONDITIONS 
OF AWARD  and  SPECIAL INSTRUCTIONS  sections of the PAR. 

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 
(http://grants.nih.gov/grants/policy/data_sharing). Applicants have 
additional requirements as described in the SPECIAL REQUIREMENTS section that 
will be considered by the reviewers.

REASONABLENESS OF THE PROPOSED BUDGET AND DURATION APPROPRIATE IN 
RELATION TO THE PROPOSED RESEARCH:  Does it indicate that the 
applicants understand the requirements of managing this sort of high-
throughput and high resolution enterprise? 

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    February 18, 2004
Application Receipt Date:         March 18, 2004
Peer Review Date:                 July 2004
Council Review:                   September 2004
Earliest Anticipated Start Date:  September 30, 2004

AWARD CRITERIA

Applications recommended by the NDDK Advisory Council will be considered for 
award based upon 
o scientific and technical merit as determined by peer review; 
o the degree of originality and innovation; 
o the creativity of the approaches and technologies; 
o the likelihood for substantial contribution by the applicants to a 
successful collaborative effort; 
o the evidence for willingness to work cooperatively; 
o program balance; and 
o the availability of funds.
 
REQUIRED FEDERAL CITATIONS 

SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking more than $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.

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 RFA 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.

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 PA 
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.

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