GENETIC STUDIES OF OBESITY-RELATED TRAITS IN MODEL ORGANISMS
 
RELEASE DATE:  October 29, 2003
 
RFA Number:  RFA-DK-03-018 (see addenda NOT-DK-04-004 and NOT-DK-04-006)

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov)
National Heart, Lung and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S) 93.847, 93.848, 93.866, and 
93.837.
 
LETTER OF INTENT RECEIPT DATE(S):  February 18, 2004 and February 17, 2005
APPLICATION RECEIPT DATE(S):  March 17, 2004 and March 17, 2005
 
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 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 Institutes of Diabetes and Digestive and Kidney Diseases 
(NIDDK), the National Institute on Aging (NIA), and the National Heart, Lung, 
and Blood Institute (NHLBI) invite investigator-initiated research projects 
(R01 and R21) designed to identify and characterize genes influencing 
obesity-related phenotypes in fruit flies (Drosophila melanogaster), soil 
nematodes (Caenorhabditis elegans), and zebrafish (Danio rerio).  Animals 
bearing alterations in these genes will be indispensable tools for 
understanding the pathogenesis of obesity and lipodystrophies, for testing 
therapeutics, and for discovering genes that can be tested in human studies 
for association with obesity and related co-morbidities such as 
cardiovascular disease.   
 
RESEARCH OBJECTIVES

Background

The rapid increase in the number of overweight and obese individuals world 
wide, including an alarming increase in overweight and obese children and 
adolescents, has highlighted the need to learn as much as possible about the 
pathways regulating the anatomical, physiological and behavioral phenotypes 
underlying obesity, such as body composition, fat distribution, adipocyte 
physiology, food consumption, physical activity, and metabolic rate.  Genetic 
analysis of these phenotypes offers the possibility of identifying previously 
unknown steps in both known and novel pathways.  Each step so discovered 
represents a potential target for intervention to prevent or treat obesity 
and its medical consequences. 

Although genetic studies in humans have identified the probable locations of 
a number of genes influencing body mass index and some of the major co-
morbidities of obesity (type 2 diabetes and cardiovascular disease), these 
studies have not yet had much success in identifying the genes themselves.  
Studies in cultured mammalian adipocytes have been largely responsible for 
our current understanding of the detailed regulation of fat storage and 
utilization.  Studies employing transgenic and knockout mice have similarly 
advanced our understanding of the regulation of food consumption, body 
composition, and metabolic rate.

Until recently non-mammalian genetic model organisms such as fruit flies 
(Drosophila melanogaster), soil nematodes (Caenorhabditis elegans), and 
zebrafish (Danio rerio) have not been exploited for research on the 
physiology underlying obesity and its attendant co-morbidities such as 
atherosclerosis, hypertension, and cardiac hypertrophy.  Identification of 
genes influencing specific phenotypes can be accomplished much more rapidly 
in these species than in mice or humans, owing to their short generation 
time, ease of breeding very large numbers of individuals, powerful resources 
for genetic mapping, and high-throughput methods for creation of mutants and 
phenocopies.  The speed and power of genetics in these model organisms could 
thus be harnessed to identify genes influencing obesity-related phenotypes, 
and the mouse and human homologues of the genes so identified could then be 
tested for effects on the corresponding phenotypes in mammalian species. This 
strategy might afford a quicker route to identification of genes influencing 
phenotypes in humans than attempts to identify such genes by direct genetic 
analysis of mice or humans themselves.  

In order for this strategy to work, the biological pathways controlling these 
phenotypes must be evolutionarily conserved among the non-mammalian species 
and mice or humans.  Although not much is known about regulation of obesity-
related phenotypes in fruit flies, nematodes, or zebrafish, an important 
proof of the principle of conservation of genetic pathways across the wide 
evolutionary distance separating C. elegans and mammals has been established 
by the recent results of a genome-wide RNAi screen in nematodes. This screen 
has identified more than 400 genes which upon inactivation, result in either 
increased or decreased fat deposition.  Some of these newly identified 
nematode fat regulatory genes have mammalian homologues that are known to 
function in lipid homeostasis.  In addition, more than half of these genes 
have mammalian homologues not previously suspected of involvement in control 
of fat deposition in mammals.  An independent study demonstrated that 
inhibition of the activity of homologues of three of these genes (or their 
products, previously unsuspected of a role in lipid homeostasis) prevented 
murine adipocytes from depositing fat when stimulated to differentiate in 
vitro. These studies support the concept that genetic studies in non-
mammalian model organisms can make important contributions to elucidating the 
physiological basis of obesity-related phenotypes in mammals (including 
humans).  

Objectives and Scope

This RFA encourages investigator-initiated projects using Drosophila 
melanogaster, Caenorhabditis elegans and Danio rerio as model systems to 
identify and characterize genes influencing obesity-related phenotypes.

Appropriate topics for investigation under this RFA would include but are not 
limited to:

o Development and use of inducible fluorescent lipid reporters to identify 
genes controlling lipid deposition and utilization 

o Development and implementation of  mutagenesis-, RNAi-, morpholino-, or 
other antisense-based screens to study control of eating behavior, level of 
physical activity, or metabolic rate 

o Development and implementation of sensitized screens for enhancers and 
suppressors of obesity-related phenotypes

o Identification of genetic polymorphisms underlying naturally-occurring 
variation in obesity-related phenotypes

o Identification of genes that influence atherosclerosis and cardiovascular 
disease

o Studies to identify genes involved in blood pressure control

o Elucidation of gene networks contributing to maladaptation of the 
cardiovascular system

o Studies to identify genes that effect changes in metabolism with aging

MECHANISM OF SUPPORT
 
This RFA will use the NIH investigator-initiated Research Project Grant (R01) 
and the Exploratory/Development Research Grant (R21) award mechanisms.  As an 
applicant you will be solely responsible for planning, directing, and 
executing the proposed project.  The total requested project period for an 
application submitted in response to this RFA may not exceed 4 years for the 
R01 mechanism, and 2 years for the R21 mechanism.  The anticipated award 
date(s) are September 30, 2004 and September 30, 2005. This RFA is a one-time 
solicitation.  R21 grants will not be renewable; continuation of projects 
developed under this program will be through the R01 grant program.  
Applications that are not funded in the competition described in this RFA may 
be resubmitted as NEW investigator-initiated applications using the standard 
receipt dates for NEW applications described in the instructions to the PHS 
398 application.  

R21 (Exploratory/Developmental) grants

The R21 mechanism is intended to encourage new exploratory/ developmental 
research projects by providing support for the early stages of their 
development.  Awards are made to demonstrate feasibility of a subsequent 
project and to obtain preliminary data testing innovative ideas.  Therefore, 
these grants are not renewable.  Continuation of projects developed under 
this program will be through the regular research project grant mechanism 
(for example, R01).  These grants are not intended to support or supplement 
ongoing funded research of an established investigator, or to serve as an 
alternative mechanism of support for projects not receiving funding as 
competitive continuation applications.  The NIH Grants Policy statement 
applies to these awards.

R01 (Research) grants

The R01 award represents an investigator-initiated research grant designed to 
support a discrete, specified research project performed by a principal 
investigator.  

This RFA uses just-in-time concepts.  It also uses the modular budgeting 
format. (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.  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. 
 
FUNDS AVAILABLE
 
The participating IC(s) intend to commit approximately $2.0 million dollars 
in FY2004 and $2.5 million in FY2005 to fund a total of 10 to 12 new grants 
in response to this RFA.  An applicant may request a project period of up to 
4 years and a budget for direct costs of up to $250,000 per year for R01 
applications.  An applicant may request a project period of up to 2 years 
with a combined budget for direct costs of up to $275,000 for the 2 year 
period for R21 applications.  (For example, you may request $100,000 in the 
first year and $175,000 in the second year.)  The request should be tailored 
to the needs of your project.  Normally, no more than $200,000 can be 
requested in a single 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 IC(s) 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 Eligible agencies of the Federal government  
o Domestic or foreign institutions/organizations
o Faith-based or community-based 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 
 
Restricted availability of unique research resources, upon which further 
studies are dependent, can impede the advancement of research and delivery of 
medical care.  Sharing biomaterials, data, and software in a timely manner has 
been an essential element in the rapid progress that has been made in the 
genetic analyses of mammalian genomes.  NIH policy requires that investigators 
make unique research resources readily available for research purposes to 
qualified individuals within the scientific community after publication [NIH 
Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps; 
Principles and Guidelines for Recipients of NIH Research Grants and Contracts 
on Obtaining and Disseminating Biomedical Research Resources:  Final Notice, 
December 1999 (http://www.ott.nih.gov/policy/rt_guide_final.html)].  
Biomaterials (constructs, cell lines and strains, etc.) and other research 
resources that can be patented (e.g., software tools, expression data) that 
are produced in projects funded by this RFA are to be made available and 
distributed to the broader scientific community.  
 
Applications will be evaluated on the adequacy of the proposed plan to share 
data and unique resources such as monoclonal antibodies, mutant strains of 
flies, worms and fish, and RNAi libraries.  Data and unique resource sharing 
are essential for expedited translation of research results into knowledge, 
products, and procedures to improve human health.  Investigators responding 
to this RFA should include a description of how final research data and 
unique research resources will be shared, or explain why data and resource 
sharing is not possible. It is expected that the data and resource sharing 
discussion will be provided primarily in the form of a brief paragraph 
immediately following the Research Plan Section of the PHS 398 application 
form (i.e., immediately after I. Letters of Support), and would not count 
towards the application page limit. For more information on data sharing, 
please see the following websites: 
http://grants.nih.gov/grants/policy/data_sharing/
http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm#goals
http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

Reviewers will make an administrative comment on the adequacy of the data and 
resource sharing plan, but this comment will not contribute to the priority 
score of the application.  The adequacy of the data and resource sharing plan 
will be considered by IC Program Staff when making recommendations about 
funding applications.  IC Program Staff may negotiate modifications of the 
data and resource sharing plan with the Principal Investigator before 
recommending funding of an application.  The final version of the data and 
resource sharing plan negotiated by the Principal Investigator and IC Program 
Staff will become a condition of the award of the grant.  The effectiveness 
of the resource sharing will be evaluated as part of administrative review of 
each Non-competing Grant Progress Report (PHS 2590).

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:

Carol Renfrew Haft, Ph.D.
Program Director, Adipocyte Biology
Division of Diabetes, Endocrinology and Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 605
Bethesda, MD  20892-5460
Telephone:  (301) 594-7689
FAX:  (301) 480-3503 
E-mail: cr84g@nih.gov

Robert Karp, Ph.D.
Program Director, Genetics and Genomics
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 671
Bethesda, MD  20892-5460
Telephone:  (301) 451-8875
FAX:  (301) 480-8300 
E-mail: rk56v@nih.gov

David Finkelstein, Ph. D.
Biology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C231
Bethesda, MD 20892-9205
Telephone: (301) 496-7847
FAX: (301) 402-0010
E-Mail: finkelsd@nia.nih.gov

Pothur Srinivas, Ph. D., MPH
Vascular Biology Research Program
Division of Heart and Vascular Diseases
National Heart, Lung and Blood Institute
6701 Rockledge Drive, 2 Rockledge Center-10188
Bethesda, MD 20892-7926
Telephone: (301) 435-0550
FAX: (301)480-2858
E-mail: ps241q@nih.gov

o Direct your questions about peer review issues to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752 
Bethesda, MD  20892-5456
Telephone:  (301) 594-8897
FAX:  (301) 480-3505
E-mail: fc15y@nih.gov

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

Denise Payne
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 733 
Bethesda, MD  20892-5456
Telephone:  (301) 594-8845
FAX:  (301) 480-3504
E-mail: dp43@nih.gov

Grace Poe
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212
Bethesda, MD 20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672 
E-mail: poeg@nia.nih.gov

Edward McGeehan
Grants Operations Branch
National Heart, Lung and Blood Institute
6701 Rockledge Drive, Room 7142
Bethesda, MD 20892-7926
Telephone:  (301) 435-0148
E-mail: mcgeehae@nhlbi.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 IC 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 
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

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms. 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.

SPECIFIC INSTRUCTIONS FOR R21 APPLICATIONS

All application instructions outlined in the PHS 398 application kit are to be 
followed, with the following requirements for R21 applications:  

1.  R21 applications will use the "MODULAR GRANT" and "JUST-IN-TIME" concepts, 
with direct costs requested in $25,000 modules, up to a combined budget for 
direct costs of up to $275,000 for the two year period.

2. Preliminary data for the actual studies proposed in the R21 application are 
not required.  However, the PI should demonstrate that he/she has the 
appropriate expertise and resources on hand to perform the proposed 
experiments.  If not evidenced by publications, this may require inclusion of 
preliminary data to demonstrate facility in the methodologies proposed.

3.  Sections a-d of the Research Plan of the R21 application may not exceed 15 
pages, including tables and figures.  

4.  R21 appendix materials should be limited, as is consistent with the 
exploratory nature of the R21 mechanism, and should not be used to circumvent 
the page limit for the research plan. Copies of appendix material will only be 
provided to the assigned reviewers of the application and will not be 
reproduced for wider distribution. The following materials may be included in 
the appendix:

o Up to 5 publications, including manuscripts (submitted or accepted for 
publication), abstracts, patents, or other printed materials directly relevant 
to the project. These may be stapled as sets.
o Surveys, questionnaires, data collection instruments, and clinical 
protocols.  These may also be stapled as sets.
o Original glossy photographs or color images of gels, micrographs, etc., 
provided that a photocopy (may be reduced in size) is also included within the 
15 page limit of items a-d of the research plan.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

USING THE RFA LABEL: The RFA label available in the PHS 398 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.  Also indicate if the application in an R01 or R21. 
The RFA label is 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, MSC 7710
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 MSC 5452
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, NIA and NHLBI. 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 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 and assigned a priority score
o Receive a written critique
o Receive a second level review by an appropriate National Advisory Council 
or Board. 
 
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 CONSIDERATIONS

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

RELEVANCE TO HUMAN OBESITY:  What is the likelihood that the project will 
advance our understanding of the physiological or behavioral basis of obesity 
or its co-morbiditites such as cardiovascular disorders in humans?

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 will be assessed. 
 
ADDITIONAL REVIEW CONSIDERATIONS

SHARING RESEARCH DATA: Applicants responding to this RFA must include a data 
and unique resources sharing plan in their application. The reasonableness of 
the sharing plan or the rationale for not sharing research data and unique 
research resources such as monoclonal antibodies, mutant strains of flies, 
worms and fish, and RNAi libraries 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. 

It is expected that the data and resource sharing discussion will be provided 
primarily in the form of a brief paragraph immediately following the Research 
Plan Section of the PHS 398 application form (i.e., immediately after I. 
Letters of Support), and would not count towards the application page limit. 
For more information on data sharing, please see the following websites: 
http://grants.nih.gov/grants/policy/data_sharing/.
http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm#goals
http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm

SPECIAL REVIEW CONSIDERATIONS FOR R21 APPLICATIONS: The NIH R21 
exploratory/developmental grant is a mechanism for supporting novel 
scientific ideas or new model systems, tools or technologies that have the 
potential to significantly advance our knowledge or the status of health-
related research.  Because the research plan is limited to 15 pages, an 
exploratory/developmental grant application need not have background material 
or preliminary information as one might normally expect in an R01 
application.  Accordingly, reviewers will focus their evaluation on the 
conceptual framework, the level of innovation, and the potential to 
significantly advance our knowledge or understanding.  Reviewers will place 
less emphasis on methodological details and certain indicators traditionally 
used in evaluating the scientific merit of R01 applications including 
supportive preliminary data.  Appropriate justification for the proposed work 
can be provided through literature citations, data from other sources, or, 
when available, from investigator-generated data.  Preliminary data are not 
required for R21 applications.

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(s):    February 18, 2004    February 17, 2005
Application Receipt Date(s):         March 17, 2004       March 17, 2005
Peer Review Date(s):                 Summer 2004          Summer 2005
Council Review:                      September 2004       September 2005
Earliest Anticipated Start Date(s):  September 30, 2004   September 30, 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.

The adequacy of the data and resource sharing plan will be considered by 
NIDDK Program Staff when making recommendations about funding applications.  
NIDDK Program Staff may negotiate modifications of the data and resource 
sharing plan with the Principal Investigator before recommending funding of 
an application.  The final version of the data and resource sharing 
plan negotiated by the Principal Investigator and NIDDK Program Staff will 
become a condition of the award of the grant.  The effectiveness of the 
resource sharing will be evaluated as part of administrative review of each 
Non-competing Grant Progress Report (PHS 2590).
 
REQUIRED FEDERAL CITATIONS 

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 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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