This Program Announcement expires on October 1, 2004 unless reissued.

PILOT AND FEASIBILITY PROGRAM IN DIABETES ENDOCRINOLOGY AND METABOLISM

Release Date:  October 10, 2001

PA NUMBER:  PA-02-008 (see reissue PA-04-137)

National Institute of Diabetes and Digestive and Kidney Diseases
 (http://www.niddk.nih.gov)

THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER 
YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 
(REVISION 5/2001) AVAILABLE AT 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

The Division of Diabetes, Endocrinology, and Metabolic Diseases (DDEM) of the 
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
invites applications through the exploratory/developmental (R21) grant 
mechanism from investigators with interests in selected areas of opportunity 
relevant to the mission of DDEM. The primary intent of this initiative is to 
foster the development of high-risk, high-impact pilot and feasibility 
research by established or newly independent investigators to develop new 
ideas sufficiently to allow for submission of a full R01 application for use 
on research problems relevant to the study of endocrine and metabolic 
diseases, especially diabetes and its complications.  These grants are not 
intended to support or supplement ongoing funded research of an established 
investigator or to compensate for projects not receiving funding as 
competitive continuation applications.  This initiative represents a reissue 
of the original PA99-036 with revised and updated research objectives.

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, Pilot and Feasibility Program 
in Diabetes Endocrinology and Metabolism, is related to the priority area of 
chronic diseases.  Potential applicants may obtain a copy of "Healthy People 
2010" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 
017-001-00473-1) through the Superintendent of Documents, Government Printing 
Office, Washington, DC 20402-9325 (telephone 202-512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit 
organizations, public and private, such as universities, colleges, hospitals, 
and laboratories, units of state and local governments, and eligible agencies 
of the Federal government.  Racial/ethnic minority individuals, women, and 
persons with disabilities are encouraged to apply as principal investigators.

MECHANISM OF SUPPORT

This program will be supported through the exploratory/developmental grant 
(R21) mechanism. These awards are to demonstrate feasibility and obtain 
preliminary data testing innovative ideas that represent clear departure from 
ongoing research interests. These grants will not be renewable; continuation 
of projects developed under this program will be through the regular research 
grant program. Projects will be limited to $100,000 direct costs per year and 
are limited to two years of duration.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the 
NIH. Complete and detailed instructions and information on Modular Grant 
applications have been incorporated into the PHS 398 (rev. 5/2001).  
Additional information on Modular Grants can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm

RESEARCH OBJECTIVES

Applications should be relevant to diabetes, endocrinology, and metabolism and 
genetic metabolic diseases.  Areas in which such scientific opportunities 
exist include but are not limited to:

Identification of novel signaling molecules and pathways involved in cell 
development, differentiation, transcription, and function.

Signaling cross talk between and among receptor systems leading to 
determination of specificity of response, including the roles of orphan 
receptors and/or nuclear accessory proteins, including coactivators, 
corepressors, and chromatin remodeling proteins, in defining specificity, and 
in integrating and coupling hormone signaling to changes in gene expression.

Development of novel cellular and animal models of endocrine and metabolic 
diseases, particularly diabetes and its complications.

Development of novel vectors and delivery systems for use in gene therapy of 
metabolic diseases, such as diabetes, and cystic fibrosis and other inborn 
errors of metabolism.

Development of new methods for temporal and spatial control of transgene 
expression.

Development or miniaturization of assays for use in metabolic phenotyping  
(physiologic and metabolic measurements) in transgenic mice.

Crystallization and/or structural biology of new regulatory and membrane 
proteins.

Use of array technology to screen for novel disease or regulatory genes, 
and/or etiologic agents or to characterize tissues of interest to NIDDK.

Development and/or use of bioinformatics tools to analyze and/or annotate 
metabolic, array, genomics, or proteomics information relevant to diabetes, 
endocrinology, and metabolic diseases.

Combinatorial chemistry for development of new and powerful reagents.

Novel approaches to the development of glucose sensors and/or closed-loop 
systems for the regulation of blood glucose levels in diabetes.

Tissue engineering relevant to diabetes, osteoporosis, cystic fibrosis, and 
other diseases within the mission of DDEM.

Development of novel approaches to prevent or delay the onset of diabetes and 
its complications

Novel behavioral approaches to implementing new findings in the prevention and 
treatment of endocrine and metabolic disease.

Development or application of tools and reagents for in vivo imaging tissues 
and processes of interest to NIDDK, such as the pancreatic beta cell.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public
Law 103-43).

All investigators proposing research involving human subjects should read the 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research," which have been published in the Federal Register of March 28, 1994 
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, 
No. 11, March 18, 1994.  Investigators also may obtain copies of the policy 
from the program staff listed under INQUIRIES.  Program staff may also provide 
additional relevant information concerning the policy.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are scientific and ethical reasons not to include them. This 
policy applies to all initial (Type 1) applications submitted for receipt 
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS

NIH policy requires education on the protection of human subject participants 
for all investigators submitting NIH proposals for research involving human 
subjects.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

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.

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in 
applying for these grants and will be accepted at the standard application 
deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the 
application kit.  This version of the PHS 398 is available in an interactive, 
searchable format. The NIH will return applications that are not submitted on 
the 5/2001 version.  For further assistance contact GrantsInfo, Telephone 
301/435-0714, Email: GrantsInfo@nih.gov.

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 the total direct costs 
limit of $100,000 per year. 

2. Although preliminary data are not required for an R21 application, they may 
be included.

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 primary reviewers of the application and  will not be 
reproduced for wider distribution.  The following materials may be included in 
the appendix:

Up to five 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.
Surveys, questionnaires, data collection instruments, and clinical protocols.  
These may be stapled as sets.
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

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only when 
there is a possibility for an award. It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers and NIH staff.  
The research grant application form PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with modular budget instructions provided in 
Section C of the application instructions.  Applicants are permitted, however, 
to use the 4/1998 revision of the PHS 398 for scheduled application receipt 
dates until January 9, 2002.  If you are preparing an application using the 
4/1998 version, please refer to the step-by-step instructions for Modular 
Grants available at http://grants.nih.gov/grants/funding/modular/modular.htm.  
Additional information about Modular Grants is also available on this site.

The program announcement title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. Mail the signed, 
original, single-sided application, along with five exact, single-sided copies 
and five collated sets of appendix materials 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)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established Public Health 
Service referral guidelines.  Applications that are complete will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened in accordance with NIH peer review procedures.  As part of the 
initial merit review, all applications will receive a written critique and 
undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of applications under review, will be 
discussed, assigned a priority score, and receive a second level review by the 
appropriate national advisory council or board.

Review Criteria

The goals of the supported research are to advance our understanding of 
biological systems, improve the control of disease, improve health care 
services, and enhance health.  In the written comments reviewers will be asked 
to discuss the following aspects of the application in order to judge the 
likelihood that the proposed research will have a substantial impact on the 
pursuit of these goals.  Each of these criteria will be addressed and 
considered in assigning the overall score, weighting them as appropriate for 
each application.  Note that 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.

o  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?

o  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?

o  Innovation: Does the project employ novel concepts, approaches or method? 
Are the aims original and innovative? Does the project challenge existing 
paradigms or develop new methodologies or technologies?

o  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)?

o  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?

o  Appropriateness of the proposed budget and duration in relation to the 
proposed research.

For studies which involve human subjects:

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

The initial review group will also examine the provisions for the protection 
of human and animal subjects, and the safety of the research environment.

AWARD CRITERIA

Applications will compete for available funds with all other approved 
applications.  The following will be considered in making funding decisions:

o  Quality of the proposed project as determined by peer review
o  Availability of funds
o  Program priority

INQUIRIES

Inquiries are encouraged. The opportunity to clarify any issues or questions 
from potential applicants is welcome.  Relevant Scientific Program Officers 
may be identified through the DDEM webpage at 
http://www.niddk.nih.gov/fund/divisions/DEM/DEMintro.htm

Or by making direct inquiries to:

Ronald N. Margolis, Ph.D.
Division of Diabetes, Endocrinology, and Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 6107
Bethesda, MD  20892-5460
Telephone:  (301) 594-8819
FAX:  (301) 435-6047
Email:  rm76f@nih.gov

Direct inquiries regarding fiscal and administrative matters to:

Cheryl Chick
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd. Room 714
Bethesda, MD  20892-5460
Telephone:  (301) 594-8825
FAX:  (301) 480-3504
Email:  cc149o@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.847.  Awards are made under authorization of the Public Health Service Act, 
Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 
241 and 285) and administered under PHS grants policies and Federal 
Regulations 42 CFR 52 and 45 CFR Part 74.  This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products. In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking 
in certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care or early 
childhood development services are provided to children. This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.

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