PILOT AND FEASIBILITY PROGRAM IN DIABETES ENDOCRINOLOGY AND METABOLISM

Release Date:  January 12, 1999

PA NUMBER:  PA-99-036

P.T.

National Institute of Diabetes and Digestive and Kidney Diseases

PURPOSE

The Division of Diabetes, Endocrinology, and Metabolic Diseases (DDEM) at
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 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.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," 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 2000" (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.

RESEARCH OBJECTIVES

Areas in which such scientific opportunities exist include but are not limited
to:

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

o  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 in defining specificity in integrating and
coupling hormone signaling to changes in gene expression.

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

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

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

o  Development of miniaturized assays for physiologic and metabolic measurements
in transgenic mice.

o  Crystallization of new regulatory and membrane proteins for study of their
structural biology.

o  Use of array technology to screen for novel disease or regulatory genes,
and/or etiologic agents.

o  Combinatorial chemistry for development of new and powerful reagents.

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

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://www.nih.gov/grants/guide/notice-files/not98-024.html.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated in
the application kit.  Application kits are available at most institutional
offices of sponsored research and may be obtained from the Division of Extramural
Outreach and Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, email:
GrantsInfo@NIH.GOV

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.

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/fund.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
45 Center Drive MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8819
FAX:  (301) 480-3503
Email:  rm76f@nih.gov

Direct inquiries regarding fiscal and administrative matters to:

Kim Law
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8869
FAX:  (301) 480-3504
Email:  LawK@extra.niddk.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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