This Program Announcement expired on May 6, 2005
PILOT AND FEASIBILITY PROGRAM RELATED TO THE KIDNEY
Release Date: August 14, 2001
PA NUMBER: PA-01-127 (This PA has been reissued, see PA-05-103)
(Expiration date extended, see NOT-DK-04-017)
National Institute of Diabetes and Digestive and Kidney Diseases
(http://www.niddk.nih.gov)
National Institute on Aging
(http://www.nih.gov/nia)
National Cancer Institute
(http://www.nci.nih.gov)
THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. USE THE
MODULAR BUDGET INSTRUCTIONS THAT BEGIN ON PAGE 13 IN THE PHS 398
(REVISION 5/2001) AVAILABLE AT
http://grants.nih.gov/grants/funding/phs398/phs398.html. THE
INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS MUST BE USED WHEN RESPONDING
TO THIS PA.
PURPOSE
The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of the
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK), the Biology of Aging Program of the National Institute on Aging
(NIA) and the Cancer Cell Biology Branch of the National Cancer
Institute (NCI) invites applications through the
exploratory/developmental (R21) grant mechanism from investigators with
research interests related to the kidney and fall within the purview the
NIH mission. The primary intent of this initiative is to foster the
development of high-risk pilot and feasibility research by newly
independent or established investigators, to develop new ideas
sufficiently to allow for subsequent submission of R01 applications
focusing on research problems relevant to the study of both acute and
chronic kidney diseases, and their complications, in both the adult and
pediatric populations. 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.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to increasing the quality
and years of healthy life and to eliminating health disparities as
described in the objectives of Healthy People 2010 . This document is
a PHS-led national activity for setting priority areas and is available
at http://www.health.gov/healthypeople.
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. Further, this mechanism is for the
support of either new investigators [defined as independent
investigators who have not held R01, R29, and subprojects of program
project (P01) or center grants (P50) or equivalent], or established
investigators entering a new research field or developing a new line of
research.
MECHANISM OF SUPPORT
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
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 a 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 (R01) program. Projects will be
limited to $100,000 direct costs per year and are limited to two years
duration.
RESEARCH OBJECTIVES
The NIDDK, the NIA and the NCI invite investigator-initiated
applications. Appropriate topics for investigation would include, but
are not limited to:
o Development of methods to identify and define novel signaling
molecules and pathways involved in renal cellular and tissue
development, and the genetic programming of renal morphogenesis and
angiogenesis.
o Development of animal models reflecting the complexity of human kidney
diseases, that permits exploration of candidate mechanisms leading to
development, injury, and/or tolerance to injury.
o Development of less complex models to take advantage of evolutionary-
conserved mechanisms involving responses to injury and repair.
o Development of new approaches for utilizing mutant organisms for the
study of membrane transport.
o Crystallization of new regulatory and membrane proteins for study of
their structural biology.
o Development of technological tools, to improve molecular studies of
renal disease, such as methods to permit parallel assessment of gene
expression on renal biopsies.
o Development of animal models of inflammation/endothelial
dysfunction/sepsis leading to kidney disease.
o Development of novel vectors and delivery systems for use in gene
therapy of systemic and inherited kidney diseases, including disorders
such as polycystic kidney disease, diabetic nephropathy, diabetes
insipidus, cystinuria, renal hypertension, tubulointerstitial
nephropathy, Alport s, Bartter s, Gittelman s, Liddle s, and Fanconi
syndromes.
o Development of new methods to determine the role of complement and
complement regulatory proteins, oxidants and proteases, cytokines,
chemokines, growth factors, and adhesion molecules and matrix components
in immunologic kidney disease.
o Combinatorial chemistry for development of new renal reagents.
o Identification and characterization of early markers of renal disease
severity.
o Identification of novel approaches to improve the immediate and long-
term outcome in pediatric chronic renal failure.
o Development of new methods for temporal and spatial control of
transgene expression in the kidney.
o Development of micro-methods and miniaturized assays for physiologic
and metabolic studies/measurements in small/young animals and children.
o Development and use of array technology and bioinformatics to
characterize renal tissues in health and disease states.
o Use of molecular and proteomic techniques, such as differential
display, arrays, second-generation library screens, 2-D gels, etc. to
screen for novel kidney tissue-specific genes, novel disease or
regulatory genes, and/or etiologic agents.
o Use of phage display or other novel approaches to identify kidney-
specific proteins.
o Development of novel strategies for treating progressive renal disease
using animal models and/or short term feasibility studies in humans.
o Identify new factors contributing to symptoms and morbidity in
patients with treated end stage renal disease.
o Use of molecular and proteomic techniques on urine, blood or tissue
to discover more sensitive markers of chronic renal disease, its
progression and response to treatment.
o Identification of new pathophysiologic mechanisms and modes of
treatment for diabetic nephropathy.
o Use of epidemiological and biochemical approaches to identifying new,
non-traditional risk factors for cardiovascular disease in patients with
chronic real disease.
o Studies focused on age-related changes in the biology of the kidney
and kidney function, and propensity for diseases of the kidney relevant
to older subjects.
o Studies focused on mechanisms of biological, chemical and physical
carcinogenesis and subsequent tumor growth and progression to kidney
metastasis.
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 UPDATED "NIH Guidelines for Inclusion of Women and Minorities
as Subjects in Clinical Research," published in the NIH Guide for Grants
and Contracts on August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a
complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm
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.
Investigators also may obtain copies of these policies from the program
staff listed under INQUIRIES. Program Staff may also provide additional
relevant information concerning policy.
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 PDF format. Although applicants
are strongly encouraged to begin using the 5/2001 revision of the PHS
398 as soon as possible, the NIH will continue to accept applications
prepared using the 4/1998 revision until January 9, 2002. Beginning
January 10, 2002, however, the NIH will return applications that are not
submitted on the 5/2001 version. For further assistance contact
GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov.
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 beginning on page 13 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.
All application instructions outlined in the PHS 398 application kit are
to be followed, with the following modifications 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:
o 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.
o Surveys, questionnaires, data collection instruments, and clinical
protocols. These may 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
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.
(1) 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?
(2) 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)? Is the investigator a new investigator, an established
investigator entering a new field, or an established establishing a new
of investigation?
(3) 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?
(4) 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?
(5) 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?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The 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.
o The reasonableness of the proposed budget and duration in relation to
the proposed research.
o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
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 DKUHD webpage at
http://www.niddk.nih.gov/welcome/org/tables/kuh_table.htm or by making
direct inquiries to:
M. James Scherbenske, Ph.D.
Renal Physiology/Cell Biology and
Kidney Centers and SBIR Programs Director
DKUHD
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 613
Bethesda, MD 20892-5458
Telephone: (301) 594-7719
FAX: (301) 480-3510
E-mail: js255f@nih.gov
Direct inquiries regarding NIA programmatic issues to:
Frank Bellino, Ph.D.
Biology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C231 MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-6402
FAX: (301) 402-0010
Email: bellinof@nia.nih.gov
Direct inquiries regarding NCI programmatic issues to:
Judy Mietz, Ph.D.
Cancer Cell Biology Branch
National Cancer Institute
6130 Executive Boulevard
Executive Plaza North, Room 5032
Rockville, MD 20852
Telephone: (301) 496-7028
FAX: (301) 402-1037
Email: mietzj@nih.gov
Inquiries regarding NIDDK fiscal and administrative matters may be
directed to:
Mrs. Helen Y.S. Ling
Division of Extramural Activities
NIDDK
6707 Democracy Blvd, Room 629
Bethesda, MD 20892
Telephone: (301) 594-8857
FAX: (301) 480-3504
E-Mail: hl12d@nih.gov
Inquiries regarding NIA fiscal and administrative matters may be
directed to:
Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: lw17m@nih.gov
Inquiries regarding NCI fiscal and administrative matters may be
directed to:
Crystal Wolfrey
National Cancer Institute GAB
Executive Plaza South, Room 243, MSC 7150
6120 Executive Boulevard
Bethesda, MD 20892
Telephone: (301) 496-8634
FAX: 301-496-8601
Email: cw104j@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance
No. 93.849 and 93.866. 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
|
|
|
|
Department of Health and Human Services (HHS)
|
|
|
|
NIH... Turning Discovery Into Health®
|