NIDDK BIOTECHNOLOGY CENTERS
Release Date: October 30, 2000
RFA: DK-01-019
National Institute of Diabetes and Digestive and Kidney Diseases
Letter of Intent Receipt Date: December 22, 2000
Application Receipt Date: January 19, 2001
PURPOSE
The purpose of this RFA is to make comprehensive gene expression technologies
widely available to researchers working in areas supported by NIDDK. This
RFA seeks to establish Biotechnology Centers that will provide genomic
profiling resources to investigators working in research areas within the
NIDDK’s mission.
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, Mouse Models of
Diabetic Complications Consortium, is related to the priority areas of
Diabetes and Chronic Disabling Conditions and to Chronic Renal Disease.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic for-profit and nonprofit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible agencies of
the Federal government. Foreign institutions are not eligible for this
solicitation. Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.
MECHANISM OF SUPPORT
This RFA will use the NIH grant-in-aid resource-related mechanism grant (R24)
award. Except as otherwise stated in this announcement, awards will be
administered as stated in the NIH Grants Policy Statement.
This RFA is a one-time solicitation. The total requested project period for
an application submitted in response to this RFA may not exceed three years.
The maximum dollar request is limited to $350,000 of direct costs for each
budget year. It is anticipated that the budget for the second and third
years will provide for pilot and feasibility studies of future projects using
this technology. Responsibility for the planning, direction, and execution
of the proposed project will be solely that of the applicant. The
anticipated award date is July 1, 2001.
FUNDS AVAILABLE
For FY 2001, $3 million will be committed to fund applications submitted in
response to this RFA. It is anticipated that about six Biotechnology Centers
will be funded, however, this funding level is dependent upon the receipt of
a sufficient number of applications of high scientific merit. Although this
program is provided for in the financial plans of the NIDDK, the award of
grants pursuant to this RFA is also contingent upon the availability of funds
for this purpose.
RESEARCH OBJECTIVES
A. Background
The tremendous acceleration in pace of scientific discovery over the last
decade, coupled with development of many new high-throughput technologies,
has created an era of unparalleled opportunity to uncover the causes of
disease and identify effective therapies. In particular, the Human Genome
Project and related efforts to identify at least some unique pieces of all
expressed genes (expressed sequence tags, ESTs) in the human genome has
resulted in an explosion of data and potential tools that will aid research
in virtually all fields of medicine. The recent development of genome-wide
expression profiling (chip or microarray) allows a comprehensive high-
throughput screening of the effects of an insult (genetic, physiologic,
pathologic, etc.) on gene expression in tissues and specific cell populations
of interest. These techniques may aid in determining the function of a gene
or discovering new biomarkers and therapeutics for patients with disease.
Many investigators with hypothesis-driven research programs want access to
these emerging technologies. Cost is a major obstacle to the application of
these techniques by large numbers of investigators. The investment required
to obtain essential equipment and personnel to establish this technology is
more than can easily be borne by a single investigator.
B. Objectives and Scope
This RFA is intended to support the cost-effective introduction of techniques
to measure patterns of gene expression in specific tissues of interest to the
NIDDK-supported investigators. This RFA will allow the formation of support
facilities that may include, but are not limited to:
1. cDNA Microarrays. The applicant might propose to print, read, and analyze
microarrays. The arrays might contain mixtures of cDNAs obtained from
commercial vendors, the Cancer Genome Anatomy Project (CGAP), or ESTs
obtained locally and of specific interest to the investigators. It is
anticipated that each printing unit will distribute arrays to 7 to 20 NIDDK
investigators. Applicants are expected to identify the sources of the cDNAs,
reference all genes to a genomic database (Entrez, Unigene, Locus Link,
etc.), and indicate plans to distribute arrays to the NIDDK community at a
reasonable cost. Applicants need not include budgets for equipment for
printing or reading arrays or for bioinformatics support if they can obtain
the necessary reagents or support from collaborative efforts or commercial
sources.
2. Oligonucleotide Chips. The applicant might propose to produce, hybridize,
read, and/or analyze gene chips from commercial or academic sources.
Applicants are expected to discuss the source and composition of the chips,
and details of the bioinformatic support.
Creation and maintenance of these technologies may require the collaboration
of investigators with expertise in many fields, such as molecular biology,
robotics, bioinformatics, genomics, and statistics. In addition, key aspects
of infrastructure may also be supported and might include the development and
maintenance of appropriate databases and specialized equipment. It is
important to emphasize that there are a variety of approaches to genome-wide
expression analysis. Therefore, a given strategy must be rigorously
justified and must demonstrate that all key personnel are involved in the
formulation of the rationale and approach.
An objective of this RFA is to provide biotechnology support for both on-
going and new hypothesis-driven research projects. Therefore, applicants will
be required to describe projects that will benefit from these technologies.
C. Annual Meetings
The Principal Investigator must be willing to be part of a Steering Committee
consisting of representatives of each Biotechnology Center. Annual meetings
will be held to encourage exchange of information among investigators who
participate in this program. A major goal of these meetings is to facilitate
progress by providing a forum that will lead to sharing skills, ideas,
technology, data, and biological reagents. At the meetings, participants
will also discuss quality assurance, bioinformatics, coordination, and
training.
D. Sharing Data and Biological Materials in Human Genetic Research
Timely sharing of information, materials, and technology will speed
scientific discovery by permitting researchers access to sufficiently large
and well-characterized resources as quickly as possible. This sharing of
materials and data, including those that have not yet or may never be
published, is essential to rapid progress and will help to avoid unnecessary
duplication of large data collections.
It is recognized that time may be required to verify the accuracy of data, to
perform initial analyses, and to protect intellectual property rights to
ensure that inventions, including therapeutic agents, are pursued and
developed rapidly for the benefit of the public. Thus, a protected period,
from the time data and materials are collected to the time they are made
available to other qualified investigators, may be appropriate. The onset
and duration of the period will vary, depending upon the nature of the
research project. Applicants must justify the length of the protected
period.
Where appropriate, grantees may work with the private sector to make unique
resources available to the larger biomedical research community at a
reasonable cost. Applicants may request funds to defray the costs of sharing
materials or submitting data, with adequate justification.
E. Post-Award Management
During the course of the grant period, technologies will improve, genomic
technologies will evolve, and the rate of progress and focus of work
supported by the grant(s) may change. It is expected that the Principal
Investigator(s), after consultation with NIDDK program staff, will make any
necessary adjustment in scientific direction to accommodate the changing
environment.
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 sub-populations must be included in all NIH-supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are provided indicating 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: The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable, and b) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
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 the policy.
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.
LETTER OF INTENT
Prospective applicants are asked to submit, by December 22, 2000, a letter of
intent that includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, the identities
of other key personnel and participating institutions, and the number and
title of the RFA in response to which the application may be submitted.
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
avoid conflict of interest in the review.
The letter of intent is to be sent to:
Chief, Review Branch
Division of Extramural Activities, NIDDK
Democracy 2, Room 655
6707 Democracy Blvd MSC 5452
Bethesda, MD 20892-5452
Telephone: (301) 594-8897
FAX: (301) 480-3505
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants. These forms 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 RFA label available in the PHS 398 (rev. 4/98) application form must be
affixed to the bottom of the face page of the application. Failure to use
this label could result in delayed processing of your 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 sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to
allow for this change. Please note this is in pdf format.
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 time of submission, two additional copies of the application must be sent
to:
Chief, Review Branch
Division of Extramural Activities, NIDDK
Democracy 2, Room 655
6707 Democracy Blvd MSC 5452
Bethesda, MD 20817-5452
Telephone: (301) 594-8897
FAX: (301) 480-3505
Applications must be received by January 19, 2001. If an application is
received after that date, it will be returned to the applicant without
review. Supplemental documents containing significant revision or additions
will not be accepted, unless applicants are notified by the Scientific Review
Administrator. 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. The CSR will not accept any application that is essentially the
same as one already reviewed. This does not preclude the submission of
substantial revisions of applications previously reviewed, but such
applications must include an introduction addressing the previous critique.
Special Instructions to Applicants
The applicants must carefully justify methodologies, technologies,
bioinformatics, statistical analytical tools, and costs, and describe the
limitations of the approaches. Genome-wide expression analysis is a rapidly
evolving field. Hence, applicants must discuss how they will be poised to
take advantage of technical and methodological advances and their impact on
the throughput and costs proposed.
The application should clearly identify both source and number of clones to
be arrayed, hybridization and standardization protocols, quality control both
of RNA and fabricated arrays, signal detection and quantitation. Particular
attention should be given to biostatistical and bioinformatics issues in both
experimental design and data analysis.
Scientific Application to Hypothesis-Driven Research Projects: Applicants
must include descriptions of five to ten ongoing representative projects that
will use the gene profiling technology. Applicants must also include
descriptions of several pilot and feasibility studies for new projects that
will use this technology. These projects should be proposed for budget years
2 and 3. Each project description should be approximately one page in length
and be included in the Experimental Design and Methods portion of the
application. Project descriptions should include a rationale for application
of array technology to the experimental problem. Experimental details should
include the tissue sources, time course, number of replicates and expected
results. The study section will consider the appropriateness of the data
analysis plan including statistics and data interpretation and prioritization
for follow-up studies.
Training and Education: Currently, only a few NIDDK-supported investigators
are in a position to use genomic technologies. To address this deficiency,
each application must include plans to establish training and education
programs. These programs should train local investigators to use these
techniques. In addition, the applicants should indicate their willingness to
provide service and training to the larger NIDDK community. The methods and
procedures for selecting qualified individuals and the duration and types of
service or training should be delineated in the application.
Internal Advisory Committee: The application must describe the composition
and functions of an internal advisory committee that would meet to discuss,
for example, quality control, prioritization of resources, funding of pilot
projects in the second and third years, training, sharing of reagents and
experimental data, and adaptation to changing technologies.
Annual Meetings: Applicants must include travel funds that will allow the
Principal Investigator and at least one other key research scientist to
participate each year for a one-day meeting in Bethesda, Maryland.
Applications should include a statement indicating willingness to participate
in these meetings.
Sharing of Data and Biological Materials: In order to ensure the timely
sharing of information and materials, applicants will be requested to
describe in detail how, when, and in what manner data, materials, and
technology will be made available to the scientific community. In addition,
the applicant should outline how the rights and interests of the participants
in genetic research will be assured.
Applicants should discuss any pre-existing intellectual property rights,
including options to for-profit research sponsors, who might be associated
with the clones, sequences, and experimental results that may be generated.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIDDK. Incomplete and/or non-responsive applications
will be returned to the applicant without further consideration.
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 receive a written
critique and may 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, assigned a priority score, and receive a
second level review by the National Diabetes and Digestive and Kidney
Diseases 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, reviewer 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 Approach: Will the technology resources significantly improve progress made
by the projects. Are the conceptual framework, design, methods, and analysis
adequately developed, well-integrated, and appropriate to the aims of the
projects? Does the applicant acknowledge potential problem areas and
consider alternative tactics? Are the applicant’s plans for quality control
of all materials adequate? Is the biostatistics and bioinformatics support
adequate? Is the applicant willing and able to participate actively in a
collaborative program? Will the applicant share resources and release data
in a timely manner, and will they train and educate other investigators in
the use of these data and materials?
o Innovation: Do the 5-10 representative projects employ novel concepts,
approaches, or methods? Do the projects challenge existing paradigms or
develop new methodologies or technologies? Are the 2-3 new pilot and
feasibility studies innovative?
o Investigator: Are the investigators appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the investigators?
o Significance: Do the scientific projects address important problems? 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 the fields?
o Environment: Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed technologies take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional support?
The initial review group will also be asked to examine how the scientific
projects will benefit from the new technologies, and how this will further
NIDDK programmatic interests.
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
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.
o The reasonableness of the proposed budget and duration to the proposed
research.
o The adequacy of the proposed protection of humans, animals, or the
environment, to the extent that they may be adversely affected by the project
proposed in the application.
AWARD CRITERIA
The anticipated date of award is July 1, 2001.
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, including program relevance of the hypothesis-
driven scientific projects that will be aided by the advanced technology,
o Total cost of the project.
INQUIRIES
Inquiries concerning this RFA are encouraged. The opportunity to clarify any
issues or questions from potential applicants is welcome. Applicants are
encouraged to review the NIDDK website for updates or responses to frequently
asked questions at http://www.niddk.nih.gov/fund/crfo/highlights.htm#biotech.
Direct inquiries regarding programmatic issues to:
Robert A. Star, M.D.
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
31 Center Drive MSC 2560
Bethesda, MD 20892-2560
Telephone: (301) 594-7715
FAX: (301) 496-2830
E-mail: Robert_Star@nih.gov
Philip F. Smith, Ph.D.
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd RM 693 MSC5460
Bethesda MD 20892-5460
Telephone: (301) 594-8816
FAX: (301) 480-3503
E-mail: ps56z@nih.gov
Jose Serrano, M.D., Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd RM 671 MSC5450
Bethesda MD 20892-5450
phone: (301) 594-8871
FAX: (301) 480-8300
E-mail:SerranoJ@extra.niddk.nih.gov
Direct inquiries regarding fiscal and administrative matters to:
Donna Huggins
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd RM 637 MSC5456
Bethesda, MD 20892-5456
Telephone: (301) 594-8848
FAX: 301-480-3504
E-mail: HugginsD@extra.niddk.nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.847, 93.848, and 93.849. Awards are 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 NIH grants policies
and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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