CYSTIC FIBROSIS CORE CENTER
Release Date: January 24, 2000
RFA: DK-00-013
National Institute of Diabetes and Digestive and Kidney Diseases
http://www.niddk.nih.gov/
Letter of Intent Receipt Date: May 16, 2000
Application Receipt Date: June 16, 2000
PURPOSE
Cystic Fibrosis (CF) Core Centers provide shared resources to enhance
research ranging from elucidation of the molecular pathogenesis of CF to
development of new therapies for this disorder. Biomedical research
cores are intended to enhance the efficiency of research and foster
collaborations at institutions with strong existing bases of research
relevant to CF. In addition to biomedical research cores, Centers
provide support for pilot and feasibility studies and an enhanced
environment for research training.
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, Cystic
Fibrosis Core Center, is related to the priority area of chronic
diseases. Potential applicants may obtain a copy of "Healthy People
2010" at http://odphp.osophs.dhhs.gov/pubs/hp2000
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 P30 grants. Racial/ethnic minority individuals, women,
and persons with disabilities are encouraged to apply as principal
investigators. An outstanding interdisciplinary program of CF research
consisting of at least $1,000,000 of peer-reviewed research projects
must be in existence at the applicant organization.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) core center
grant (P30). Except as otherwise stated in this announcement, awards
will be administered under NIH grants policy as stated in the NIH Grants
Policy Statement. Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the applicant.
The anticipated award date is April 1, 2001.
Applicants from institutions which have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the proposed
research. In such a case, a letter of agreement from either the GCRC
program director or principal investigator should be included with the
application.
FUNDS AVAILABLE
The NIDDK intends to commit approximately $1.1 million in FY 2001 to
fund one new or competitive continuation grant in response to this RFA.
The receipt of one competing continuation application is anticipated,
which will be in competition together with other applications received
in response to this RFA. An applicant may request a project period of
up to 5 years and a budget for direct costs of up to $750,000 per year,
excluding facilities and administrative(F&A)costs on consortium
arrangements. Because the nature and scope of the research proposed may
vary, it is anticipated that the size of each award will also vary.
Although the financial plans of the NIDDK 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
applications of outstanding scientific and technical merit. At this
time, it is not known if competing renewal applications will be accepted
and/or if this RFA will be reissued.
RESEARCH OBJECTIVES
Cystic fibrosis is the most common fatal genetic disease in caucasians,
affecting approximately one in 2500 newborns. Since the cloning of the
CF gene and identification of its protein product as a cAMP-regulated
chloride channel, there has been impressive progress in the molecular
understanding of this disorder. CF Core Centers are part of an
integrated program of CF-related research support within the NIDDK
directed at further defining the molecular mechanisms underlying CF and
translating information about the molecular basis of the disease into
new treatments. Continued progress will depend on multidisciplinary
collaborations among clinical and basic scientists. Core centers
provide a focus for enhancing such collaborations. Centers promote
efficient management of resources, interaction and collaboration among
scientists in multiple disciplines, and a multifaceted approach to a
common goal. The objective of the core center is facilitation of
progress in research on CF with the ultimate goal of developing new
therapies for this disorder.
CF Core Centers are designed to enhance the efficiency and effectiveness
of an established, ongoing program of research through provision of core
resources, support of pilot and feasibility studies, and support of
program enrichment activities. Thus, an outstanding existing program of
biomedical research in the area of CF is an essential prerequisite for a
CF Core Center. This research should be in the form of NIH-funded
research projects (R01 or R29), program projects (P01), Specialized
Centers of Research (P50), or other peer-reviewed research such as that
supported by the Cystic Fibrosis Foundation. This established research
program must be in existence at the time of submission of a CF Core
Center application.
A CF Core Center is composed of shared resources (cores) that enhance
productivity or in other ways benefit a group of investigators pursuing
a multifaceted approach to significant problems related to the
pathogenesis and treatment of CF. The CF Core Center is intended to
improve the quality and efficiency of research on CF by providing shared
access to specialized technical resources and expertise. Examples of
cores that would be considered responsive to this RFA include the
following: electrophysiology, cell morphology, imaging, tissue culture,
protein expression, mutagenesis, structural biology, transgenic, animal
models, gene transfer, and clinical resources. Specific cores should be
proposed based on the requirements of the investigators at the applicant
institution.
Two other types of activities may also be supported with center funding:
a pilot and feasibility program and an enrichment program. The pilot
and feasibility program provides modest support for initiatives by new
investigators, established investigators entering CF research, or
established CF investigators exploring a new research direction related
to CF. The Center grant may also include limited funds for program
enrichment such as, but not limited to, seminars, visiting scientists,
consultants, and workshops.
SPECIAL REQUIREMENTS
Applicants must be willing to participate in an annual Centers
Directors" meeting and are advised to include such travel in their
budget request.
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 was 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, available on the
web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html
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 may also obtain copies of these policies from the program
staff listed under INQUIRIES. Program staff may also provide additional
relevant information concerning the policy.
LETTER OF INTENT
Prospective applicants are asked to submit, by May 16, 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 the title of the RFA in your letter of intent.
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
6707 Democracy Blvd, Room 653 MSC 5452
Bethesda, MD 20892-5452
Bethesda, MD 20817 (for express/courier service)
Telephone: (301) 594-8885
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.
Applicants should request a copy of "Administrative Guidelines for Cystic
Fibrosis Core Centers." These guidelines contain important additional
information on the format, content, and review of applications and review
criteria. In addition, they include information on new formats and just-
in-time policies. Prospective applicants may obtain guidelines from Dr.
Catherine McKeon at the address listed under INQUIRIES.
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 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.
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
6707 Democracy Blvd, Room 653 MSC 5452
Bethesda, MD 20892-5452
Bethesda, MD 20817 (for express/courier service)
Applications must be received at NIH by June 16, 2000. 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.
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 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.
(1) 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?
(2) 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?
(3) 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?
(4) 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)? Are the scientific and administrative abilities of the Center
Director and Associate Director and their commitment and ability to devote
adequate time to the effective management of the Core Center appropriate?
(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 commitment to the program, including lines of
accountability regarding management of the Core Center grant and a
commitment to establish new positions as necessary?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o Scientific excellence of the Center"s research base which should have a
central focus on cystic fibrosis. The integration of the research base
into the goals of the Center and collaboration between Center
investigators must be described,
o Appropriateness, impact, relevance and uniqueness of the services
provided by the cores. Renewal applications must demonstrate core usage,
cost effectiveness and research progress,
o For new applications, the pilot and feasibility program is judged on
the basis of (1) scientific merit of the submitted projects and (2) the
merit of the administrative process for selecting subsequent studies. In
competing renewal applications, emphasis is placed on the program as a
whole, including past research accomplishments, success in attaining
research support and management of the program,
o The appropriateness of the Core Center budgets for the core facilities,
pilot and feasibility studies, and for enrichment and the proportion of
funds devoted to each component in relation to the total Center program,
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 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.
Schedule
Letter of Intent Receipt Date: May 16, 2000
Application Receipt Date: June 16, 2000
Peer Review Date: November - December 2000
Council Review: January 2001
Earliest Anticipated Start Date: April 1, 2001
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.
INQUIRIES
Inquiries concerning this RFA are encouraged. The opportunity to
clarify any issues or questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Catherine McKeon, Ph.D.
Division of Diabetes, Endocrinology and Metabolic DIseases
NIDDK
45 Center Drive MSC 6600
Bethesda, MD 20892-6600
Telephone: (301) 594-8810
FAX: (301) 480-3503
E-mail: Catherine_McKeon@nih.gov
Address after March 31, 2000:
6707 Democracy Blvd, Rm 6103 - MSC 5460
Bethesda 20892-5460
Bethesda, MD 20817 (for express/courier service)
Direct inquiries regarding fiscal matters to:
Cheryl Chick
Division of Extramural Activities
NIDDK
45 Center Drive MSC 6600
Bethesda, MD 20892-6600
Telephone: (301) 594-8825
FAX: (301) 480-3504
E-mail: chickc@extra.niddk.nih.gov
Address after March 31, 2000:
6707 Democracy Blvd, Rm 606 - MSC 5456
Bethesda 20892-5456
Bethesda, MD 20817 (for express/courier service)
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance
No. 93.847. 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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