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 301-435-0714, 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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