CENTERS OF EXCELLENCE IN MOLECULAR HEMATOLOGY

Release Date:  April 30, 1998

RFA:  DK-98-015

P.T.

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  October 20, 1998
Application Receipt Date:  November 19, 1998

PURPOSE

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
invites grant applications for Centers of Excellence in Molecular Hematology. 
The NIDDK anticipates the award of three competing Core Center Grants (P30) in
Fiscal Year 1999.

The Centers of Excellence in Molecular Hematology are part of an integrated
program of hematologic diseases-related research support provided by the NIDDK. 
The Centers currently funded in this program have provided a focus for increasing
collaboration and improving the cost-effectiveness of supported research among
groups of successful investigators at institutions with an established,
comprehensive hematologic diseases research base.

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 Request for Applications (RFA),
Centers of Excellence in Molecular Hematology, is related to the priority area
of diabetes and chronic disabling conditions.  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,
laboratories, units of State and local governments, and eligible agencies of the
Federal government.  Foreign institutions are not eligible for core center (P30)
grants.  Minority individuals and women are encouraged to submit as Principal
Investigators.

Applicant institutions must have an adequate base of established programs of high
quality in laboratory and/or clinical hematologic diseases-related research.  The
quality of the programs must be evidenced by support awarded through peer
reviewed competition.  This may include NIDDK research project grants (R01),
program project grants (P01), First Independent Research Support and Transition
(FIRST) (R29) awards, Mentored Clinical Scientist Development Awards (K08),
cooperative agreements, and contracts.  Existing support also may be through
other Federal agencies or non-federal groups.  It is required that at least fifty
percent of the hematologic diseases-related research being conducted at a new
applicant institution be supported by the NIH.

MECHANISM OF SUPPORT

Support of this program will be through the NIH Core Center (P30) award. 
Responsibility for the planning, direction, and execution of the proposed center
will be solely that of the applicant.

This RFA is a one-time solicitation.  The receipt of three competing continuation
applications is anticipated.  These applications will compete for three awards
along with other applications received in response to this RFA.  The total
project period for an application submitted in response to this RFA will not
exceed five years.  The earliest possible award date will be September 1, 1999. 
Applicants must limit their requests to not more than $700,000 direct costs for
the initial budget period.  Included in this $700,000 may be a maximum of
$100,000 for a pilot and feasibility program.  Future budget period escalations
may not exceed a 3 percent increase over the previous budget period.

Applicants from institutions that 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.  If so, a letter of
agreement from either the GCRC program director at the National Center for
Research Resources or a Principal Investigator must be included with the
application.

FUNDS AVAILABLE

For FY 1999, up to $3,000,000 in total costs will be committed to fund three
applications submitted in response to this RFA.  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 contingent upon the
availability of funds for this purpose.

RESEARCH OBJECTIVES

The objective of these Core Centers is to bring together investigators from
relevant disciplines to enhance and extend the effectiveness of research related
to hematologic diseases and their complications.  A Core Center must be an
identifiable unit within a single university medical center or a consortium of
cooperating institutions, including an affiliated university.  The overall goal
of the Core Center is to bring together clinical and basic science investigators
in a manner that will enrich the effectiveness of hematologic diseases research. 
An existing program of excellence in biomedical research in the area of
hematologic diseases and disorders is required.  This research must be in the
form of NIH funded research projects, program projects, or other peer reviewed
research that is already funded at the time of submission of a Center grant
application.  Close cooperation, communication, and collaboration among all
involved personnel of all professional disciplines are ultimate objectives.

The Core Center must have a central focus of research investigation. The central
focus must be a hematologic disease, group of diseases or functional studies
relating to hematologic diseases; at least half of the research must relate to
this central focus.  The purpose of Centers as organizational mechanisms is to
promote the joint efforts of both basic scientists and clinical researchers. 
Areas addressed by the NIDDK Centers of Excellence in Molecular
Hematology should relate to research emphases of the NIDDK in the area of
hematologic research.  The program's areas of emphasis include:

*  The molecular and cellular biology of hematopoiesis and hematopoietic stem
cell biology

*  Erythropoietin and hematopoietic growth factors

*  Receptor biology and signaling

*  Blood cell metabolism; membrane biology and ion transport heme metabolism

*  Globin biosynthesis and its genetic regulation

*  Iron absorption, storage and metabolism; pathophysiology of iron overload, and
strategies for therapeutic intervention

*  Development of approaches and techniques for gene therapy using hematopoietic
cells.

Examples of relevant investigations include the study of gene structure and
function, the structural biology of proteins and the complex biochemistry of
protein interactions, studies of the mechanisms of intracellular iron toxicity;
investigation of the mechanisms of hematopoietic gene regulation and of
differential gene expression during hematopoietic cell maturation and
differentiation, and clinical research to test the efficacy and safety of
therapeutic strategies derived from basic investigation.  These studies will have
as their ultimate goal the development of preventive, curative, or intervention
strategies in the treatment of hematopoietic diseases.  Studies may require
involvement of a broad range of investigators with training as virologists,
experimental hematologists, molecular geneticists, cell biologists,
veterinarians, and clinicians.  Concentration of efforts such as vector
development, creation of animal models, and the application of advanced
instrumentation will allow economies of scale and will generate technologies that
will be broadly applicable to the understanding of molecular disorders.  These
centers also will serve the function of facilitating the training of new
professional personnel to satisfy future manpower needs.

Applicants should consult with NIDDK staff concerning plans for the development
of the Center and the organization of the application.

Centers of Excellence in Molecular Hematology are based on the core concept. 
Three to six cores usually are included in a Center.  Cores are defined as shared
resources that enhance productivity or in other ways benefit a group of
investigators working in a Center to accomplish the stated goals of the Center. 
Examples of such resources include electron microscope, transgenic animal, and
membrane preparation facilities.

Two other types of activities may also be supported with Center funding: a pilot
and feasibility (P/F) program and an enrichment program.  The P/F program
provides modest support for new initiatives or feasibility research studies. 
This program is directed at new investigators, at investigators established in
other research disciplines with expertise that may be applied to hematologic
disease research, and, occasionally, at investigators already working in
hematologic diseases who wish to make a substantial change in the direction of
their research.  In addition, temporary salary support for one Named New
Investigator in a specified area of research with a defined P/F study may be
requested for up to 24 months. Subsequent individuals for this slot will be named
by the Center Director and approved by the Center's External Advisory Board and
the NIDDK.  The Core Center grant may include limited funds for program
enrichment such as seminars, visiting scientists, consultants, and workshops.

SPECIAL REQUIREMENTS

At least 50 percent of the already funded research base in a new application must
be supported by the NIH.  In competing continuation applications, the percent may
be less than 50 percent due to, for example, a growing research base of
investigators entering hematologic diseases from other fields.  The initial
review group will determine the significance of the research base.

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, Volume 23,
Number 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.

NIH POLICY AND GUIDELINES ON THE 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:
https://grants.nih.gov/grants/guide/notice-files/not98-024.html

LETTER OF INTENT

Prospective applicants are asked to submit, by October 20, 1998, 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
this RFA.  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 to
avoid conflicts of interest in the review.

The letter of intent is to be sent to:

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AS-37F - MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8886
FAX:  (301) 480-3505

APPLICATION PROCEDURES

The research grant applications form PHS 398 (rev. 5/95) 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
Avenue, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email:
asknih@od.nih.gov.

Administrative Guidelines for Centers of Excellence in Molecular Hematology may
be requested from the NIDDK program staff listed under INQUIRIES below.

The RFA label available in the PHS 398 (rev. 5/95) 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.

Submit a signed, typewritten original of the application, including the
Checklist, plus 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 also be sent
to:

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AS-37F - MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8886
FAX:  (301) 480-3505

Applications must be received by November 19, 1998.  If an application is
received after that date, it will be returned to the applicant without review. 
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 initially reviewed for completeness and
responsiveness.  Incomplete applications or non-responsive applications will be
returned to the applicant without further consideration.  Evaluation for
responsiveness to the program requirements and criteria stated in the RFA is an
NIDDK staff function.

Applications that are complete and are 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 NIH peer review procedures.  Applications are
unlikely to be reviewed by a site visit team; therefore, the written application
must be complete to facilitate review without a site visit.  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 will be discussed, assigned a priority score, and receive a
second level review by the National Diabetes and Digestive and Kidney Diseases
Advisory Council.

The most important component of a Center of Excellence in Molecular Hematology
is an ongoing, strong base of hematologic disease-related research.

Specific review criteria for Centers of Excellence in Molecular Hematology are:

o  The scientific excellence of the Center's research base (its strengths, its
breadth and depth) as well as the relevance and interrelation of these separately
funded research projects to the central theme(s) or focus of the Center and the
likelihood for meaningful collaborations among Center investigators.  The
existence of a base of established, independently supported biomedical research
of high quality is a prerequisite for the establishment of a Center of Excellence
in Molecular Hematology and is the most important component of the review.  (The
results of previous peer reviews of its content will weigh heavily in the
assessment of the application's overall strength as a potential recipient of an
award.)

o  The qualifications, experience, and commitment of the Center investigators
responsible for the individual research projects, and their willingness to
interrelate with each other and contribute to the overall objectives of the
Centers of Excellence in Molecular Hematology.

o  The appropriateness and relevance of the proposed Cores and their modes of
operation (such as how usage will be prioritized), facilities, and potential for
contribution to ongoing research.  Competing continuation applications must
document the use, utility, quality control, and cost effectiveness of each core
requested to continue as part of the Center.  Progress will be judged in part by
the list of publications arising from the cores.  At least two users are required
to establish a core.  However, a greater number of users will be considered to
be more cost effective.

o  For all applications, four P/F studies should be submitted for evaluation as
part of the review of the P/F program.  In general, for new applications, the
proposed P/F projects will be examined to assess the eligibility of the P/F
applicant and the adequacy of the selection process by which the individual
studies were selected.  Applicants should refer to the Administrative Guidelines
for Centers of Excellence in Molecular Hematology for specific details regarding
the P/F program and its review by the IRG.

o  The Named New Investigator, if requested, will be considered separately (see
above-referenced Administrative Guidelines for details).

o  The scientific and administrative leadership abilities of the proposed Center
Director and Associate Director and their commitment and ability to devote
adequate time to the effective management of the program.

o  The administrative organization proposed for the following:

(a) Coordination of ongoing research between the separately funded projects and
the Center, including mechanisms for internal monitoring;

(b) Establishment and maintenance of internal communication and cooperation among
the Center investigators;

(c) Mechanism for selecting and replacing professional or technical personnel
within the Core Center;

(d) Mechanism for reviewing the use of and administering funds for the P/F
program;

(e) Management capabilities that include fiscal administration, procurement,
property and personnel management, planning, budgeting, and other appropriate
capabilities;

o  The institutional commitment to the program, including lines of accountability
regarding management of the Center grant and the institution's contribution to
the management capabilities of the Center;

o  The academic environment and resources in which the activities will be
conducted, including the availability of space, equipment, facilities, and the
potential for interaction with scientists from other departments and
institutions;

o  Efficient and effective use and/or planned use of the limited enrichment
funds, including the contribution of these activities in enhancing the objectives
of the Center;

o  The appropriateness of the budgets for the proposed and approved work to be
done in Core facilities, for P/F studies (these are restricted funds and are
capped at $100,000), and for enrichment in relation to the total Center program. 
Requested Total Costs are limited to $1,000,000 (including the P/F program).

As part of the scientific and technical merit evaluation of the research plan,
reviewers will be instructed to address the adequacy of plans for including both
genders, minorities and their subgroups, and children as appropriate for the
scientific goals of the research, or justification for exclusion.

AWARD CRITERIA

The earliest anticipated date of award is September 1, 1999.

Applications recommended by the National Diabetes and Digestive and Kidney
Diseases Advisory Council will be considered for funding on the basis of overall
scientific and technical merit of the research as determined by peer review,
program needs and balance, and availability of funds.

INQUIRIES

Inquiries concerning this RFA are encouraged. The opportunity to clarify any
issues or questions from potential applicants is welcome.  It is strongly
suggested that the pamphlet "Administrative Guidelines for Centers of Excellence
in Molecular Hematology" be obtained before an application is prepared.

Inquiries regarding programmatic issues and requests for the Administrative
Guidelines may be directed to:

Dr. David G. Badman
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AS-13C MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-7717
FAX:  (301) 480-3510
Email:  David_Badman@nih.gov

Direct inquiries regarding fiscal matters to:

Aretina Perry-Jones
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AN-38B, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8862
FAX:  (301) 480-3504
Email:  PerryA@extra.niddk.nih.gov

Schedule

Letter of Intent Receipt Date:  October 20, 1998
Application Receipt Date:       November 19, 1998
Initial Review:                 March 1999
Second Level Review:            May 1999
Anticipated Date of Award:      September 1, 1999

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.848.  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
routing 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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