Full Text DK-94-013

CENTERS OF EXCELLENCE IN MOLECULAR HEMATOLOGY

NIH GUIDE, Volume 22, Number 43, November 26, 1993

RFA:  DK-94-013

P.T. 04

Keywords: 
  Hematology 
  Biology, Cellular 
  Biology, Molecular 
  Biomedical Research, Multidiscipl 
  0715132 


National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  February 4, 1994
Application Receipt Date:  March 17, 1994

PURPOSE

This Request for Applications (RFA) invites investigators to submit
research applications for Centers of Excellence in Molecular
Hematology.  The emphases for this program are fourfold:  (1) to
create a focus for multi-disciplinary investigations into the
cellular and molecular basis of genetic diseases of the blood; (2) to
encourage the efficient assembly of the needed expertise, equipment,
and technologies to generate advances in molecular hematology; (3) to
attract new scientific expertise into the study of the molecular
mechanisms of hematologic diseases and disorders; and (4) to utilize
cellular and molecular biology techniques to develop methods to
characterize, identify, treat, and cure inherited diseases of the
blood and genetic diseases of other systems.

Individual institutions with both basic and clinical research
capabilities are eligible to apply for a grant under this
announcement.  Inter-institutional collaborative research
arrangements are also appropriate and encouraged.  Coordination for
such arrangements must be evident and clearly meaningful and
appropriate for the research proposed.

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 RFA,
Centers of Excellence in Molecular Hematology, is related to the
priority area of chronic disabling conditions.  Potential applicants
may obtain a copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0) or "Healthy People 2000" (Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).

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 or local governments, and
eligible agencies of the Federal government.  Foreign institutions
are not eligible to apply.  Minority individuals and women are
encouraged to submit as Principal Investigators.

MECHANISM OF SUPPORT

Support of this program will be through the NIH specialized center
(P50) award.  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the
applicant.  Except as otherwise stated in this announcement, awards
will be administered under PHS grants policy as stated in the PHS
Grants Policy Statement.

FUNDS AVAILABLE

The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) expects to award up to three center grants for molecular
hematology research in fiscal year 1994.  The anticipated awards are
for five years and are contingent upon the availability of
appropriated funds.  The total amount of available funds to support
this program is anticipated to be no more than $2.25 million per
year.  No applicant may request more than $750,000 in total costs
(including both direct and indirect costs) in the initial budget
period.  A standard escalation factor may be used for subsequent
budget periods.  The award date for these grants will be September
30, 1994.

RESEARCH OBJECTIVES

During the past two decades, major advances have been made in
understanding the molecular basis for inherited diseases.  The
clinical and biochemical effects of some diseases have been
clarified, and the molecular defects have been described in an
ever-increasing number of genetic disorders.  Notable examples of
this new knowledge are the genes for Cooley's anemia, sickle cell
disease, and hemophilia.  Application of sensitive biochemical and
molecular techniques has made molecular diagnosis of these disorders
a reality.  Now, with these important diagnostic achievements in
hand, even greater efforts must be directed toward development of
technologies to formulate specific therapies for these and other
debilitating hematologic disorders.  Centers of Excellence in
Molecular Hematology will allow development of the broad range of
scientific expertise and technologies involved in investigation of
genetic diseases and genetic therapy to be brought together in a
unified effort.  The technologies include knowledge of viruses, cell
culture, bone marrow cells, growth factors, animal models, and the
molecular basis of genetic diseases.

The development of Centers as an organizational mechanism will
promote the joint efforts of both basic scientists and clinical
researchers toward the study of gene structure and function, the
structural biology of proteins and the complex biochemistry of
protein interactions, 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 genetic diseases.  This may include somatic gene
therapy and will 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.

The capability to design and implement strategies for clinical
application of molecular genetic knowledge will be essential for the
Centers.  However, Center funds will not be available for full-scale
clinical trials, and investigators will be encouraged to apply for
support of clinical trials by other mechanisms.

Due to the breadth of expertise in a variety of disciplines needed
for successful application of molecular genetic technologies to
genetic diseases, some applications will combine expertise from
several institutions.  Therefore, applicants are encouraged to
propose consortium arrangements with other suitable institutions with
needed expertise.  Such consortia may include geographic separation,
as long as acceptable plans for effective collaboration are proposed.
Where possible, applicant institutions are strongly encouraged to
develop relationships with traditionally minority institutions and
investigators.

Areas addressed by the NIDDK Centers of Excellence in Molecular
Hematology should relate to announced 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;
hematopoietic stem cell biology; erythropoietin and other
hematopoietic growth factors; erythrocyte metabolism and ion
transport; hematopoietic membrane biology; hemoglobin biosynthesis
and regulation; and iron absorption, storage and metabolism.

Administrative guidelines are available from the NIDDK that describe
the Centers of Excellence in Molecular Hematology (P50) and the
application process for the Centers.  These guidelines should be
requested before applying for a Center of Excellence in Molecular
Hematology Grant.

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 or Principal Investigator may be included with
the application.

SPECIAL REQUIREMENTS

Successful applicants are expected to attend a yearly meeting of
Center Directors convened by the NIDDK.  Funds to support travel to
this meeting may be requested in the budget proposed for the center.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are required to include minorities and women
in study populations so that research findings can be of benefit to
all persons at risk of the disease, disorder or condition under
study; special emphasis must be placed on the need for inclusion of
minorities and women in studies of diseases, disorders and conditions
which disproportionately affect them.  This policy is intended to
apply to males and females of all ages.  If women or minorities are
excluded or inadequately represented in clinical research,
particularly in proposed population-based studies, a clear compelling
rationale must be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues must be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information must be included in the form PHS 398
(rev. 9/91) in Item 4 (Research Design and Methods) of the Research
Plan AND summarized in Item 5, Human Subjects.  Applicants/offerors
are urged to assess carefully the feasibility of including the
broadest possible representation of minority groups.  However, NIH
recognizes that it may not be feasible or appropriate in all research
projects to include representation of the full array of United States
racial/ethnic minority populations; i.e., Native Americans [including
American Indians or Alaskan Natives], Asian/Pacific Islanders,
Blacks, Hispanics.

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research is defined as human
biomedical and behavioral studies of etiology, epidemiology,
prevention [and preventive strategies], diagnosis, or treatment of
diseases, disorders or conditions, including but not limited to
clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

If the required information is not contained within the application,
the application will be returned without review.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and reflected
in assigning the priority score to the application.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants or cooperative agreements that do not comply with these
policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by February 4, 1994, 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 subsequent applications, the information
that it contains is helpful in planning for the review of
applications.  It allows NIDDK staff to estimate the potential review
workload and to avoid possible conflict 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
Westwood Building, Room 605
Bethesda, MD  20892
Telephone:  (301) 594-7515
FAX:  (301) 594-7503

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  The form is available from most
institutional offices of sponsored research and from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone 301/435-0714.

The RFA label available in the PHS 398 application form must be
affixed to the bottom of the face page.  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 2a of the face page of
the application form and check the YES box.

Applications must include the following items:

A Table of Contents;

A Rationale for the proposed Center and a Statement of Objectives;

Institutional Environment and Resources;

Organization and Administrative Structure of the Center;

Specific Managerial Responsibilities for the Center;

Travel funds in the proposed budget for an annual meeting of Center
Directors;

A description of the method for replacement of the Center Director
(should the need arise);

A description of the proposed research projects;

A description of the proposed cores;

A description of the procedure to be used for the addition/deletion
of cores and projects during the proposed period of operation;

A description of the administrative relationship of the Center to the
applicant institution.

Submit a signed, typewritten original of the application, including
the Checklist, and three signed, exact photocopies, in one package
to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At time of submission, two additional copies of the application must
also be sent under separate cover to:

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
Bethesda, MD  20892

Applications must be received by March 17, 1994.  If an application
is received after that date, it will be returned to the applicant.

REVIEW CONSIDERATIONS

Upon receipt, applications will be examined 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.

Those applications that are complete and responsive will be evaluated
in accordance with the criteria stated below for scientific/technical
merit by an appropriate peer review group convened by the NIDDK.  If
the number of applications is large compared to the number of awards
to be made, a preliminary scientific peer review may be conducted and
applications withdrawn from further competition when they are not
competitive for the award.  The NIDDK will notify the applicant and
institutional official of this action.

Those applications judged to be competitive will be reviewed for
scientific and technical merit in accordance with the usual NIH peer
review procedures by an initial review group specifically convened
for this RFA.  Following this review, the applications will be given
a secondary review by the NIDDK Advisory Council unless not
recommended for further consideration by the initial review group.

The review criteria for individual research projects include:

o  The scientific, technical or medical significance and originality
of the proposed research;

o  The feasibility and adequacy of the experimental design;

o  The qualifications and research experience of the proposed
personnel;

o  The availability of resources necessary for the research;

o  The appropriateness of the budget and timetable in relation to the
scope of the proposed research;

The review criteria for scientific cores include:

o  The appropriateness and utility of the core to the proposed
Center;

o  Each core unit must provide facilities or services to at least two
research projects recommended for approval;

o  The quality of the proposed facilities or services including
administrative arrangements for utilizing the core;

o  The qualifications, experience, and commitment of the personnel
involved in the core;

o  The appropriateness of the budget.

The review criteria for the overall Center program include:

o  The scientific merit of the program as a whole;

o  The significance of the overall goals of the Center;

o  The cohesiveness and multi-disciplinary scope of the Center and
the coordination and interrelationship of the projects and cores to
the common theme of the Center;

o  The leadership, scientific expertise, and commitment of the
proposed Center Director.

Administrative Considerations

o  The institutional environment for and resources available to
Center investigators;

o  The institutional commitment to the proposed Center;

o  The administrative leadership necessary to provide for the quality
control of supported projects in the Center, the allocation of funds,
and the ability to foster communication and cooperation among Center
investigators;

o  The appropriateness of the budget in relation to the proposed
activities of the Center;

o  The adequacy of addressing the protection of human subjects,
animal welfare, and biohazard issues.

AWARD CRITERIA

The anticipated date of award is September 30, 1994.  Factors that
will be taken into consideration in making awards include the
scientific merit of the proposed Center as determined by peer review
and the availability of funds and programmatic balance among the
topics represented in this RFA.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Inquiries regarding programmatic issues may be directed to:

David G. Badman, Ph.D.
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 5A-04
Bethesda, MD  20892
Telephone:  (301) 594-7541
FAX:  (301) 594-7501

Inquiries regarding fiscal matters may be directed to:

Aretina D. Perry
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 649
Bethesda, MD  20892
Telephone:  (301) 594-7543

Schedule

Letter of Intent Receipt Date:  February 4, 1994
Application Receipt Date:       March 17, 1994
Initial Review:                 July 1994
Second Level Review:            September 1994
Anticipated Date of Award:      September 30, 1994

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.849.  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.

.

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