Full Text HL-94-012

SPECIALIZED CENTERS OF RESEARCH:  TRANSFUSION BIOLOGY AND MEDICINE

NIH GUIDE, Volume 23, Number 13, April 1, 1994

RFA:  HL-94-012

P.T.


Keywords: 


National Heart, Lung, and Blood Institute

Letter of Intent Receipt Date:  May 31, 1994
Application Receipt Date:  September 15, 1994

PURPOSE

The objectives of the Specialized Centers of Research (SCOR) program
in Transfusion Biology and Medicine are to improve the safety and
efficacy of blood and blood components, define the indications for
their use, evaluate and possibly modify immunological responsiveness
following their administration, and develop and evaluate alternative
treatment strategies that substitute for certain of their functions
or stimulate their endogenous production so as to reduce transfusion
needs.  This initiative also encourages the use of new and innovative
technologies to pursue fundamental research studies in transfusion
biology and clinical investigations in transfusion medicine.  The
goals of this program are to understand better the basic biology of
transfusion; make optimal use of blood, blood components, and plasma
protein derivatives in specific replacement therapy; improve
transfusion practice; and perform basic and applied research on blood
substitutes.

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), Specialized Centers of Research in
Transfusion Biology and Medicine, is related to the priority area of
maternal and infant health.  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 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by for-profit and non-profit domestic
institutions, public and private, such as universities, colleges,
hospitals, and laboratories.  This RFA is intended to support SCOR
grants for basic and clinical investigations.  Therefore,
applications that include only basic or only clinical research will
not be responsive to this RFA.  In addition, clinical research
projects focused on large epidemiologic studies or large clinical
trials will be considered unresponsive to this RFA.  Awards will not
be made to foreign institutions.  However, under exceptional
circumstances, a foreign component critical to a project may be
included as a part of that project.  Women and minority investigators
are encouraged to apply.

MECHANISM OF SUPPORT

This RFA will use the National Heart, Lung, and Blood Institute
(NHLBI) SCOR (P50) grant to support this research program.
Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.  All current
policies and requirements that govern the research grant programs of
the NIH will apply to grants awarded under this RFA.

Basic and Clinical Research

The overall concept of a SCOR program focuses on scientific issues
related to diseases and therapies relevant to the mission of the
NHLBI.  It is essential, therefore, that all applications include
both basic and clinical research.  Interactions between basic and
clinical scientists are expected to strengthen the research, enhance
transfer of fundamental research findings to the clinical setting,
and identify new research directions.  Plans for transfer of findings
from basic to clinical studies should be described.

Each SCOR grant application and award must include research involving
human patients/subjects.  Support may be provided for human
biomedical and behavioral studies of etiology, pathogenesis,
prevention and prevention strategies, diagnostic approaches, and
treatment of diseases, disorders, or conditions.  Small
population-based studies, where the research can be completed within
five years, may also be proposed.  In addition, basic research
projects must be included that relate to the clinical focus.  A SCOR
may also contain one or more core units that support the research
projects.

The Principal Investigator should be an established research
scientist with the ability to ensure quality control and the
experience to administer effectively and integrate all components of
the program.  A minimum time commitment of 25 percent is expected for
this individual.  The Principal Investigator must also be the project
leader of one of the component research projects.  Project leaders
must agree to commit at least 20 percent effort to each project for
which they are responsible.

Applications 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 the GCRC
program director/principal investigator could be included with the
application.

Length of SCOR Programs

Each NHLBI SCOR program is limited to 10 years of support.
Exceptions to this policy will be made only if a thorough evaluation
of needs and opportunities, conducted by a committee composed of
non-federal experts, determines that there are extraordinarily
important reasons to continue a specific SCOR program.

Thus, under this policy, a given SCOR grant is awarded for a
five-year project period following an open competition.  If the one
five-year competing renewal that is permitted is awarded, a total of
no more than 10 years of support is possible, unless the SCOR program
is recommended for extension.

The NHLBI comprehensive evaluation of the Transfusion Biology and
Medicine SCOR program will be conducted during the second project
period according to the following timetable:

Program Announced:                          FY 1994

Project Period (First Competition):         FY 1996 to
                           FY
                                            FY 2000

Program Reannounced:                        FY 1999

Project Period:                             FY 2001 to
                                            FY 2005
(Second Competition)

Letter to SCOR Directors Regarding
SCOR Evaluation:                            FY 2002
(midway in year 02 of 2nd project period)

SCOR Evaluation Meeting:                    FY 2003
(late in year 02 of 2nd project period)

Notification of SCOR Directors
Regarding NHLBI Decision:                   FY 2003
(midway in year 03 of 2nd project period)

Number of Applications

The NHLBI does not limit the number of SCOR applications in a given
SCOR program from one institution provided there is a different SCOR
Principal Investigator for each application and each application is
self-contained and independent of the other(s).  This arrangement
does not preclude cooperation planned or possible among participants
of SCORs after awards are made.  Scientific overlap among
applications will not be accepted.  If more than one application is
envisioned from an institution, the institution is encouraged to
discuss its plans in advance with the NHLBI SCOR program
administrator.

FUNDS AVAILABLE

Applicants may request up to $1,125,000 in direct costs, not
including indirect costs for collaborating institutions, in the first
year with a maximum increase of no more than four percent in each
additional year requested in the application.  Award of grants
pursuant to this RFA is contingent upon receipt of funds for this
purpose.  It is anticipated that at least two SCOR grants will be
funded.  NHLBI's FY 1996 plans for this initiative include a maximum
of $4.4 million.  The specific amount to be funded will, however,
depend on the merit and scope of the applications received and on the
availability of funds.

Equipment is included in the budget limitation.  However, requests
for expensive special equipment that cause an application to exceed
this limit may be permitted on a case-by-case basis following staff
consultation.  Such equipment requires in-depth justification.  Final
decisions will depend on the nature of the justification and the
fiscal situation of the NHLBI.

Consortium Arrangements

If a grant application includes research activities that involve
institutions other than the grantee institution, the program is
considered a consortium effort.  Such activities may be included in a
SCOR grant application, but it is imperative that a consortium
application be prepared so that the programmatic, fiscal, and
administrative considerations are fully explained.  The published
policy governing consortia is available in the business offices of
institutions that are eligible to receive Federal grants-in-aid.
Consult the latest published policy governing consortia before
developing the application.  If clarification of the policy is
needed, contact Ms. Jane Davis, Grants Operations Branch, NHLBI,
301-594-7436.  Applicants of SCOR grants should exercise great
diligence in preserving the interactions of the participants and the
integration of the consortium project(s) with those of the parent
institution, because synergism and cohesiveness can be diminished
when projects are located outside of the group at the parent
institution.  Indirect costs paid as part of a consortium agreement
are excluded from the limit on the amount of direct costs that can be
requested.

RESEARCH OBJECTIVES

Background

During the past decade, significant scientific advances have been
made in Transfusion Medicine that have improved the safety and
quality of blood, blood components, and plasma derivatives and
changed transfusion practices.  Advances have been made in detecting
evidence for viral pathogens such as HIV-1, HIV-2, HTLV-I/HTLV-II and
hepatitis C in donated blood, thus preventing such agents from
entering the blood supply.  Moreover, procedures have been developed
to inactivate viruses in plasma derivatives and soon in plasma
itself.  Improved apheresis technologies have been developed that
permit more efficient collection and manipulation of blood components
and bone marrow.  Investigators have described properties of newly
developed plasma derivatives.  Techniques have been developed that
may lead to the use of stem cells from umbilical cord blood for bone
marrow transplantation.  As a result, the importance of blood
transfusion has been greatly expanded through the use of components
and derivatives in increasingly specialized and effective forms of
therapy.

The use of blood and blood components continues to increase.
Improved patient care, including aggressive cancer chemotherapy
programs, bone marrow transplantation, and sophisticated cardiac
surgery procedures have contributed heavily to this growth, which is
expected to continue into the future.  Consequently, the
implementation of research programs to determine the optimal use of
this valuable resource is important and timely.

Blood centers, as well as medical centers with large transfusion
services, provide an important environment for research in
transfusion medicine.  These centers also provide a variety of
educational opportunities aimed at several groups, both within and
outside the special blood bank community, including laboratory
technicians, undergraduate and graduate students, and practicing
physicians.

The SCOR mechanism is a very important and vital approach to address
issues and problems confronting transfusion medicine today.  Some of
the advantages of this mechanism are:

o  A SCOR brings together multidisciplinary groups of investigators
with valuable expertise to transfusion medicine.

o  With its multidisciplinary mix of basic, applied, and clinical
research, a SCOR offers investigators invaluable resources for
research through coordinated interactions.

o  The information that emerges from the research program of a SCOR
may be useful in addressing important national policy issues in
transfusion medicine. In the past, the SCOR program made important
contributions to the NHLBI and other federal agencies. This
involvement was particularly important during the turbulent times
brought about by the AIDS epidemic.

o  A SCOR also addresses difficult clinical questions and provides
the research needed to address related policy questions.

The Transfusion Medicine SCOR program, like the subspecialty that it
serves, is in an early, but continually evolving, state of
development.  Nevertheless, in the brief history of the program there
have been major accomplishments in basic and clinical research that
include:

o  Discovery of gp120 in the envelope of HIV-1 and recognition of its
importance for use as an antigen to detect HIV-1 antibody in blood.

o  Discovery of HIV-1 and HIV-2 specific regulatory proteins and
demonstration that they provide a means of distinguishing between the
two viruses.

o  Initial development of assays to detect HIV-2 by serological
means.

o  Recognition of the importance of the Tax gene product of
HTLV-I/HTLV-II for screening blood.

o  Discovery of a pronounced downturn in national rates of blood
collection and transfusion of red blood cells following proof that
HIV is transmissible by transfusion.

o  Discovery of significant differences across hospitals in
transfusion practice in patients undergoing the same surgical
procedures.

o  Recognition of the importance of type specific screening of
HTLV-II for the blood supply.

o  Use of soluble HLA Class I antigens to induce tolerance.

o  Performance of some feasibility studies in unrelated bone marrow
transplantation.

o  Characterization of transfusion-related tolerance induction for
solid organ transplantation.

o  Development of practical management strategies for platelet
transfusion therapy.

Since inception of the Transfusion Medicine SCOR program eight years
ago, a large proportion of studies in this program have dealt with
transfusion-transmitted infectious diseases, particularly AIDS.  This
focus on infectious disease was in part a response to the recognition
that HIV-1 could be transmitted by blood transfusion.  The
multidisciplinary configuration of the SCOR program was ideally
suited to meet the challenge of transfusion-associated AIDS.  As a
consequence, significant contributions were made in the understanding
of HIV-1, HIV-2 and other human retroviruses.  The knowledge gained
from the Transfusion Medicine SCOR program contributed significantly,
for example, in the selection, design and development of specific
assays to detect the presence of human retroviruses in blood donors.

With implementation of donor screening procedures that virtually
eliminate HIV-1 and significantly reduce the likelihood of other
transfusion-transmitted viruses from entering the blood supply, the
NHLBI is now redirecting its SCOR program to address other important
areas of scientific need and opportunity in Transfusion Biology and
Medicine.

Proposed Research

Five areas of special emphasis have been identified that are
essential for the optimal use and improvement of transfusion therapy.
Recent progress in the understanding in such areas as immune
regulation and hematopoiesis make this an opportune time to encourage
research in the following areas of emphasis.

Immunomodulatory Aspects of Transfusion

The immune system occupies a central role in the safety and efficacy
of transfusion therapy.  One of the major problems in transfusion
therapy is alloimmunization.  In some situations, the occurrence may
be of little consequence, but as a general problem, alloimmunization
is of great importance as it limits the effectiveness of transfusions
and in some cases results in death of the patient.  Investigators in
this SCOR program are encouraged to pursue studies that focus on the
mechanisms, prevention, and management of alloimmunization to
transfused blood and blood components.  One approach could include
strategies for rendering transfused products such as platelets
nonimmunogenic by removing, altering, or masking surface antigens or
interfering with immune "trigger cells."  More information is needed
about factors that determine immune responses in different
individuals and the ways of predicting patients' potential responses.
It is also important to improve our understanding of possible
deleterious immunologic effects of transfusions such as enhancement
of tumor growth and tumor recurrence as well as increasing
susceptibility to infections.  Studies on potential therapeutic
applications of immune modulation might be pursued such as the use of
intravenous immune globulins, staph protein A columns, photopheresis,
and soluble class I and class II HLA antigens.

Development of Novel Cell Therapies and Cytokine Therapies

Recent developments in the understanding of hematopoiesis and stem
cell biology, the identification of hematopoietic growth factors and
cytokines, and cell culture technology hold promise for the creation
of novel cellular components and transfusion therapies.  Studies are
needed on the identification, collection, purification, and
preservation of hematopoietic stem cells for use in transplantation.
Studies on the in vitro expansion of hematopoietic stem cells for
later use in vivo are also encouraged.  Significant advances have
been made that create realistic prospects for the establishment of in
vitro culture systems for production of stem cells for
transplantation and for the production of specific cell populations
for transfusion therapy. Studies are encouraged to further the
understanding of the in vitro requirements for such culture systems
including the use of cytokines.  In addition to the use of cytokines
to support the in vitro expansion of cells, studies are also needed
to determine the optimal use of cytokines in vivo to reduce
transfusion needs.  Studies might address the identification of those
disease states where cytokine therapy might be of use.  Studies are
needed on the dose and timing of cytokine therapy.  Research studies
on the regulation of endogenous cytokine production are important and
could eventually lead to clinical therapies.

Structure/Function Relationships of Human Blood Cell Surface Antigens

Studies are needed to better understand the relation of structure to
function in human blood cells, particularly red blood cells and
platelets.  There is a need for studies on the characterization and
biological significance of blood cell surface antigens, particularly
as they relate to the structural integrity of the cells, to specific
cell functions, and to specific disease processes.  Until recently,
the major reasons for identifying blood group antigens and antibodies
has been their importance in assuring safe and effective blood
transfusions.  In recent years, however, clinical information
regarding the relation of blood cell antigens to disease has
accumulated, as has knowledge of blood cell membrane structure and
function.  Platelet antigens are known to be associated with
functional glycoproteins on platelet membranes and platelet
antibodies have been shown to affect platelet function.  Similar
studies are needed to determine what role antibodies may play in
altering red blood cell function.  Basic research studies might also
be pursued into understanding membrane biology and signaling in blood
cells.  In the area of applied research, more studies are needed on
the improvement in the quality of cellular products used in
transfusion therapy.  With the recent emergence of new technologies
to study cellular membranes and other cellular elements, this is an
opportune time to pursue studies to improve the quality of platelet
concentrates used for transfusion.

Blood Substitutes

Research on oxygen-carrying red cell substitutes could lead to the
development of products that provide short or even possibly long term
support for anemic patients with the advantages of being universally
compatible, pathogen free, and without the requirement for
cross-matching.  They would ideally have a long shelf-life and offer
convenient storage.  There are currently several Phase I human safety
trials of artificial oxygen carriers in various stages of study.  The
results reported thus far, have been disappointing as unexpected
toxicities have been observed.  Studies are needed to understand the
mechanisms of toxicity of hemoglobin-based oxygen carriers.  Projects
might address the apparent vasoactivity of these preparations.
Animal models or in need to be delineated.  Studies on the efficacy
of artificial oxygen carriers also need to be conducted under the
experimental conditions that reflect the intended clinical use.  Of
particular importance are the function of artificial oxygen carriers
in the presence of red cells; the measurement of tissue and organ
function as an indication of efficacy; and the comparison of the
efficacy of artificial oxygen carriers with that of red cells.

Indications for Red Blood Cell or Platelet Transfusion

Despite the obvious advantages of blood transfusion, there is concern
that blood components such as red blood cells and platelets are at
times given to patients who do not really need them, are given too
frequently to patients who do need them, and occasionally, either are
not given or are given in insufficient quantities when treatment is
urgently required.  Clinical decisions regarding red blood cell and
platelet transfusions are hampered by a general lack of well designed
clinical studies, by imprecise methods of evaluating clinical need
and by uncertain methods for measuring effects.  The time-honored and
useful measurements of hemoglobin concentration and hematocrit are
clearly not sufficient, by themselves, for many patients much of the
time.  Research studies are clearly needed to improve knowledge in
these areas.  Studies might focus on the detection or development of
predictors that better define the need for red blood cell
transfusion.  The identification of organs that are specifically at
risk during acute anemia and the development of clinical monitors
that measure the state of perfusion and the presence of cellular
hypoxia in those organs that are specifically sensitive to low
hemoglobin values or a combination of low Hb and low perfusion are
promising approaches that could be pursued.  Studies are also needed
to determine the appropriate indications for platelet transfusions.
The platelet levels that predispose thrombocytopenic patients to
hemorrhage and the efficacy of therapeutic modalities other than
transfusion are not well understood and require investigation.  The
development of a practical test that predicts the likelihood of
clinically significant platelet-related bleeding would be extremely
useful.

An area of special interest to the NHLBI is neonatal transfusion
therapy.  Dramatic advances in the care of infants of low to
extremely low birth weight have resulted in survival beyond the
immediate intrapartum period.  Current practice often includes
transfusions with red blood cells as part of the therapy for most of
these infants.  However, adequacy of red blood cell transfusion in
the premature infant is most often assessed by measuring hemoglobin
and hematocrit, two parameters that, as in adults, have limited
correlation with both the need to transfuse as well as transfusion
outcome.  Research is needed to establish quantitative, clinically
useful criteria to be used in addition to or instead of hemoglobin
and hematocrit measurements in determining when to begin and end
blood transfusions in newborns.  There is a need for new, innovative
methods to assess oxygen delivery in the newborn.  Furthermore,
studies to determine transfusion outcomes in this population are also
needed.

The different research topics and approaches described in the five
areas of emphasis are intended to provide potential applicants with
examples of the types of topics that are of interest to the NHLBI and
worthy of pursuit.  These examples, however, are not meant to be all
inclusive.  Investigators are encouraged to consider pursuing other
important and innovative scientific topics as well.  It should be
emphasized, however, that the topics chosen must relate directly to
the five areas of emphasis identified in this initiative.
Furthermore, the topics may address one or more than one area of
emphasis.  For example, it would be appropriate for a SCOR applicant
to propose projects that address research issues pertaining to one
area of interest such as structure/function relationships of human
blood cell surface antigens or a combination such as
structure/function relationships of human blood cell surface antigens
and immunomodulatory aspects of transfusion.  Applicants should also
note that a SCOR program must meet the following criteria:  (1)
address areas of significant national need and clinical importance;
(2) attract talented investigators who foster the development of a
multidisciplinary and collaborative synergistic approach; (3) include
both basic and clinical components; and, most importantly; (4) have
the potential to accelerate the transfer of basic research to
clinical application.  Applicants are requested to contact the
project officer of this initiative prior to preparing a SCOR
application to make certain that their proposed program is compatible
with the objectives of this solicitation.

The major emphasis of this SCOR program is on basic, applied and
clinical research in transfusion biology and medicine, the nature of
which will depend upon the interests and areas of expertise of its
investigators, as well as on the physical resources and population
available.  However, each institution requesting SCOR support should
have a basic range of competence and potential that will enable it to
develop a program addressing the objectives and goals of this
initiative. SCORs should also provide a challenging environment for
attracting talented young scientists into biomedical research and
offering opportunities for career development.

STUDY POPULATIONS

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 new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.

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 9, 1994 (FR 59 11146-11151) and reprinted
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.

(NOTE:  When the proposed study or studies in the RFA or PA involves
a gender specific study or a single or limited number of minority
population groups, this should also be stated to inform potential
applicants and reviewers.)

LETTER OF INTENT

Prospective applicants are asked to submit, by May 31, 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 NHLBI staff to estimate the potential review
workload and to avoid conflict of interest in the review.

The letter of intent is to be sent to:

Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 557A
Bethesda, MD  20892

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) 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 Office of Grants Information, Division of Research Grants,
National Institutes of Health, Westwood Building, 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 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, to identify the application as a response
to this RFA, check "YES", enter the title "Specialized Centers of
Research in Transfusion Biology and Medicine", and the RFA number
HL-94-012 on line 2a of the face page of the application.

Send or deliver a signed, typewritten original of the application,
including the checklist, and three signed photocopies, in one package
to:

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

Send two additional copies of the application to the Chief, Review
Branch at the address listed under LETTER OF INTENT.  It is important
to send these two copies at the same time as the original and three
copies are sent to the Division of Research Grants (DRG), otherwise
the NHLBI cannot guarantee that the application will be reviewed in
competition for this RFA.

Applications must be received by September 15, 1994.  If an
application is received after that date, it will be returned to the
applicant.  DRG 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.  DRG
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 already reviewed, but such
applications must include an introduction addressing the previous
critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed by National Institutes of
Health (NIH) staff for completeness and responsiveness.  Incomplete
applications or applications deemed not responsive to the RFA will be
returned to the applicant without further consideration.

Those applications that are complete and responsive will be evaluated
for scientific and technical merit by an appropriate peer review
group convened by the NHLBI.  Crucial to the initial scientific
review will be a triage process that will eliminate all applications
that are deemed not scientifically competitive within the goals and
criteria of the RFA.  The second level of review will be provided by
the National Heart, Lung, and Blood Advisory Council.

If, through peer review, this project is not recommended for further
consideration, the overall SCOR application will not be considered
further.  If this project is judged by peer review to be of low
scientific merit, it will markedly reduce the overall scientific
merit ranking assigned to the entire application by the review
committee.

Factors to be considered in the evaluation of each application will
be similar to those used in review of traditional research grant
applications and, in addition, will include overall proposed
interactions among basic and clinical research projects.  Major
factors to be considered in the evaluation of applications include:

o  Scientific merit of the proposed basic and clinical research
projects including significance, importance, and appropriateness of
the theme; innovation, originality, and feasibility of the approach;
and adequacy of the experimental design.

o  Leadership, scientific stature, and commitment of the program
director; competence of the investigators to accomplish the proposed
research goals and their time commitment to the program; and the
feasibility and strength of consortium arrangements.

o  Collaborative interaction among basic and clinical research
components, the balance between them, and plans for transfer of
potential findings from basic to clinical studies.

o  Adequacy of the environment for performance of the proposed
research including clinical populations and/or specimens; laboratory
facilities; proposed instrumentation; quality controls;
administrative structure; institutional commitment; and, when needed,
data management systems.

o  Appropriateness of the budget for the proposed program.

INQUIRIES

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

Direct inquiries regarding scientific issues to:

George J. Nemo, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
Federal Building, Room 504
Bethesda, MD  20892
Telephone:  (301) 496-1537
FAX:  (301) 402-4843

Direct inquiries regarding fiscal and administrative matters to:

Ms. Jane Davis
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 4A15C
Bethesda, MD  20892
Telephone:  (301) 594-7436
FAX:  (301) 594-7492

AUTHORITY AND REGULATIONS

The programs of the Division of Blood Diseases and Resources, NHLBI
are described in the Catalog of Federal Domestic Assistance No.
93.839.  Awards will be made under the 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
requirement of Executive Order 12372 or Health Systems Agency review.

.

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