SPECIALIZED CENTERS OF RESEARCH (SCOR) IN HEMOSTATIC AND THROMBOTIC DISEASES

Release Date:  July 29, 1999

RFA: HL-99-022

National Heart, Lung, and Blood Institute

Letter of Intent Receipt Date: December 1, 1999
Application Receipt Date: January 14, 2000

PURPOSE

This solicitation invites grant applications to enter a single open
competition for Specialized Centers of Research (SCOR) in Hemostatic and
Thrombotic Diseases. The goal of this initiative is to support quality basic
research, facilitate transfer of the basic knowledge to the clinical setting
and stimulate clinical studies in these areas.  Such a program will involve
innovative technology, a close interaction between the subprojects and contain
one or more clinical components.

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 initiative, Specialized Centers of
Research (SCOR) in Hemostatic and Thrombotic Diseases, is related to the
priority area of Heart Disease and Stroke.  Potential applicants may obtain a
copy of "Healthy People 2000," (Full Report: Stock No. 017-001-00474-0 or
Summary Report: Stock No. 017-001-00473-01) 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
institutions, public and private, such as universities, colleges, hospitals,
and laboratories.  This RFA is intended to support SCOR grants for basic and
clinical investigations.  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.  Foreign institutions are
ineligible from receiving awards under this solicitation.  Under exceptional
circumstances, a foreign component critical to a project may be included as a
part of that project.  Racial/ethnic minority individuals, women, and persons
with disabilities are encouraged to apply as Principal Investigators or
responsible project investigators.

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.  If, through peer review, this project is determined to be of low
scientific merit, the over all 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.  Project leaders must agree
to commit at least 20 percent effort to each project for which they are
responsible.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) specialized centers
(P50) mechanism to support this research program.  Responsibility for planning
the proposed project will be solely that of the applicant.  The total project
period for applications submitted in response to the present RFA may not
exceed five years.  The anticipated start date of award is February 1, 2001.

Although multidisciplinary approaches are required, it is not the intent of
this announcement to solicit applications for large clinical trials or large
epidemiologic studies.  In general, funds will not be provided for the
purchase and installation of expensive, new equipment.

Upon initiation of the program, there will be required communications between
SCORs, usually in the setting of a biennial combined meeting of SCOR
participants.  Applicants should request travel funds for this purpose in
fiscal years 2002, 2004, and 2006 of the budget.  Applicants should also
include a statement in their applications indicating their willingness to
participate in these meetings.

Basic and Clinical Research

The overall concept of a SCOR program focuses on scientific issues related to
diseases relevant to the mission of the National Heart, Lung, and Blood,
Institute (NHLBI).  It is essential, therefore, that all applications include
both basic and clinical research projects.  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, which is defined as research conducted with human
patients/subjects or on material of human origin such as tissue or other
specimens for which an investigator directly interacts with 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 epidemiologic 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.

Length of SCOR Programs

Each NHLBI SCOR program is limited to ten 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.

Under this policy, a given SCOR grant is awarded for a five-year project
period following an open competition.  Only one five-year competing renewal is
permitted, for a total of ten years of support, unless the SCOR program is
recommended for extension.

The SCOR program in Hemostatic and Thrombotic Diseases  is in the initial
five-year project period and this competition is for the second five-year
competition.  The comprehensive evaluation of this SCOR Program will be
conducted during the second project period according to the following
timetable:

Announcement of SCOR renewal competition  FY 1999

Project Period (Second Competition)       FY 2001 to FY 2005

Letter to SCOR Directors                  FY 2002 (mid-way through year -02 of
regarding SCOR evaluation plans            the second project period)

SCOR Evaluation Meeting                   FY 2002 (late in year -02 of the
                                           second project period)

Notification of SCOR Directors            FY 2003 (mid-way through year -03 of
of NHLBI Decision                          of second project period)

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 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 with the NHLBI SCOR program administrator.

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 and can
provide scientific expertise in areas and topics that may not be readily
available at the applicant institution.  However, the consortium projects must
not constitute greater than 50 percent of the proposed projects.  It is also
imperative that a consortium application be prepared so that the programmatic,
fiscal, and administrative considerations are explained fully.  Applicants
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.

Facilities and Administrative costs paid as part of a consortium agreement are
excluded from the limit on the amount of direct costs that can be requested.
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
of the Grants Operation Branch, NHLBI, (301) 435-0166.

FUNDS AVAILABLE

Applicants for new SCOR programs may request up to $1.28 million in direct
costs, not including Facilities and Administrative costs for collaborating
institutions, in the first year with a maximum increase of no more than three
percent in each additional year requested in the application.  Competing
renewal applicants may request an increase in their budget in the first
competing year (Year 06), not to exceed ten percent of the costs awarded in
the last noncompeting award year (Year 05) or $1.28 million, whichever is
greater (excluding Facilities and Administrative costs on subcontracts). 
Applicants may request up to a three percent increase for subsequent
noncompeting years.  NHLBI's FY 2001 plans for this initiative include a
maximum of $5.0 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.

Award of grants pursuant to this RFA is contingent upon receipt of funds for
this purpose.  Designated funding levels are subject to change at any time
prior to final award, due to unforeseen budgetary, administrative, and/or
scientific developments.

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 justification.  Final decisions will depend on the nature
of the justification and the availability of funds.

RESEARCH OBJECTIVES

Background

Nearly 50 percent of mortality in the United States is related to
cardiovascular disease and amounts to about 1 million deaths per year. 
Thrombotic events precipitate myocardial infarction, deep vein thrombosis  and
pulmonary embolism, and stroke.  Formation of a blood clot and the resulting
ischemia cause the tissue damage and the associated disability or death.  In
spite of the seriousness of the disease and its impact, there has been
significant improvements in our ability to combat thrombotic disorders and
cardiovascular diseases.  This improvement would not have been possible
without major progress in research on thrombosis.  The application of
innovative technology in molecular biology, immunology, genetics and protein
chemistry has led to the development of new tools in the following areas of
emphasis and provide opportunities to further reduce the risk of thrombotic
and hemostatic disorders.

o  Polygenic analysis of thrombotic disorders

The pathogenesis of thrombosis is complex and its etiology is likely to
involve both hereditary and acquired conditions.  There are a number of
proteins - antithrombin, protein C, protein S, clotting factor V, prothrombin,
thrombomodulin, plasminogen activator inhibitor 1 - in which a genetic
alteration may be prothrombotic.  Significant progress has been made in
establishing the structure-function and polymorphism of platelet membrane
proteins.  Some of the cytoplasmic proteins that are critical in the two-way
signal transduction pathway in platelets have also been identified. However,
heterozygosity for a particular mutant allele can be clinically silent in some
individuals but not in others.  These differences could be due to intergene
interactions or the effect of environmental factors.  The gene structure of
many candidate proteins involved in hemostasis and thrombosis are known. The
availability of knockout and transgenic animals and new information from human
genome studies may allow genetic delineation of the causative factors and
provide an objective definition of predisposition to thrombosis.  Many human
diseases are related to behavior, nutrition and other environmental factors. 
Recent developments on prevention of thrombosis by alterations in lifestyle or
in nutritional elements offer exciting research opportunities.

o  Diagnosis, Assays, and Treatment of Venous Thrombosis

Two million Americans develop deep vein thrombosis a year.  About 600,000 of
them will have pulmonary embolism and approximately ten percent will die. 
There are important issues involving diagnosis, anticoagulation therapy,
laboratory assays, efficacy of thrombolytic therapy which need further
studies.  There is a need for more specific and better anticoagulant agents. 
Systematic, controlled studies on their efficacy and potential complications
are critical for effective clinical application.  Optimal therapy to prevent
growth of thrombi at early stages and restoration of involved vessels to as
normal a state as possible are likely to be beneficial.

o  Thrombosis in Special Populations

Clinical research that addresses thrombosis in special population groups such
as children, women, and minorities is needed.  The incidence of established
genetic risk factors, for example Factor V Leiden, is known to be different in
minority populations. Studies in special population groups offer opportunities
to identify unknown thrombophilic factors.  Thrombotic disorders most commonly
encountered in critically ill children and neonates is of the acquired type
and genetic risk factors can rarely be identified.  Antithrombotic therapy for
the prevention and treatment of thrombosis in children is mostly based on
modifications of recommendations for adults.  The magnitude and seriousness of
thrombotic problems in the pediatric population are only recently being
recognized.  The optimal diagnosis, management, treatment, dosing, duration of
anticoagulation, efficacy of thrombolytic therapy all remain important
questions to be answered.

o  Inflammation and Thrombosis

Recent studies indicate a close relationship between inflammation and
thrombosis.  Monocytes may be a major source of tissue factor and initiate
coagulation.  Blood monocytes also stick to adhesive proteins translocated on
the surface of activated platelets. This cell-cell contact may differentially
affect monocyte gene expression and the secretion of chemokines in
inflammatory lesions in vivo. Studies on the role of leukocytes in thrombosis
and the contribution of markers of inflammation to thrombolytic resistance are
needed.  There seems to be an interplay between inflammation, cytokines and
thrombosis. The role of adhesive proteins and receptors in leukocyte
migration, and the interaction of the complement system with the coagulation
and fibrinolytic processes need to be defined. Septic shock with attendant 
disseminated intravascular coagulation (DIC)annually affects 400,000
hospitalized patients and has a high mortality rate. Basic research on the
pathogenesis of DIC, improved therapy and clinical management of the patients
remains a challenge.

o  Immune Disorders

Immune related disorders have been known to have serious hematologic and
thrombotic consequences.  A better understanding of the pathogenesis of
heparin-induced thrombocytopenia (HIT) and thrombosis may allow improved
diagnosis and treatment of the disorder.  Activation of platelets by an
antigen-antibody complex and their subsequent removal by the phagocytic system
appears to be the basis of the thrombocytopenia although why certain patients
with HIT develop thrombosis while others do not remain unexplained.  The
nature of the PF4 antigen, formation of the antigen-antibody complex, its
effects on platelets, endothelial cells and the coagulation system require
further studies. Treatment of HIT, particularly those associated with the use
of low molecular weight heparin, are needed.  Additional studies on immune
disorders with thrombotic or hemostatic consequences such as systemic lupus
erythematosus (SLE), neonatal alloimmune thrombocytopenia, autoimmune
thrombocytopenia (ITP), thrombotic thrombocytopenic purpura (TTP), paroxysmal
nocturnal hemoglobinuria (PNH) may be proposed.

o  von Willebrand Factor

The von Willebrand factor (vWF) is being increasingly recognized as a key
player in hemostasis and thrombosis.  vWF binds to platelet surface
glycoprotein GP Ib and mediates their aggregation, especially at a high shear
rate.  Basic research on the initial steps of platelet adhesion and its
application to the development of antithrombotic agents directed to GP Ib-vWF
are needed.  Moreover, von Willebrand disease is the most common familial
bleeding disorder affecting both men and women.  There is a need for
additional basic and clinical studies on vWD, its treatment, products for
therapy, assays and clinical correlation.

o  Protease-Activated Receptors

A group of cell surface G-protein coupled receptors that are involved in the
proteolytic activation of different cells has been identified.  At this time
four such receptors (PAR 1 to PAR 4) have been reported and cloned. 
Activation of human platelets by thrombin probably involves two such
receptors.  Thrombin may also activate endothelial cells through PAR(s) and
regulate the adhesive protein expression on the surface.  Leukocyte
infiltration in inflammation, smooth muscle cell proliferation, angiogenesis
are likely to involve these receptors.  A better understanding of the unique
mechanism of PAR-mediated activation of cells by thrombin seems essential for
the identification of therapeutic targets and clinical applications in
thrombosis, atherosclerosis and inflammation.

o  Vascular Diversity

Vascular endothelial cells play a critical role in hemostasis and thrombosis. 
Vascular beds differ in structure, metabolic function and molecular diversity. 
Genetic approaches and phage display have revealed organ-specific molecular
differences of the endothelium in different tissues.  This diversity could be
a determinant factor in the interaction of coagulation factors leading to the
generation of thrombin, the interaction of platelets and formation or
dissolution of thrombi in different organs.  The molecular address of the
endothelium in different tissues e.g. heart, brain, kidney and its regulation
are important areas in the pathogenesis of thrombosis.  Structure-function
studies on the natural anticoagulant molecules on the endothelial surface and
their genetic manipulation may be a productive research area.

Proposed Research

There are significant opportunities in basic thrombosis research and the
application of the results to clinical situations.  The following are examples
only, one or more of which may constitute a multidisciplinary research
approach to clinical problems.

o Analysis of the multiple genetic factors involved in thrombosis and the
effect of environmental interactions in precipitating disease.

o Studies on the diagnosis, assays and treatment for venous thrombosis.

o Investigations on the diagnosis, management and treatment of thrombosis in
special population groups such as pediatric, women, minorities, elderly, and
the obese.

o Elucidation of the relationship between inflammation and thrombosis and
studies on disseminated intravascular coagulation.

o Research on immune disorders with thrombotic and hemostatic involvement..

o Studies on von Willebrand Factor and regulation of hemostasis and platelet
function.

o Investigations on genetic regulation of the synthesis, catabolism and
function of fibrinolytic proteins

o Studies on protease-activated receptors and their function in platelets and
endothelial cells.

o Examination of endothelial diversity and its implications in hemostasis and
thrombosis.

SPECIAL REQUIREMENTS

Special features of SCOR grants are:

o  They provide opportunities for young and established investigators with
mutual or complementary interests to engage in multidisciplinary basic and
clinical research in a synergistic fashion such that major therapeutic
advances will be realized.

o  A SCOR has a central theme to which all research projects pertain.  In
addition, a SCOR may include core units to provide services to the various
research projects and to support the organizational and administrative aspects
of the program.

o  Inherent in the SCOR program is a special interaction between the SCOR
director, the grantee institution and the Division of Blood Diseases and
Resources (DBDR).  Upon initiation of the program, DBDR will hold periodic
meetings to encourage exchange of information among investigators who
participate in this program and to stimulate collaboration.  Applicants should
include travel funds for a two-day meeting every other year, most likely to be
held in Bethesda, Maryland.  Applicants should also include a statement in
their applications indicating their willingness to participate in these
meetings.

o  The Division's overall SCOR program and each SCOR grant undergo periodic
evaluation.  The progress reports are prepared for the information of the
National Heart, Lung, and Blood Advisory Council, the Division of Blood
Diseases and Resources staff, and ad hoc members of SCOR evaluation groups.

Requirements of SCOR grants:

o  The overall concept of a SCOR program focuses on scientific issues related
to the mission of the NHLBI.  It is essential, therefore, that all
applications include both basic and clinical research projects.  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.

o  Each SCOR must have a well-delineated organizational structure and
administrative mechanism that foster interactions between investigators,
accelerate the pace of research, and ensure a productive research effort.

o  Each SCOR grant application and award must include research involving human
patients/subjects, which is defined as research conducted with human
patients/subjects or on material of human origin such as tissue or other
specimens for which an investigator directly interacts with 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. Each
component project requires a well-described hypothesis, preliminary data and a
time-table for conducting the proposed investigations.  A SCOR may also
contain one or more core units that support the research projects.  The
relationship between each research project and one or more core units should
be described.

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

o  The principal investigator should be an established 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.  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.

o  Project leaders must agree to commit at least 20 percent effort to each
project for which they are responsible.  Investigators with minimal research
experience, but promising credentials, may participate; however, it is
expected that most of the project directors will be investigators with
significant research experience.

o  If a project director transfers to another institution, support for the
project will normally not be continued as a consortium.

Because of the size and complexity of a SCOR, prospective applicants are urged
to consult with the staff of the Division of Blood Diseases and Resources
early in the preparation of the application (see Inquiries section).  To
provide opportunity for such interactions, the time frame for implementation
of this program includes an ample interval between the release of this RFA and
the receipt date for applications, January 14, 2000.

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). 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 (F59 14508-14513), and in
the NIH Guide for Grants and Contracts of March 18, 1994, Volume 23, Number
11.

Investigators may obtain copies from these sources or from the program staff
or contact person listed under Inquiries.  Program staff may also provide
additional relevant information concerning the policy.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the 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 Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

LETTER OF INTENT

Prospective applicants are asked to submit, a letter of intent, by December 1,
1999, 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, it assists the 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:

Dr. C. James Scheirer
Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung and Blood Institute
6701 Rockledge Drive, Suite 7093, MSC 7924
Bethesda, MD 20892-7924
Tel: (301) 435-0266
Fax: (301) 480-3541
Email: js110j@nih.gov

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 or 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, and from the NIH program administrator
listed under INQUIRIES.  Specific instructions for preparing a SCOR
application are also available from the program contact listed under
INQUIRIES.

The RFA label included in grant application PHS 398 (rev. 4/98) must be
affixed to the bottom of the face page of the application.  The RFA label and
line 2 of the application should both indicate the RFA number.  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, SCOR in Hemostatic and Thrombotic Diseases  and number, HL-99-022 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.

Send or deliver 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)

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
Center for Scientific Review (CSR).

Applications must be received by January 14, 2000.  If an application is
received after that date, it will be returned to the applicant without review. 
The 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 already
reviewed, but such applications must include an introduction addressing the
previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by the NHLBI staff.  Incomplete applications or applications
deemed not responsive to the RFA 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 NHLBI in accordance with the review criteria stated below.  Applicants
should submit the highest quality applications possible to CSR as no site
visits or reverse site visits will be held.  As part of the initial merit
review, a streamlined process may be used by the initial review group in which
the scientific merit of applications relative to other applications received
in response to the RFA will be determined.  Applications judged to be of high
scientific merit will be discussed and be assigned a priority score, and will
also receive a second level of review by the National Heart, Lung, and Blood
Advisory Council.  Applications determined to be of low scientific merit will
be withdrawn from further consideration and the principal investigator and the
official signing for the applicant organization will be notified.

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.

o  Appropriateness of the central theme and coordination and interrelation of
the research projects and core units.

AWARD CRITERIA

The anticipated date of award is February 1, 2001,  for the SCORs in
Hemostatic and Thrombotic Diseases.  Awards will be made according to priority
score, availability of funds, and programmatic priorities.

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 programmatic issues to:

Pankaj Ganguly , Ph.D.

Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7950
Bethesda, MD  20892-7950
Telephone:  (301) 435-0070
FAX:  (301) 480-1046
Email:  gangulyp@nih.gov

Direct inquiries regarding fiscal and administrative matters to:

Ms. Jane Davis
Division of Extramural Affairs
National Heart, Lung and Blood Institute
6701 Rockledge Drive, Suite 7174, MSC 7926
Bethesda, MD 20892-7926
Telephone:  (301)-435-0166
FAX: (301)-480-3310
Email: davisj@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.839, Blood Diseases and Resources.  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.  All current
policies and requirements that govern the research grant programs of the NIH
will apply to grants awarded under this RFA.

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.


Return to Volume Index

Return to NIH Guide Main Index


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.