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Full Text HL-96-002


NIH GUIDE, Volume 24, Number 39, November 3, 1995

RFA:  HL-96-002

National Heart, Lung, and Blood Institute

P.T. 04

  Blood Diseases 
  Biomedical Research, Multidiscipl 

Letter of Intent Receipt Date:  March 1, 1996
Application Receipt Date:  September 18, 1996


The Division of Blood Diseases and Resources (DBDR) of the National
Heart, Lung, and Blood Institute (NHLBI), National Institutes of
Health (NIH), invites applications for the support of Comprehensive
Sickle Cell Centers to focus on multidisciplinary programs of basic,
applied, and clinical research, and also to include relevant service
activities in diagnosis, counseling and education concerning sickle
cell disease and related disorders.


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), Comprehensive Sickle Cell Centers, is related
to the priority areas of chronic disabling conditions and 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 202-512-1800).


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.  Applicant organizations
must be associated with an established medical institution with
facilities and patient populations available for clinical
investigations in sickle cell disease.

Awards will not be made to foreign institutions.  However,
subprojects to foreign institutions may be considered for research of
unusual merit, programmatic need, unique potential, and documented
evidence of effective collaborative arrangements.  Applications from
minority individuals, women, and persons with disabilities are
encouraged.  Minority health professional institutions are strongly
encouraged to apply.


This RFA will use the National Institutes of Health (NIH)
Comprehensive Center (P60) mechanism.  Sickle Cell Center grants are
identifiable units within sponsoring institutions that are organized
around a group of investigators and other health professionals
engaged in ongoing basic and clinical research and community service
related to sickle cell disease.  Centers provide support for multi
disciplinary programs of basic, clinical and behavioral research; for
core resources such as laboratory and data analysis; and for quality
service activities including diagnosis, counseling, and education.

A Center is headed by a Program Director who is responsible for and
provides leadership to all Center components, and who may also be
principal investigator on one or more of the projects contained
within the Center.  Although individual components may enjoy a
certain amount of autonomy in the conduct of a specific project, each
is directly accountable to the Center Program Director, who has
overall responsibility for program coordination, implementation, and

The Program Director must maintain close contact with NHLBI program
administrators and grants management officers responsible for each
grant.  Committees, internal and external, which provide scientific
and fiscal overview of Center activities are required. In addition, a
formal ongoing agreement between the sponsoring institution and the
Center must be developed spelling out the commitment of each to the
other.  In particular, the sponsoring institution should make a
formal commitment of financial support to all components of a
proposed Center specifically defining the resources for the salaries,
equipment, supplies, and facilities that will be available to the
investigators for the entire project period.

Under the guidance of the Program Director, each of the required
program components and services (research, education, diagnosis, and
counseling) should be coordinated and integrated to strengthen the
overall program, enhance transfer of new findings to the clinical
setting, and identify new research directions.  Such interaction
should be frequent, formalized, and documented to facilitate
continuous exchange of relevant information between projects and
components, thus contributing to greater program productivity and
effectiveness.  Regular meetings of project directors, seminars,
poster sessions, and staff lectures are excellent mechanisms for
fostering communication and interaction among Center staff.

Finally, each Program Director will be expected to develop a
mechanism for the ongoing evaluation of the effectiveness and impact
of the activities constituting the Center program.
While NHLBI will continue to assess the quality and performance
characteristics of the program through periodic peer review and staff
evaluation, each of the Centers must consider approaches by which it
can demonstrate how the local program has influenced understanding
and practice in matters related to sickle cell disease.  Only by
establishing and validating the benefits of the Center program can
the long term support of this approach be justified.


The FY 95 fiscal support for the Centers program is $19.3 million.
Although the NHLBI will consider a modest expansion of this program,
it should be noted that the availability of FY 98 funding is
contingent on the provision of money through the appropriation
process.  It is anticipated that ten grants will be awarded under
this program.  The specific number to be funded will, however, depend
on the merit and scope of the applications received and on the
availability of funds.



Sickle cell disease is a worldwide health problem and is one of the
most common inherited disorders of man.  This genetic blood disorder
is probably the best understood disease at the molecular level and
Linus Pauling coined the term "molecular disease" over forty years
ago in ascribing the abnormality to the globin portion of the
hemoglobin molecule.  Almost ten years later, the specific molecular
defect was identified as a single amino acid substitution of valine
for glutamic acid at position 6 of the beta-globin polypeptide chain.
With the advent of recombinant DNA technology, investigators were
able to further define this genetic mutation in the globin gene as a
change in the codon GAG to GTG.  The substitution of glutamic acid by
valine results in a loss of two negative charges on the surface of
the molecule making sickle hemoglobin less soluble than normal
hemoglobin upon deoxygenation.  This abnormal hemoglobin aggregates
and forms fibers within the red cells, leading to morphological
changes that subsequently affect the ability of the cells to traverse
the microvasculature, causing occlusion of these small vessels that
results in acute pain, and acute as well as chronic organ damage.  In
addition, sickle red cells are less resilient than normal cells,
leading to their early destruction and thus a chronic anemia.  This
cascade of events caused by the abnormal cell morphology affects the
structure and function of the red cells, blood flow through tissues
and organs throughout the body, and abnormal interaction of these
cells with the microvasculature.  The complex pathophysiology of this
disorder is a direct consequence of the change in morphology of red
cells containing sickle hemoglobin.  Despite the distinction of being
the first described molecular disease, there is no cure or effective
treatment currently available.

The NIH established the Comprehensive Sickle Cell Center Program in
1972, in response to a Presidential initiative and Congressional
mandate.  After an open competition, ten Centers were funded in 1972
and five additional Centers in 1973.  Subsequent RFAs were announced
in 1977, 1978, 1983, 1988, and 1993.  Ten Comprehensive Sickle Cell
Centers are currently funded.  With this RFA, the Sickle Cell Disease
Scientific Research Group, Blood Diseases Program, Division of Blood
Diseases and Resources, National Heart, Lung, and Blood Institute,
announces its plan to fund 10 Comprehensive Sickle Cell Centers, for
the period 1998-2003.

Research Opportunities

Although significant progress has been made over the past two decades
in understanding the pathophysiology of sickle cell disease, many
unresolved problems remain.  Research in the Center's program should
take advantage of new scientific advances to address the broad and
interdisciplinary spectrum of research questions about sickle cell
disease that will ultimately lead to improvement in treatment and
prevention of complications of this disorder.  The scope of research
is unlimited, however, emphasis is placed on the development of
innovative approaches, and new hypotheses applied to understanding
this disease process.

While a Center must devote its major effort to basic and clinical
research, it must also provide supporting activities in diagnosis,
education and counseling.  It is anticipated that the total program,
i.e., all ten Centers combined, will achieve a mix of outstanding
projects that are two-thirds research oriented and one-third devoted
to supporting activities.  The actual balance between research and
other activities will vary from Center to Center and will depend on
local circumstances and competencies.

Examples of ongoing research and/or new areas of opportunity in
basic, clinical, behavioral, and other services include, but are not
limited to, the following:

Basic Research

o  Gene therapy, including the development of methods to improve the
propagation of hematopoietic stem cells and alternative gene delivery

o  Study of the regulation of globin gene expression, including the
regulation of fetal to adult globin gene switch environment of the
red cells in sickle cell disease

o  Analysis of the pathogenesis/pathophysiology of red cell adhesion
and of the microenvironment of the red cells in sickle cell disease

o  Examination of the pathogenesis/pathophysiology of vaso-occlusion

o  Study of non-red cell contributors to sickle cell disease
pathophysiology, including clotting factors, cytokines, white cells,
endothelial cells, free radicals, etc.

o  Analysis of the role of genetic polymorphism on phenotypic
expression in sickle cell disease

o  Improving animal and cellular model systems to clarify
pathogenesis and to evaluate new approaches to treatment

Clinical Research

o  Collaborative clinical research - Joint efforts are strongly
encouraged to develop, design, implement, conduct, and publish
findings from clinical studies for sickle cell disease; to foster the
development of standardized approaches for the care of patients; and
to support centralized data and statistical services for clinical

Collaborative clinical research among Center applicants can be
proposed as a part of the original application.  It may also be
planned following the Center competition.

Research areas appropriate for single center or collaborative
approaches to clinical studies include, but are not limited to:

o  Development of disease severity indices
o  Drug therapies
o  Central nervous system disease
o  Pulmonary disease
o  Renal disease
o  Immune system dysfunction
o  Pain management - pharmacologic interventions

Behavioral Research

o  Pain management - non-pharmacologic interventions

o  Newborn (or perinatal/neonatal) medicine - e.g., outcome
evaluation of early intervention in newborn screening

o  Adolescent medicine - e.g., assessing barriers to treatment,
enrolling in clinical trials

o  Adult medicine - e.g., achieving optimal transition from
pediatric/adolescent to adult care modes

o  Patient compliance with treatment regimens

o  Outcomes research - e.g. assessing the impact of different health
care systems (e.g. managed care organizations) on patterns of care
for sickle cell patients

o  Evaluating the effectiveness of intervention strategies to achieve
optimal adjustment of the patient and family to sickle cell disease

Other Supporting Activities

A number of ancillary integrated activities are needed for the
successful implementation of the sickle cell center concept.  These
other activities include education, counseling, and diagnostic
testing.  The provision of community outreach programs is also
encouraged.  Although supporting activities are not research
projects, they should be well described with objectives and

o  Diagnostic Testing - providing facilities where accurate diagnosis
including hemoglobin genotyping can be performed

o  Counseling - all counseling should be non-directive and aimed at
helping counselees to make informed decisions about health-related
and/or family planning issues that they believe to be in their best

o  Education - sponsoring activities that provide training and
information about sickle cell disease to health care professionals at
the Center and in the community or region that the Center serves; and
to patients, their families and communities

o  Community Outreach - developing a liaison between the Center and
the community which would inform the community about Center programs
and provide community input into their development

New Components

In May 1995, the Division of Blood Diseases and Resources convened a
Concept Review Committee that included active participation by
current Sickle Cell Center Directors to make recommendations to the
NHLBI that would facilitate and enhance the operations of the
Comprehensive Sickle Cell Centers and offer opportunities for career
development.  As a result of Committee deliberations, the following
new components have been incorporated into this Center competition:

Data Management Core (Data Coordinating Center)

This central resource core will provide data management and
statistical needs for specific aspects of the Centers program sharing
common clinical protocols, as well as for information related to
health services utilization and health outcomes. This core will
coordinate the clinical collaboration between the ten centers and
will serve as the primary unit to collect, manage, statistically
analyze, and store clinical data obtained from the individual
Centers.  This will require the full range of coordinating center
activities including study design and protocol development;
preparation of forms and Manual of Operations; training center staff
in data collection procedures; maintaining the study database;
monitoring clinical center performance; providing patient accrual
reports; performing appropriate statistical analyses of study data;
and participating in the preparation of study publications.  It is
anticipated that the centers will share two to three clinical
research protocols each year; however, it is unlikely that all
centers will participate in each clinical study.  For health services
data, a standardized reporting format would be developed across all
centers that would permit accurate annual reporting to the Institute.

Centers wishing to apply for the data management core will submit a
separate document with an application face page, budget, and project
description, which will be reviewed separately from the main
application.  The maximum possible total costs for this facility will
be $300,000.  This will be supplemental to the allowable funding cap
for each Center and will be covered within the total funds allocated
to the Centers for each year.  (See Document on "Special
Instructions").  Because of the Data Management Center, large
separate data cores will not be funded at individual Centers.
However, support can be requested in the administrative core for
statistical expertise and data services related to research projects
at each Center.

Sickle Cell Research Scholars Program

This component offers modest career development support for up to
three years in the field of basic or clinical sickle cell research to
a young scientist at the institution where a Comprehensive Sickle
Cell Center is located.  Each Center will set aside $100,000 per year
for the exclusive purpose of providing partial salary and research
support for a Scholar who would be chosen by a panel of principal
investigators at each Center with final approval from the Institute.
These funds cannot be rebudgeted by the Program Director for other
purposes.  The Sickle Cell Research Scholar is expected to spend at
least 75 percent of his/her effort in sickle cell anemia-related
research under the guidance of an established investigator at the

Pilot Projects

Pilot studies will be allowed (i.e., "seed money") for the pursuit of
promising, but untested innovative research that emerges during the
project period for established scientists who did not previously work
in sickle cell related research or new investigators with state-of-
the-art core technologies that will enable them to be competitive in
the field.  Pilot projects, with funding up to $25,000 in direct
costs (within the total cost allocation), will be purely optional and
will be reviewed and selected by experts within each Center.
Progress will be reported to the Institute upon completion.

Center Program Directors are also encouraged to use the Scholars
Program and Pilot Projects to attract young minority scientists into
biomedical research.


Active cooperation among Centers is required.  Collaborative efforts
among Center projects and between Centers enhance productivity and
facilitate technology transfer between research and clinical
application. Center Program Directors shall meet annually to review
their progress and to plan new approaches for future collaborative
work.  Thus, the accomplishments of Centers will be shared freely and


Studies of the clinical course ("natural history") of sickle cell
disease are currently being conducted in a multi-institutional
collaborative Cooperative Study of Sickle Cell Disease.  Therefore,
applications to pursue such investigations are not appropriate for
this competition.  Applications lacking any of the required
components (basic and clinical research; supporting services for
education, diagnosis, and counseling; and the Scholars Program) will
be considered as non-responsive to this RFA and will not be accepted.


1.  Application Funding Levels:

a.  New Center Applications:

New applications may request up to $1.17 million direct costs
(exclusive of indirect costs on subcontracts) in the first year with
a maximum increase of no more than four percent for each additional
year requested in that application.  Applications that exceed these
limits will be returned to the applicant.

Requests for expensive pieces of equipment that cause the application
to exceed these limits, will be considered on an individual basis.
However, applicants should make every attempt to include all
equipment in the ceiling amount and must discuss any equipment
requests that cause the application to exceed the ceiling with NHLBI
staff early in the planning phase of the application.  Such requests
for equipment will require in-depth justification and will be
carefully considered throughout the review process.  Final decisions
will depend on the nature of the justification and the Institute's
fiscal situation.

b.  Competing Renewal Center Applications:

Competing renewal applications whose total costs currently exceed
$2.0 million will be allowed to apply to apply for up to $2.2 million
in total costs for the first year, with a maximum increase of no more
than four percent in each succeeding year.

Other competing renewals can request 10 percent above the recommended
direct costs of the last noncompeting year or up to $1.6 million in
total costs, whichever is greater, with a maximum increase of no more
that four percent in each succeeding year.

The same policy regarding equipment, which is described under "New
Applications" applies to competing renewals.  Applications that
exceed these limits will be returned to the applicant.

2.  NHLBI-sponsored annual meetings will be held to encourage the
exchange of information among investigators who participate in this
program.  In the preparation of the budget for the grant application,
applicants should request additional travel funds for one meeting
each year to be held at various locations where there are
Comprehensive Sickle Cell Centers.  Applicants should also include a
statement in the applications indicating their willingness to
participate in such meetings.


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 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 new 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 28, 1994 (FR 59 14508-14513), and reprinted 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 below.  Program staff may also
provide additional relevant information concerning the policy.


Prospective applicants are asked to submit, by March 1, 1996, 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
identification of any other participating institutions.  The letter
should also indicate any interest in applying for the Data Management
Core.  Such letters are requested only for the purpose of providing
an indication of the number and scope of applications to be received;
therefore their receipt is usually not acknowledged.  A letter of
intent is not binding, and it will not enter into the review of any
application subsequently submitted, nor is it a necessary requirement
for the application.  This letter of intent is to be sent to:

Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7924
Bethesda, MD  20892-7924
Telephone:  (301) 435-0266
FAX:  (301) 480-3541
Email:  james_scheirer@nih.gov


Applications are to be submitted on the research grant application
form PHS 398 (rev. 5/95).  This form is available in an applicant
institution's office of sponsored research and from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 6701 Rockledge Drive, Room 3034, MSC 7762, Bethesda, MD
20892-7762 telephone (301) 710-0267, email: girg@drgpo.drg.nih.gov.
Use the conventional format for research grant applications and
ensure that the points identified in the section on REVIEW
CONSIDERATIONS are fulfilled.  The page limitations described in the
form PHS 398 (rev. 5/95) instructions are to be considered as
applicable to all subprojects.  Supplemental application guidelines
for Comprehensive Sickle Cell Center applications may be obtained
from Dr. Junius Adams at the address listed under INQUIRIES.

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 could be included
with the application.

If collaborative arrangements involve sub-contracts with other
institutions, Ms. Jane R. Davis of the NHLBI Grants Operations Branch
(telephone: (301) 435-0166) should be consulted regarding procedures
to be followed.

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 (Comprehensive
Sickle Cell Center -HL-96-002) must be typed on line 2 of the face
page of the application form and the YES box must be marked.

Send or deliver the completed application and three signed, exact
photocopies of it to the following, making sure that the original
application with the RFA label attached is on top:

6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for courier/overnight mail service)

Send an additional two 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.  Otherwise the
NHLBI cannot guarantee that the application will be reviewed in
competition for this RFA.

Applications must be received by September 18, 1996.  If an
application is received after that date, it will be returned to the
applicant without review.


Upon receipt, applications will be reviewed for completeness by the
DRG and responsiveness by the NHLBI.  Incomplete applications will be
returned to the applicant without further consideration.  If NHLBI
staff determine that the application is not responsive to the RFA, it
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 in accordance with the standard NIH peer review
procedures.  As part of the initial merit review, all applications
will receive a written critique and undergo a process in which only
those applications deemed to have the highest scientific merit,
generally the top half of applications under review, will be
discussed, assigned a priority score, and receive a second level
review by the appropriate national advisory council or board.

Applications should be prepared so that they can be reviewed without
the necessity of interaction between the applicants and the
reviewers, since no site visit or reverse site visit will be part of
the technical review.

Review Criteria

Criteria for evaluation of the application will include:

1.  The qualifications, experience and commitment of the Center
Director and the ability to devote adequate time and effort to
provide effective leadership.

2.  The scientific merit and quality of the proposed projects.  Each
project will be assigned a priority score based on scientific merit
and relevance to the goals of the Center.

3.  The competence of the senior personnel to accomplish the proposed
goals of the Center, their commitment, and time they will devote to
the project.

4.  The adequacy of the facilities to conduct the proposed research
including laboratory and clinical facilities, access to patients,
instrumentation and data management systems, when needed.

5.  The nature of the overall structure and management of the Center,
including scientific and fiscal management, integration of the parts,
and quality control.

6.  The appropriateness of the budget in relationship to the proposed

7.  The committee structure, both internal and external, and process
for ongoing evaluation of the Center's effectiveness.

8.  The institutional commitment to the program as evidenced by
provision of resources, and the appropriateness of the institutional
resources and policies for the administration  of a center program of
the type proposed.

9.  The willingness of the Center leadership to work cooperatively
with other Sickle Cell Centers and with the NHLBI.

Criteria for the evaluation of the Data Management Center will

1.  Adequacy of the plans for data management, analysis, and
coordination of clinical protocols

2.  Qualifications, experience and commitment of the Data Management
Core Director to provide effective leadership

3.  Competence of the senior personnel to accomplish the proposed
goals of the Data Management Core, their commitment, and time they
will devote to the project

4.  The adequacy of the facilities to conduct data management,
analysis, and coordination of clinical protocols

5.  Overall structure and management of the Core including fiscal
management and quality control

6.  Appropriateness of the budget in relationship to the proposed

7.  Institutional commitment to the Data Management Core as evidenced
by provision of resources, and the appropriateness of the
institutional resources and policies for the administration of a Data
Management Core of the type proposed

8.  Willingness of the Core leadership to work cooperatively with all
Sickle Cell Centers and the NHLBI.


The anticipated date of award is April 1, 1998.  Funding decisions
will be made on the basis of scientific and technical merit as
determined by peer review, program needs and balance, and the
availability of funds.


Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.

Inquiries regarding programmatic issues and requests for the program
guidelines may be directed to:

Dr. Junius G. Adams, III
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7950
Bethesda, MD  20892-7950
Telephone:  (301) 435-0055
FAX:  (301) 480-0868
Email:  ja33m@nih.gov

For fiscal and administrative matters, contact:

Ms. Jane R. Davis
Blood Division Grants Management Section
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7926
Bethesda, MD  20892-7926
Telephone:  (301) 435-0166
FAX:  (301) 480-3310
Email: jane_davis@nih.gov


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 authority of the Public Health
Service Act, Section 301 (42 USC 241) and administered under PHS
grant policies and Federal regulations, most specifically 42 CFR Part
52 and 45 CFR Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372, or to
Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.


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