Full Text HL-97-005
 
TISSUE ENGINEERING, BIOMIMETICS, AND MEDICAL IMPLANT SCIENCE
 
NIH GUIDE, Volume 26, Number 13, April 25, 1997
 
RFA:  HL-97-005
 
P.T. 34

Keywords: 
  BIOMEDICAL ENGINEERING 
  0740027 
  Biomedical Research, Multidiscipl 

 
National Heart, Lung, and Blood Institute
National Institute of Dental Research
National Institute of Arthritis and Musculoskeletal and Skin Diseases
 
Letter of Intent Receipt Date: July 1, 1997
Application Receipt Date: August 25, 1997
 
THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" PROCEDURES. THIS
COMPLETE RFA INCLUDES THE MODIFICATIONS TO STANDARD APPLICATION
INSTRUCTIONS WHICH MUST BE USED WHEN PREPARING APPLICATIONS TO THIS
RFA.
 
PURPOSE
 
The National Heart, Lung, and Blood Institute (NHLBI), the National
Institute of Dental Research (NIDR), and the National Institute of
Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invite
applications to design and engineer natural and novel approaches for
the repair, restoration, and replacement of tissues and whole organs
based on a comprehensive scientific understanding of biological
structures and their function.  The overall goal of this RFA is to
facilitate multidisciplinary research, design, and training aimed at
development of a new generation of natural and synthetic medical
implants, including totally biological solutions for instances in
which synthetic implants have historically been used.
 
Research projects focusing on devices intended primarily for short
term use, specifically 24 hours or less (e.  g., hemodialysis and
cardiopulmonary bypass), will not be considered to be responsive to
this RFA.
 
This Program will support both design directed and hypothesis driven
research applicable to the missions of NHLBI, NIDR, and NIAMS.
Applicants are encouraged to indicate to which institute, NHLBI,
NIDR, or NIAMS, their application should be directed.
 
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, "Tissue Engineering, Biomimetics, and Medical
Implant Science", is related to the priority areas of heart disease
and stroke, oral health, immunization and infectious diseases,
cancer, diabetes, and musculoskeletal injuries and diseases.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary
Report: Stock 017-001-00474-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202-783-3238).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic non-profit and for-profit
organizations, public and private, such as universities, colleges,
companies, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal Government.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.
Applications from foreign institutions will not be accepted. However,
subcontracts to foreign institutions are allowable, with sufficient
justification.
 
MECHANISMS OF SUPPORT
 
Support of this program will be through NHLBI, NIDR, and NIAMS.  The
mechanisms available for support of applications to this RFA include
individual research project grants (R01) and collaborative R01
projects.  In the case of collaborative R01 projects, a group of
investigators may submit simultaneously at least 3, and no more than
5, R01s with a common theme.  Collaborative R01 projects may be from
a single institution or several institutions, may include shared
resources, and must demonstrate the interdependence of the individual
components.  All R01 applications, both collaborative and individual,
must provide evidence that the research will be multidisciplinary in
nature; applicants are encouraged to specify how the research will
further the objectives of both NHLBI, NIDR, and NIAMS.
 
Specific RO1 application instructions are modified to include
"MODULAR GRANT" AND "JUST-IN-TIME" streamlining efforts being
examined by the NIH.  The modular grant concept establishes specific
modules in which direct costs may be requested as well as a maximum
level for requested budgets.  Only limited budget information is
required under this approach.  The just-in-time procedure allows
applicants to submit certain information only when there is a
possibility for an award.  It is anticipated that these changes will
reduce the administrative burden for the applicants, applicant
institutions, reviewers, and NIH staff.
 
For this RFA, funds must be requested in $25,000 direct cost modules,
up to a maximum of eight modules ($200,000 direct costs) per year,
per RO1, whether individual or collaborative.  A feature of the
modular grant is that no escalation is provided for future years, and
all anticipated expenses for all years of the project must be
included within the number of modules being requested.  Only limited
budgetary information will be required and any budget adjustments
made by the Initial Review Group will be in modules of $25,000.
Instructions for completing the Biographical Sketch have also been
modified.  In addition, Other Support information and the application
Checklist page are not required as part of the initial application.
If there is a possibility for an award, necessary budget, Other
Support and Checklist information will be requested by NHLBI, NIDR,
or NIAMS staff following the initial review. The APPLICATION
PROCEDURES section of this RFA provides specific details of
modifications to standard PHS application kit procedures.
 
Upon initiation of the program, NHLBI will sponsor annual meetings,
most likely to be held in Bethesda, Maryland, to encourage exchange
of information among investigators who participate in this program.
In considering the number of modules to request, budget projections
should include travel funds that will allow principal investigators,
other key research scientists, and young investigators to participate
in these meetings.
 
Applicants are expected to furnish their own estimates of time
required to achieve the objectives of the proposed research project.
Since a variety of approaches would represent valid responses to this
RFA, it is anticipated that there will be a range of costs among
individual grants awarded.
 
There may be another open competition at the end of this program.  If
not, future unsolicited competing applications will compete with all
investigator-initiated applications and be reviewed according to the
customary peer review procedures.  It is anticipated that support for
this program will begin in April 1998.  Administrative adjustments in
project period and/or amount may be required at the time of the
award.
 
FUNDS AVAILABLE
 
NHLBI and NIDR will each allocate approximately $2 million in direct
costs (approximately $3 million in total costs) to support projects
from this RFA during FY 98.  It is anticipated that about 4 or 5
collaborative R01 projects consisting of 3 to 5 individual R01s per
project will be awarded, and that in addition 6 to 8 individual R01s
will be awarded, provided that the applications are of high
scientific merit.  Although NIAMS has an interest in collaborative
projects, for this RFA only, NIAMS will allocate approximately
$400,000 in direct costs (approximately $600,000 in total costs) for
FY 98 to support 2 to 3 individual R01's, provided that the
applications are of high scientific merit.  It is possible that a
collaborative project in a topic area that overlapped the interests
of NIAMS and NIDR could be co-funded by these two institutes if the
project was of high scientific merit.  The maximum total costs for
the first year of a collaborative R01 project are $1 million.  Direct
costs will be awarded in modules of $25,000, less any overlap or
other necessary administrative adjustments.  Facilities and
administrative (indirect) costs will be awarded based on the
negotiated rates.  Applicants may request up to five years of
support. Although this program is provided for in the financial plans
of NHLBI, NIDR, and NIAMS, the award of grants pursuant to this RFA
is contingent upon the receipt of a sufficient number of high quality
applications and the availability of funds for this purpose.
Policies that govern research grant programs of the National
Institutes of Health will prevail.
 
RESEARCH OBJECTIVES
 
Background
 
Biomimetics is an emerging interdisciplinary field that combines
information from the study of biological structures and their
functions with physics, mathematics, chemistry and engineering in the
development of principles that are important for the generation of
novel synthetic materials and organs.  Tissue engineering is the
application of these principles for the restoration, repair,
replacement and assembly of functional tissues and organs.  Medical
implant science is the application of scientific and clinical
principles to the design, fabrication, and evaluation of medical
implants.  In the area of heart, lung, and blood diseases, principles
from tissue engineering, biomimetics, and medical implant science
have been applied to the development and design of mechanical and
bioprosthetic heart valves, prosthetic vascular grafts, vascular
stents, infusion pumps, pacemakers, and implantable cardiac
defibrillators.  In the area of oral, craniofacial, and dental
disease, principles from tissue engineering, biomimetics, and medical
implant science are applied to developing dental and facial implants,
temporomandibular joint (TMJ) prostheses, formation of bone matrix
substitutes, and artificial replicas of bone, skin, and mucosa.  In
the area of musculoskeletal injury and disease, principles from
tissue engineering, biomimetics, and medical implant science are
applied to developing orthopaedic implants/prostheses, and assessing
the biologic response to formation of bone and connective matrix
substitutes and artificial replicas of bone, connective tissues, and
skin.
 
Advances in engineering materials for such uses include new
biodegradable polymers for controlled, site-directed delivery of
drugs, gene vectors, antisense oligonucleotides, and growth factors
that stimulate angiogenesis, revascularization, and repair, or
inhibit thrombosis, cellular hyperplasia, and infection; synthetic
biodegradable polymeric scaffolds for construction of heart valve
leaflets from autologous cells; construction of vascular grafts from
autologous cells grown on synthetic templates or scaffolds; new
polymers for guided tissue regeneration used in treating periodontal
disease and bone and connective tissue defects; demineralized
allogenic bone matrix for craniofacial and other bone reconstruction
procedures; coral-based hydroxyapatite replicas for reconstruction of
alveolar ridges and other osseous defects; dermal/epidermal skin
substitutes; fibrin-based sealants to weld tissues and blood vessels
in a variety of surgical settings; and synthetic, biodegradable
polymeric scaffolds for bone, cartilage, ligament, tendon, and
meniscal repair from autologous cells. Most implants have resulted in
improving the quality of life and saving or prolonging lives.
However some implants, such as TMJ prostheses and certain heart valve
designs, have failed catastrophically.  For orthopaedic implants,
osteolysis has emerged as a major problem.
 
Rationale
 
There is a need for a firmer scientific and technical basis in order
to develop the next generation of medical implants that are safe,
reliable, "smart", and long-lasting. Integrated and multidisciplinary
research should advance our understanding of biological systems and
provide the bases for the design and development of novel synthetic
medical materials that are compatible with the environment of the
host and significantly increase the functional lifetime of implants.
Future advances in this field will require materials and computer
scientists, physicists, bioengineers, clinicians, biologists, and
industry working together towards a shared vision rather than
pursuing their separate objectives as has commonly been the case.
 
Additional factors that have inhibited progress in tissue
engineering, biomimetics, and medical implant science are the current
concerns of medical device manufacturers over medical liability,
regulatory issues, and public payment policy for experimental
implants.  In response to the scientific opportunities and public
concerns in this area, the National Institutes of Health (NIH)
convened two workshops, October 16-17, 1995 and September 24-26,
1996, bringing together more than 150 university, industry, and
government specialists in biomaterial, biomimetics, tissue
engineering, medical implant, biological and clinical sciences.
These experts were charged with recommending research directions that
would advance this important field. They agreed that progress in
characterization and rational synthesis of advanced biomaterials,
together with advances in understanding the molecular basis of
biological responses, has set the stage for an integrated approach
and ultrastructural basis for advancing biomaterials, tissue
engineering, biomimetics, and medical implant science.  The specific
research and career recommendations of these two groups and which
guide this RFA were:
 
o Designing and developing biomaterials and implants endowed with
desirable biological structures and functions for the treatment of
various disorders.  This will involve multidisciplinary approaches to
synthesizing new, perhaps "smart" or self-monitoring, biomaterials
designed for cell, drug, and gene based therapies.
 
o Advancing the scientific basis for predicting quality and lifetime
of implants, and improving the efficiency of assessing human
acceptance of implants.  Potential approaches include a focus on
reliability, accelerated testing, failure analysis, imaging models,
biosensors, and improved understanding of the tissue implant
interface.
 
o Fostering biomimetics, new tissue engineering processing and
advanced manufacturing technologies.
 
o Enhancing research careers with new cross-disciplinary strategies
in tissue engineering, biomimetics and medical implant science.
 
One intent of this RFA is to encourage and promote multidisciplinary
research on tissue engineering, biomimetics, and medical implant
science.  Applicants for both individual and collaborative R01s are,
therefore, encouraged to include on research teams individuals whose
expertise broadens the scope of the scientific approach of the team.
The type of expertise and justification for addition of the
individual, proposed percent effort, biographical sketch, and letters
of agreement to join the team from the applicant and his/her
supervisor in the event that the application is funded, must be
provided in the application.
 
An additional intent of the RFA is to encourage new investigators to
enter this area of research.  These may be senior investigators who
have no previous experience in this field, or scientists from any
field who are at the beginning stages of their research careers.
Applicants are encouraged to include either category of new
investigator on their research team.  In addition, applications are
encouraged from new investigators of either category.
 
PROPOSED RESEARCH
 
The following research topics are provided as examples, and are not
intended to be inclusive or restrictive:
 
o explore novel scientific bases for designing and developing medical
implants (e.g., autogeneration of a coronary artery, a tooth organ,
or articular cartilage);
 
o development of advanced methodologies for evaluating the cellular
responses to implants, such as fibrous encapsulation, osteolysis, and
infection; identification of inflammatory mediators; use of in vitro
and in vivo models to predict short- and long-term human responses;
understanding the biology of biointegration, biofilm formation, and
osteolysis;
 
o development of computer/mathematical modeling systems for
evaluation of TMJ and other joint biomechanics; creation of a new
generation of biomaterials which will permit effective repair or
replacement of bone, cartilage, and other connective tissue
structures in the TMJ and other joints and their associated muscles;
 
o development of heart valves, small-diameter blood vessels, and
other organs and tissues for use in the systemic, pulmonary, and
craniofacial circulations, using autologous cells in bioreactors, and
synthetic biodegradable matrices, scaffolds, mandrels, or other
innovative means;
 
o design of matrices that would promote the formation of facial
musculature, neurological pathways, bone, connective tissues, and
skin for use in the repair of orofacial, cardiovascular, pulmonary,
and musculoskeletal disorders;
 
o use of high resolution cellular and molecular imaging techniques to
evaluate the interface between implants and their biological
environment, including methods for imaging dynamic and living
structures;
 
o use of computational fluid mechanics for improved design of
implants for the management of cardiovascular, pulmonary,
hematologic, and musculoskeletal disorders;
 
o advancement of the fundamental knowledge of biomineralization,
including biomineralization precursor phases, microstructure
formation, templating, growth, and morphogenesis of bones and teeth;
 
o development, for drug and cell delivery in applications to tissue
engineering, biomimetics, and medical implant science, of "smart"
biomaterials that can act as molecular switches to control biological
functions and sense environmental changes (e.g., delivery of iron
chelators for the treatment of conditions characterized by iron
overload); delivery of growth factors, cytokines, chemotactic agents,
morphogenic proteins, and other biological factors influencing the
repair and regeneration of myocardium, the orofacial complex, skin
and musculoskeletal tissues;
 
o development of cell-specific systems for gene delivery applicable
to oral, craniofacial, and skin and musculoskeletal disorders (e.g.,
salivary gland disorders, orofacial neoplasias, or osteogenesis
imperfecta);
 
o use of combinatorial chemistry for rapid development of lead
compounds for basic research and drug discovery applied to tissue
engineering, biomimetics, and medical implant science, and
development of time and site specific systems for their delivery;
 
o identification of stem cells and immature committed cells for
tissue repair other than for burns or other traumatic injury;
development of culture systems (e.g., biodegradable scaffolds,
templates, or extracellular matrix analogues) that allow cells to
adopt their three-dimensional architecture and to be suitable for
transplantation or repair; and
 
o investigations of the molecular basis of tissue maintenance and
regeneration as applied to tissue engineering, biomimetics, and
medical implant science (e.g. cell-cell interactions, extracellular
matrix, or apoptosis), in instances other than following burns or
other traumatic injury.
 
All submissions must be pertinent to the objectives of the RFA.
 
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 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, Vol. 23, No. 11, March 18,
1994. Investigators may obtain copies from these sources or from the
program staff listed under INQUIRIES.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by July 1, 1997, a letter
of intent.  This should include the number and title of this RFA
(HL-97-005; "Tissue Engineering, Biomimetics, and Medical Implant
Science"), a descriptive title of the proposed research, the names,
addresses, and telephone numbers of the Principal Investigator(s),
and the identities of other key personnel and participating
institutions.  The letter of intent is to be addressed to Dr.C. James
Scheirer at the address listed under APPLICATION PROCEDURES.
 
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the
information that it contains is helpful in planning for the timely
review of the applications.  It allows NHLBI, NIDR, and NIAMS staff
to estimate the potential review workload and to avoid possible
conflicts of interest in the review.
 
APPLICATION PROCEDURES
 
Prospective applicants are encouraged to communicate with program and
grants management staff of NHLBI's, NIDR's and NIAMS's Divisions of
Extramural Research as early as possible in the planning phase of
application preparation. Advice and suggestions by staff may
materially assist applicants to ensure that the objectives and
structure and the budget format are acceptable.
 
Applications must be prepared on form PHS 398 (Rev.  5/95). An
Application for a PHS Grant is available at most institutional
business or grants and contracts offices and may be obtained from the
Office of Grants Information, Division of Research Grants (DRG),
National Institutes of Health, Suite 3032, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone:  301/ 435-1099).  The instructions
accompanying Form PHS 398 must be followed as far as possible.
 
THE RFA LABEL FOUND 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, THE RFA TITLE AND NUMBER, "Tissue Engineering, Biomimetics,
and Medical Implant Science" HL-97-005," MUST BE TYPED ON LINE 2 OF
THE FACE PAGE OF THE APPLICATION FORM AND THE YES BOX MUST BE MARKED.
 
APPLICANTS WITHOUT PRIOR R29 OR R01 SUPPORT, AND NEW INVESTIGATORS TO
THE FIELD, ARE STRONGLY ENCOURAGED TO IDENTIFY THEIR STATUS AS A NEW
INVESTIGATOR IN A COVER LETTER AND IN THE APPLICATION.
 
This RFA is restricted to R01 grants.  All applications must be
submitted as modular grants.  The modular grant concept establishes
specific modules (increments) in which direct costs may be requested,
and the maximum level for requested direct cost.  Only limited
budgetary information is required in the application; a detailed
budget need not be provided.
 
Sample budgets and justification page will be provided upon request
or following the submission of a letter of intent.
 
In the case of collaborative R01 projects, the individual R01s
comprising the project must be submitted as one packet accompanied by
a cover letter which lists the principal investigators of each R01,
their institution, and their project title, and defining how and why
the individual participants propose to collaborate.
 
BUDGET INSTRUCTIONS
 
The total direct costs must be requested in accordance with the
program guidelines and the modifications made to the standard PHS 398
application instructions described below:
 
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD Do not complete Form
Page 4 of the PHS 398 (rev 5/95).  It is not required nor will it be
accepted at the time of application.
 
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT Do not complete
the categorical budget tables on Form page 5 of the PHS 398 (rev.
5/95).  Only the requested total direct costs line for each year must
be completed based on the number of $25,000 modules being requested.
Applicants may not request a change in the amount of each module.  A
maximum of EIGHT modules ($200,000 direct costs) per year may be
requested and each applicant may request up to FIVE years of support
for this RFA.  Direct cost budgets will remain constant throughout
the life of the project (i.e., the same number of modules requested
for all budget periods).  Any necessary escalation should be
considered when determining the number of modules to be requested.
However, in the event that the number of modules requested must
change in any future year due to the nature of the research proposed,
appropriate justification must be provided.  Total Direct Costs for
the Entire Proposed Project Period should be shown in the box
provided.
 
o BUDGET JUSTIFICATION
 
Budget justifications should be provided under "Justifications" on
Form Page 5 of the PHS 398.
 
List the names, role on the project and proposed percent effort for
all project personnel (salaried or unsalaried) and provide a
narrative justification for each person based on his/her role on the
project.
Identify all consultants by name and organizational affiliation and
describe the services to be performed.
 
Provide a general narrative justification for individual categories
(equipment, supplies, etc.) required to complete the work proposed.
More detailed justifications should be provided for high cost items.
Any large one-time purchases, such as equipment requests in excess of
$10,000, must be accommodated within these limits.
 
The budget should include a request for funds for attendance at an
annual meeting of the principal investigators and other key
investigators including young investigators and investigators new to
the field.
 
o CONSORTIUM/CONTRACTUAL COSTS - If collaborations or subcontracts
are involved that require transfer of funds from the grantee to other
institutions, it is necessary to establish formal subcontract
agreements with each collaborating institution.  A letter of intent
from each collaborating institution should be submitted with the
application.  Only the percentage of the consortium/contractual TOTAL
COSTS (direct and indirect) relative to the total DIRECT COSTS of the
overall project needs to be stated at this time.  The following
example should be used to indicate the percentage cost of the
consortium, "The consortium agreement represents 27% of overall
$175,000 direct costs requested in the first year.". A budget
justification for the consortium should be provided as described in
the "Budget Justification" section above (no Form Page 5 is required
for the consortium).  Please indicate whether the consortium will be
in place for the entire project period and identify any future year
changes in the percentage relative to the parent grant.
 
If there is a possibility for an award, the applicant will be
requested to identify actual direct and indirect costs for all years
of the consortium.  Please note that total subcontract costs need not
be calculated in $25,000 modules. However, when subcontract funds are
added to the parent grant budget, the total direct cost amount must
be included in the number of $25,000 modules requested.
 
o BIOGRAPHICAL SKETCH - A biographical sketch is required for all key
personnel, following the modified instructions below.  Do not exceed
the two-page limit for each person.
 
Complete the educational block at the top of the form page; List
current position(s) and those previous positions directly relevant to
the application; List selected peer-reviewed publications directly
relevant to the proposed project, with full citation; The applicant
has the option to provide information on research projects completed
and/or research grants participated in during the last five years
that are relevant to the proposed project.
 
o OTHER SUPPORT - Do not complete the "Other Support" pages (Form
Page 7).  Selected other support information relevant to the proposed
research may be included in the Biographical Sketch as indicated
above.  Complete Other Support information will be requested by NHLBI
staff if there is a possibility for an award.
 
o CHECKLIST - No "Checklist" page is required as part of the initial
application.  A completed Checklist will be requested by staff if
there is a possibility for an award.
 
o The applicant should provide the name and phone number of the
individual to contact concerning fiscal and administrative issues if
additional information is necessary following the initial review.
 
Applicants 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
either the GCRC program director or principal investigator should be
included with the application.
 
APPLICATIONS NOT CONFORMING TO THESE GUIDELINES WILL BE CONSIDERED
UNRESPONSIVE TO THIS RFA AND WILL BE RETURNED WITHOUT FURTHER REVIEW.
 
Submit a signed, typewritten original of the application, including a
cover letter (if appropriate) and three signed photocopies, in one
package to:
 
Division of Research Grants (DRG)
National Institutes of Health
6701 Rockledge Drive, Room 1040-MSC 7710
Bethesda, MD 20892 (use 20817 for Federal Express)
 
At the time of submission, three additional copies of the application
must also be sent to:
 
Dr. C. James Scheirer
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Rockledge Building 2, Room 7220
6701 Rockledge Drive
Bethesda, MD 20892
 
Applications must be received by August 25, 1997.  If an application
is received after that date, it will be returned to the applicant
without review.
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by NHLBI, NIDR, and NIAMS. Incomplete applications
will be returned to the applicant without further consideration.  If
NHLBI, NIDR, and NIAMS staff find that the application is not
responsive to the RFA, it will be returned without further
consideration. Remaining applications may be subjected to a
streamlined review process by a Special Emphasis Panel convened by
NHLBI, NIDR, and NIAMS Scientific Review Offices, to determine their
scientific merit relative to other applications received in response
to the RFA.  The roster of reviewers for the RFA will be available on
the NHLBI home page approximately four weeks prior to the scheduled
review date.  Applications determined to be meritorious will be
evaluated for scientific and technical merit by the review committee,
be discussed and receive a priority score.  All other applications
will not be discussed or scored.  The initial review group will
evaluate all R01s, whether single or collaborative, as individual
investigator-initiated grant applications.  Additionally the IRG will
comment on the overall strength and likelihood of effective
collaboration of each collaborative program, and on the
multidisciplinary nature of both individual and collaborative R01s.
Each R01 within a collaborative program will receive a priority
score.  Secondary review of the applications will be conducted by the
National Heart, Lung and Blood Advisory Council (NHLBAC), the
National Advisory Dental Research Council (NADRC), and the National
Arthritis and Musculoskeletal and Skin Diseases Advisory Council
(NAMSAC).
 
Major factors to be considered in the evaluation of the applications
include:
 
o the degree of innovativeness of the approaches proposed;
 
o the likelihood of success of the research objectives proposed;
 
o the scientific merit of all components of the proposed research
project, including its significance, originality, feasibility, and
experimental design;
 
o the degree to which the project will represent collaborative
research among investigators from different disciplines within an
individual R01, or among individual R01s submitted as a collaborative
R01 project, and the likelihood of effective collaboration among the
investigators;
 
o the qualifications and research experiences of the collaborating
investigators;
 
o the likelihood that the proposed research will advance the fund of
knowledge in tissue engineering, biomimetics, and medical implant
science for application to heart, lung, and blood diseases, oral
health, musculoskeletal and skin diseases, as well as other fields;
and
 
o the ability to recruit individuals from appropriate study
populations (i.e., women, subpopulations of minorities and disabled
individuals) as defined by the NIH guidelines along with provisions
for their protection from research risks and the humane treatment of
animal research subjects that may be used.
 
The personnel category will be reviewed for appropriate staffing
based on the requested percent effort and justification provided.
The direct costs budget request will be reviewed for consistency with
the proposed methods and specific aims.  Any budgetary adjustments
recommended by the reviewers will be in $25,000 modules.  The
duration of support will be reviewed to determine if it is
appropriate to ensure successful completion of the requested scope of
the project.
 
AWARD CRITERIA
 
Applications will receive a secondary level of review by NHLBI's,
NIDR's, and NIAMS's Advisory Councils in May 1998. The earliest
anticipated date of award is July 1998. Applicants should be aware
that, in addition to scientific merit, program priorities and program
balance, the total cost of the proposed project and the availability
of funds will be considered by NHLBI, NIDR, and NIAMS staff as well
as the NHLBAC, NADRC, and NAMSAC in making funding recommendations.
In addition, NHLBI, NIDR, and NIAMS appreciate the value of
complementary funding from other public and private sources including
foundations and industrial concerns.  In circumstances in which
applications have similar scientific merit, but vary in cost
competitiveness, NHLBI, NIDR, and NIAMS are likely to select the more
cost competitive application for funding.
 
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:
 
Dr. Paul Didisheim
Head, Biomaterials Program
Division of Heart and Vascular Diseases
National Heart, Lung and Blood Institute
Rockledge 2 Building, Room 9180
Bethesda, MD 20892-7940
Telephone: 301-435-0513
FAX 301-480-1336
E-mail: pd16i@nih.gov
 
Dr. Eleni Kousvelari
Program Director for Biomaterials, Biomimetics, and Tissue
Engineering
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AN 18A
Bethesda, MD 20892-6402
Telephone: 301-594-2427
FAX: 301-480-8318
E-mail: kousvelari@de45.nidr.nih.gov
 
Dr. James S. Panagis
Director, Orthopaedics Program
National Institute of Arthritis and Musculoskeletal and Skin
Diseases
Natcher Building, Room 5AS 37K
Bethesda, MD 20892-6500
Telephone: 301-594-5055
FAX: 301-480-4543
E-mail: panagisj@ep.niams.nih.gov
 
Direct inquiries regarding grants management issues to:
 
Mr. William Darby
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Rockledge Building 2, Room 7128
6701 Rockledge Dive
Bethesda, MD 20892-7924
Telephone: 301-435-0177
FAX: 301-480-3310
Email: darbyw@gwgate.nhlbi.nih.gov
 
Mr. Martin R. Rubinstein
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AN 44A
Bethesda, MD 20892-6402
Telephone: 301-594-4800
FAX:
E-mail: Martin.Rubinstein@nih.gov
 
Ms. Vicki Maurer
Grants Management Specialist
National Institute of Arthritis and Musculoskeletal and Skin
Diseases
Natcher Building, Room 5AS 49A
Bethesda, MD 20892-6500
Telephone: 301-594-3504
FAX: 301-480-5450
E-mail: maurerv@ep.niams.nih.gov
 
The National Institute of General Medical Sciences (NIGMS)
has an interest related to this RFA.  Direct inquiries
regarding this interest to:
 
Dr. Scott Somers
National Institute of General Medical Sciences
Natcher Building, Room 2AS 49J
Bethesda, MD 20892-6402
Telephone: 301-594-5560
FAX: 301-480-2802
E-mail: somerss@gm1.nigms.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance Nos. 93.121, 93.837, 93.838, 93.839, and 93.846. Awards
are made under authorization of the Public Health Service Act, Title
IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42
USC 241 and 285) and administered under PHS grants policies and
Federal Regulations 42 CFR 52 and 45 CFR Part 74.  This program is
not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review.
 
The Public Health Service strongly encourages all grant recipients to
provide a smoke free workplace and promote the non use of all tobacco
products.  This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
 
.

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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