This Program Announcement expires on March 12, 2004 unless reissued.

FUNCTIONAL TISSUE ENGINEERING FOR HEART, VASCULAR, LUNG, BLOOD and SLEEP 
DISORDERS AND DISEASES:  SBIR/STTR INITIATIVE

Release Date:  October 25, 2000

PA NUMBER:  PAR-01-006

National Heart, Lung, and Blood Institute
 (http://www.nhlbi.nih.gov)

Application Receipt Dates:  March 13, 2001 and March 13, 2002 for Phase I and 
II applications.  March 13, 2003 and March 12, 2004 for Phase II 
applications only.

PURPOSE

This announcement is to encourage small businesses to participate in the 
research and development of new approaches, technologies, tools, methods, 
devices, cells, biomolecules and biomaterials that can be used to engineer 
functional tissues in vitro for implantation in vivo as a biological 
substitute for damaged or diseased tissues and organs or to foster tissue 
regeneration and remodeling in vivo for the purpose of repairing, replacing, 
maintaining, or enhancing organ function.  Applications should address a 
significant cardiovascular, pulmonary, hematologic, or sleep problem and 
propose research that will significantly improve clinical therapies for 
heart, vascular, lung, blood, and sleep disorders and diseases.  In addition, 
research plans should emphasize rapidly transferring products and services to 
the patient and should integrate scientific disciplines such as 
bioengineering, biology, clinical medicine, materials science, chemistry, and 
physics.    

This program will use the Small Business Innovation Research (SBIR) and Small 
Business Technology Transfer (STTR) funding mechanisms.  The SBIR and STTR 
applications received in response to this program will undergo review by a 
Special Emphasis Panel (SEP) with the combined breadth of expertise necessary 
to review the broad range of proposals anticipated.  Specific review 
criteria, which are included in this Program Announcement (PA), will be used 
in the review of all application received to ensure that the objectives of 
the solicitation are met.  Because the length of time and cost of research 
involving advanced technology projects may exceed that normally awarded for 
SBIR/STTR grants, the NHLBI will allow well justified Phase I applications 
with a project period of up to two years and a budget not to exceed $100,000 
per year direct costs (maximum of $200,000 direct costs for 2 years).  Phase 
II applications in response to this PA will only be accepted as competing 
continuations of previously funded NIH Phase I SBIR/STTR awards.  The 
previously funded Phase I award need not have been awarded under this PA but 
the Phase II proposal must be a logical extension of the Phase I research.  
The NHLBI will consider Phase II projects with a project period up to three 
years and a budget not to exceed $400,000 per year direct costs. 

The March 13, 2001 and March 13, 2002 receipt dates will be for Phase I and 
Phase II applications.  Only Phase II applications will be accepted on the 
last two receipt dates, March 13, 2003 and March 12, 2004.  After the initial 
four receipt dates, this initiative will be evaluated and a decision will be 
made as to whether or not to continue the initiative.

This PA must be read in conjunction with the Omnibus Solicitation of the 
Public Health Service for Small Business Innovation Research Grant 
Applications (PHS 99-2), and the Omnibus Solicitation of the National 
Institutes of Health for Small Business Technology Transfer Grant 
Applications (PHS 99-3).  All of the instructions within the Omnibus 
Solicitations apply with the following exceptions:

o  Special Receipt Dates;
o  Additional review considerations;
o  Opportunity for two years of Phase I support with a budget not to exceed     
$100,000 in direct costs per year;
o  Opportunity for three years of Phase II support with a budget not to 
exceed $400,000 in direct costs per year.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a PHS 
led national activity for setting priority areas.  This Program Announcement 
(PA), “Functional Tissue and Organ Engineering for Heart, Vascular, Lung, 
Blood, and Sleep Disorders and Diseases: SBIR/STTR Initiative”, is related to 
the priority areas of cardiovascular, lung, blood, and sleep disorders and 
diseases as well as additional priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Eligibility requirements for SBIR and STTR are described in the NIH Omnibus 
Solicitation for SBIR/STTR grant applications which is available on the 
Internet at: http://grants.nih.gov/grants/funding/sbirsttr1/index.htm.  A 
limited number of hard copies of the NIH Omnibus SBIR/STTR Solicitation are 
available from: 

PHS SBIR/STTR Solicitation Office
13685 Baltimore Avenue
Laurel, MD 20707-5096
Telephone: (301) 206-9385
FAX (301) 206-9722
Email: a2y@cu.nih.gov

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) SBIR/STTR award 
mechanisms.  Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant.

A.  INDIVIDUAL PHASE I APPLICATIONS

Phase I applications in response to this PA will be funded as Phase I SBIR 
Grants (R43) or Phase I STTR Grants (R41) with modifications as described 
below.  Applications for Phase I grants should be prepared following the 
directions for Phase I SBIR/STTR applications as described in the Omnibus 
Solicitation which is available at:
http://grants.nih.gov/grants/funding/sbirsttr1/11instructions.htm.

Well-justified Phase I applications with a project period up to two years and 
a budget not to exceed $100,000 per year direct cost (maximum of $200,000 
direct costs) will be allowed.

B.  INDIVIDUAL PHASE II APPLICATIONS

Phase II applications in response to this PA will be awarded as Phase II SBIR 
Grants (R44) or STTR Grants (R42) with modifications as described below.  
Phase II applications will only be accepted as competing continuations of 
previously funded NIH Phase I SBIR/STTR awards.  The Phase II application 
must be a logical extension of the Phase I research and must be responsive to 
this PA.

Applications for Phase II awards should be prepared following the 
instructions for NIH Phase II SBIR/STTR applications.  The Phase II SBIR 
instructions and application may be found on the Internet at:
http://grants.nih.gov/grants/funding/sbir2/index.htm
The Phase II STTR instructions and application may be found on the Internet 
at:  http://grants.nih.gov/grants/funding/sttr2/index.html
Well-justified Phase II applications with a project period up to three years 
and a budget not to exceed $400,000 in direct costs per year will be allowed.  

RESEARCH OBJECTIVES

Every day thousands of people of all ages are admitted to hospitals because 
of the malfunction of some vital organ.  Estimates of the total U.S. health 
care costs for patients with tissue loss or end-stage organ failure exceed 
four hundred billion dollars annually.  Moreover, because of the dearth of 
transplantable organs, many of  these people die.  As an example, the 
American Heart Association reports only 2,300 of the 40,000 Americans who 
needed a heart transplant in 1997 received one.  Existing prosthetic 
replacements for diseased or damaged tissue and organs are imperfect and 
subject patients to one or more ongoing risks including thrombosis, limited 
durability, increased susceptibility to infection, and need for re-
operations.  Taken together, these points illustrate the need for long-term, 
safe, and cost-effective solutions. 

Until very recently, most scientists and clinicians believed that damaged or 
diseased human tissue could be replaced only by donor transplants or with 
totally artificial parts.  Today, however, tissue and organ engineering 
promises to revolutionize the treatment of patients who need new vital 
structures.  It applies the principles of engineering and the life sciences 
in an effort to reach a fundamental understanding of structure-function 
relationships in normal and pathological tissues and to develop biological 
substitutes that can grow and remodel to restore, maintain, or improve tissue 
and organ function.  The field has already made headway in the synthesis of 
structural tissues such as skin, cartilage, and bone.  Furthermore, bladders 
have been successfully bioengineered and implanted in dogs.  Thus, progress 
to date predicts future success in the bioengineering of more complex 
internal organs such as hearts, blood vessels, lungs, and blood and the field 
is now poised for moving ahead in that direction.  However, the development 
of enabling tissue engineering technologies in a few critical areas, and the 
application of those technologies through an integrated systems approach, 
could serve as a catalyst for engineering functional cardiovascular, lung, 
and blood tissue and help lay the foundation for success that could impact 
tremendously on human health.  

Although more than a decade of research may be required before an entire 
heart, lung, or blood cell system is available, laboratory grown components 
of these organs, such as vascular grafts, heart valves, alveoli, and 
hematopoietic stem cells are currently being developed.  Vascular grafts are 
critical for the treatment of peripheral vascular and coronary artery 
disease. Grafts currently in use for bypass surgery are obtained from the 
patients’ own vessels or are constructed of synthetic materials.  In either 
case, problems with vessel availability and complications due to thrombosis, 
infection, intimal hyperplasia, and occlusion make these grafts less than 
optimal.  Efforts to develop tissue-engineered vascular grafts with improved 
long-term patency are needed.  

Another promising area for cardiovascular tissue engineering involves cardiac 
valves.  Congenital and acquired diseases of the heart valves and great 
arteries are leading causes of morbidity and mortality. Current prosthetic or 
bioprosthetic replacement implants do not grow or remodel with the patient 
and are associated with risks including thrombosis, limited durability, 
infection, and the need for re-operations. Through a tissue-engineering 
approach, progress has been made in growing heart valves that function short-
term in animals.  These types of studies need to be expanded.

Cell engineering and cell transplant procedures have the potential to treat 
heart failure.  After a myocardial infarct, scar tissue might be replaced 
with muscle by transplanting cardiac cells or stem cells directly into the 
scar area.  Another concept could be to grow a living tissue patch that could 
be applied to the scarred tissue or sewn into the heart after removal of the 
infarcted tissue.  For the treatment of sleep disorders, transplantation of 
engineered cells to replace missing hypocretin/orexin-producing neurons in 
the brain may reverse some of the symptoms of narcolepsy. 

Growing blood and blood product-producing cells in the laboratory is another 
area of considerable interest.  The ability to expand stem cells in culture 
would assure adequate reconstitution of patients, supply cells for gene 
therapy of blood diseases such as hemophilia, and allow for the production of 
patient-specific blood products or products with minimal antigenicity. To 
date, the expansion of transplantable stem cells in culture has not been 
possible.  Additional studies to develop this field would be an important 
step forward in making stem cell technologies a therapeutic choice for more 
patients. 

Creating venous valves for the treatment of deep venous thrombosis is another 
area of opportunity.  Acute and chronic anticoagulation are the only existing 
treatments for the valvular dysfunction associated with this disease.   
Bioengineering of functional replacements for diseased venous valves would 
provide an important treatment option in an area where no other options 
exist.

Lung researchers have been able to propagate the lung bud in culture up to 
the stage of branching morphogenesis and have demonstrated augmentation and 
inhibition of alveolization with various compounds that function as 
morphogens and/or negative regulators. The implantation of a primitive lung 
bud that could grow in vivo might circumvent the existing problems of 
transplantation rejection and shortage of organs. 

In addition to laboratory grown tissues, more immediate returns may be 
realized in the area of regenerating functional structures in vivo.  There is 
increasing evidence that lung may be capable of regeneration.  Unilateral 
pneumonectomy in animals results in growth of new alveoli in the remaining 
lung tissue.  Other studies have demonstrated that retinoic acid leads to 
lung growth and increased numbers of alveoli in neonatal animals and in a 
rodent model of emphysema.  Future studies are needed to assess the 
functional significance of these changes in lung structure, and the potential 
of other agents to regenerate lung tissue in diseases such as emphysema or 
bronchopulmonary dysplasia.  

Another important goal for the future is to develop the ability to assemble 
extracellular matrix in emphysema or rebuild lung structure damaged by 
pulmonary fibrosis.  Rebuilding lung regions or fostering repair of lung 
injury incurred in conjunction with inflammatory processes, interruption of 
normal development, or proteolytic degradation will significantly impact 
treatment for lung disease.

In the quest to develop laboratory or in vivo grown tissues and organs, 
partners are needed in many disciplines including physics, mathematics, 
chemistry, computer sciences, engineering, biology and medicine.  It is 
anticipated that the creativity of interdisciplinary teams will result in new  
understandings, novel products, and innovative technologies.  It is thus the 
intention of this PA to encourage close interactions among researchers 
working in different fields. The NHLBI also recognizes that applications for 
tissue engineering projects may be either design-directed toward technology 
development, or hypothesis-driven and either type of application is 
acceptable under the SBIR/STTR mechanism. 

This PA was developed because of the nascence of this scientific area, and 
the need for the development of novel concepts and approaches to engineering 
functional tissues and organs,  The primary purpose of the solicitation is to 
provide investigators with the opportunity to explore new approaches and test 
imaginative new ideas in areas that will have a significant impact on 
developing functional cardiovascular, lung, and blood tissues and organs.  In 
addition, it is intended to encourage the development of substantial and 
meaningful changes to existing technology.  The proposed research should be 
at the frontiers of tissue engineering and it must have the potential for an 
impact on current efforts directed at growing or regenerating tissues for 
repair or replacement. 
 
Cardiovascular, lung and blood tissuegenesis/organogenesis share some common 
scientific challenges and can all benefit from some common technological 
approaches.  At the same time, each application area also presents its own 
challenges that relate to specific clinical problems and the unique biology 
and physiology of the tissue.  Thus research should proceed along two 
parallel fronts: cross-cutting science and technology, and focused approaches 
aimed at well-defined clinical problems.  This solicitation is open to all 
innovative approaches to engineering tissues and organs for heart, vascular, 
lung, blood, and sleep disorders and diseases.  Possible applications, listed 
below for illustrative purposes only, are to develop:

o  functional heart, vascular, lung, or blood tissues or organs;

o  cell culture systems for optimal growth and maintenance of tissue-    
engineered constructs with differentiated cellular functions.  These     
constructs might include vascular grafts, heart valves, myocardial patches,     
lung buds, or bone marrow;

o  techniques for creating scaffolds with the complex architecture and     
chemistry necessary to elicit differentiated phenotypes of cardiovascular,     
lung and blood cells and tissues grown in vitro;

o  bioreactors that simulate physiologically relevant biomechanical and     
biological environments for growing heart, vascular, lung and blood     
tissues; 
o  ways to create vascular networks, ranging from capillaries to     
arteries/veins, that are capable of anastomosing with vessels at the site     
of implantation for those constructs grown in vitro;

o  ways to engineer immunologically-tolerant autologous tissue; 

o  cellular markers to distinguish progenitor cells of the heart, blood     
vessels, lung and blood; 

o  methods for cell sourcing including isolation, expansion and     
differentiation of stem and progenitor cells for cardiovascular, lung and     
blood tissues; 

o  quantitative analyses and modeling of how signals are presented physically     
and temporally to cells and how cells integrate multiple signals to     
generate a response which could provide a design basis for the manipulation     
of the environment to achieve tissuegenesis;

o  quantitative methods for non-invasively assessing or monitoring the     
function of engineered tissues; 

o  animal models for in vivo testing of engineered tissue or for in vivo     
tissue engineering;

o  techniques for in vivo regenerative medicine using cells and/or polymer     
delivery of genes, molecules or drugs;

o  technology for preservation of engineered tissues; 

o  technology to support large-scale manufacturing of engineered tissues.


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 are provided that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research.  This 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 
UPDATED “NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research,” published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of 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 and Contracts, March 6, 1998, and is available at the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site. 

APPLICATION PROCEDURES

OMNIBUS SOLICITATIONS for both the SBIR and STTR programs are available 
electronically through the NIH, Office of Extramural Research Small Business 
Funding Opportunities Web site at 
http://grants.nih.gov/grants/funding/sbir.htm.  Hard copies, subject to 
availability, may be obtained from the PHS SBIR/STTR Solicitation Office at 
301-206-9385 (phone); 301-206-9722 (fax); or a2y@cu.nih.gov (Email).  Helpful 
information for preparing the application can be obtained on the Web at 
http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf.

Applications in response to the PA are to be submitted on the grant 
application form PHS 6246-1 (1/98) for SBIR Phase I 
(http://grants.nih.gov/grants/funding/sbirsttr1/index.htm), PHS-6246-3 (1/98)for 
STTR Phase I (http://grants.nih.gov/grants/funding/sbirsttr1/index.htm),PHS-6246-2 
(1/98) for SBIR Phase II (http://grants.nih.gov/grants/funding/sbir2/index.htm), 
and PHS-6246-4 (1/98) for STTR Phase II 
(http://grants.nih.gov/grants/funding/sttr2/index.html)

THE TITLE AND NUMBER OF THIS PA MUST BE TYPED IN LINE 2 ON THE FACE PAGE OF 
THE APPLICATION.  For Phase I applications, applicants are strongly 
encouraged to highlight the innovation of their proposed research and to 
clearly state the milestones that will be used to demonstrate feasibility.  
For Phase II applications, the demonstration of feasibility accomplished in 
Phase I should be clearly indicated.

The OMNIBUS SOLICITATIONS give the normal levels of support and period of 
time for SBIR and STTR Phase I and II awards.  However, as stated under 
MECHANISM OF SUPPORT section, Phase I applications submitted in response to 
this PA can have a project period of up to two years and a budget not to 
exceed $100,000 per year direct costs. 

The second year of the Phase I budget should be included on the Budget 
Justification page, using categorical totals if costs deviate significantly 
from the first year of the budget, with narrative justifications for the 
increases (s).  If the second year simply escalates due to cost of living 
factors, a statement to that effect with the escalation factor should be 
included rather than categorical totals.  
Phase II applications submitted in response to this PA can have a project 
period no longer than three years with a budget up to $400,000 in direct 
costs per year.  The total duration (Phase I and Phase II application) cannot 
exceed five years.

An annual meeting of all investigators funded through this program will be 
held to share progress and research insights that may further progress in the 
program.  Applicants should request travel funds in their budgets for the 
principal investigator and one additional young investigator to attend this 
annual meeting.

Submit a signed, typewritten original of the application, including the 
Checklist, and two 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)

REVIEW CONSIDERATIONS

Phase I and Phase II applications submitted under this PA will be accepted on 
the first two receipt dates.  Only Phase II applications will be accepted on 
the last two receipt dates.  Thereafter, this initiative will be evaluated 
and a decision will be made as to whether the initiative will be re-
announced.

Upon receipt, applications will be reviewed by the Center for Scientific 
Review for completeness and by the NHLBI program staff for adherence to the 
guidelines of this PA.  Applications not adhering to application instructions 
described above, and those applications that are incomplete as determined by 
the Center for Scientific Review or by NHLBI program staff, will be returned 
to the applicant without review.  

Applications that are complete and adhere to the guidelines of this PA will 
be evaluated for scientific and technical merit by an appropriate peer review 
group convened by the Center for Scientific Review in accordance with the 
review criteria stated below.  As part of the initial merit review, all 
applicants will receive a written critique and may undergo a process in which 
only those applications deemed to have the highest scientific merit, 
generally the top half of the applications, will be discussed, assigned a 
priority score, and receive a second level review by the National Heart, 
Lung, and Blood Advisory Council.

Review Criteria

Review criteria are described in the NIH Omnibus Solicitation and are 
available on the Internet at the following URL address: 
http://grants.nih.gov/grants/funding/sbirsttr1/index.htm

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments reviewers will be asked to discuss the following aspects 
of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals.  Each 
of these criteria will be addressed and considered in assigning the overall 
score, weighting them as appropriate for each application.  Note that the 
application does not need to be strong in all categories to be judged likely 
to have major scientific impact and thus deserve a high priority score.  For 
example, an investigator may propose to carry out important work that by its 
nature is not innovative but is essential to move a field forward.

(1) Significance:  Does this study address an important problem?  Does the 
proposed project have commercial potential to lead to a marketable product or 
process?  What may be the anticipated commercial and societal benefits of the 
proposed activity?  If the aims of the application are achieved, how will 
scientific knowledge be advanced?  Does the proposal lead to enabling 
technologies (e.g., instrumentation, software) for further discoveries?  Will 
the technology have a competitive advantage over existing/alternate 
technologies that can meet the market needs? 

(2) Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Is the proposed plan a sound approach for establishing technical 
and commercial feasibility?  Does the applicant acknowledge potential problem 
areas and consider alternative strategies?  Are the milestones and evaluation 
procedures appropriate? 

(3) Milestones: For Phase I applications, how appropriate are the proposed 
milestones against which to evaluate the demonstration of feasibility for 
transition to the R42/R44 development phase?  For Phase II applications, to 
what degree was progress toward the Phase I objectives met and feasibility 
demonstrated in providing a solid foundation for the proposed Phase II 
activity?

(4) Innovation:  Does the project challenge existing paradigms or develop new 
methodologies, approaches, or technologies?  Are the aims original and 
innovative? 

(5) Investigator:  Is the Principal Investigator capable of coordinating and 
managing the proposed SBIR/STTR?  Is the work proposed appropriate to the 
experience level of the Principal Investigator and other researchers, 
including consultants and subawardees (if any)?

(6) Environment:   Is there sufficient access to resources (e.g. equipment, 
facilities)?  Does the scientific and technical environment in which the work 
will be done contribute to the probability of success?  Do the proposed 
experiments take advantage of unique features of the scientific environment 
or employ useful collaborative arrangements? 

In addition to the above criteria, the following additional criteria should 
be considered and addressed:
 
Are the results of the study likely to enable research in this area of 
biomedical research?  What will be the effect of these studies on the 
concepts or methods that drive this field?  To what degree does the 
technology, tools, reagents, etc. support the needs for the targeted 
diseases?  What is the time frame for developing the proposed technologies, 
methods, reagents, etc. and what is the suitability of this time frame for 
meeting the needs of this area of biomedical research?  How easy will it be 
to use the developed technology, method, reagent, etc?  Are the plans for 
dissemination of the proposed endpoints, tools, technologies, methods, 
reagents, etc. developed under this project adequate?  If partnerships are 
proposed, how will they facilitate the development and integration of system 
components?  Does the project adequately address end user needs?  Will there 
be additional application opportunities for the approach, technology, tool, 
method, reagent, etc?  What is the cost effectiveness of the proposed 
technology?  Does the project team have adequate expertise in the areas of 
bioengineering and biomedical research?  Is there evidence of institutional 
support?       

In accordance with NIH policy, all applications will also be reviewed with 
respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated.

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research

o  The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project  
proposed in the application.

AWARD CRITERIA

Applications will compete for available funds with all other recommended SBIR 
and STTR applications. Funding decisions for Phase I will be based on quality 
of the proposed project as determined by peer review, availability of funds, 
and program priority.  Phase II applications will be selected for funding 
based on the above criteria as well as peer review assessment of attainment 
of Phase I goals.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Cardiovascular

Christine A. Kelley, Ph.D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Rockledge II, Room 9142
Bethesda, MD  20892
Telephone:  (301) 435-0513
FAX:  (310) 480-1336
Email: kelleyc@nhlbi.nih.gov

Blood

Phyllis Mitchell, M.S.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
Rockledge II, Room 10163
Bethesda, MD  20892-7950
Telephone:  (301) 435-0481
FAX:  (301) 480-1060
EMAIL:  mitchelp@nhlbi.nih.gov


Lung

Mary Anne Berberich, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
Rockledge II, Room 10102
Bethesda, MD  20892
Telephone: (301) 435-0222
FAX: (301) 480-3557
Email: berberim@nhlbi.nih.gov

Sleep

Michael Twery, Ph.D.
National Center on Sleep Disorders Research
National Heart, Lung, and Blood Institute
Rockledge II, Room 10038
Bethesda, MD  20892
Telephone: (301) 435-0199
FAX: (301) 480-3451
Email: twery@nih.gov

Direct inquiries regarding fiscal matters to:

Mr. David Reiter
Division of Extramural Affairs
Grants Operations Branch						
National Heart, Lung, and Blood Institute
Rockledge II, Room 7154
Bethesda, MD  20892
Telephone: (301) 435-0177
FAX: (301) 480-3310
Email: reiterd@nhlbi.nih.gov

AUTHORITY AND REGULATIONS 

This program is described in the of Federal Domestic Assistance No. 93.837, 
93.838, 93.839.  Awards are made under authorization of sections 301 and 405 
of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies and Federal Regulations 42 CFR 52 and 
45 CFR Parts 74 and 92.  This program is not subject to the intergovernmental 
review requirements of Executive Order 12372 or 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, and 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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