This Program Announcement expires on January 2004 unless reissued.

SBIR/STTR TECHNOLOGIES FOR MONITORING AND PERFORMING RESUSCITATION

Release Date:  February 16, 2001

PA NUMBER:  PA-01-054

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

PURPOSE

This announcement is to encourage small businesses to participate in the 
research and development of new approaches, tools, methods, devices, and 
biomaterials to provide bioengineering-based methodologies for monitoring and 
performing resuscitation.  Ultimately, the goal of this program is to reduce 
morbidity and mortality from circulatory, hypoxemic or traumatic arrest.  For 
this purpose, this announcement is interested in fostering better systems and 
methods for out-of-hospital and basic resuscitation research that 1) enables 
monitoring of genetic, molecular, biochemical, physical or metabolic 
derangements associated with circulatory, hypoxemic, or traumatic arrest; and 
2) elucidates the unique pathophysiology of irreversible injury following 
multiple organ or whole-body ischemia and reperfusion,  Applications should 
address critical cardiac, vascular, pulmonary, or hematologic and/or surgical 
strategies and propose research that will significantly improve clinical 
outcomes of resuscitation efforts.  Research plans should emphasize 
specialties such as medicine, surgery, imaging, computer science, 
bioengineering and materials science, chemistry and physics. 

This program will use the Small Business Innovation Research (SBIR) and Small 
Business Technology Transfer (STTR) funding mechanisms.  Because the length of 
time and cost of research involving advanced technology projects may exceed 
that normally awarded for SBIR/STTR grants, the National Heart, Lung, and 
Blood Institute (NHLBI) will allow well justified Phase I applications with a 
project period of up to two years and a budget not to exceed, including fixed 
fees, $150,000 per year total costs (maximum of $300,000 total costs for 2 
years).  Phase II applications in response to this Program Announcement (PA) 
will only be accepted as competing continuations of previously funded National 
Institutes of Health (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 $500,000 per year total costs, including fixed fees. 

This PA must be read in conjunction with the current calendar year publication 
of the Omnibus Solicitation of the Public Health Service for Small Business 
Innovation Research Grant Applications, and the Omnibus Solicitation of the 
National Institutes of Health for Small Business Technology Transfer Grant 
Applications: https://grants.nih.gov/grants/funding/sbirsttr1/index.pdf.  All of 
the instructions within the Omnibus Solicitations apply with the 
following exceptions:

o  Opportunity for two years of Phase I support with a budget not to exceed 
$150,000 in total costs, including fixed fees, per year;
o  Opportunity for three years of Phase II support with a budget not to exceed 
$500,000 in total costs, including fixed fees, 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, "SBIR/STTR 
Technologies for Monitoring and Performing Resuscitation", 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: https://grants.nih.gov/grants/funding/sbirsttr1/index.pdf. 

MECHANISM OF SUPPORT

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

A.  INDIVIDUAL PHASE I APPLICATIONS

Phase I applications in response to this PA will be funded as Phase I SBIR 
Grants (R43) or Phase 1 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: 
https://grants.nih.gov/grants/funding/sbirsttr1/index.pdf. 

Well-justified Phase I applications with a project period up to two years and 
a budget not to exceed $150,000 per year total cost, including fixed fees, 
(maximum of $300,000 total costs for two years) 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:
https://grants.nih.gov/grants/funding/sbir2/index.htm. 

The Phase II STTR instructions and application may be found on the Internet 
at: https://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 $500,000 in total costs, including fixed fees, per 
year will be allowed.  

RESEARCH OBJECTIVES					

For the purpose of this solicitation resuscitation research will include the 
population of patients who collapse as a consequence of sudden circulatory, 
hypoxemic, or traumatic arrest.  Circulatory, hypoxemic or traumatic arrest is 
a significant public health problem cutting across age, race, and gender.  It 
often occurs without warning in persons who are healthy prior to their 
collapse.  The national estimated mortality for all cause arrest is 350,000 
lives per year, with economic costs for trauma related injuries estimated at 
over $400 billion dollars per year, in productive life years.  In contrast to 
most problems in cardiovascular medicine, current death rates have not 
improved significantly despite scientific advances throughout medicine.  In 
recognition of this public health burden, in June 2000, the NHLBI led a multi-
agency conference entitled, "Post-Resuscitative and Initial Utility in Life 
Saving Efforts" (PULSE) co-sponsored by the National Institute of Child Health 
and Human Development (NICHD), the National Institute of General Medical 
Sciences (NIGMS), the National Institute of Neurological Disorders and Stroke 
(NINDS), of the National Institutes of Health (NIH), the Food and Drug 
Administration (FDA), and the Department of Defense (DOD).  Nearly 200 
conference participants, from the domestic and international scientific and 
practice community, spanning basic, applied, and trauma science expertise, met 
for two and a half days to identify obstacles and to forge a research agenda 
that would save lives and restore arrest victims to their pre-event neurologic 
and physical condition.  

Conference participants concluded new therapies and technologies to increase 
survival outcomes in resuscitation are realistic and should be fostered.  A 
key obstacle for contemporary treatment strategies is the acutely limited time 
window for effective treatment.  Beyond ten minutes after victim collapse, the 
likelihood of complete physical and neurologic recovery with conventional 
resuscitation is very low and overall survival for arrest victims is less than 
ten percent.  Extension of therapeutic time windows and support of  critical 
physiologic functions provides an opportunity to expand strategies for the 
treatment of arrest syndromes and for dramatic improvement in survival.  The 
need to stimulate the development of enabling technology and new scientific 
avenues to expand basic and applied resuscitation research was a recurring 
theme throughout the Workshop deliberations.  It became a key recommendation 
of the conference, and is the basis for this solicitation. 

The theoretical basis for cardiopulmonary resuscitation (CPR) practice, closed 
chest compressions and ventilation, was established in the 1960's.  The 
fundamental strategies for CPR have not changed since these original concepts 
emerged and there is a paucity of contemporary CPR research.  Outcomes in 
trauma related battlefield statistics have not improved significantly since 
the Civil War.  Recognition of ventricular fibrillation, a common cause of 
circulatory arrest, and the efficacy of cardioversion in restoration of normal 
conduction and spontaneous circulation occurred in the 1940's.  Despite 
numerous advances in the identification of patients at risk and the use of 
therapeutic interventions including drugs and devices the outcome of 
resuscitation efforts for arrest victims remains poor.  Even with contemporary 
use of the automated external defibrillator to enhance successful patient 
discharge rates in controlled studies remains less than twenty percent.  
Survival is significantly lower if complete neurologic recovery is included.  
 Existing strategies known to restore circulation, shorten ischemia, and save 
lives should be refined to encourage and facilitate rapid, widespread and 
effective out-of-hospital application and are encouraged by this announcement. 
 
Current investigations are limited by underutilization of systems correlations 
and understanding of interrelated factors which contribute to irreversible 
cellular, vascular and organ damage in arrest states.  Expansion of basic and 
applied research with a goal of identifying new therapies to minimize or 
tolerate whole-body ischemic insults holds promise for a dramatic improvement 
in survival rates. Scientific evidence exists to support assumptions that 
metabolic modulation of cellular and tissue systems could improve survival. 
New therapeutic interventions are likely to be derived from an understanding 
of cellular biology and gene expression that provide protection or tolerance 
to ischemia, reperfusion injury and other derangements of inadequate 
perfusion.  

A critical obstacle to improve survival, particularly for out-of-hospital 
arrest, is the lack of methods and systems to identify, monitor, and trend 
physiologic (biochemical, metabolic or cellular) parameters.  Noninvasive or 
minimally invasive devices to be applied in the field to detect blood and 
tissue oxygen, carbon dioxide levels, pH, blood pressure, and assess vital 
organ perfusion are desperately needed.   These devices need to be 
interrelated and should not impede resuscitation efforts.   Such technology 
would facilitate research, identify critical markers, or trends of these 
markers, and provide critical baselines for monitoring and assessment of 
arrests victim during resuscitation efforts.  Rapid out-of-hospital 
application of a percutaneous, or noninvasive continuous flow circulatory 
support system with the ability to administer fluids and deliver medications 
can be vital to survival of arrest victims.

Enhancement of survival outcomes following resuscitation and development and 
piloting of innovative strategies which may, directly or indirectly, effect 
this outcome is the primary goal of this announcement.  The primary potential 
target is the control and/or alleviation of whole-body ischemia and 
reperfusion injury before, during, and following resuscitation.  Several 
factors contribute to the eventual demise of heart, lung or vascular cells, 
including oxidant stress, calcium overload, osmotic stress, energy depletion, 
and inflammation.  New therapeutic interventions may focus on addressing 
mechanisms of regional or whole-body ischemia and reperfusion to improve 
survival. 

Hypothermia successfully preserves cells, tissue, organs and organ systems in 
a variety of settings, however, there are hypothermia-related complications, 
including changes in electrical stability of the heart, clotting factors, 
blood chemistries and tissue oxygen that need further investigation.  Research 
projects to evaluate novel methods to induce controlled hypothermia in the 
field or during resuscitation efforts, offer novel opportunities to increase 
the functional time window in resuscitation victims and significantly improve 
survival.  Investigations in hibernation, birth, and shock, that are 
associated with sudden profound changes in circulation, metabolism, and basal 
physiologic processes may provide insight for new therapeutic or protective 
strategies for complete physiologic and neurocognitive recovery.

Trauma arrest victims provide unique challenges and opportunities for 
resuscitation research. Thrombosis and hemorrhage control are critical in the 
care of trauma victims.  Resuscitation can be successful only if hemostasis is 
achieved and delivery of critical substrate is adequately restored.  The 
identification, development, and testing of an optimal resuscitation fluid, 
which can prolong tissue viability, whether a temporary or long-term 
substitute for blood derived products, would be a boon for trauma 
resuscitation survival outcomes.  Innovative strategies or systems to provide 
rapid vascular access and appropriate replacement fluid delivery will be  a 
major advance in reducing trauma related deaths.   Noninvasive or minimally 
invasive imaging techniques providing rapid assessment of multiple vital organ 
function, volume status, or cellular or organ perfusion rates during 
resuscitation efforts is critical to assess patient status and would provide 
timely feedback to implement and assess appropriate treatment.

Unwitnessed arrest or collapse in a public facility presents another critical 
resuscitation challenges.  Instantaneous interactive communications systems, 
such as global positioning technology, is needed as a rapid alert system for 
paramedical personnel and to provide bystanders with instructions for 
initiation of life-saving resuscitation measures. 

This PA seeks to encourage potential applicants to take full advantage of the 
SBIR/STTR program mechanism for multi-disciplinary research projects that 
develop monitoring systems and approaches to perform resuscitation that are 
safe and effective for use in humans.  In the pre-clinical or clinical 
development phases, collaborations with approved animal facilities and 
healthcare organizations may be required.  Research proposals should focus on 
improving out-of-hospital resuscitation, but the need to evaluate specific 
technologies and approaches in the clinic during design development is 
recognized.  This program seeks innovative projects to provide new 
capabilities in systems and methods.  Projects that offer only incremental 
advances of existing in-hospital technologies will not be responsive to this 
PA.  Examples of topics the research and clinical communities have identified 
are listed below: however this program announcement is not limited to these 
examples and is open to all relevant, meritorious research ideas:

o  Develop ultra fast methods for recognition and identification of patient 
collapse and location.
o  Design to improve defibrillator technology.
o  Develop enabling technologies for research of whole body ischemia and 
reperfusion injury in appropriate animals models and humans. 
o  Develop methods to augment rapid delivery and transfer of oxygen to cells, 
tissues and organs.
o  Develop methods for rapid functional restoration of circulation, both 
neurologic and cardiovascular, during cardiac, hypoxemic and/or traumatic 
arrest.
o  Develop methods for rapid vascular access and delivery of medications and 
resuscitation fluids, either traditional or novel synthetic preparations
o  Develop materials and methods for rapid induction of controlled hypothermia
o  Develop alternative methods to traditional CPR to maintain vital organ 
blood flow and nutrient delivery during cardiac, hypoxemic, and/or traumatic 
arrest.
o  Develop biosensors, using natural and synthetic substrates, for acquisition 
and monitoring of critical vital organ function, (e.g. cardiac, neurologic, 
cellular and tissue oxygen levels).
o  Develop methods to rapidly identify and implement hemostasis in trauma 
victims.

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 Contract shave 
been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) 
and in the NIH Guide for Grants and Contracts, on August 2, 2000 
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a 
complete copy of the updated Guidelines are available at 
https://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 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:  https://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 https://grants.nih.gov/grants/funding/sbir.htm.  
Hard copies are not available. 

Applicants planning to submit an SBIR or STTR Phase I or Phase II application 
AFTER April receipt dates should check the NIH Small Business Funding 
Opportunities is website https://grants.nih.gov/grants/funding/sbir.htm for 
more specific details and instructions.

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 $150,000 
per year direct costs, including fixed fees. 

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 
increase(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 $500,000 in total costs 
per year, including fixed fees.  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 
after the date of issuance up until December 2003.  There after, 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.  Applications not adhering to application 
instructions described above, and those applications that are incomplete as 
determined by the Center for Scientific Review, 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 appropriate Advisory Council.

Review Criteria

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

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 
essential to move a field forward but is not innovative.

(1) Significance:  Does the proposed project have commercial potential to lead 
to a marketable product or process?  Does this study address an important 
problem?   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) Innovation: Does the project challenge existing paradigms or employ novel 
technologies, approaches or methodologies?  Are the aims original and 
innovative?

(4 Investigators:  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 sub-awardees (if any)?

(5) Environment:  Is there sufficient access to resources (e.g., equipment, 
facilities)?  Does the scientific and technological 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 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 well as any differences noted within subset 
analysis as to treatment strategies 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:

Heart and Vascular

Caroline C. Webb, MSN, CCRN
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Rockledge II, Room 9174, MSC 7940
Bethesda, MD  20892-7940
Telephone:  (301) 435-0515
FAX:  (301) 480-1336
Email:  webbca@nhlbi.nih.gov

Pulmonary

Ms. Ann Rothgeb
Division of Lung Diseases
National Heart, Lung, and Blood Institute
Rockledge II, Room 101114, MSC 7952
Bethesda, MD  20892-7952
Telephone:  (301) 435-0202
FAX:  (301) 480-3557
Email: rothgeba@nih.gov

Hematology and Blood Resources

Henry Chang, M.D.
Division of Blood Diseases and Resources
Rockledge II, Room 10170 MSC 7950
Bethesda, MD 20892-7950
Telephone: (301) 435-0067
FAX: (301) 480-1060
Email:  changh@nih.gov

Epidemiology

Lawton Cooper, M.D.
Division of Epidemiology and Clinical Application
Rockledge II, Room 8124 MSC 7936
Bethesda, MD 20892

Telephone: (301) 435-3077
FAX: (301) 480-1669
Email: cooperl@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Shelia Ortiz
Division of Extramural Affairs
Grants Operations Branch
National Heart, Lung, and Blood Institute
Rockledge II, Room 7154, MSC 7926
Bethesda, MD  20892-7926
Telephone:  (301) 435-0166
FAX:  (301) 480-3310
Email:  Ortizs@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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