SBIR/STTR TECHNOLOGIES FOR MONITORING AND PERFORMING RESUSCITATION

RELEASE DATE:  February 5, 2004

PA NUMBER:  PA-04-059 (This PA has been reissued, see PA-06-126 
                       and PA-06-127)

EXPIRATION DATE:  January 23, 2006

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:  
National Institutes of Health (NIH) 
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION: 
National Heart, Lung and Blood Institute (NHLBI) 
 (http://www.nhlbi.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.837, 93.838, 93.839 

APPLICATION RECEIPT DATE(S):  Applications submitted in response to this 
program announcement will be accepted at the standard application deadlines 
[April 1, August 1, December 1]

THIS PA CONTAINS THE FOLLOWING INFORMATION:

o  Purpose of the PA
o  Research Objectives
o  Mechanism(s) of Support
o  Project Period and Amount of Award
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Where to Send Inquiries
o  Submitting an Application
o  Supplementary Instructions
o  Peer Review Process
o  Review Criteria
o  Award Criteria
o  Receipt and Review Schedule 
o  Required Federal Citations

NOTICE: This program announcement (PA) must be read in conjunction with the 
current Omnibus Solicitation of the National Institutes of Health, Centers 
for Disease Control and Prevention, and Food and Drug Administration for 
Small Business Innovation Research (SBIR) and Small Business Technology 
Transfer (STTR) Grant Applications. The solicitation (see 
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf [PDF] or 
http://grants.nih.gov/grants/funding/sbirsttr1/index.doc (MS Word] contains 
information about the SBIR and STTR programs, regulations governing the 
programs, and instructional information for submission. All of the 
instructions within the current SBIR/STTR Omnibus Solicitation apply.

PURPOSE OF THE PA 

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.

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 
resuscitation efforts, successful hospital discharge rates in controlled 
studies remains less than five percent.  Success 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 arrest victims 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 could 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, affect 
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 in some settings.  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 
are 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 between basic scientists 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 improved 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.
o  Develop ultra fast methods for recognition and identification of patient 
collapse and location.

MECHANISM(S) OF SUPPORT

This PA uses the SBIR and STTR mechanisms, which are set-aside programs. As 
an applicant, you will be solely responsible for planning, directing, and 
executing the proposed project. Future unsolicited, competing-continuation 
applications based on this project will compete with all SBIR/STTR 
applications and will be reviewed according to the customary peer review 
procedures.  

This PA uses just-in-time concepts. It also uses the modular budgeting 
format. Specifically, if you are submitting an application budget of $100,000 
total costs (direct, F&A and fee) or less, use the modular format and 
instructions as described in the current SBIR/STTR Omnibus Solicitation. 
Otherwise follow the instructions for non-modular budget research grant 
applications.  This program does not require cost sharing as defined in the 
current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm#matching_or_cost_sharing.

Except as otherwise stated in this PA, awards will be administered under NIH 
grants policy as stated in the NIH Grants Policy Statement, December 2003, 
available at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm.  

Applications may be submitted for support as Phase I STTR (R41) or Phase I 
SBIR (R43) grants; Phase II STTR (R42) or Phase II SBIR (R44) grants; or the 
SBIR/STTR FAST-TRACK option as described in the SBIR/STTR Omnibus 
Solicitation.  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 Phase II application must be a logical extension of 
the Phase I research but not necessarily a Phase I project supported in 
response to this PA.  

PROJECT PERIOD AND AMOUNT OF AWARD

The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines of 
funding support and project duration periods for SBIR and STTR Phase I and 
Phase II awards.  For this PA, budgets up to $150,000 total costs per year 
and time periods up to 2 years for Phase I may be requested.  Budgets up to 
$500,000 total costs per year and up to 3 years may be requested for Phase 
II.  Total costs include direct costs, F&A, and a profit/fee.  

ELIGIBLE INSTITUTIONS

Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation.  
Only small business concerns are eligible to submit applications. A small 
business concern is one that, on the date of award for both Phase I and Phase 
II agreements, meets ALL of the criteria as described in the SBIR/STTR 
Omnibus Solicitation.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.  On an SBIR application, the principal 
investigator must have his/her primary employment (more than 50%) with the 
small business at the time of award and for the duration of the project. The 
PI on an STTR application may be employed with the small business concern or 
the participating non-profit research institution as long as s/he has a 
formal appointment with or commitment to the applicant small business 
concern, which is characterized by an official relationship between the small 
business concern and that individual. 

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues:

o Direct your questions about scientific/research issues to:

Suzanne Goldberg, M.S.N., R.N.
Division of Heart and Vascular Diseases
National Heart, Lung and Blood Institute
Two Rockledge Center, Rm 9174
6701 Rockledge Dr., MSC 7940
Bethesda, MD 20892-7940
Telephone:  (301) 435-0532
Fax:  (301) 480-1336
E-mail: goldbergsh@mail.nih.gov

Ms. Ann Rothgeb
Division of Lung Diseases
National Heart, Lung, and Blood Institute
Rockledge II, Room 10114, MSC 7952
Bethesda, MD  20892-7952
Telephone:  (301) 435-0202
Fax:  (301) 480-3557
Email: rothgeba@nih.gov

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

Lawton Cooper, M.D.
Division of Epidemiology and Clinical Application
National Heart, Lung and Blood Institute
Rockledge II, Room 8124 MSC 7936
Bethesda, MD 20892
Telephone: (301) 435-3077
Fax: (301) 480-1669
Email: cooperl@nih.gov

o Direct your questions about financial or grants management 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

SUBMITTING AN APPLICATION

The PHS 398 research grant application must be used for all SBIR/STTR Phase 
I, Phase II and Fast-Track applications (new and revised.)  Effective October 
1, 2003, applications must have a DUN and Bradstreet (D&B) Data Universal 
Numbering System (DUNS) number as the Universal Identifier when applying for 
Federal grants or cooperative agreements. The DUNS number can be obtained by 
calling (866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on line 
11 of the face page of the PHS 398 form. The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html.  Prepare your 
application in accordance with the SBIR/STTR Omnibus Solicitation and the PHS 
398. Helpful information for advice and preparation of the application can be 
obtained at: http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf. The 
NIH will return applications that are not submitted on the 5/2001 version of 
the PHS 398.  For further assistance contact GrantsInfo, Telephone: (301) 
435-0714, Email: GrantsInfo@nih.gov. 

The title and number of this PA must be typed on line 2 of the face page of 
the application.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: This PA uses the 
modular budgeting format. Specifically, if you are submitting an application 
budget of $100,000 total (direct, F&A and fee) or less, use the modular 
format and instructions as described in the SBIR/STTR Omnibus Solicitation. 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five 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 (FOR USPS EXPRESS or REGULAR MAIL)
Bethesda, MD  20817 (FOR EXPRESS/COURIER NON-USPS SERVICE)

APPLICATION PROCESSING:  Applications must be received by or mailed on or 
before the receipt dates described on the first page of this program 
announcement. The CSR will not accept any application in response to this PA 
that is essentially the same as one currently pending initial review unless 
the applicant withdraws the pending application.  The CSR will not accept any 
application that is essentially the same as one already reviewed. This does 
not preclude the submission of a substantial revision of an unfunded version 
of an application already reviewed, but such application must include an 
Introduction addressing the previous critique.  

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Applications submitted for this PA that are complete will be assigned on the 
basis of established PHS referral guidelines.  Appropriate scientific review 
groups convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the appropriate advisory council or board.  

REVIEW CRITERIA

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: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

ALL SBIR/STTR APPLICATIONS

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 subcontractors (if any)? Are the relationships of 
the key personnel to the small business and to other institutions appropriate 
for the work proposed?
 
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? 

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be applied to ALL applications in the determination of scientific 
merit and the priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See additional information and 
criteria included in the section on Federal Citations, below). 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups 
(and subgroups), and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated. (See additional information and Inclusion Criteria in the sections 
on Federal Citations, below).

Human Subjects: 

1.  Protection of Human Subjects from Research Risks - for all studies 
involving human subjects. See instructions and "Guidance for Preparing the 
Human Subjects Research Section.” If an exemption is claimed, is it 
appropriate for the work proposed? If no exemption is claimed, are the 
applicant's responses to the six required points appropriate? Are human 
subjects placed at risk by the proposed study? If so, are the risks 
reasonable in relation to the anticipated benefits to the subjects and 
others? Are the risks reasonable in relation to the importance of the 
knowledge that reasonably may be expected to be gained? Are the plans 
proposed for the protection of human subjects adequate? 

2.  Inclusion of Women Plan - for clinical research only.  Does the applicant 
propose a plan for the inclusion of both genders that will provide their 
appropriate representation? Does the applicant provide appropriate 
justification when representation is limited or absent? Does the applicant 
propose appropriate and acceptable plans for recruitment/outreach and 
retention of study participants? 

3.  Inclusion of Minorities Plan - for clinical research only.  Does the 
applicant propose a plan for the inclusion of minorities that will provide 
their appropriate representation? Does the applicant provide appropriate 
justification when representation is limited or absent? Does the applicant 
propose appropriate and acceptable plans for recruitment/outreach and 
retention of study participants? 

4.  Inclusion of Children Plan - for all studies involving human subjects.  
Does the applicant describe an acceptable plan in which the representation of 
children of all ages (under the age of 21) is scientifically appropriate and 
recruitment/retention is addressed realistically? If not, does the applicant 
provide an appropriate justification for their exclusion? 

5.  Data and Safety Monitoring Plan – for clinical trials only.  Does the 
applicant describe a Data and Safety Monitoring Plan that defines the general 
structure of the monitoring entity and mechanisms for reporting Adverse 
Events to the NIH and the IRB? 

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the required five items described under Vertebrate 
Animals (section f of the Research Plan instructions) will be assessed. If 
vertebrate animals are involved, are adequate plans proposed for their care 
and use? Are the applicant's responses to the five required points 
appropriate? Will the procedures be limited to those that are unavoidable in 
the conduct of scientifically sound research? 

BIOHAZARDS:  Is the use of materials or procedures that are potentially 
hazardous to research personnel and/or the environment proposed? Is the 
proposed protection adequate? 

ADDITIONAL REVIEW CONSIDERATIONS: The following items may be also be 
considered by reviewers but will not be included in the determination of 
scientific merit.

SHARING RESEARCH DATA:  Applicants requesting $500,000 or more in direct 
costs in any year of the proposed research must include a data sharing plan 
in their application. The reasonableness of the data sharing plan or the 
rationale for not sharing research data will be assessed by the reviewers. 
However, reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score. 
http://grants.nih.gov/grants/policy/data_sharing 
     
BUDGET:  The reasonableness of the proposed budget may be considered.  For 
all applications, is the percent effort listed for the PI appropriate for the 
work proposed? On applications requesting up to $100,000 total costs, is the 
overall budget realistic and justified in terms of the aims and methods 
proposed? On applications requesting over $100,000 in total costs, is each 
budget category realistic and justified in terms of the aims and methods? 

PERIOD OF SUPPORT: The appropriateness of the requested period of support in 
relation to the proposed research.

PHASE II APPLICATIONS
 
In addition to the above review criteria:

1.  How well did the applicant demonstrate progress toward meeting the Phase 
I objectives, demonstrating feasibility, and providing a solid foundation for 
the proposed Phase II activity?

2.  Did the applicant submit a concise Commercialization Plan that adequately 
addresses the seven areas described in the Research Plan item J? 

3.  Does the project carry a high degree of commercial potential, as 
described in the Commercialization Plan? 

AMENDED APPLICATIONS

In addition to the above criteria, the following criteria will be applied to 
revised applications.

1.  Are the responses to comments from the previous SRG review adequate? 

2.  Are the improvements in the revised application appropriate? 

PHASE I/PHASE II FAST-TRACK APPLICATION REVIEW CRITERIA

For Phase I/Phase II Fast Track applications, the following criteria also 
will be applied:

1.  Does the Phase I application specify clear, appropriate, measurable goals 
(milestones) that should be achieved prior to initiating Phase II? 

2.  Did the applicant submit a concise Commercialization Plan that adequately 
addresses the seven areas described in the Research Plan, item J? 

3.  To what extent was the applicant able to obtain letters of interest, 
additional funding commitments, and/or resources from the private sector or 
non-SBIR/ STTR funding sources that would enhance the likelihood for 
commercialization? 

4.  Does the project carry a high degree of commercial potential, as 
described in the Commercialization Plan? 

Phase I and Phase II Fast-Track applications that satisfy all of the review 
criteria will receive a single rating. Failure to provide clear, measurable 
goals may be sufficient reason for the scientific review group to exclude the 
Phase II application from Fast-Track review.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended SBIR and STTR applications.  The following will be 
considered in making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

For FAST-TRACK applications, the Phase II portion may not be funded until a 
Phase I final report and other documents necessary for continuation have been 
received and assessed by program staff that the Phase I milestones have been 
successfully achieved.

RECEIPT AND REVIEW SCHEDULE  
See http://grants.nih.gov/grants/funding/sbirsttr_receipt_dates.htm 

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained. 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking $500,000 or more in 
direct costs in any single year are expected to include a plan for data 
sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing. Investigators should seek 
guidance from their institutions, on issues related to institutional 
policies, local IRB rules, as well as local, state and Federal laws and 
regulations, including the Privacy Rule. Reviewers will consider the data 
sharing plan but will not factor the plan into the determination of the 
scientific merit or the priority score.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating 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 clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  
The NIH maintains a policy 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 is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects. You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://stemcells.nih.gov/index.asp and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide, in the project 
description and elsewhere in the application as appropriate, the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: 
The Department of Health and Human Services (DHHS) issued final modification 
to the “Standards for Privacy of Individually Identifiable Health 
Information”, the “Privacy Rule,” on August 14, 2002.  The Privacy Rule is a 
federal regulation under the Health Insurance Portability and Accountability 
Act (HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as “covered entities”) must do so by April 14, 2003 (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on “Am I a covered 
entity?”  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

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 PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 
284)and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm 

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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Research (OER)
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Bethesda, Maryland 20892
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