and Human Services (HHS)
EXPIRED
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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)
710-0267, Email: [email protected].
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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