and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
BIOENGINEERING APPROACHES TO ENERGY BALANCE AND OBESITY (SBIR/STTR)
RELEASE DATE: September 3, 2004
PA NUMBER: PA-04-156
EXPIRATION DATE: August 2, 2007, unless reissued.
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATION:
National Heart, Lung, and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
(http://www.nibib.nih.gov)
National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov)
National Cancer Institute (NCI)
(http://www.nci.nih.gov)
National Institute on Aging (NIA)
(http://www.nia.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):
93.837, 93.286, 93.847, 93,848, 93.393, 93.399, 93.866
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) through August 1, 2007.
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 Special Requirements
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
The purpose of this PA is to solicit applications to develop and validate new and
innovative bioengineering technology to address clinical problems related to
energy balance, intake, and expenditure. Novel sensors, devices, imaging, and
other approaches are expected to be developed and evaluated by collaborating
engineers, physical scientists, and scientists from other relevant disciplines
with expertise in obesity and nutrition. The goal is to increase the number of
useful technologies and tools available to scientists to facilitate their research
in energy balance and health. Eventually these research tools should facilitate
therapeutic advances and behavioral changes to address such problems as weight
control and obesity.
RESEARCH OBJECTIVES
Background
Public health need
Obesity is a problem of energy balance, wherein adipose tissue stores accumulate
to excess levels when expenditure does not keep up with intake. At present,
approximately 65% of American adults are either overweight (?25 kg/m2) or obese
(?30 kg/m2), and approximately 15% of American children are similarly categorized
(by age-adjusted percentiles of weight for height). This situation reflects the
high-energy efficiency of American life, where little physical effort is needed
for work and recreation, and where the national diet is abundant in low-cost,
energy-dense food. Popular approaches to weight control have been generally
unsuccessful, despite constant publicity about the problem and considerable
individual efforts at weight loss.
The health consequences of obesity (e.g., diabetes, cancer, heart disease) are
predicted to grow worse. Type 2 diabetes rates are rising in adults and children,
and a substantial increase in morbidity and mortality from cardiovascular disease
is expected. Furthermore, obesity has been linked to the development of several
types of cancer. Ultimately, resolution of the obesity epidemic at the population
level will depend on individual behavioral change that takes place within the
larger societal environment. Such changes may be facilitated through better
medical therapies. However, technologies and tools to more easily monitor
behavior and achieve treatment goals are also be needed.
Conversely, inadvertent weight loss (cachexia) is also of high concern,
particularly in the aging population. Cachexia represents a situation of
persistent negative energy balance that often is accompanied by disproportionate
loss of muscle tissue, weakness, and steady deterioration of physical function.
Aged individuals are less likely than younger persons to be able to restore body
weight after a period of impaired intake, perhaps due to aging-related blunting of
compensatory effects on appetite. Overall, little is known about how best to
reverse cachexia once it develops; methods for detecting the onset of such periods
would be useful. Cachectic states also are common among patients with advanced
stages of chronic diseases such as heart failure, chronic obstructive pulmonary
disease, and cancer.
Aging poses additional interesting questions related to energy balance and its
assessment. When studying these, one must distinguish between the normal biology
of aging, as opposed to age-associated ailments that are part of the health and
social experience of the aged population. Even relatively healthy, high
functioning individuals will experience age-related declines in metabolic rate,
muscle mass, energy intake, energy expenditure. However many aged individuals are
characterized by existing poor function, an ever-increasing propensity to adverse
unpredictable events (such as falls and sudden illness), and impaired response to
such events. Prediction of the propensity to such events, and detection of early
stages of impaired adaptive responses, is needed in order to preserve functional
capacity.
Clearly, the ability to measure states of energy balance and its various
components, such as dietary intake, resting metabolism, and physical activity, is
a critical public health need. However, this is remarkably difficult to achieve
in satisfactory fashion, and the inconvenience, expense, and relative inaccuracy
of current methods are a persistent and serious barrier to progress. Engineering
approaches have the potential to overcome these limitations, but represent a
relatively untapped area of scientific expertise for tackling the research issues
and practical aspects of the obesity epidemic. Emerging technologies, such as
nanotechnology, also offer unique opportunities for interfacing with engineering
approaches to help address some of the problems in obesity research.
Challenges in measuring energy balance
Assessment of human energy balance, the net difference between energy intake (by
diet) and expenditure (by work and heat), is a key component of obesity research,
prevention, and treatment. The importance of accurate measurement of states of
energy balance can be appreciated by considering average weight gain in middle-
aged adults (~10 lb/decade). This significant gain in weight results from very
small, persistent excesses of intake over expenditure of approximately 0.3% of the
daily calorie consumption. This imbalance is well below the level of perception
for most individuals. Similarly, energy expenditure from physical activity must
be quantified accurately in order to understand the dose effects of exercise on
body weight and other aspects of health, such as blood pressure. Weight loss
programs often include ~5% increments of expenditure and ~20% decrements of
intake. Research on the degree of increased activity or dietary changes that
include energy reduction necessary for weight loss suggests that objective
measurable differences can be undetectable, even if reported behavior varies
between groups. At present, apart from body weight, objective measures of
achievement of behavioral goals related to weight control is difficult.
To overcome the limitations of current methods to assess energy balance and
control weight, innovative approaches are needed. The problems associated with
measuring and monitoring components of human energy balance present unique
opportunities for engineers with expertise in the disciplines of thermodynamics,
mechanics, heat transfer, instrumentation, imaging, and design. By collaborating
with obesity researchers, such engineers, especially those with biomedical
backgrounds, may develop the novel approaches to successfully address the problem
of obesity.
Each component of the energy balance equation presents unique challenges. For
example, the difficulty of ascertaining food intake with acceptable levels of
accuracy is well known to nutritionists. The standard self-report questionnaire
and recall techniques can provide valuable data on dietary patterns, and have been
improved by electronic information technologies and by judicious use of results
from cognitive process research. Nevertheless, these techniques are time-
consuming and inconvenient. Furthermore, considerable under-reporting of total
energy intake is typical, with this error more severe in overweight than non-
overweight individuals. At the other extreme of precision and cost is the
research technique (also occasionally used in therapeutic situations) of providing
a controlled diet with all food intake observed and defined by chemical analysis.
Use of these techniques is severely limited by their high cost and limited
applicability because of the population samples typically enrolled and the highly
controlled conditions used. Therefore, new and improved methods of determining
energy intake are critically needed for research as well as practical purposes.
Measuring the various modes of physical activity is difficult as well,
particularly outside the laboratory. Devices must be convenient, cost-effective,
suitable for short-term and habitual activity, and valid for an array of
circumstances and states of health and fitness. None of the available methods
(pedometers, accelerometers, electronic load transducers, foot contact time
monitors, heart rate monitoring) is fully satisfactory, because they only capture
a fraction of needed information. They do not yield data that are easily
understood, particularly by the lay public, nor can they easily detect changes in
behavior, except for the pedometer, which yields data in terms of steps and can
foster behavior change (i.e., more walking). In addition, the data yielded by
these devices do not readily translate into calories expended over the entire
course of a day, which must be compared with energy from food intake to obtain an
estimate of energy balance. Therefore, there is a problem of inter-converting
measurements of energy expenditure and intake into the same units as food intake.
Assessment of states of total energy balance also is a critical research need.
Recently improved research tools include small or portable indirect calorimeters
for short-term expenditure measurements during physical tasks, room calorimeters
with floor mounted force plates to study movement energetics, and global
positioning system (GPS) transponders to track outdoor activity patterns. Doubly-
labeled water is valuable for determining total expenditure but is expensive,
involves stable isotopes, and only is suitable for basic research. Nevertheless,
we need to be able to accurately, precisely, and directly measure whether an
individual is in energy balance, deficit, or excess, and to translate the results
into everyday behavior. The overall state of body energy stores also cannot be
easily ascertained, particularly at the individual level, because data outputs are
usually based on group-derived algorithms. However, there has been some recent
progress in techniques used to estimate energy stores (e.g., bioelectric impedance
for percent body fat, MRI-quantified adipose depots to define metabolically active
compartments).
Such imaging and sensor technologies will also be beneficial to the elderly. In
this population, such tools are needed to assess rates of change in total energy
intake, balance, and expenditure, and in the size and function of multiple
metabolic compartments (especially muscle mass), over relatively long intervals
and in response to rare but cumulative events. These technologies need to be able
to distinguish between changes related to the physiological process of aging, as
opposed to age-associated ailments and other changes reflecting the health and
social experience of the aged population. Any methodology used for the elderly
population must accommodate a spectrum of functioning ranging from the unusually
fit, to typical level, to the frail. Also, the information gathered should be
translatable to research and/or practical applications related to preservation or
impairment of ability to undertake activities of daily living. Assessment
techniques and data analysis methods need to be able to distinguish between true
capacity vs. elicited performance; these are highly variable among the aged, and
are unusually susceptible to measurement biases and errors. Human factors issues
are particularly important for the elderly population, and must acknowledge
participant burdens related to time (including that of caregivers/assistants),
transportation, cognitive capacity and effort, discomfort, and physical
capabilities (such as vision, hearing, strength, mobility).
In conclusion, most techniques for measuring either side of the energy equation
are costly, cumbersome, and suitable primarily for research use. They do not
address the critical issue of overall energy balance, nor do they take advantage
of new knowledge of biochemical markers. Moreover, the available devices are not
sufficiently precise or specific for guiding individual behavior, and their
measurement errors may be greater than the treatment effect. Devices designed for
use by the public are particularly hampered by these problems. At present, we do
not have the equivalent of a "magic wristwatch" that can readily convey whether
the wearer has exceeded an intake goal or fallen short on expenditure. New
approaches might provide accurate, convenient, easily understood, and inexpensive
devices to foster research and improve clinical management of adults and children.
The greatest scientific need is for improved ways to achieve short- and long-term
measurement of total energy intake, expenditure, exchange, and balance, and
components thereof (e.g., resting and basal metabolic rate, physical activity,
thermic effect of food) under various physiologic conditions and activities,
including work, sleep, and leisure activity, and related body composition and
metabolic compartments. The use of micro-electro-mechanical systems for
biomedical applications (BioMEMs) to measure appropriate biomarkers of energy
balance may be of great benefit to assessing energy balance. Since many materials
exhibit novel and unique properties at the nano level, their use might represent a
new approach for precise measurements of energy status and metabolic activity.
Summary of priority areas
In summary, the objective of this PA is to encourage and enable engineers and
scientists at small businesses to develop and evaluate new technologies,
instrumentation, and medical devices to better assess appropriate biomedical
parameters and provide feedback and/or therapy to reduce the prevalence of obesity
and overweight. Development of new technologies and application of existing
technologies may be proposed. Studies may include use of animal models and/or
human participants, but are not required to do so. If appropriate, plans for
manufacturing and clinical evaluation of developed instrumentation and medical
devices should be included in the application.
Applications are encouraged that represent scientific and technical expertise and
collaborations from fields such as biomedical engineering, computer sciences,
physics, human and animal nutrition, aging, exercise sciences, behavioral
sciences, medicine, biochemistry, and biotechnology.
Appropriate topics for development and validation under this PA include, but are
not limited to, the following:
o Diagnostic and therapeutic systems to monitor energy balance and appropriate
biomarkers.
o Biosensors, including intra- and extra-cellular systems, for measuring calorie
consumption and energy expenditure. Sensors that are non-invasive, minimally
invasive, miniature, stable, and durable.
o Mathematical models for predicting interrelationships between energy balance
and weight control.
o Implantable devices for monitoring and treating obesity and overweight.
o Bioengineering tools that integrate self-reported information with biologic
and/or sensor measures of physical activity, diet/nutrition, and energy
balance/obesity. This would include tools that measure this integrated information
in real-time.
o Methodologies for imaging structure and function, blood flow, perfusion, and
metabolism from the molecular/cellular to whole organs for the purpose of
measuring and studying energy balance, intake and expenditure, and weight control.
o Miniaturized non-invasive sensors to detect motion, thermal output,
pressure/other mechanical forces, body position, geophysical location;
o Energy balance indicators, such as “smart” clothing, household or office
furnishings, that incorporate sensors, bar codes or other identifying technologies
to calculate energy expenditure.
o Development of sensors to continuously measure physiological
parameters/biomarkers which regulate or reflect appetite and metabolism (e.g.
insulin, leptin, vagus nerve activity).
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
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.
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 she/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.
SPECIAL REQUIREMENTS
Grantees’ Meetings
In order to ensure maximum progress in the projects funded by this PA and to
realize the maximum benefit for the research community, all funded investigators
will be invited to an annual meeting of investigators funded by SBIR/STTR. The
annual meeting will facilitate sharing of progress and research insights with
other investigators. In the preparation of the budget, applicants should request
travel funds for the Principal Investigator and one additional senior investigator
to attend this annual meeting.
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:
NHLBI
Abby G. Ershow, Sc.D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Two Rockledge Center, Suite 10-193, MSC 7956
6701 Rockledge Drive
Bethesda, MD 20892-7956
Phone (301) 435-0550
Fax (301) 480-2858
Email: ErshowA@mail.nih.gov
Tim Baldwin, Ph.D.
Biomedical Engineer
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Two Rockledge Center, Room 9051, MSC 7956
6701 Rockledge Drive
Bethesda, MD 20892-7956
Phone (301) 435-0513
Fax (301) 480-1335
Email: BaldwinT@mail.nih.gov
NIBIB
Peter Moy, Ph.D.
Division of Discovery Science & Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 200
Bethesda, MD 20892-5469
Phone: 301-451-4772
Fax: 301-480-1614
Email: moype@mail.nih.gov
NIDDK
Maren R. Laughlin, Ph.D.
Senior Advisor for Integrative Metabolism
National Institute of Diabetes & Digestive & Kidney Diseases
National Institutes of Health
6707 Democracy Blvd, Room 6101
Bethesda, Maryland 20895
(fed ex 20817)
301-594-8802
FAX 301-480-3503
maren.laughlin@nih.gov
NCI
Sharon Ross, Ph.D.
Program Director,
Nutritional Sciences Research Program
Division of Cancer Prevention
National Cancer Institute
6130 Executive Blvd EPN-3157
BETHESDA MD 20892-7328
301-594-7547
FAX 301-480-3925
sr75k@nih.gov
Connie Dresser, RDPH, LN
Acting NCI SBIR Liaison
Program Director, Multimedia Technology/
Health Communication SBIR/STTR Grants
Health Communication & Informatics Research Branch
Behavioral Research Program
Division of Cancer Control & Population Sciences
National Cancer Institute
6130 Executive Blvd, EPN-4072
Bethesda, MD 20892-7365
301-435-2846
FAX 301-480-2087
cd34b@nih.gov
Audie A. Atienza, Ph.D.
Division of Cancer Control & Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPN 4074A
Bethesda, MD 20892-7335
Phone: 301-402-8426
Fax: 301-480-2087
Email: atienzaa@mail.nih.gov
NIA
Winifred K. Rossi, M.A.
Special Assistant for Planning
Geriatrics and Clinical Gerontology Program
National Institute on Aging, NIH, DHHS
7201 Wisconsin Avenue, Suite 3C307
Bethesda, Maryland 20892-9205 (Express: 20814)
Telephone: 301-496-3836
Fax: 301-402-1784
Email: rossiw@nia.nih.gov or Winnie_Rossi@nih.gov
o Direct your questions about financial or grants management matters to:
Mr. Edward (Gene) McGeehan
Grants Operations Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Two Rockledge Center, Suite 7142
6701 Rockledge Drive, MSC 7926
Bethesda, MD 20892-7926
Telephone: (301) 435-0177
FAX: (301) 480-0422
Email: mcgeehae@nhlbi.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.
SUPPLEMENTARY INSTRUCTIONS
Certain types of research require clinical evaluation and federal regulatory
approvals prior to commercialization. Applicants are encouraged to contact the
FDA to identify approvals which may be required in the course of development and
to obtain guidance regarding data required by the FDA to obtain such approvals.
Applicants may include FDA guidance in the application to justify experimental
plan.
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 Bethesda, MD 20817 (FOR EXPRESS/COURIER SERVICE)
APPLICATION PROCESSING: Applications must be 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
eight 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 national 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.
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.
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://grants1.nih.gov/grants/funding/sbirsttr_receipt_dates.htm
REQUIRED FEDERAL CITATIONS
ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as
mandated by the Health Research Extension Act of 1985
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal
Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as
applicable.
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. The inclusion
of children is not necessary if the proposed research is focused on the aged
population.
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.
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).
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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