RELEASE DATE:  September 3, 2004

PA NUMBER: PA-04-156 (PA-04-156 has been reissued, see PA-06-055 and PA-06-056)
EXPIRATION DATE: November 25, 2005 

Department of Health and Human Services (DHHS)

National Institutes of Health (NIH) 

National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK)
National Cancer Institute (NCI)
National Institute on Aging (NIA) 

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. 


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 [PDF] or (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.


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. 



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 
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 

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 

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).


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

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.  


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 


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 


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. 


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.


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:


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

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

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  


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)
FAX 301-480-3503 


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  
FAX 301-480-3925

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
FAX 301-480-2087

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


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: or

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

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 The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is 
available at  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: 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: 

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


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 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the 
application, including the checklist, and five signed photocopies in one package 

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.


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 
( 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 


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


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 

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:

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.)

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 

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.


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? 


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? 


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


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 



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 
(, as 
mandated by the Health Research Extension Act of 1985 
(, and the USDA Animal 
Welfare Regulations (, as 

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.

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:  

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. 
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.

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 

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, 
a complete copy of the updated Guidelines are available at  
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.

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 

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

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

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

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.

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 ( 
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

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal 
Domestic Assistance at 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 

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

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
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Bethesda, Maryland 20892
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