INITIATIVE FOR ALCOHOL SENSING AND DATA ANALYSIS SYSTEM (SBIR)

RELEASE DATE:  September 29, 2004

RFA NUMBER: RFA-AA-05-002  

EXPIRATION DATE:  December 21, 2004

Department of Health and Human Services (DHHS)

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

COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute on Alcohol Abuse and Alcoholism (NIAAA) 
 (http://www.niaaa.nih.gov) 

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.273

LETTER OF INTENT RECEIPT DATE: November 22, 2004
APPLICATION RECEIPT DATE: December 20, 2004  

THIS RFA CONTAINS THE FOLLOWING INFORMATION 

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

NOTICE: This Request for Applications (RFA) 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 (http://grants.nih.gov/grants/funding/sbirsttr1/index.doc or 
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf) contains 
information about the SBIR programs, regulations governing the programs, and 
instructional information for submission. All of the instructions within the 
SBIR Omnibus Solicitation apply with the following exceptions: 

o Application Receipt Date: December 20, 2004
o Initial review convened by the NIAAA Division of Extramural Activities
o Modified guidelines for Project Period and Amount of Award

PURPOSE OF THIS RFA

This Request for Applications (RFA) invites SBIR grant applications for 
research on unobtrusive monitoring and continuous quantitation of alcohol 
(ethanol) content in humans.

In recognition of the complexity of the requirements, the duration and 
amounts of individual grants awarded under this RFA may be greater than those 
routinely awarded under the SBIR program.  Few small businesses possess the 
highly specialized resources needed to develop an alcohol sensor; analysis of 
resulting data using techniques such as spatial/temporal pattern analysis and 
data reduction/compression; and attendant technologies such as power supply, 
to enable calibrated, accurate, high-resolution continuous measurements of 
alcohol content.  Therefore, this RFA encourages team approaches to research, 
combining the expertise and resources of investigators from commercial, 
academic and other sectors of the research community.  Partners to the small 
businesses may play important roles in these projects and may receive 
appropriate support for their efforts.  In addition to requiring 
collaboration from various sectors, it is expected that this initiative will 
require expertise from a variety of disciplines relevant to alcohol research, 
including physiology, biochemistry, engineering, physics, and mathematical 
sciences.

RESEARCH OBJECTIVES

Background

The NIAAA understands that achievement of program objectives will require the 
exercise of technologies beyond the current state of the art in biomedical 
research and therefore requires research efforts entailing a significant 
level of technical risk.  It is likely that these efforts will require the 
integration of diverse technologies and methodologies, including some not 
traditionally associated with biomedical applications.  Therefore, 
applications involving teams of investigators with expertise in key areas of 
sensor system design, data analysis, and/or relevant biomedical application 
areas are appropriate.  Applications involving individual investigators or 
investigator teams of narrower expertise may also be appropriate if they show 
strong potential applicability to the program goals and include a clear 
mechanism for ultimately integrating successful developments into full sensor 
system development.

Several basic requirements can be identified for the measurement, monitoring, 
recording, and reporting of alcohol data.  Because of the rapid uptake of 
alcohol upon ingestion, a rapid response and good time resolution is 
desirable for a measuring system.  Also, any monitoring system must provide 
measurement data, which are detailed and reliably accurate.  The measurement 
process should be minimally obtrusive on behavior, and should be immune to 
accidental or intentional disruption or discontinuation of the measurement 
functions.  Ideally the individual will act naturally during the data 
collection period, with essentially no awareness of the measurement process.  
Other features needed depend on the particular uses intended.  Some uses may 
be for short time periods while others may require continuous measurements 
over extended periods, up to a month or more.  Additional desirable features 
might include the ability to monitor alcohol levels in different body organs 
and systems simultaneously; a capability to provide other physiologic 
measurements such as blood pressure, temperature; a capability to provide 
measurements of metabolite, enzyme and hormone levels; the ability to sense 
and record information about the individual's location and activity; and the 
ability to report data telemetrically. 


Research Topics

A set of target performance goals and properties for an innovative blood 
alcohol sensor has been identified through consultation with application and 
technology experts from the alcohol research community as well as experts 
from other application areas in biomedical sensing.  NIAAA is interested in 
development of integrated sensing and processing systems capable of but not 
limited to the following:  

- Accurate determination of alcohol concentration every 1 to 5 minutes, with 
concentration resolution of (<5 mg/dL) within a range of (5 - 500 mg/dL).
- Measurement fidelity should be robust to subject's activities up to and 
including active efforts at tampering.
- System should provide for either data storage or telemetric data 
transmission without removal of the sensor.
- Sensor system should have no demonstrably deleterious effects on subject's 
comfort, health, and safety.

With a variety of monitoring purposes possible, it is not necessary that any 
one system satisfy all applications.  Instead, specific additional features 
would be desirable for specific purposes.  Examples of these include but are 
not limited to: 

- Capacity for extended data monitoring, storage and reporting over time 
periods up to a month or more.
- Capacity to monitor alcohol levels in different body organs and systems 
simultaneously, with spatial and temporal resolution sufficient to study 
concentration kinetics between different compartments of the body.
- Capacity to monitor and record other physiologic measurements, such as 
heart rate, blood pressure, temperature, galvanic skin impedance, and blood 
chemistry measurements (e.g., PO2, metabolites, enzymes, and hormone levels).
- Ability to sense and record information about the individual's physical 
activity and/or sleep-wake cycle.
- Ability to monitor an individual’s geographic location.
- Ability to report data telemetrically.
- Ability to monitor and provide immediate feedback when alcohol 
concentrations exceed a predetermined cutoff (e.g., 200 mg/dL). 

Assessment of the current practice in sensing of various analytes present in 
blood has suggested that radical new approaches are required to obtain joint 
measurement and analysis of specific high-resolution vital data through 
tissue.  Challenges include obtaining high-fidelity measured data out of 
tissue, particularly if spatial localization is to be included and multiple 
physiologic effects are to be monitored.  This is difficult because tissue is 
a dispersive and scattering medium, which often foils simple methods of 
moving high-resolution, detailed spatiotemporal information in and out of the 
body.  Another significant challenge will be maintaining calibration over the 
long operating periods and variable operating conditions anticipated for the 
system.

In any system, power requirements for sensing and processing must be 
considered carefully. In each case, system output data must be stored for 
eventual use.  One possibility would employ periodic telemetric data dumps to 
a small base station, possibly installed in the individual's home residence.  

In any sensing approach, there will be a significant need of signal 
processing for elucidating the information contained in the raw sensor 
measurements.  The selection of measurement features and the post-processing 
of these features must be matched to the physical sensor design and the 
ultimate application end use to ensure the production and recording of 
calibrated and robust information suitable to the end use.  In several 
possible approaches, physical fields are used to probe or report the state of 
physical observables.  As these signals pass in or out of tissue, they will 
be significantly modified by the transmitting medium, which must be taken 
into account in the design of these signals and the data processing 
associated with their use.  Modeling of the environment for the purpose of 
matched field processing or physics-based processing will be appropriate to 
several approaches. 

Consideration of the challenges associated with this program indicates that 
advances in signal processing, data analysis, and the creation of valid and 
verifiable models of the basic phenomena under consideration are integral 
parts of any system developed in this program.  Developments in this arena 
should be performed jointly with the development of the sensor hardware, 
rather than as an ancillary activity conditioned on a fixed hardware design.  
In any system, signal processing and physical sensing should be optimized 
jointly rather than independently in order to obtain maximum system 
performance.

The desired end-to-end design and optimization of sensor systems for this 
program will also require an explicit consideration of the various uses for 
the data outputs of the system.  This will include an understanding of the 
experiments which are likely to be conducted using the sensor, possible 
interventions or probing of a person, and attendant requirements of data 
reduction and analysis and pattern discovery.  This is an essential activity, 
too often ignored initially, and ultimately incurring a great downstream cost 
in degraded system performance and resources expended in retrofit activities.  
Program success will require the development of not simply a physical sensor 
device, but rather an integrated sensing, processing, and analysis system and 
methodology.  The ultimate goal of such a system is to enable the elucidation 
of useful information patterns, rather than merely providing new means for 
producing enormous stores of unreduced data.

MECHANISMS OF SUPPORT

This RFA uses the SBIR 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 applications 
and will be reviewed according to the customary peer review procedures.  The 
anticipated award date is July 1, 2005.  Applications that are not funded in 
the competition described in this RFA may be resubmitted as NEW SBIR 
applications using the standard receipt dates for NEW applications described 
in the current SBIR/STTR Omnibus Solicitation.

This RFA uses just-in-time concepts. It also uses the modular budgeting as 
well as the non-modular budgeting formats. Specifically, if you are 
submitting an application budget of $100,000 total costs (direct, F&A and 
fee) or less, use the modular budget format.  For applications requesting 
more than $100,000, use the non-modular budget format.  Instructions for both 
are described in the current SBIR/STTR Omnibus Solicitation.  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.

Except as otherwise stated in this RFA, awards will be administered under NIH 
grants policy as stated in the NIH Grants Policy Statement, March 2001, 
available at http://grants.nih.gov/grants/policy/nihgps_2003/.

Applications may be submitted for support as Phase I SBIR (R43) grants or 
Phase II SBIR (R44) grants; or the FAST-TRACK option as described in the 
SBIR/STTR Omnibus Solicitation.  Phase II applications in response to this 
RFA will only be accepted as competing continuations of previously funded NIH 
Phase I SBIR 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 RFA. Fast Track applications will benefit from expedited 
evaluation of progress following the Phase I feasibility study for transition 
to Phase II funding for expanded developmental work. 

PROJECT PERIODS AND AMOUNT OF AWARD

Because the duration and costs of research to develop an alcohol sensor and 
associated data analyses are likely to exceed that routinely awarded for SBIR 
grants, well-justified Phase I applications under this RFA will be considered 
with a project period up to two years and a budget not to exceed a total cost 
of $400,000 (i.e., an average of $200,000 per year).  Similarly, well-
justified Phase II applications under this RFA will be considered with a 
project period up to four years and a budget not to exceed a total cost of 
$1,200,000 (i.e., an average of $400,000 for each of three years).  Total 
costs include direct costs, F&A, and fee/profit. 

Consultant and Contractual Costs

The normal limits for consultant costs and contractual costs are described in 
the Omnibus Solicitation for SBIR/STTR applications. Grant applications 
submitted under this RFA, however, may exceed these limits if the resources 
required for developing an alcohol sensor and data analysis system are 
relatively scarce, highly specialized, and multidisciplinary. Deviations must 
be appropriate and fully justified.  

FUNDS AVAILABLE 

NIAAA intends to commit approximately $2,000,000 to fund approximately 3-6 
Phase I and/or Phase II applications under the SBIR set-aside funding 
mechanism. Although the financial plans of the NIAAA provide support for this 
program, awards pursuant to this RFA are contingent upon the availability of 
funds and the receipt of a sufficient number of meritorious applications. At 
this time, it is not known if competing renewal applications will be accepted 
or if this RFA will be reissued.

ELIGIBLE INSTITUTIONS

Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation.  
Only small business concerns are eligible to submit SBIR 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 current 
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. 

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas: scientific/research, peer review, and financial or grants management 
issues:

Direct your questions about scientific or research issues to:

R. Thomas Gentry, Ph.D.
Division of Metabolism and Health Effects
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2025, MSC 9304
Bethesda, MD  20892-9304 
(For express mail delivery, use Rockville, MD  20852-1705)
Telephone: 301-443-6009
Fax: 301-594-0673 
Email: tgentry@niaaa.nih.gov

Direct your questions about peer review issues to:

Ernestine Vanderveen, Ph.D.
Acting Chief, Extramural Project Review Branch
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3039, MSC 9304
Bethesda, MD  20892-9304 
(For express mail delivery, use  Rockville, MD  20852-1705)
Telephone: 301-443-2531
Fax: 301-443-6077

Direct your questions about financial or grants management matters to:

Ms. Judy Fox
Chief, Grants Management Officer
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD  20892-9304 
(For express mail delivery, use  Rockville, MD  20852-1705)
Telephone: 301-443-4704
Fax: 301-443-3891
Email: jfox@niaaa.nih.gov

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent by November 22, 
2004 that includes the following information:

o Descriptive title of the proposed research 
o Name, address, and telephone number of the Principal Investigator 
o Names of other key personnel 
o Participating institutions 
o Number and title of this RFA

Although a letter of intent is not required, is not binding, and does not 
affect the review of a subsequent application, the information that it 
contains allows NIAAA staff to estimate the potential review workload and 
plan the review.

The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Karen P. Peterson, Ph.D.
Acting Chief, Research Policy and Special Projects Branch
Office of Scientific Affairs, NIAAA
5635 Fishers Lane
Room 2017, MSC 9304
Bethesda, MD  20892-9304
Federal Express: Rockville, MD 20852-1705
Telephone 301-451-3883
Fax 301-480-2358
Email: kpeterso@mail.nih.gov

SUBMITTING AN APPLICATION

The PHS 398 research grant application must be used for all SBIR 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 D&B number can be obtained by 
calling (866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The D&B 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. 

USING THE RFA LABEL:  The RFA label available in the PHS 398 application form 
must be affixed to the bottom of the face page of the application. Type the 
RFA number on the label.  Failure to use this label could result in delayed 
processing of the application such that it may not reach the review committee 
in time for review.  In addition, the RFA title and number must be typed on 
line 2 of the face page of the application form and the YES box must be 
marked. The RFA label is also available at: 
http://grants1.nih.gov/grants/funding/phs398/labels.doc or 
http://grants.nih.gov/grants/funding/phs398/labels.pdf. 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and three 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) 

To expedite the review process, at the time of submission, two additional 
copies of the application 
must be sent to: 

Extramural Project Review Branch 
Office of Scientific Affairs 
Attn: RFA-AA-05-002
National Institute on Alcohol Abuse and Alcoholism 
5635 Fishers Lane, Room 3039, MSC 9304
Bethesda, MD  20892-9304 
(For express mail delivery, use  Rockville, MD  20852-1705)
Telephone: 301-443-2531
Fax: 301-443-6077

RECEIPT OF APPLICATIONS. Applications must be received on or before the 
receipt date listed on the first page of this announcement. If an application 
is received after that date, it will be returned to the applicant without 
review.

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.

The Center for Scientific Research (CSR) will not accept any application in 
response to this RFA 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. However, when a previously unfunded application, originally 
submitted as an investigator-initiated application, is to be submitted in 
response to an RFA it is to be prepared as a NEW application.  That is, the 
application for the RFA must not include an Introduction describing the 
changes and improvements made, and the text must not be marked to indicate 
the changes from the previous unfunded version of the application.  

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIAAA. Incomplete and/or nonresponsive applications 
will not be reviewed. 
Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the NIAAA in accordance with the review criteria stated below.  
As part of the initial merit review, all applications will:

o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the NIAAA 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 evaluate the application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals within the context of the 
SBIR Program.  The scientific review group will address and consider each of 
the following criteria in assigning the application’s overall score:

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

ALL SBIR 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 or research methods 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? 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? 

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).

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. Information on NIH data 
sharing policy and procedures can be found at:  
http://grants.nih.gov/grants/policy/data_sharing/index.htm.

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 [formerly 
Product Development 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? 
TYPE 2 PHASE II COMPETING CONTINUATION APPLICATIONS 

In addition to the above review criteria, the following items will be applied 
to ALL Type 2 Competing Continuation Phase II applications in the 
determination of scientific merit and the priority score:

o  Does the activity as proposed address issues related to Federal regulatory 
approval processes?

o  What will be the effect of these studies on the concepts or methods that 
drive this field? 

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 [formerly 
Product Development 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 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.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  November 22, 2004
Application Receipt Date:  December 20, 2004
Peer Review Date:  March/April, 2005
Council Review:  May, 2005
Earliest Anticipated Start Date:  July 1, 2005

AWARD CRITERIA

Applications submitted in response to an RFA will compete for available funds 
with all other recommended SBIR 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. 

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:  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. 

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 RFA 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 
RFA 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 inter governmental 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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