RELEASE DATE:  October 1, 2002 (see reissue PA-05-003)

PA NUMBER: PA-03-001

EXPIRATION DATE:  December 2004, unless reissued. 

National Center for Research Resources (NCRR) 
National Institute of Mental Health (NIMH) 
National Cancer Institute (NCI) 
National Heart, Lung, and Blood Institute (NHLBI) 
National Institute of Biomedical Imaging and Bioengineering (NIBIB) 


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


The purpose of this PA is to encourage small businesses to develop 
innovative software for addressing the integration of distributed 
cross-disciplinary data sources into coherent knowledge bases for 
biomedical research. Federating such data sources requires solving a 
large number of technical, scientific, financial, social and legal 
issues, and new tools are needed for aiding in almost every aspect of 
this problem. Applications are expected to describe at least one 
biomedical research problem that will benefit from the proposed tool or 
tool set, as well as to describe how the approach will scale when 
applied to additional data sources and/or to other biomedical problems. 
A clear description should be provided of how the impact of these tools 
on biomedical research will be measured. Finally, a reasonable 
mechanism for maintenance and expansion of the software as well as 
integration with existing solutions should be carefully outlined. 


Industry has over the past five years shown increased interest in 
information technology's (IT) promise to aid in the assembling of a 
corporation's knowledge that is typically distributed across 
individuals and vast numbers of unconnected documents and databases 
into a coherent, accessible entity known as a knowledge base. Although 
much of the promise remains unfulfilled, some technologies resulting 
from initial efforts appear to be moving from the research stage to 
mainstream production (e.g. IBM's Discovery Link). 

Like a corporation, the biomedical research community is greatly 
hindered by its inability to easily access knowledge that may have 
already been painstakingly acquired. Existing approaches and tools from 
corporate knowledge base efforts should be employed wherever they can 
to improve this situation. However, the biomedical research community 
is more diverse than a typical corporation in almost every aspect, from 
document and data types to philosophies of data sharing. Accordingly, 
new tools and processes for knowledge integration must be developed 
that facilitate cooperative approaches to solving biomedical research 
problems that span a broad array of subdisciplines. These tools and 
processes must be designed with openness, flexibility and extreme 
scalability if they are to address the diverse needs of this community 
with regard to knowledge integration, and if they are to be able to 
grow and adapt with the rapidly changing developments in this field 
that are expected to come. 

Awards made under this PA will support software and system development 
that address one or more aspects of the components necessary for 
integrating knowledge across data sources that reside at multiple 
laboratories and institutions and that encompass disparate data types 
from multiple subdisciplines. Tools for visualization and summarization 
of results from such systems may also be supported, as well as tools 
for managing data security, data integrity, query efficiency, and data 


This PA will use the National Institutes of Health (NIH) SBIR award and 
Fast Track SBIR award mechanisms with award duration and amounts 
greater than those routinely allowed under the SBIR program.  This PA 
must be read in conjunction with the current calendar year Omnibus 
Solicitation at Phase I 
applications in response to this PA will be funded as Phase I SBIR  
Grants (R43) with modifications as described below. Responsibility for 
the planning, direction, and execution of the proposed research will be 
solely that of the applicant.  Applications for Phase I grants should 
be prepared using the PHS 398 instructions and forms:  Please refer 
to  Chapter VI of the PHS 398 instructions prior to preparing an SBIR  
application.  PHS 398 forms specific to SBIR applications are 
available.  See 

Because the duration and cost of research to develop knowledge 
integration tools are likely to exceed that routinely awarded for SBIR 
grants, well-justified Phase I applications under this PA will be 
considered. These applications can request 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). 

Phase II applications in response to this PA will be awarded as Phase 
II SBIR grants (R44) with modifications as described below.  Individual 
Phase II applications in response to this PA will only be accepted as 
competing continuations of previously funded NIH Phase I SBIR awards.  
The previously funded Phase I award need not have been awarded under 
this PA but the Phase II proposal must be a logical extension of the 
Phase I research. 

Applications for Phase II awards should be prepared using the PHS 398  
instructions and forms: .  Please refer 
to  Chapter VI of the PHS 398 instructions prior to preparing an SBIR 
application.  PHS 398 forms specific to SBIR applications are 
available.  See 

Because the duration and cost of research to develop knowledge 
integration tools are likely to exceed that routinely awarded for SBIR 
grants, well-justified Phase II applications under this PA will be 
considered. These applications can request a project period up to three 
years and a budget not to exceed a total cost of $1.2 million (i.e., an 
average of $400,000 for each of three years). 
Applications may be submitted for the FAST-TRACK review option.  
Information on the FAST-TRACK process may be found in Section VI-B of 
the PHS 398 at: 

To be eligible for the FAST-TRACK option, the Phase I SBIR application 
must include well defined quantifiable milestones that will be used to 
judge the success of the proposed research, as well as a credible plan 
to apply the selected technology in a pilot study of interest to test 
the feasibility for site remediation or monitoring technology for the 
Phase II R44 application.  The FAST-TRACK must have a section labeled 
Milestones at the end of the Research Plan Phase I.  This section must 
include well-defined quantifiable milestones for completion of Phase I, 
a discussion of the suitability of the proposed milestones for 
assessing the success in Phase I, and a discussion of the implications 
of successful completion of these milestones on the proposed Phase II. 
In addition, Fast-Track applications must include a concise Product 
Development Plan (limited to ten pages).  Label this section clearly 
and include it in Section J of the Phase II Research Plan.  

Applications submitted through the FAST-TRACK option are subject to the 
same total cost limits per year as when submitted outside of the FAST-
TRACK option.  The total duration (Phase I plus Phase II applications) 
cannot exceed five years. 

This PA uses just-in-time concepts.  It also uses the modular as well 
as the non-modular budgeting formats (see  
Specifically, if you are submitting an application with direct costs in 
each year of $100,000 or less, use the modular format.  Otherwise 
follow the instructions for non-modular research grant applications. 


Eligibility requirements for SBIR are described in the NIH  Omnibus 
Solicitation for SBIR/STTR Grant Applications, which is  available on 
the internet at 


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. 

The primary employment of the Principal Investigator must be with the 
small business concern at the time of award and during the conduct of 
the proposed project. Primary employment means that more than one half 
of the Principal Investigator's time is spent in the employ of the 
small business concern.  Primary employment with a small business 
concern precludes full-time employment at another organization. 


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: 

Bret Peterson, Ph.D. 
National Center for Research Resources (NCRR) 
Building RKL1, Room 6158 
Bethesda, MD  20892 
Telephone:  (301) 435-0758 
FAX:  (301) 480-3659 

Margaret Grabb, Ph.D. 
National Institute of Mental Health (NIMH) 
6001 Executive Blvd, Rm 7201 (MSC 9645) 
Bethesda, MD  20892 
Telephone:  (301) 443-3563 
FAX:(301) 443-1731 

Anne Heath, Ph.D. 
National Cancer Institute (NCI) 
Bethesda, MD  20892 
Telephone:  (301) 435-5225 
FAX:  (301) 480-2854 

Susan E. Old, Ph.D. 
National Heart, Lung, and Blood Institute (NHLBI) 
6701 Rockledge Drive, MSC 7940 
Bethesda, MD  20892 
Telephone:  (301) 435-1802 
FAX:  (301) 480-3659 

Mary S Pastel, ScD 
National Institute of Biomedical Imaging and Bioengineering (NIBIB) 
6707 Democracy Blvd, Suite 920 
Bethesda, MD  20892-5469 
Telephone:  (301) 451-4781 
FAX:(301) 480-4973 

o Direct your questions about financial or grants management matters 

Kimberly Pendleton 
Office of Grants Management National Center for Research Resources 
Rockledge 1, Room 6216 
Bethesda, MD  20892 
Telephone:  (301) 435-0845 
FAX:  (301) 480-3777 

Kathy Hancock 
Grants Management Branch  
National Institute of Child Health and Human Development 
6001 Executive Blvd, Rm 8A17M 
Bethesda, MD  20892 
Telephone: (301) 496-5482 
FAX:  (301) 402-0915 

Shane Woodward 
Grants Administration Branch National Cancer Institute Executive Plaza 
South, Room 243 
Bethesda, MD  20892-7150 
Telephone:  (301) 496-8649 
FAX:  (301) 496-8601  

Edward (Gene) McGeehan 
Grants Management  
National Heart, Lung, and Blood Institute (NHLBI) 
6701 Rockledge Drive, Room 7044 
Bethesda, MD  20892 
Telephone:  (301) 435-0148 
FAX:  (301) 480-3659 

Lisa Moeller 
Office of Grants Management National Institute of Biomedical Imaging 
and Bioengineering 
6707 Democracy Blvd, Suite 900 
Bethesda, MD  20892-5469 
Telephone:  (301) 451-4793 
FAX:  (301) 480-4974 


You may submit your application as a Phase I or Phase II application or 
as a Fast Track pair of Phase I and Phase II applications.  See 
"Specific Instructions" below.  

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at in 
an interactive format.  For further assistance contact Grants Info, 
Telephone (301) 710-0267, Email: 

APPLICATION RECEIPT DATES: Applications submitted in response to this 
program announcement will be accepted at the standard application 
deadlines (April 1, August 1, December 1).  See   Application deadlines are 
also indicated in the PHS 398 application kit. 

requirements, and procedures are the same as listed in the Omnibus 
Solicitation for Phase I SBIR/STTR Grant applications 
(, except for 
the  following: 

o  Type the title and number of this PA on line 2 on the face page of 
the  application. 

SPECIFIC INSTRUCTIONS FOR Phase II Applications:  We will only accept 
Phase II applications as competing continuations of previously funded 
NIH Phase I SBIR awards.  The Phase II application must be for 
developmental work that is a logical extension of the feasibility 
research conducted during Phase I.  When preparing an application for a 
Phase II award, you should follow the instructions for NIH Phase II 
SBIR applications.  The instructions and forms for a Phase II SBIR 
award are available at 

SPECIFIC INSTRUCTIONS FOR Fast Track Applications:  For Fast Track 
applications, the NIH expedites evaluation of progress following the 
Phase I feasibility study, for transition to the Phase II funding for 
expanded developmental work.   

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 received by or mailed on 
or before the receipt dates described at 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 
application already reviewed, but such application must include an 
Introduction addressing the previous critique. 


Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review 
group 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 Receive a written critique 
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 
o Receive a second level review by the appropriate national advisory 
council or board 	 


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 your 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    

The scientific review group will address and consider each of these 
criteria in assigning your application's overall score, weighting them 
as appropriate for each application.  Your application does not need to 
be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score.  For example, 
you may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward. 

In considering the scientific and technical merit of each application, 
the following criteria will be used:

Does the proposed project have commercial potential to lead to a 
marketable product or process? Does this study address an important 
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 application 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? 


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?


Does the project challenge existing paradigms or employ novel 
technologies, approaches or methodologies? 

Are the aims original and innovative? 


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? 

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, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, 
animals, or the environment, to the extent they may be adversely 
affected by the project proposed in the application. 

INCLUSION:  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 
Inclusion Criteria included in the section on Federal Citations, below) 

BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research. 

In addition to the above 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 Product Development Plan that 
adequately addresses the four areas described in the Research 
Plan item J? 
3. Does the project carry a high degree of commercial potential, as 
described in the Product Development Plan? 
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 Product Development Plan that 
adequately addresses the four 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 Product Development 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 this PA will 
compete for available funds with all other recommended SBIR 
applications.  The following will be considered in making funding 
decisions for Phase I or Phase II applications: 

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

Phase II applications will be selected for funding based on the 

o  Quality of the proposed project as determined by peer review 
o  Assessment of Phase I progress  
o  Determination that the Phase I goals were achieved 
o  The project's potential for commercial success  
o  Availability of funds 

Fast-Track Phase II applications that are recommended for approval may 
be funded following submission of the Phase I progress report and other 
documents necessary for continuation.  Phase II applications will be 
selected for funding based on the project's scientific and technical 
merit, the awarding component's assessment of the Phase I progress 
report and determination that the Phase I goals were achieved, an 
update and verification of the Product Development Plan and any 
commitment(s) for funds and/or resources from an investor or partner 
organization, as described below, the project's potential for meeting 
the mission of the awarding component and for commercial success, and 
the availability of funds.


components involving Phase I and II clinical trials must include 
provisions for assessment of patient eligibility and status, rigorous 
data management, quality assurance, and auditing procedures.  In 
addition, it is NIH policy that all clinical trials require data and 
safety monitoring, with the method and degree of monitoring being 
commensurate with the risks (NIH Policy for Data Safety and Monitoring, 
NIH Guide for Grants and Contracts, June 12, 1998:   

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 

All investigators proposing clinical research should read the AMENDMENT 
"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 
(; 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 

SUBJECTS: The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial 
(Type 1) applications submitted for receipt dates after October 1, 

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  

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 

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 

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. 

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 

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 Nos. 93.371, 93.242, 93.396, 93.839 and 
93.286 and is not subject to the intergovernmental review requirements 
of Executive Order 12372 or Health Systems Agency review.   Awards are 
made under authorization of Sections 301 and 405 of the Public  Health 
Service Act as amended (42 USC 241 and 284) and administered under NIH 
grants policies described at and under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 

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.

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