This Program Announcement expires on November 27, 2002, unless reissued.
INNOVATIONS IN BIOMEDICAL INFORMATION SCIENCE AND TECHNOLOGY:
SBIR/STTR INITIATIVE
Release Date: June 29, 2000 (see NOT-OD-03-031)
PA NUMBER: PA-00-118
National Cancer Institute
National Center for Complementary and Alternative Medicine
National Center for Research Resources
National Eye Institute
National Human Genome Research Institute
National Heart, Lung, and Blood Institute
National Institute on Aging
National Institute of Alcohol Abuse and Alcoholism
National Institute of Allergy and Infectious Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Child Health and Human Development
National Institute on Drug Abuse
National Institute on Deafness and Other Communication Disorders
National Institute of Dental and Craniofacial Research
National Institute of Diabetes and Digestive and Kidney Disease
National Institute of Environmental Health Sciences
National Institute of General Medical Sciences
National Institute of Mental Health
National Institute of Neurological Disorders and Stroke
National Institute of Nursing Research
National Library of Medicine
Application Receipt Dates: November 27, March 27, and July 27 annually
(The solicitation begins with the November 27, 2000, receipt date and ends
with the November 27, 2002, receipt date.)
PURPOSE
Participating Institutes and Centers of the National Institutes of Health
invite applications for innovative research in biomedical information science
and technology to promote the progress of biomedical research.
There exists an expanding opportunity to speed the progress of biomedical
research through the power of computing to manage and analyze data and to
model biological processes. The NIH is interested in promoting research and
developments in biomedical information science and technology that will
support rapid progress in areas of scientific opportunity in biomedical
research. As defined here biomedical computing or biomedical information
science and technology includes, database design, graphical interfaces,
querying approaches, data retrieval, data visualization and manipulation,
data integration through the development of integrated analytical tools,
synthesis, and tools for electronic collaboration, as well as computational
research including the development of structural, functional, integrative,
and analytical models and simulations.
This program will use the Small Business Innovation Research (SBIR) and Small
Business Technology Transfer (STTR) mechanisms and will be run in parallel
with a program of identical scientific scope that will use the newly-created
Phased Innovation Award mechanism (TPA-00-109). The SBIR and STTR
applications received in response to this announcement will have the
opportunity for expedited transition of successful technology research into
an expanded development phase and will be subject to cost and duration limits
comparable to the parallel Phased Innovation Award applications.
This program announcement must be read in conjunction with the Omnibus
Solicitation of the Public Health Service for Small Business Innovation
Research Grant Applications (PHS 99-2), and the Omnibus Solicitation of the
National Institutes of Health for Small Business Technology Transfer Grant
Applications (PHS 99-3). All of the instructions within the Omnibus
Solicitations apply with the following exceptions:
o Additional review considerations
o Opportunity for 2 years of Phase I support
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 program announcement
(PA), Innovations in Biomedical Information Science and Technology:
SBIR/STTR Initiative , 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/ .
ELIGIBILITY REQUIREMENTS
Eligibility requirements for SBIR and STTR are described in the NIH Omnibus
Solicitation for SBIR/STTR grant applications.
MECHANISM OF SUPPORT
This PA will expire two years from the initial receipt date as indicated by
the dates on the front of this solicitation. Responsibility for the
planning, direction, and execution of the proposed project will be solely
that of the applicant. Except as otherwise stated in this program
announcement, awards will be administered under PHS grants policy as stated
in the NIH Grants Policy Statement, NIH Publication No99-8, October 1998.
A. FAST-TRACK APPLICATIONS. Applications may be submitted for the FAST-
TRACK review option. Information on the FAST-TRACK process may be found
at: http://grants.nih.gov/grants/funding/sbir.htm. Applications will be
accepted only on the receipt dates listed on the first page of this
document.
To be eligible for the FAST-TRACK option, the Phase I (R41/43) application
must include well defined quantifiable milestones that will be used to judge
the success of the proposed research, as well as a credible development plan
for the Phase II (R42/44) application. The FAST-TRACK must have a section
labeled Milestones at the end of the Research Plan for Phase I R41/43. This
section must include well-defined quantifiable milestones for completion of
Phase I R41/43, a discussion of the suitability of the proposed milestones
for assessing the success in Phase I R41/43, and a discussion of the
implications of successful completion of these milestones on the proposed
Phase II R42/R44.
Applications submitted through the FAST-TRACK option are subject to the same
direct costs limits per year as when submitted outside of the FAST-TRACK
option: Phase I R41/43, not to exceed $100,000 per year total direct costs
excluding subcontractor indirect costs; Phase II R42/44, no dollar limit.
However, for this solicitation the total duration (Phase I plus Phase II
applications) cannot exceed four years. In any case, the Phase I
applications cannot exceed two years duration.
Applications over $500,000. Although the Phase II application has no
official budgetary limit, applications requesting in excess of $500,000
dollars direct costs in any single year of the grant period require prior
approval before submission. Applicants who plan to submit a Phase II
SBIR/STTR application requesting $500,000 or more in any year are advised
that it is important that they contact program staff listed under INQUIRIES
as they begin to develop plans. Applications requesting more than $500,000
received without prior staff contact may be delayed in the review process or
returned to the applicant without review (NIH GUIDE, Volume 22, Number 45,
December 17, 1993)
B. INDIVIDUAL PHASE I APPLICATIONS. Phase I applications in response to
this PA will be funded as Phase I SBIR Grants R43 or STTR Grants R41 with
modifications as described below following the directions for Phase I
SBIR/STTR applications as described in the NIH Omnibus Solicitation. The NIH
Omnibus SBIR Solicitation is available on the Internet at:
http://grants.nih.gov/grants/funding/sbirsttr1/index.htm. The NIH OMNIBUS STTR
Solicitation is available at: http://grants.nih.gov/grants/funding/sbirsttr1/index.htm
A limited number of hard copies of the NIH Omnibus SBIR and STTR
Solicitations are available from:
PHS SBIR/STTR Solicitation Office
13685 Baltimore Avenue
Laurel, MD 20707-5096
Telephone: 301-206-9385
FAX: 301-206-9385
Email: a2y@cu.nih.gov
Project Period and Amount of Award. Because the length of time and cost of
research involving advanced information science and technology projects often
exceeds that normally awarded for SBIR/STTR grants, NIH will entertain well-
justified Phase I applications with a project period up to two years and a
budget not to exceed $100,000 per year direct cost (maximum of $200,000
direct costs for to 2 years excluding subcontractor indirect costs).
Page Limitations. The requirements for normal Phase I applications apply
(see NIH OMNNBUS Solicitation).
C. INDIVIDUAL PHASE II APPLICATIONS
Phase II applications in response to this PA will be awarded as Phase II SBIR
Grants R44 or STTR Grants R42 with modifications as described below. 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.
Applications for Phase II awards should be prepared following the
instructions for NIH Phase II SBIR/STTR applications. The Phase II SBIR
instructions and application may be found on the Internet at:
http://grants.nih.gov/grants/funding/sbir2/index.htm
The Phase II STTR instructions and application may be found on the Internet
at: http://grants.nih.gov/grants/funding/sttr2/index.html
Project Period and Amount of Award. Because the length of time and cost of
research often exceeds that normally awarded for SBIR grants, NIH will
entertain well-justified Phase II applications for this SBIR/STTR award with
a project period up to three years with no budget limitation.
Applications over $500,000. Although the Phase II application has no
official budgetary limit, applications requesting in excess of $500,000
dollars direct costs in any single year of the grant period require prior
approval before submission. Applicants who plan to submit a Phase II
SBIR/STTR application requesting $500,000 or more in any year are advised
that it is important that they contact program staff listed under INQUIRIES
as they begin to develop plans. Applications requesting more than $500,000
received without prior staff contact may be delayed in the review process or
returned to the applicant without review (NIH GUIDE, Volume 22, Number 45,
December 17, 1993)
BACKGROUND
Computing and computational tools have become increasingly important in
enabling progress in biomedical research. In recognition of the critical
role computing will play in biomedical research, the NIH Director
commissioned a Working Group on Biomedical Computing to:
Investigate the needs of NIH-supported investigators for computing
resources, including hardware, software, networking, algorithms, and
training. It should take into account efforts to create a national
information infrastructure, and look at working with other agencies
(particularly NSF and DOE) to ensure that the research needs of the
NIH-funded research community are met.
It should also investigate the impediments biologists face in utilizing
high-end computing, such as a paucity of researchers with cross-
disciplinary skills. The panel should consider both today’s unmet needs
and the growing requirements over the next five years (a reasonable
horizon for extrapolating the advances in the rapidly changing fields
of computing and computational biology).
The result of the deliberations of the Working Group on Biomedical Computing
is a report entitled The Biomedical Information Science and Technology
Initiative (BISTI) which can be accessed at the following site:
http://www.nih.gov/welcome/director/060399.htm. A critical recommendation of
the BISTI is that the NIH should provide additional resources and incentives
for basic research to provide adequate support for those who are inventing,
refining, and applying the tools of biomedical computing. The promotion of
the interface of biomedical information science and technology with
biomedical research should result in new digital and electronic tools that
will have substantial impact on broad areas of biomedical research.
The Institutes and Centers of the NIH acknowledge the wisdom of this
recommendation and are offering support to small business through the current
solicitation for fundamental research in biomedical information science and
technology, as well as for the development of new informatics and
computational tools and technologies.
RESEARCH GOALS AND OBJECTIVES:
This solicitation targets support for fundamental research in biomedical
computing science and technology as well as the development and application
of new biocomputing tools or technologies for a particular area(s) of
scientific opportunity in biomedical research. Programs may target one or
multiple areas of biomedical computing that will enable progress in
biomedical research. Specific research areas solicited in informatics or
computational science include but are not limited to:
o Tools for data collection
o Tools for archiving large data sets
o Research on databases, querying approaches, and information retrieval
o Research on data visualization
o Analysis tools for interpretation of large data sets
o Computing algorithms and new analysis and statistical methodologies for
social science research related to areas of biomedical interest, such as
population aging
o Research on new approaches to data integration
o Development of platform-independent translational tools for data exchange
o Research on the development of models or simulation environments
o Development of models or simulation environments
o Tools or models to promote interoperability
o Development of web-based linkage tools for data sharing
o Tools for electronic communication
Areas of biomedical research likely to be critically dependent on
biocomputing advances include but are not limited to:
o Behavioral science
o Biological rhythms
o Biomedical imaging
o Cell biology
o Clinical research
o Clinical trials
o Developmental biology
o Drug design at the molecular and cellular levels
o Dynamic modeling of retirement
o Dynamic modeling of health, chronic disease, and disablement
o Endocrinology
o Environmental science
o Epidemiology
o Genetics
o Genomics
o Immunology/inflammation
o Medical genetics
o Morphology
o Neurobiology and cognitive science
o Pharmacology
o Physiology
o Population biology
o Structural biology
o Substance abuse research
o Surgery and virtual tools
o Temporal patterns
Projects must span the interface of biomedical research and biomedical
information science and technology. Applications will be expected to
demonstrate fundamental understanding and adequate expertise in both the
relevant areas of information science and technology and biomedical research.
Cross-disciplinary collaborations are strongly encouraged. Applications will
also be expected to address the anticipated enabling aspects of the research
or development proposed in the context of the targeted area of opportunity in
biomedical research the research is expected to benefit.
Given the expanding needs in biomedical research for advances in a variety of
areas of information science and technology, the approaches and technologies
proposed under this announcement should ultimately be generalizable,
scalable, extensible, interoperable and use sophisticated computational
resources. The projects should take in to account the needs of the biomedical
research community that will be the ultimate end users of the products of the
research. The projects should also address plans for ensuring the
dissemination of useful products of the research, including approaches,
technologies and tools, to the relevant research and user communities. The
informatics and computational research proposed should be future-oriented,
fill an area of need or projected need, and seek to exceed the current state-
of-the-art.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their subpopulations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification is provided 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 research involving human subjects should read the
NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research , which have been published in the Federal Register of March 28,
1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts,
Volume 23, Number 11, March 18, 1994, and is available on the Internet at
http://grants.nih.gov/grants/guide/notice-files/not94-100.html .
Investigators also may obtain copies of the policy from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH 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 or ethical reasons not to include them. This
policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html .
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
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 for the review because reviewers are under no
obligation to view the Internet sites. Reviewers are cautioned that their
anonymity may be compromised when they directly access an Internet site.
APPLICATION PROCEDURES
OMNIBUS SOLICITATIONS for both the SBIR and STTR programs are available
electronically through the NIH, Office of Extramural Research Small Business
Funding Opportunities Web site at
http://grants.nih.gov/grants/funding/sbir.htm. Hard copies, subject to
availability, may be obtained from the PHS SBIR/STTR Solicitation Office at
301-206-9385 (phone); 301-206-9722 (fax); or a2y@cu.nih.gov (email). Helpful
information for preparing the application can be obtained on the Web at
http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf .
Applications are to be submitted on the grant application forms PHS 6246-1
(1/99) (SBIR) and PHS 6246-3 (STTR) (3/99) located in the back pages of the
OMNIBUS SOLICITATIONS, and will be accepted at the application deadlines
indicated on the first page of this document.
THE TITLE AND NUMBER OF THIS PA MUST BE TYPED IN LINE 2 ON THE FACE PAGE OF
THE APPLICATION.
The OMNIBUS SOLICITATIONS give the normal levels of support and period of
time for SBIR and STTR Phase I and II awards. However, these award levels
are guidelines and not ceilings. Therefore, larger budgets with longer
periods of time may be requested if required to complete the proposed
research. As stated under MECHANISM OF SUPPORT section, Phase I applications
submitted in response to this PA can have a project period of up to two years
and a budget not to exceed $100,000 per year direct cost excluding
subcontractor indirect costs.
An annual meeting of all investigators funded through this program will be
held to share progress and research insights that may further progress in the
program. Applicants should request travel funds in their budgets for the
principal investigator and one additional senior investigator to attend this
annual meeting
The second year of the Phase I budget should be included on the Budget
Justification page using categorical totals if costs deviate significantly
from the first year of the budget with narrative justifications for the
increase(s). If the second year simply escalates due to cost of living
factors, a statement to that effect with the escalation factor should be
included rather than categorical totals. Phase II applications submitted in
response to this PA have no budget limitations. The total duration (Phase I
and Phase II application) cannot exceed four years.To apply for the FAST-
TRACK option, applications for both Phase I and Phase II must be submitted
together according to the instructions for FAST TRACK applications as
described in the OMNIBUS SOLICITATIONS. The Phase I application must specify
clear, well-defined quantifiable milestones that should be achieved prior to
Phase II funding. Milestones should be located in a separate section at the
end of the Research Plan of the Phase I and should be indicated in the Table
of Contents. Failure to provide measurable milestones and sufficient detail
may be sufficient reason for the peer review committee to exclude the Phase
II application from FAST-TRACK review. If so, at a later date, the applicant
may apply for Phase II support through normal application procedures.
An additional requirement of the FAST-TRACK mechanism is the Product
Development Plan. The small business must submit a concise Product
Development Plan (limited to five pages) as an Appendix to the Phase II
application addressing the four areas described in the instructions for FAST-
TRACK applications in the OMNIBUS SOLICITATIONS. In the event that an
applicant feels that technology is too proprietary to disclose, applicants at
a minimum should provide a demonstration (e.g., results) of the capabilities
of the proposed technology.
The completed and signed original application and two legible and signed
copies must be sent or delivered 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)
Applications must be received by the receipt dates listed at the beginning of
this program announcement.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed by the CSR for completeness and
by the NIH program staff for responsiveness. Applications not adhering to
application instructions described above and those applications that are
incomplete or non-responsive as determined by CSR or by NIH program staff
will be returned to the applicant without review.
Applications that are complete and responsive to the PA will be evaluated for
scientific and technical merit by an appropriate peer review group convened
by the NIH in accordance with the review criteria stated below. As part of
the initial merit review, all applicants will receive a written critique and
may undergo a process in which only those applications deemed to have the
highest scientific merit generally the top half of the applications will be
discussed, assigned a priority score, and receive a second level review by
the appropriate Institute or Center Advisory Board.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to discuss the following
aspects of the application to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. Each of the
following criteria will be addressed and considered in assigning the overall
score, weighing them as appropriate for each application. Note that the
application does not need to be strong in all categories to be judged likely
to have a major scientific impact and thus deserve a high priority score.
For example, an investigator may propose to carry out important work that by
its nature is not innovative but is essential to move a field forward.
1. Significance.
o Does this study address an important problem?
o Are the results of the study likely to enable a compelling area of
biomedical research?
o If the aims of the application are achieved, how will scientific knowledge
be advanced?
o What will be the effect of these studies on the concepts or methods that
drive this field?
o To what degree does the research or development of technologies or tools
support the needs of the targeted biomedical research community?
o For systems intended for clinical research or use the additional criteria
will be considered:
? To what degree is the approach, technology, or tool appropriate for
clinical research and likely to have utility in a clinical setting?
? Do the applicants adequately address such issues as the protection of
patient information and confidentiality?
2. Approach.
o Are the conceptual framework, design, methods, and analyses adequately
developed, well-integrated, and appropriate to the aims of the project?
o Does the applicant acknowledge potential problem areas and consider
alternative tactics?
o What is the time frame for developing the proposed approaches, tools, or
technologies and suitability of this time frame for meeting the needs of the
relevant biomedical research community's needs?
o How easy will it be to use the proposed approach, tool, or technology?
o Are the plans for dissemination of the proposed endpoints, tools or
technologies of the project adequate?
3. Milestones.
o How appropriate are the proposed milestones against which to evaluate the
demonstration of feasibility for transition to the R42/R44 development phase?
4. Innovation.
o Does the project employ novel concepts, approaches or method?
o Are the aims original and innovative?
o Does the project challenge existing paradigms or develop new methodologies
or technologies?
o Does the project adequately address end user needs?
o Will there be additional application opportunities for the approach,
technology or tool proposed?
o Does the project use high-end computing?
5. Investigator.
o Is the investigator appropriately trained and well suited to carry out
this work?
o Does the project team have adequate expertise in both the areas of
biomedical information science and technology and biomedical research?
o Is the work proposed appropriate to the experience level of the principal
investigator and other researchers (if any)?
6. Environment.
o Does the scientific environment in which the work will be done contribute
to the probability of success?
o Do the proposed experiments take advantage of unique features of the
scientific environment or employ useful collaborative arrangements?
o Is there evidence of institutional support?
In addition to the above criteria, in accordance with NIH policy, all
applications will be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated.
o The reasonableness of the proposed budget and duration in relation to the
proposed research.
o The adequacy of the proposed protection for humans, animals, and the
environment to the extent they may be adversely affected by the proposed
project.
Additional scientific/technical merit criteria specific to the objectives of
the PA and the mechanism must be included if they are to be used in the
review.
AWARD CRITERIA
Applications will compete for available funds with all other approved SBIR
and STTR applications. Funding decisions for Phase I will be based on
quality of the proposed project as determined by peer review, availability of
funds, and program priority. Fast-Track Phase II applications 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 initial priority score, NIHs assessment of the Phase I
progress and determination that Phase I milestones were achieved,
programmatic relevance, the project potential for commercial success, and the
availability of funds.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome.
Inquiries or contacts concerning institute-specific technical or financial
issues should be directed to the NIH BISTI technical and financial contacts
listed at the following Web site:
http://www.bisti.nih.gov/bistic_contacts.cfm.
Inquiries regarding general programmatic issues or notices of intent should
be directed to:
Dr. James Cassatt
NIGMS
45 Center Drive
Bethesda, MD 20892-6200
TEL: 301-594-0828
FAX: 301-480-2004
Email: jc12b@nih.gov
Inquiries regarding review matters should be directed to:
Elliot Postow, Ph.D.
Center for Scientific Review
6701 Rockledge Drive
Bethesda, MD 20892
TEL: (301) 435-0911
FAX: (301) 480-2241
Email: postowe@csr.nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.394, Cancer Detection and Diagnosis Research. Awards are made under
authorization of the Sections 301 and 405 of the Public Health Service Act,
as amended (42 USC 241 and 284) and administered under PHS grants policies
and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and part 92. This
program is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-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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