and Human Services (HHS)
EXPIRED
APPLICATIONS OF INNOVATIVE TECHNOLOGIES FOR THE MOLECULAR ANALYSIS OF CANCER:
SBIR/STTR
Release Date: May 31, 2001
PA NUMBER: PAR-01-107
National Cancer Institute
Letter of Intent Date: June 15, 2001, October 17, 2001, February 14, 2002,
June 10, 2002, October 18, 2002, February 14, 2003,
and June 16, 2003
Application Receipt Date: July 20, 2001, November 21, 2001, March 21, 2002,
July 22, 2002, November 22, 2002, March 21, 2003,
and July 21, 2003
This Program Announcement (PA) replaces PA-99-103, which was published in the
NIH Guide on May 14, 1999.
PURPOSE
The National Cancer Institute (NCI) invites applications for research projects
to evaluate the utility and pilot the application of molecular analysis
technologies in studies relevant to cancer research. Molecular analysis
technologies of interest include those that are entirely novel, or emerging
but not currently in broad scale use where the technologies have not yet been
demonstrated to be robust or reproducible in supporting molecular analysis in
cancer research, or technologies currently in use for one application or set
of applications, that are being evaluated for utility for alternative
applications. The Program Announcement (PA) provides support for a first
phase for technology evaluation and a second phase for pilot application of
the technology in a study of biological interest to cancer research. The first
(evaluation) phase should include proof of principle experiments that will
demonstrate the utility of the technology on samples comparable to those that
will be used in the second phase study. Applicants will be expected to
demonstrate the utility of all components of the process required for a fully
integrated system, including sample preparation, molecular analysis assay, and
data capture and analysis. The second (application) phase supports the
transition of the technology optimized in the first (evaluation) phase to
pilot application in a study of biological interest to cancer research. The
design of the second phase study should allow the demonstration that the
technology can reproducibly obtain molecular data from the selected sample
type and produce information of biological interest to cancer research.
Studies might appropriately target analysis of precancerous, cancerous, or
metastatic cells, or host derived samples, from model cancer systems,
preclinical or clinical research, or from population based research.
Technologies suited for this solicitation, include those that enable the
detection of alterations and instabilities of genomic DNA, measurement of
expression of genes and gene products, analysis and detection of gene and or
cellular products including differential expression, quantitation, post
translational modification, and function of proteins, identification of
exogenous infectious agents in cancer, and assaying the function or major
signal transduction networks involved in cancer. Additionally, technologies
that will support molecular analysis in vitro, in situ, or in vivo (by imaging
or other methods) are suitable for this PA. Technologies are defined as
instrumentation, techniques, devices and analytical tools (e.g., computer
software) but are distinct from resources such as databases, reagents, and
tissue repositories.
This Program Announcement (PA) must be read in conjunction with the OMNIBUS
SOLICITATION OF THE NATIONAL INSTITUTES OF HEALTH, SMALL BUSINESS INNOVATION
RESEARCH (SBIR) and SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) GRANT
APPLICATIONS.
All of the instructions within the Omnibus Solicitation apply with the
following exceptions:
o Special receipt dates
o Opportunity for two years of Phase I support and three years of Phase II
support
o Initial review convened by the NCI Division of Extramural Activities
o Additional review considerations
o Modular grant concept is not used.
This PA will expire on July 22, 2003, unless reissued.
BACKGROUND
Rapid molecular analysis tools will expedite the molecular characterization of
normal cells, precancerous, cancerous, and metastatic cells, as well as,
expand our understanding of the biological basis of cancers. Comprehensive
analysis of cancers at the molecular level will facilitate cancer detection
and diagnosis, as well as identify new targets for therapeutic and
preventative agents.
The definition of the molecular alterations in cancer will require the
continued development and dissemination of comprehensive molecular analysis
technologies as well as identification of all of the molecular species encoded
in genomes of cancer and normal cells. The National Cancer Institute
implemented the Cancer Genome Anatomy Project (CGAP) to create an information
infrastructure of the molecular changes associated with cancer development,
and to develop technological tools to support the analysis of molecular
profiles of cancer cells and their normal counterparts. The current CGAP
program comprises Tumor Gene Indices for the human and mouse (hTGI and mTGI),
a Genetic Annotation Initiative (GAI) and the Cancer Chromosome Aberration
Project (cCAP). The TGI and GAI, are focused toward building a catalog of
annotated genes associated with cancer. The third component, cCAP, is
developing resources to catalog and facilitate the molecular characterization
of cancer-related chromosomal aberrations. Complete information about CGAP can
be found at http://cgap.nci.nih.gov/. The NCI is also targeting support for
the development and dissemination to basic, preclinical, and clinical
researchers of novel technologies that will allow high-throughput analysis of
genetic alterations, expression of genome products, and monitoring of signal
transduction pathways in cancers. A complimentary program on "Innovative
Technologies for the Analysis of Cancer" to support technology development was
announced in May 1998 and has recently been reissued for the next two years.
This initiative, "Applications of Innovative Technologies for the Molecular
Analysis of Cancer" is intended to support the demonstration that newly
developed and emerging technologies have matured and are suitable for use in
cancer research, followed by the initial application of these technologies in
well-defined studies of biological interest to cancer research using model
cancer systems, preclinical or clinical samples, or in population research.
The routine use of improved molecular analysis tools will lead to a better
understanding of the molecular basis of cancer, and will facilitate the
identification of molecular characteristics of individuals, that influence
cancer development and prognosis.
Molecular analysis technologies of interest include those that will support:
--A more complete understanding of the biological basis of cancer.
--The identification of molecular variations between normal, precancerous,
cancerous, and metastatic cells that can serve as targets for the detection,
diagnosis, therapy, and prevention.
--An examination of genetic factors that influence an individual"s likelihood
to develop cancer or their ability to respond to external damaging agents,
such as radiation and carcinogens.
--The molecular correlation between individuals with therapeutic or toxic
responses to treatment and prevention measures and genetic factors that
influence the efficacy and safety of these strategies and agents
(pharmacogenomics).
--Identification of molecular markers in the individual that correlate with
the body"s response to the onset or clearance of disease and the development
of biomarkers to track and even image the efficacy of therapy (therametrics)
and prevention, as well as the onset of secondary cancers.
--Tracking of the damage to the genome from exogenous agents such as
carcinogens, radiation and existence of exogenous infectious agents resident
in cancer cells.
The comprehensive molecular analysis of cancer will require:
--High through put analysis strategies to elucidate the processing and
expression of genetic material in the cell.
--Detection of molecular changes in the cell without preconceived ideas about
which information will be most valuable to monitor.
--Adequate adaptations to accommodate technical issues specific to the study
of cancer in vitro and in vivo, such as limited cell number, sample
heterogeneity, and heterogeneity of specimen types (i.e., bodily fluids and
waste, tissues, cells).
--Adaptation of novel technologies for use in cancer research, including use
on tumor specimens, in patient imaging, and in population research.
--Integration of sample preparation components that maintain the efficiencies
of the assay system and effectively accommodate human tumor specimens.
--Data analysis tools for interpreting the information from highly multiplexed
molecular analyses.
Novel technologies for comprehensive molecular analysis are being developed.
Many of these technologies have not yet been demonstrated to have utility or
cost effectiveness in application to cancer model systems, cancer specimens,
or in population-based research. It will be necessary to demonstrate that
relevant technologies have adequate sensitivity to discriminate differences
between tumors and normal tissues, and tumors of different stages. Therefore,
the need exists to demonstrate the ability of emerging molecular analysis
technologies to provide routine assay performance, adequate sensitivity and
discrimination, and associated robust data analysis tools, that can be adapted
to basic, pre-clinical, and clinical research settings for the purpose of
cancer research.
Translation of new in vitro technologies for the multiplexed analysis of
molecular species in clinical specimens will require a multidisciplinary team
approach with broad expertise in a variety of research areas. Such varied
expertise, potentially including but not limited to, expertise in pathology,
specimen acquisition and preparation, informatics and biostatistics exists in
ongoing cancer centers and clinical trials cooperative groups. The
coordination and collaboration of investigators from these various disciplines
to demonstrate the utility and applicability of new analytical tools in
clinical and population based studies is considered to be a high priority.
Existing technologies for molecular analysis are also largely restricted to in
vitro analysis. While these systems are suitable for discovery and many basic
and clinical research questions, they are limited in their ability to offer
information relative to molecular changes in real time and in the appropriate
context of the intact cell or body. Imaging in situ or in vivo is becoming
increasingly important for extending molecular analysis of early cancer
formation. The application of high-resolution imaging at the cellular or
molecular levels to, tissue samples, pre-clinical models, or human
investigations is therefore considered to be an important extension of
molecular analysis methods. Similarly, the application of molecular probes
for imaging molecular events is also of interest for pre-clinical and human
investigations. Finally, the use of molecular contrast enhancement
techniques, such as contrast modifications of gene expression are considered
critical to improve the sensitivity of detection of molecular changes in vivo.
The molecular imaging methodologies proposed, including hardware and software,
are specifically understood as being within the context of molecular analysis
tools. They include specialized high resolution or microscopic imaging
methods dedicated to detection and analysis of molecular events related to
cancer formation or as applied to pre-clinical drug discovery. Improvements
in these areas will bring capabilities for real time molecular analysis at
whole body levels. Investigations of tumor models that do not target
molecular species are not responsive to this application. Investigators are
encouraged to contact NCI program staff for further information.
RESEARCH OBJECTIVE
The National Cancer Institute (NCI) invites applications for research projects
to evaluate the utility and pilot the application of newly developed molecular
analysis technologies in studies relevant to cancer research. The Program
Announcement (PA) provides support for a first phase for technology evaluation
and a second phase for pilot application of the technology in a study of
biological interest to cancer research. The first (evaluation) phase should
include proof of principle experiments that will demonstrate the utility of
the technology on samples comparable to those that will be used in the second
phase study. Applicants will be expected to demonstrate the utility of all
components of the process required for a fully integrated system, including
sample preparation, molecular analysis assay, and data capture and analysis.
The second (application) phase supports the transition of the technology
optimized in the first (evaluation) phase to pilot application in a study of
biological interest to cancer research. The design of the second phase study
should allow the demonstration that the technology can reproducibly obtain
molecular data from the selected sample type and produce information of
biological interest to cancer research. Studies might appropriately target
analysis of precancerous, cancerous, or metastatic cells, or host derived
samples, from model cancer systems, preclinical or clinical research, or from
population based research.
The application of new tools that support the comprehensive molecular
characterization of normal, precancerous, cancerous, and metastatic cells, as
well as the identification of new targets for detection, diagnosis,
preventative, and therapeutic strategies, is needed to support the basic
discovery process and the translation of basic discoveries to pre-clinical and
clinical research. Application of improved molecular analysis technologies
will also allow a more thorough examination of the variations that influence
predisposition to cancer, and individual variability in response to
therapeutic and prevention agents as well as the identification of exogenous
infectious agents that may be associated with the development of cancer.
Examples given below are not intended to be all-inclusive, but are
illustrative of the types of molecular analysis capabilities that are of
interest for evaluation and pilot application in response to this
solicitation.
--In vitro identification and characterization of sites of chromosomal
aberrations, which arise from inherited or somatic alterations resulting from
aging or oxidation, or exposure to radiation or carcinogens, including those
that are suitable for scaling for use across whole genomes, detecting DNA
adducts, detecting rare variants in mixed populations, or identifying
infrequently represented mutations in mixed populations of DNA molecules.
--Detection and characterization of nucleic acid sequences of novel exogenous
infectious agents including viruses, bacteria or other microscopic forms of
life that may be etiologic factors or co-factors in the initiation and/or
progression of human cancers. New technologies are demonstrating that
microorganisms may play a more important role in the initiation of
malignancies than was previously appreciated.
-- In vitro scanning for and identification of sites of mutations and
polymorphisms which reflect inherited aberrations or variations, or somatic
alterations resulting from aging or oxidation, or exposure to radiation or
carcinogens, including those that are suitable for scaling for screening whole
genomes, detecting DNA adducts, of identifying infrequently represented
mutations in mixed populations of DNA molecules.
-- Highly specific and sensitive detection of specific mutations in
multiplexed high through put analysis.
-- Detection of mismatch and recombinational DNA repair anomalies related to
cancer susceptibility, cancer progression, and drug sensitivity.
-- In vitro multiplexed analysis of the expression of genes.
-- Computer assisted quantitation of gene expression.
-- In vitro detection of expression of proteins and their post-translationally
modified forms, including technologies suitable for expansion to profiling of
all proteins expressed in cells, detecting rare variants in mixed populations,
and detecting protein adducts involved in chemical mutation.
--Assaying the function of proteins and genetic pathways, including
measurement of ligand-protein complexes and technologies for monitoring
protein function of all members of a class of proteins or members of a
complete genetic pathway.
Translation of the utility of the technologies described above and basic
research findings into tools for pre-clinical and clinical applications
requires additional technological innovation with regard to sample
preparation, enhanced sensitivity, and expanded data analysis tools. Of
interest is the application of technologies suitable for:
-- Detection, quantification and analysis of DNA mutations and polymorphisms
and functional proteins in clinical specimens (e.g. tissue, serum, plasma,
nipple aspirates, bronchioalveolar lavage, sputum, urine, pancreatic juice,
colonic wash, and bladder wash).
--Imaging in situ or in vivo in order to extend molecular analysis to early
cancer formation. The application of high-resolution imaging at the cellular
or molecular levels to, tissue samples, pre-clinical models, or clinical
investigations are therefore considered to be an important extension of
molecular analysis methods. Similarly, the application of molecular probes
for imaging molecular events is also of interest for pre-clinical and human
investigations. Finally, the use of molecular contrast enhancement
techniques, such as contrast modifications of gene expression are considered
critical to improve the sensitivity of detection of molecular changes in vivo.
The molecular imaging methodologies proposed, include hardware and software,
are specifically understood as being within the context of molecular analysis
tools. They include specialized high resolution or microscopic imaging
methods dedicated to detection and analysis of molecular events related to
cancer formation or as applied to pre-clinical drug discovery. Improvements
in these areas will bring capabilities for real time molecular analysis at
whole body levels.
The Phase I component of the proposal supports a first phase for technology
evaluation. Applicants should describe proof of principle experiments that
will demonstrate the utility of the technology. The applicant should:
--Demonstrate performance of the selected technology on samples comparable to
those to be used in the proposed study in Phase II.
--Have a detailed plan to optimize and troubleshoot the technology for
complete adaptation of the technology for the Phase II pilot application.
--Discuss how they will evaluate cost effectiveness of the technology relative
to existing and competing technologies.
--Specifically address approaches to sample preparation, molecular analysis
assays, data collection, and data management.
Applicants must include in a separate section the milestones to be
accomplished in the first phase of the application. Milestones are separate
from specific aims. They provide a clear measure of the success of the Phase
I application which is necessary to proceed to the second phase, therefore
they should be clearly stated and presented in a manner that is easily
quantifiable.
The Phase II study is intended to support the pilot application of technology
evaluated and refined in the Phase I proposal, to a study of biological
interest to cancer research. Technology developers are strongly encouraged to
seek collaborations with qualified cancer researchers. In the Phase II the
applicants should:
--Describe how they will assess the performance of the technology in providing
useful molecular data relative to existing technologies.
--Address plans to refine study design parameters based on Phase I results.
--Provide a more refined plan detailing the biological questions to be asked
by the study and how the forthcoming data will be translated, either directly
or indirectly, into information relevant to the study of cancer.
--Comment in detail on the suitability of the study design (i.e. numbers,
types of samples) for asking the biological questions posed by the study. This
should be discussed in the context of information and data to be obtained from
Phase I studies. The study design parameters (i.e. number of samples, data
analysis, etc.) should be of a scale to reflect that this is a pilot
application of the technologies.
--Clearly define what is considered to be a high quality sample for the
technology to be used.
--Document a strategy for obtaining access to high-quality samples that will
be needed to carry out the study.
--Discuss the ease of transition of the technology from Phase I to Phase II
application with respect to scaling up the technology and implications related
to sample cost, availability, and sample through-put.
Effective data management and analysis will be critical to the successful and
productive application of the proposed technology. Therefore applications
must:
--Address the ability to acquire, store, analyze, and extract information from
data collected through the course of the study.
--Demonstrate capabilities to capture the data and to perform the complex
multiplex analysis on data a acquired through the course of the study.
--Describe bioinformatics, other analytical systems, and approaches that will
be used to interpret data obtained from the study.
Applicants are encouraged to discuss potential strategies for making resulting
molecular data sets available to the cancer research community in both peer
reviewed-publications as well as in complete electronically accessible data
sets.
MECHANISM OF SUPPORT
Support for the PA is through the SBIR and STTR mechanisms, which are set-
aside programs.
Applications can be submitted for support as Phase I STTR (R41) or Phase I
SBIR (R43) grants: Phase II STTR (R42) or Phase II SBIR (R44) grants, or under
the SBIR/STTR FAST-TRACK option as described in the OMNIBUS SOLICITATION
(http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf). Phase II
applications in response to this PAR will only be accepted as competing
continuations of previously funded NIH Phase I SBIR/STTR awards. The Phase II
proposal must be a logical extension of the Phase I research.
Because the length of time and cost of research involving advanced technology
projects often exceeds that normally awarded for SBIR/STTR grants, NCI 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 Facility and
Administrative costs). Phase II applications with a project period up to
three years with well-justified budget levels appropriate for the work
proposed would also be accepted. 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, the total duration (Phase I plus
Phase II applications) cannot exceed four years. In any case, Phase I
applications cannot exceed two years duration.
This program will run in parallel with a program of identical scientific scope
(http://grants.nih.gov/grants/guide/pa-files/PAR-01-106.html) that will
utilize the newly created Phased Innovation Award mechanism. 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.
Except as otherwise stated in this program announcement, 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_2001/. Hard copies are not
available.
ELIGIBILITY REQUIREMENTS
Eligibility requirements are described in the OMNIBUS SOLICITATION. Any small
business, independently owned by United States citizens and located in the
United States, may apply. Partnerships and collaborations are encouraged.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Carol A. Dahl, Ph.D.
Office of Technology and Industrial Relations
National Cancer Institute
31 Center Drive, Room 11A03
Bethesda, MD 20892-2590
Telephone: (301) 496-1550
FAX: (301) 496-7807
Email: [email protected]
Direct inquiries regarding fiscal matters to:
Ms. Kathleen J. Shino
Grants Administration Branch
National Cancer Institute
6120 Executive Blvd. Room 243
Bethesda, MD 20892-7150
Telephone: (301) 846-1016
FAX: (301 846-5720
Email: [email protected]
Direct inquiries regarding review matters to:
Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8326
Bethesda, MD 20892-8326
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496 -3428
FAX: (301) 402-0275
Email: [email protected]
LETTER OF INTENT
Prospective applicants are asked to submit, by the dates indicated on the
front page, a Letter of Intent that includes a descriptive title of the
proposed research, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the PA in response to which the
application may be submitted. Although a Letter of Intent is not required, is
not binding, and does not enter into the review of a subsequent application,
the information that it contains allows IC staff to estimate the potential
review workload and plan the review.
The Letter of Intent is to be sent to Dr. Carol Dahl listed under INQUIRIES by
the Letter of Intent receipt date.
APPLICATION PROCEDURES
Application forms, requirements and procedures are the same as listed in the
Omnibus Solicitation for Phase I SBIR/STTR Grant applications
(http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf), with the following
exceptions:
o Type the title and number of this PA on line 2 on the face page of the
application.
o The Omnibus Solicitation states levels of Phase I and Phase II budgets that
are guidelines, not ceilings. Under this PA the NCI will consider larger
budgets for longer periods of time that are well-justified and necessary to
complete the proposed research and development. Phase I budgets are limited
to project periods up to a two year ceiling, and up to a guideline of $100,000
direct costs per year, excluding subcontractor facilities and administrative
costs. Include a second budget page, and expand the narrative budget
justification page(s) to provide second year justification if there are
significant line item differences. If second year changes reflect only cost
of living factor(s), include a statement to that effect, the factor(s) used,
and omit repetition of detail already provided for first year line items.
o There are no dollar limitations under this PA for Phase II budgets, but
requested amounts are subject to peer review recommendations, availability of
funds, and program priority. Under this PA, budget proposals for direct costs
of $500,000 or more in any one year require a letter of justification and
approval of the NCI prior to submission.
o A flexible SBIR/STTR Phase I budget period of one or two years (versus the
Omnibus Solicitation guideline of 6 months for the SBIR and 1 year for the
STTR).
o A flexible SBIR/STTR Phase II budget period of one to three years (versus
the Omnibus Solicitation guideline of up to two years).
o A four-year limit to funding for a Fast Track, or five year limit to
funding for a Phase I and renewal Phase II application.
PHASE I APPLICATIONS. Because the length of time and cost of research
involving advanced technology projects may exceed that normally awarded for
SBIR/STTR grants, NCI will entertain well-justified Phase I applications with
a project period up to two years and a budget guideline that may not exceed
$100,000 per year direct costs (maximum of $200,000 direct costs for up to 2
years, excluding subcontractor facilities and administrative costs).
PHASE II APPLICATIONS. Phase II applications in response to the PA will only
be accepted as competing continuations of previously funded NIH Phase I SBIR
or STTR awards. The Phase II application must be for developmental work that
is a logical extension of the Phase I feasibility research. Because the
length of time and cost of research often exceeds that normally awarded for
SBIR grants, NCI will entertain well-justified Phase II applications for this
SBIR/STTR award with project periods up to three years with well-justified
budget levels appropriate for the work proposed. Applications for Phase II
awards should be prepared following the instructions for NIH Phase II SBIR or
STTR applications. The Phase II SBIR instructions and application may be
found on the Internet at: http://grants.nih.gov/grants/funding/phs398/phs398.html.
The Phase II STTR instructions and application may be found on the Internet at
http://grants.nih.gov/grants/funding/phs398/phs398.html.
Helpful information for preparation of the application(s) can be obtained at:
http://grants.nih.gov/grants/funding/sbir_policy.htm.
FAST-TRACK APPLICATIONS. Applications may be submitted for the Fast Track
review option. Information on the Fast Track option may be found at
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf.
Phase I Milestones: The R41 or R43 phase of a Fast Track application must
include 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 such information for Phase I application
and/or sufficient detail in the Phase II application may be sufficient reason
for the peer review committee to exclude the Phase II from consideration. If
so, at a later date, the applicant will be reviewed by standard Study Section
of the Center for Scientific Review or by a special review group convened in
response to this PAR, if applicable.
Project Period and Amount of Award. Because the length of time and cost of
research often exceeds that normally awarded for SBIR grants, NCI will
entertain well-justified Phase II applications for this SBIR/STTR award with
project periods up to three years with budget levels appropriate for the work
proposed (subject to the four year funding limit for Phase I and Phase II
grants).
Both Phase II applications and Fast Track applications must include a succinct
commercialization plan, also referred to as a "Product Development Plan"
(PDP). The PDP is limited to ten pages and must be included as part of the
Research Plan. Refer to Phase II grant application instructions
http://grants.nih.gov/grants/funding/phs398/phs398.html or the Fast-Track
instructions contained in the Omnibus SBIR/STTR solicitation
(http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf) for more specific
details and instructions. In the event that an applicant feels their
technology is too proprietary to disclose, applicants at a minimum should
provide a demonstration (e.g., results) of the capabilities of the proposed
technology.
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
FOR ALL APPLICATIONS
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
Bethesda, MD 20817 (for express/courier service)
To expedite the review process, at the time of submission, send two copies of
the application to:
Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8236
Bethesda, MD 20892-8236
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Applications must be received by the receipt dates listed at the beginning of
this PA.
The Center for Scientific Review (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 substantial
revisions of applications already reviewed, but such applications must include
an introduction addressing the previous critique.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed by the CSR for completeness and by
the NCI program staff for adherence to the guidelines. Applications not
adhering to application instructions described above and those applications
that are incomplete as determined by CSR or by NCI program staff will be
returned to the applicant without review.
Applications that are complete and adhere to the guidelines of this PA will be
evaluated for scientific and technical merit by an appropriate peer review
group convened by the NCI 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 National Cancer Advisory Board (NCAB).
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In the
written comments reviewers will be asked to discuss the following aspects of
the application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. Each of these
criteria will be addressed and considered in assigning the overall score,
weighting 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 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.
Review criteria as described in the NIH OMNIBUS SOLICITATION have been
included in the following:
1. Significance. Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
What may be the anticipated commercial and societal benefits of the proposed
activity? What will be the effect of these studies on the concepts or methods
that drive this field? To what degree does the technology support the needs
of the targeted research community? For systems intended for clinical
research the additional criteria will be considered: to what degree is the
analysis system appropriate for clinical research and likely to have utility
for the analysis of clinical specimens or patients? Does the proposed project
have commercial potential to lead to a marketable product or process? 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? Does the applicant acknowledge potential problem areas and consider
alternative tactics? What is the time frame for developing the proposed
technologies and suitability of this time frame for meeting the scientific
community’s needs? How easy will it be to use the proposed technology? Are
the plans for proposed technology dissemination adequate? Is the proposed
plan a sound approach for establishing technical and commercial feasibility?
3. Milestones. How appropriate are the proposed milestones against which to
evaluate the demonstration of feasibility for transition to the Phase II
development phase?
4. Innovation. Does the project employ novel concepts, approaches, or
method? Are the aims original and innovative? Does the project challenge
existing paradigms or develop new methodologies or technologies? What is the
throughput and cost effectiveness of the proposed technology? What additional
uses can be projected for the proposed technology?
5. Investigator. Is the investigator appropriately trained and well suited
to carry out this work? 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 subawardees (if any)?
6. Environment. 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? Does not make sense
for small business. Is there sufficient access to resources (e.g. equipment,
facilities)?
In addition to the above criteria, the following will also be considered for
Phase II applications and Phase I/Phase II FastTrack applications.
1. To what degree was progress toward the Phase I objectives met and
feasibility demonstrated in 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 Omnibus SBIR/STTR
solicitation?
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?
The initial review group will also examine: the appropriateness of the
proposed project budget and duration, the adequacy of plans to include both
genders and minorities and their subgroups, and children as appropriate for
the scientific goals of the research and plans for the recruitment and
retention of subjects, the provisions for the protection of human and animal
subjects, and the safety of the research environment.
AWARD CRITERIA
Applications will compete for available funds with all other recommended SBIR
and STTR applications. Funding decisions for Phase I or Phase II applications
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, NCI’s assessment of the Phase I progress and determination that Phase I
goals were achieved, the project’s potential for commercial success, and the
availability of funds.
SCHEDULE
Letter of Intent Receipt Dates: June 15, 2001, October 17, 2001,
February 14, 2002, June 10, 2002,
October 18, 2002, February 14, 2003,
and June 16, 2003
Application Receipt Dates: July 20, 2001, November 21, 2001,
March 21, 2002, July 22, 2002,
November 22, 2002, March 21, 2003,
and July 21, 2003
NCAB Review Dates: February 2002, May 2002, September 2002,
February 2003, May 2003, September 2003,
February 2004
Earliest Anticipated Award Date: April 1, 2002, July 1, 2002, November 1, 2002,
April 1 2003, July 1, 2003, November 1, 2003,
April 1, 2004
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 sub- populations 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 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 research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html),
a complete copy of the updated Guidelines is available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to 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) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
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 clear and compelling scientific and 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 the policy from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
All investigators proposing research involving human subjects should read the
NIH policy on education in the protection of human research participants now
required for all investigators, which is published in the NIH Guide for Grants
and Contracts, June 5, 2000 (Revised August 25, 2000), available at the
following URL address
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
A continuing education program on the protection of human
participants in research is now available online at http://cme.nci.nih.gov/.
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. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a PHS led national
activity for setting priority areas. This PA, Applications of Innovative
Technologies for the Molecular Analysis of Cancer: SBIR/STTR is related to
the priority area of cancer. 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 No.
93.394. 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts
74 and 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 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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