and Human Services (HHS)
EXPIRED
INNOVATIVE TECHNOLOGIES FOR THE MOLECULAR ANALYSIS OF CANCER: SBIR/STTR
Release Date: May 31, 2001 (see addendum NOT-CA-03-007)
PA NUMBER: PAR-01-105
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-99-101, which was published in the
NIH Guide on May 14, 1999.
PURPOSE
The National Cancer Institute (NCI) invites applications for research projects
to develop novel technologies that will support the molecular analysis of
cancers and their host environment in support of basic, clinical, and
epidemiological research. Technology encompasses methods and tools that
enable research including, but not limited to, instrumentation, techniques,
devices, and analysis tools (e.g., computer software). Technology is distinct
from resources such as databases, reagents, and tissue repositories.
Applications for support of such resources will not be considered to be
responsive to this Program Announcement (PA). Technologies solicited include
those that are suitable for the detection of alterations and instabilities of
genomic DNA; measurement of the expression of genes and gene products;
analysis and detection of gene and or cellular products including post
translational modification, and function of proteins; identification and
characterization of exogenous infectious agents in cancer; and assaying the
function of major signal transduction networks involved in cancer. This PA is
intended to support the development of all required components of fully
integrated systems for analysis including front end preparation of sample
materials from cells, bodily fluids, and tumor specimens; novel chemistries or
contrast agents; molecular detection systems; data acquisition methods; and
data analysis tools. Technologies under consideration include those that will
support molecular analysis either in vitro, in situ, or in vivo (by imaging or
other methods) in the discovery process, as well as in pre-clinical models and
clinical research.
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
In the past several decades it has become clear that cancer is not one disease
but many, and that cancers arise as the result of the gradual accumulation of
genetic changes in single cells. Identifying which subset of the genes encoded
within the human genome can contribute to the development of cancer remains a
challenge. The identification of these cancer genes and their associated gene
products remains a high priority in cancer research. Identifying the
molecular alterations that distinguish any particular cancer cell from a
normal cell will ultimately help to define the nature and predict the
pathologic behavior of that cancer cell, as well as the responsiveness to
treatment of that particular tumor. By understanding the profile of molecular
changes in any particular cancer it will become possible to correlate the
resulting phenotype of that cancer with molecular events. Resulting knowledge
will offer the potential for a better understanding of cancer biology; the
discovery of new tools and biomarkers for detection, diagnosis, and prevention
studies; and new targets for therapeutic development.
The definition of the molecular profiles of cancer will require the
development and dissemination of enhanced molecular analysis technologies, as
well as elucidation 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 the 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. Products of this PA are intended to
contribute to this goal.
This solicitation is intended to support the development of molecular analysis
tools that will allow for the more careful examination of the molecular basis
and profiles of cancer, and also provide the ability to identify the molecular
characteristics of individuals that influence cancer development and
prognosis. These tools will allow for an examination of genetic factors that
influence an individual’s likelihood to develop cancer or their ability to
respond to damaging external agents, such as radiation, carcinogens, and
therapeutic regimes. Correlating the molecular variations between individuals
with therapeutic or toxic responses to treatment and prevention measures
should define genetic factors that influence the efficacy and safety of these
strategies and agents (pharmacogenomics). Identification of molecular markers
in the individual that characterize the body’s response to the onset or
clearance of disease will allow for the development of biomarkers to track and
even image the efficacy of therapy (therametrics) and prevention, as well as
the onset of secondary cancers. The ability to completely screen the genome
for variations should enable tracking of the damage to the genome from
exogenous agents such as carcinogens, infectious agents, radiation, and
therapeutic regimes. Products of this PA such as molecular imaging in situ
are intended to contribute to this goal.
Modern molecular technology can contribute to 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. New molecular analysis tools resulting from this initiative are
intended to contribute to this goal.
In order to fully understand cancer and define the molecular response of the
host to cancer, it will be critical to not only have knowledge at the DNA
level, but to have a complete understanding of the processing of genetic
information in cellular function. Current discoveries indicate that
alterations in many of the cellular processes, pathways, or networks may
contribute to the genesis of cancer and could be exploited for therapeutic or
prevention intervention. Therefore, it is important to put in place
technologies that can detect molecular changes in the cell without
preconceived ideas about which information will be most valuable to monitor or
which technologies will have the greatest impact. It is currently possible to
monitor very specific changes in the expression and function of genes and gene
products at the DNA, RNA, or protein level. However, many existing
technologies do not adequately address technical issues specific to the study
of cancer in vitro and in vivo, such as limited cell number, sample
heterogeneity, heterogeneity of specimen types (i.e. bodily fluids and waste,
tissues, cells), and cost effectiveness. Adaptation of novel technologies to
support use in cancer research, including use on tumor specimens, and in
patient imaging, is encouraged.
In the discovery phase, it will be of great utility to have technologies that
can effectively scan variations or function, in many or all members of the
populations of DNA, RNA or protein molecules present in cells through highly
multiplexed analysis. Current technologies for the multiplexed analysis of
molecular species are at a stage where the greatest utility exists for the
analysis of large numbers of relatively homogeneous cell populations that can
be assayed in vitro. While many of the existing technologies have relatively
sophisticated multiplexing capability in the assay format of the system, none
of the existing systems is comprehensive for any particular molecular species
(DNA, RNA or protein). In addition, none of the existing systems for in vitro
analysis have well integrated sample preparation components that maintain the
cost efficiencies of the assay system and effectively accommodate human tumor
specimens. Similarly, data analysis tools for interpreting the information
from highly multiplexed molecular analyses have not been sufficiently
developed and tested for use in the context of basic, preclinical, and
clinical cancer research questions. Therefore, the opportunity exists for
further development to insure that resulting technologies provide enhanced
assay potential, adequate sensitivity and discrimination, robust data analysis
tools, and are easily adapted to the basic, preclinical, and clinical research
settings.
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 including but not limited to 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 preclinical, clinical and in
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, preclinical, 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 development of high-resolution imaging at the
cellular or molecular scales in tissue samples, pre-clinical models, or human
investigations is considered to be an important extension of molecular
analysis methods. Similarly, the development 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 modification 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.
RESEARCH OBJECTIVES
The purpose of this program announcement is to encourage applications from
individuals and groups interested in developing novel technologies suitable
for the molecular analysis of cancers and their host environment in support of
basic, clinical, and epidemiological research. Technologies to support
research in the following areas are considered to be appropriate. Examples
given below are not intended to be all-inclusive, but are illustrative of the
types of capabilities that are of interest.
New tools that allow development of a more complete molecular profile of
normal, precancerous, and cancerous cells, as well as the process of
carcinogenesis, are needed to support the basic discovery process. These tools
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. Of interest are technologies and data
analysis tools for:
--In vitro scanning of or identification of the sites of chromosomal
aberrations which reflect inherited aberrations 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, or detecting rare variants in mixed populations.
--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, or identifying infrequently represented
mutations in mixed populations of DNA molecules.
--Technologies for detection and characterization of nucleic acid sequences of
novel exogenous infectious agents that may be present in human cancer.
--Highly specific and sensitive detection of specific mutations.
--Detecting mismatch and recombinational DNA repair related to cancer
susceptibility 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 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.
--Monitoring 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 a complete genetic
pathway.
Translation of the utility of the technologies described above and basic
research findings into tools for preclinical, and clinical research; requires
additional technological innovation with regard to sample preparation,
enhanced sensitivity, and expanded data analysis tools. Of interest are
technologies for:
--In vitro sample and specimen preparation that is suitable for human tissues
and tumor (including solid tumor) specimens that interface with molecular
analysis tools of the type listed above.
--Detection, quantification and analysis of DNA mutations, polymorphisms and
functional proteins in clinical specimens (e.g. tissues, urine, serum, plasma,
nipple aspirates bronchioalveolar lavage, sputum, pancreatic juice, colonic
wash and bladder wash).
During the basic discovery process enhanced capability is critically needed
for the following:
--Delineating molecular expression, function and analysis at the cellular
level in the context of both the whole body and in situ, including molecular
imaging technologies suitable at this scale, contrast agents, gene
amplification techniques and related data analysis tools.
Applications may request support for the development of individual components
of the final system, for example, front-end sample preparation components for
in vitro systems, molecular detection systems, data acquisition systems, and
data analysis tools. Issues related to the integration of the entire analysis
process should be discussed particularly in the context of the Phase II
application.
For all technologies proposed it will be important to substantiate the
ultimate value of and role for the technology in deciphering the molecular
anatomy of cancer cells or analyzing the molecular profile of the individual.
It is also important for applicants to discuss the ultimate potential for the
transfer of ensuing technology to other laboratories or the clinic, and for
more mature technologies, plans to ensure dissemination of the technology. In
the case of technologies intended for use on clinical specimens or in
patients, applications from or collaborations with investigators involved in
the clinical research of cancer are encouraged.
The focus of this Program Announcement is technology development. Support for
mechanistic studies of basic questions will not be provided, although testing
on biological samples or in whole organisms in the course of enhancing the
utility of the technology is appropriate. Support for the pilot applications
of new technologies to questions of interest to cancer research is outside the
scope of this PA, but is the subject of another solicitation entitled
Application of Innovative Technologies for the Molecular Analysis of Cancer.
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 PA 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 [indirect] 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-01-104.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: carol_dahl@nih.gov
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: shinok@gab.nci.nih.gov
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: tf12w@nih.gov
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? 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? 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? 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.
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.
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 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, Innovative Technologies for the
Molecular Analysis of Cancer: SBIR/STTR Initiative 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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