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.


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