Application of Emerging Technologies for Cancer Research (SBIR/STTR)

Application of Emerging Technologies for Cancer Research (SBIR/STTR) is sponsored by National Cancer Institute (NCI) of the National Institutes of Health (NIH). This initiative invites applications for research projects to evaluate the usefulness of emerging technologies ready for initial application to clinical or biological questions in cancer research.

Expired RFA-CA-05-007: APPLICATION OF EMERGING TECHNOLOGIES FOR CANCER RESEARCH (SBIR/STTR) This notice has expired. Check the NIH Guide for active opportunities and notices.

APPLICATION OF EMERGING TECHNOLOGIES FOR CANCER RESEARCH (SBIR/STTR) RELEASE DATE: January 7, 2004 RFA Number: RFA-CA-05-007 (This RFA has been reissued, see RFA-CA-06-006 ) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) COMPONENT OF PARTICIPATING ORGANIZATION: National Cancer Institute (NCI) ( http://www. nci. nih.

gov ) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93. 393, 93. 394, 93.

395, LETTER OF INTENT RECEIPT DATES: February 10, 2004; May 17, 2004; APPLICATION RECEIPT DATES: March 10, 2004; June 17, 2004; October 18, 2004 o Project Period and Amount of Award o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Receipt and Review Schedule o Required Federal Citations NOTICE: This Request for Application (RFA) must be read in conjunction with the current OMNIBUS SOLICITATION OF THE NATIONAL INSTITUTES OF HEALTH, CENTERS FOR DISEASE CONTROL AND PREVENTION, and FOOD AND DRUG ADMINISTRATION FOR SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) GRANT APPLICATIONS.

The solicitation (see http://grants. nih. gov/grants/funding/sbirsttr1/index.

pdf ) contains information about the SBIR and STTR programs, regulations governing the programs, and instructional information for submission.

All of the instructions within the SBIR/STTR Omnibus Solicitation apply with the o Initial review convened by the NCI Division of Extramural Activities; o Additional review considerations; and o In certain cases, larger budgets and longer project periods than statutory This RFA will utilize the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) mechanisms, but will be run in parallel with a RFA of identical scientific scope (CA-05-003, http://grants.

nih. gov/grants/guide/rfa-files/RFA-CA-05-003. html ) that will utilize the, NIH R21/R33 Phased Innovation Award and the R33 Exploratory/Developmental Award.

The National Cancer Institute (NCI) invites applications for research projects to evaluate the usefulness of emerging technologies that are ready for initial application to clinical or biological questions in cancer research. Projects should be designed to demonstrate that the technology is robust and yields reproducible measurements.

Projects should also be designed to gather preliminary data to support the use of the technology in a future project(s) with a clinical or biological focus. It is expected that some refinement or adaptation of the technology may be appropriate in the initial phase of the project, but projects requiring significant technology development effort are not appropriate.

In addition, applications that propose the use of commercially available technology under standard conditions, or any technology that is already commonly accepted for the proposed use, are not appropriate. (Applicants proposing projects focused on biological or clinical questions are encouraged to contact their program This initiative is part of a broader technology development program within the NCI.

That program underscores the desire of NCI to develop and integrate novel technologies focused on the molecular analysis of cancers and their micro-environment in support of cancer research, diagnosis, and treatment. In the research continuum of discovery, development, and delivery, this program thus emphasizes the link between development and delivery.

This specific initiative will serve as a tool to develop emerging technologies in an appropriate biological or clinical context.

This RFA capitalizes on both the success and intent of the original NCI sponsored Innovative Molecular Analysis Technologies (IMAT) program in bringing together a multi-disciplinary group of scientists and engineers to work on cancer and the expansion of interest in technology development across the NCI and other NIH institutes.

This continuation of the IMAT program consists of the following three initiatives: Innovative Technologies for the Molecular Analysis of Cancer; Innovations in Cancer Sample Preparation; and Application of Emerging Technologies for Cancer Research. This RFA is designed to replace and expand on the Applications of Innovative Technologies for the Molecular Analysis of Cancer ( PAR-01-107 ).

It will support studies that start with an unproven technology, adapt or refine the technology slightly as needed, and begin to generate biological data to assess the relative robustness of the technology in the chosen biological or clinical context. Projects requiring significant technology development may be most suitable for RFA (CA-05-006), Innovative Technologies for the Molecular Analysis of Cancer SBIR/STTR ( http://grants. nih.

gov/grants/guide/rfa-files/RFA-CA-05-006. html ). Technologies developed or adapted for sample preparation methodology may be most suitable for RFA (CA-05-008), Innovations in Cancer Sample Preparation SBIR/STTR ( http://grants.

nih. gov/grants/guide/rfa-files/RFA-CA-05-008. html ) (see MECHANISMS OF SUPPORT).

Applications of in vivo imaging technologies and projects with bioinformatics or statistics as their primary focus are not included under this RFA. Researchers who emphasize the assessment of in vivo imaging technologies as the primary focus of their grant application should contact the Cancer Imaging Program ( http://www. cancer.

gov/cip/ ) for applying new bioinformatics or statistical techniques as the primary focus of their application should consider one of the BISTI initiatives ( http://www. bisti. nih.

gov/bistic_funding. cfm ). In order to meet the goal of eliminating death and suffering due to cancer, the NCI will continue to support the development and application of creative methods to understand, prevent, diagnose and treat cancer.

In the past several decades, basic discovery research has revealed that cancer is a complex disease involving myriad molecular and cellular processes, and that cancers arise as the result of the gradual accumulation of genetic changes in specific cells. Identifying which subset of the genes encoded within the human genome can contribute to the development of cancer remains a challenge.

The identification and characterization of these cancer genes and their associated gene products remains a high priority in cancer research. New technologies and approaches not only address specific questions in basic research and clinical practice but are also beneficial in uncovering and developing new directions and paradigms in cancer research.

Taken together, these developments highlight the leading and critical role technological advances play throughout the NCI’s mission. 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.

Assessing the usefulness of emerging technologies applied in biologically or clinically relevant settings is crucial to moving these technologies from the hands of the technology developer into the hands of biological and clinical researchers. As new technologies and experimental approaches develop, focus gradually shifts from assessment of technical feasibility toward application to biological and clinical research questions.

Novel technologies are invented and refined until technical feasibility has been demonstrated. These new technologies (together with existing technologies that can be modified or adapted for new uses) then pass into a developmental phase. It is during this phase that the technologies are first applied to the research or clinical uses for which they are intended.

If successful, this developmental phase produces two deliverables: a robust and reproducible tool and the preliminary supporting data resulting from its initial application. Both of these deliverables form the basis for new biological or clinical research projects, enabled by the new technologies.

This RFA is intended to support projects to evaluate the usefulness of emerging technologies in appropriate biological contexts in order to assess reproducibility and produce preliminary data toward answering a biological or clinical question. Technologies proposed for this RFA should be sufficiently advanced in development to be applied in a relevant clinical or biological context.

(Applications proposing to use technologies that still require significant development before they can be applied to the analysis of biological materials should consider applying to the Innovative Technologies for the Molecular Analysis of Cancer SBIR/STTR, RFA (CA-05-006) ( http://grants. nih. gov/grants/guide/rfa-files/RFA-CA-05-006.

html ). Researchers may propose, in Phase I, to continue minor refinement of newly developed technologies or minor adaptations of existing technologies to new uses. Phase II should be used for applying the technology in a relevant setting to generate the preliminary biological data to prove that the technology functions reproducibly and effectively in the chosen biological context.

These projects should provide investigators with sufficient data to demonstrate the capabilities of the technology in a biologically relevant setting. These data may then be used by the investigator or by others to propose new projects using the technology to answer biological or clinical questions, through other existing program announcements (for example, see http://www3. cancer.

gov/prevention/cbrg/edrn/ and http://spores. nci. nih.

gov/ ) or as investigator-initiated R01 applications.

The data generated may also be used by technology developers in partnership with clinical or biological investigators with questions that the new technology could elucidate or to partner with industry to further refine the technology into a commercial It is expected that investigators who developed successful cancer-relevant technologies under previous IMAT initiatives or under the new RFA CA-05-002 (Innovative Technologies for the Molecular Analysis of Cancer) will propose projects for this RFA.

However, this RFA is not limited to technologies developed under the IMAT program. Investigators may propose to begin to utilize any emerging cancer-relevant technology.

Areas of emerging technologies of interest to be applied in these projects include, but are not limited to, those technologies that enable the following approaches: o In vitro scanning for and identification of the sites of chromosomal aberrations that reflect inherited aberrations or somatic alterations resulting from aging, 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; o In vitro scanning for and identification of sites of mutations and polymorphisms that reflect inherited aberrations or variations, or somatic alterations resulting from aging, 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; o Detection and characterization of nucleic acid sequences of novel exogenous infectious agents that may be present in human cancer; o Highly specific and sensitive detection of specific mutations; o Detecting mismatch and recombinational DNA repair related to cancer susceptibility and drug sensitivity; o In vitro multiplexed analysis of the expression of genes; o 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; o 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 o 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; o Elucidation of molecular modifications of macromolecules that may be indicative of and critical to the transformation process; o Development of delivery technologies and approaches to enable faster and more accurate delivery of molecular and cellular labels and drugs to and within cells for research and treatment, with the overall goals being speed, accuracy, and biocompatibility; and/or o Development of high-throughput, quantitative assays for epigenetic alternations, e.g., acetylation and methylation, in promoter region of genes and histone proteins isolated from biological fluids and tissues.

For all projects 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. Inherent in this early technology application is the potential for ultimately transferring knowledge gained, technology and/or methodology to other laboratories or the clinic.

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. This RFA uses the SBIR and STTR mechanisms, which are set-aside programs. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

Future unsolicited, competing-continuation applications based on this project will compete with all SBIR/STTR applications and will be reviewed according to the customary peer review procedures. The anticipated award date is approximately nine months from the This RFA uses just-in-time concepts. It also uses the modular budgeting format.

Specifically, if you are submitting an application budget of $100,000 total costs (direct, F&A, and fee) or less, use the modular budget format and instructions as described in the current SBIR/STTR Omnibus Solicitation. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.

nih. gov/grants/policy/nihgps_2001/part_i_1. htm .

Except as otherwise stated in this RFA, 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 .

Applications may 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 the SBIR/STTR Fast-Track option as described in the SBIR/STTR Omnibus Solicitation. The Phase II application must be a logical extension of previously funded Phase I SBIR/STTR research but not necessarily a Phase I project supported in response to this RFA.

Fast-Track applications will benefit from expedited evaluation of progress following the Phase I feasibility study for transition to Phase II funding for expanded The Phase I portion of the Fast-Track application must contain well-defined quantitative milestones that will be used to judge the success of the proposed research, as well as a credible plan for the pilot application of the proposed technology in Phase II.

The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines of funding support and project duration periods for SBIR and STTR Phase I and Phase II awards. Under this RFA, an applicant may request a project period of up to 2 years for Phase I, up to 3 years for Phase II, and up to 4 years for a combined Phase I/Phase II Fast-Track, of which the Phase I portion may be no more than 2 years.

An applicant may request a budget for total costs of up to $100,000 per year for Phase I and the Phase I portion of Fast-Track applications. Phase I budgets can exceed this cap to accommodate indirect costs to subcontracts to the project, but funds for such may not be rebudgeted. Budgets for Phase II and the Phase II portion of Fast-Track grant applications should be appropriate for the science proposed.

Because the nature and scope of the proposed research will vary from application to application, NCI will consider budgets that exceed the statutory guidelines. Total costs include direct costs, F&A, and fee/profit. The NCI intends to commit approximately $1,250,000 in FY 2005 to fund two to four Phase I, Phase II, and/or Fast-Track applications under the SBIR/STTR set-aside funding mechanism.

Although the financial plans of the NCI provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if competing renewal applications will be accepted and/or if this RFA will be reissued. Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation.

Only small business concerns are eligible to submit SBIR/STTR applications. A small business concern is one that, on the date of award for both Phase I and Phase II agreements, meets ALL of the criteria as described in the current SBIR/STTR Omnibus Solicitation.

Also, for eligibility clarification see the July 25, 2003 Notice in the NIH Guide for Grants and Contracts ( NOT-OD-03-053 ) SMALL BUSINESS ELIGIBILITY REQUIREMENTS FOR APPLICANTS TO THE SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMS.

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

On an SBIR application, the principal investigator must have his/her primary employment (more than 50%) with the small business at the time of award and for the duration of the project.

The PI on an STTR application may be employed with the small business concern or the participating non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant small business concern, which is characterized by an official relationship between the small business concern and that individual.

An annual meeting of all investigators funded through this program will be held to share progress and research insights that may lead to 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.

We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into Four areas: scientific/research, intellectual property, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Gregory J. Downing, D.

O. , Ph. D.

Office of Technology and Industrial Relations National Cancer Institute Rockville, MD 20652 (or express/courier service) Telephone: (301) 496-1550 E-mail: [email protected] o Direct your questions regarding intellectual property management plans to: Technology Transfer Branch National Cancer Institute, NIH, DHHS 6120 Executive Boulevard, EPS Room 450 Rockville, MD 20652 (or express/courier service) Telephone: (301) 496-0477 E-mail: [email protected] o Direct your questions about peer review issues to: National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8041, MSC 8329 Telephone: (301) 496-3428 E-mail: [email protected] o Direct your questions about financial or grants management matters to: Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, EPS Room 243 Bethesda, MD 20892 (for regular mail) Rockville, MD 20852 (for express mail) Telephone: (301) 496-8785 E-mail: [email protected] Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 NCI staff to estimate the potential review workload and plan The letter of intent is to be sent at least one month prior to the targeted receipt date.

The receipt dates and respective letter of intent dates are listed at the beginning of this document. The letter of intent should be Gregory J. Downing, D.

O. , Ph. D.

Office of Technology and Industrial Relations National Cancer Institute Rockville, MD 20652 (or express/courier service) Telephone: (301) 496-1550 E-mail: [email protected] The PHS 398 research grant application must be used for all SBIR/STTR Phase I, Phase II, and Fast-Track applications (new and revised).

Effective October 1, 2003, applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www. dunandbradstreet.

com/ . The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.

nih. gov/grants/funding/phs398/phs398. html .

Prepare your application in accordance with the SBIR/STTR Omnibus Solicitation and the PHS 398. Helpful information for advice and preparation of the application can be obtained at: http://grants. nih.

gov/grants/funding/sbirgrantsmanship. pdf . For further assistance contact GrantsInfo, Telephone: (301) 710-0267, E-mail: SUPPLEMENTARY INSTRUCTIONS Applications may be submitted for Phase I or Phase II support, or as a combined Phase I and II (Fast-Track).

The Phase II proposal must be a logical extension of previously funded Phase I SBIR/STTR research but not necessarily a Phase I project supported in response to this initiative. The total duration for a Phase I/Phase II Fast-Track application cannot PHASE I: Demonstration of feasibility of the innovative approach.

Research should be proposed with quantitative feasibility milestones that, when accomplished, would provide sufficient reason to continue the technology development in Phase II. It is expected that technology feasibility will be established. If two years of support are requested, the goals for the first year should be clearly stated and not be simply a reiteration of specific aims.

Support for the second year will be contingent upon Institute programmatic evaluation to ensure that investigators are reaching milestones and accomplishing the goals presented. PHASE II: Development of approach to a stage at which the innovation can be piloted for implementation. Extensive studies designed to validate the approach would be expected.

Goals and milestones for each year of support should be clearly presented. Support for years 2 and 3, if requested, is dependent upon Institute programmatic review of progress and achievement of FAST-TRACK: Applications may be submitted for combined Phase I and Phase II, Fast- Track consideration as described in the OMNIBUS SOLICITATION.

The Phase I part of Fast-Track applications must specify clear, quantitative milestones that should be achieved prior to Phase II funding. These must be presented in a section labeled Milestones at the end of the Research Plan.

A discussion of the suitability of the proposed milestones for assessing success in Phase I, and a discussion of the implications of successful completion of these milestones for the proposed Phase II, should also be presented in this section.

Failure to provide such information in the 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, a Phase I grantee may apply later for Phase II support. Such applications will be reviewed by an appropriate scientific review group convened by the NIH.

Special provisions described in this RFA pertaining to Phase I and Phase II applications also apply to Fast-Track applications. All Phase II and Fast-Track applications must include a succinct Commercialization Plan (limited to 15 pages). The Commercialization Plan must be included as part of the Research Plan.

Refer to the Phase II grant application instructions for more specific details and instructions. See http://grants. nih.

gov/grants/funding/sbirsttr2/PhaseII_SBIRSTTR. pdf or http://grants. nih.

gov/grants/funding/sbirsttr2/PhaseII_SBIRSTTR. doc . Potential applicants are encouraged to contact program staff for guidance and to read the advice and information on the web sites.

However, responsibility for planning, direction, and execution of the proposed research will be solely that of the applicant. INTELLECTUAL PROPERTY MANAGEMENT PLAN: Certain research plans will require collaboration and coordination between investigators at different institutions, some of whom may not be NIH funding recipients and who may have pre-existing intellectual property (IP) obligations to third parties.

It is anticipated that commercial embodiments of the results of such research may incorporate single inventions shared by several institutions, or multiple inventions each from a separate institution.

Therefore, prior to funding, Phase II grant applicants must address how they will coordinate patent prosecution and licensing activities, if necessary to enable a licensee to access the bundle of IP needed to take a product to market on commercially viable terms.

Suggested strategies include: (1) assigning IP rights to related inventions to an invention management firm; (2) designating one organization to take the lead on patenting and licensing related inventions: (3) agreeing in advance that, if multiple parties are to independently license related inventions, the total of stacked royalties will not exceed a predetermined percentage rate.

The technology transfer/IP management/licensing officer or equivalent at the small business concern is to submit an IP management plan including at least those elements above. Alternatives to the suggested strategies, which accomplish the same goals, will be considered.

IP management plans are a just-in-time requirement; it is not necessary to include the plan in the grant application, but plans will be required before a Phase II grant can be Applicants should avoid exclusively licensing those inventions that are research tools unless either: (1) the field of use of the exclusive license is restricted to commercial use, or (2) the exclusive licensee will make the research tool available on reasonable terms.

Applicants should refer to the NIH policy on the dissemination of biological research resources ( research tools ), which can be found at http://www. ott. nih.

gov/policy/rt_guide_final. html . USING THE RFA LABEL: The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application.

Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. The RFA label is also available at: http://grants.

nih. gov/grants/funding/phs398/labels. pdf .

The title and number of this RFA must be typed on line 2 of the face page of the application and the YES box must be marked.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies in one Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20817 (for express/courier service) To expedite the review process, at the time of submission, two additional copies of the application and all copies of the appendix material must be National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8041, MSC 8329 Rockville, MD 20852 (for express/courier service) Appendices should be comprised of single-sided, unbound materials, with separators between documents.

APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e., FEDEX, UPS, DHL, etc.) ( http://grants. nih.

gov/grants/guide/notice-files/NOT-CA-02-002. html ). This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice http://grants.

nih. gov/grants/guide/notice-files/NOT-OD-02-012. html .

RECEIPT OF APPLICATIONS: Applications must be received on or before the application receipt dates listed in the heading of this RFA. If applications are received after these dates, they will be returned to the applicant Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks.

The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. This does not preclude the submission of a substantial revision of an unfunded version of an application already reviewed, but such an application must include an Introduction addressing the previous critique.

An application through this RFA that is unsuccessful may be resubmitted as amended by the Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCI.

Incomplete or non-responsive applications will Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below.

As part of the initial merit review, o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score; o Receive a written critique; o Receive a second level review by the National Cancer Advisory Board.

The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals within the context of the SBIR/STTR program.

The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. ALL SBIR/STTR APPLICATIONS 1. Significance: Does this study address an important problem?

Does the proposed project have commercial potential to lead to a marketable product or process? What may be the anticipated commercial and societal benefits of the proposed activity? If the aims of the application are achieved, how will scientific knowledge be advanced?

Does the 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? Is the proposed plan a sound approach for establishing technical and commercial feasibility? Does the applicant acknowledge potential problem areas and consider alternative strategies?

Are the milestones and evaluation 3. Innovation: Does the project challenge existing paradigms or employ novel technologies, approaches or methodologies? Are the aims original and 4.

Investigators: Is the Principal Investigator capable of coordinating and managing the proposed SBIR/STTR? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers, including consultants and subcontractors (if any)? Are the relationships of the key personnel to the small business and to other institutions appropriate 5.

Environment: Is there sufficient access to resources (e.g., equipment, facilities)? Does the scientific and technological environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the MILESTONES: In the case of Phase I or Fast-Track applications, are appropriate and quantitative scientific milestones included that will show, when completed by the end of Phase I, whether or not the project has shown feasibility to pursue Phase II aims?

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See