INNOVATIVE TECHNOLOGIES FOR THE MOLECULAR ANALYSIS OF CANCER: SBIR/STTR INITIATIVE Release Date: May 14, 1999 PA NUMBER: PAR-99-101 P.T. National Cancer Institute Letter of Intent Receipt Dates: June 18, October 18, 1999; February 18, June 19, October 19, 2000 and February 20, 2001 Application Receipt Dates: July 21, November 21, 1999; March 21, July 21, November 21, 2000 and March 21, 2001 This PA is a reissuance of PAR-98-066, which was published in the NIH Guide on May 8, 1998. PURPOSE The National Cancer Institute (NCI) invites Small Business 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 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 will utilize the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) mechanisms, but will be run in parallel with a program of identical scientific scope that will utilize the newly created Phased Innovation Award mechanism (PAR-99-100). The SBIR and STTR applications received in response to this program announcement will undergo expedited review, have the opportunity for expedited transition of successful technology research into an expanded development phase, and will be subject to cost and duration limits comparable to the parallel Phased Innovation Award applications. This program announcement must be read in conjunction with the Omnibus Solicitation of the Public Health Service for Small Business Innovation Research Grant Applications (PHS 99-2), and the Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer Grant Applications (PHS 99- 3).All of the instructions within the Omnibus Solicitations apply with the following exceptions: o Special receipt dates o Initial review convened by the NCI Division of Extramural Activities o Additional review considerations o Opportunity for 2 years of Phase I support HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," 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 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001- 00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800), or at http://www.crisny.org/health/us/health7.html. ELIGIBILITY REQUIREMENTS Eligibility requirements for SBIR and STTR are described in the NIH Omnibus Solicitation for SBIR/STTR grant applications. As stated in the REVIEW CONSIDERATIONS section, applications submitted in response to this PA will be reviewed by one or more NCI Special Emphasis Panels convened especially for this solicitation. MECHANISM OF SUPPORT This PA will expire two years from the initial receipt date as indicated by the dates on the front of this solicitation. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement, NIH Publication No99-8, October 1998. A. FAST-TRACK APPLICATIONS. Applications may be submitted for the FAST-TRACK review option. Information on the FAST-TRACK process may be found at: http://www.nih.gov/grants/funding/sbir.htm. Applications will be accepted only on the receipt dates listed on the first page of this document. To be eligible for the FAST-TRACK option, the Phase I (R41/43) application must include well defined quantifiable milestones that will be used to judge the success of the proposed research, as well as a credible development plan for the Phase II (R42/44) application. The FAST-TRACK must have a section labeled Milestones at the end of the Research Plan for Phase I R41/43. This section must include well-defined quantifiable milestones for completion of Phase I R41/43, a discussion of the suitability of the proposed milestones for assessing the success in Phase I R41/43, and a discussion of the implications of successful completion of these milestones on the proposed Phase II R42/R44. Applications submitted through the FAST-TRACK option are subject to the same direct costs limits per year as when submitted outside of the FAST-TRACK option: Phase I R41/43, not to exceed $100,000 per year total direct costs excluding subcontractor indirect costs; Phase II R42/44, no dollar limit. However, the total duration (Phase I plus Phase II applications) cannot exceed four years. In any case, the Phase I applications cannot exceed two years duration. B. INDIVIDUAL PHASE I APPLICATIONS. Phase I applications in response to this PA will be funded as Phase I SBIR Grants R43 or STTR Grants R41 with modifications as described below following the directions for Phase I SBIR/STTR applications as described in the NIH Omnibus Solicitation. The NIH Omnibus SBIR Solicitation is available on the Internet at: http://www.nih.gov/grants/funding/sbir1/SBIR.HTM. The NIH OMNIBUS STTR Solicitation is available at: http://www.nih.gov/grants/funding/sttr1/toc.htm A limited number of hard copies of the NIH Omnibus SBIR and STTR Solicitations are available from: PHS SBIR/STTR Solicitation Office 13685 Baltimore Avenue Laurel, MD 20707-5096 Telephone: 301-206-9385 FAX: (301) 206-9722 Email: a2y@cu.nih.gov Project Period and Amount of Award. 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 indirect costs). Page Limitations. The requirements for normal Phase I applications apply (see NIH OMNIBUS Solicitation). C. INDIVIDUAL PHASE II APPLICATIONS Phase II applications in response to this PA will be awarded as Phase II SBIR Grants R44 or STTR Grants R42 with modifications as described below. Phase II applications in response to this PA will only be accepted as competing continuations of previously funded NIH Phase I SBIR/STTR awards. The Phase II application must be a logical extension of the Phase I research. Applications for Phase II awards should be prepared following the instructions for NIH Phase II SBIR/STTR applications. The Phase II SBIR instructions and application may be found on the Internet at: http://www.nih.gov/grants/funding/sbir2/index.htm The Phase II STTR instructions and application may be found on the Internet at: http://www.nih.gov/grants/funding/sttr2/index.html Project Period and Amount of Award. Because the length of time and cost of research often exceeds that normally awarded for SBIR grants, NCI will entertain well-justified Phase II applications for this SBIR/STTR award with a project period up to three years with no budget limitation. Applications over $500,000. Although the Phase II application has no official budgetary limit, applications requesting in excess of $500,000 dollars direct costs in any single year of the grant period require prior approval before submission. Applicants who plan to submit a Phase II SBIR/STTR application requesting $500,000 or more in any year are advised that it is important that they contact program staff listed under INQUIRIES as they begin to develop plans. Applications requesting more than $500,000 received without prior staff contact may be delayed in the review process or returned to the applicant without review (NIH GUIDE, Volume 22, Number 45, December 17, 1993) BACKGROUND 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 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. To this end, the NCI has established the Cancer Genome Anatomy Project (CGAP), which will put in place the tools that will allow deciphering of the molecular anatomy of a cancer cell at the DNA, RNA and protein levels. The NCI has established the Tumor Gene Index, an index identifying genes that are expressed in normal, precancerous, and cancerous cells. This project is well under way and further information about the Index can be found at: http://www.ncbi.nlm.nih.gov//ncicgap/. The NCI has also begun a project to identify cancer chromosome aberrations (Cancer Chromosome Aberration Project, CCAP). The NCI has started the generation of a public repository of a standardized set of bacterial artificial chromosome (BAC) clones anchored across the whole human genome at 1 megabase intervals, for the identification of cancer chromosomes aberrations and reference points/landmarks clones for the integration of cancer chromosome aberrations and genomic data. Information on the repository will be released on CCAP homepage (http://www.ncbi.nlm.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 will 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 the 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 by 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 are therefore 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, include hardware and software, are specifically understood as being within the context of molecular analysis tools. They include specialized high resolution or microscopic imaging methods dedicated to detection and analysis of molecular events related to cancer formation or as applied to pre-clinical drug discovery. Improvements in these areas will bring capabilities for real time molecular analysis at whole body levels. 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 epidemiologic 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 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. --Assaying the function of proteins and genetic pathways, including measurement of ligand-protein complexes and technologies for monitoring protein function of all members of a class of proteins or 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". INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. 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. NIH POLICY AND GUIDELINES ON THE 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://www.nih.gov/grants/guide/notice-files/not98-024.html As part of the scientific and technical merit evaluation of the research plan, reviewers will be instructed to address the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion. LETTER OF INTENT Prospective applicants are asked to submit, by the dates listed at the beginning of this program announcement, 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 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 NCI staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Jay George at the address listed under INQUIRIES. APPLICATION PROCEDURES OMNIBUS SOLICITATIONS for both the SBIR and STTR programs are available electronically through the NIH, Office of Extramural Research mall Business Funding Opportunities web site at http://www.nih.gov/grants/funding/sbir.htm. Hard copies, subject to availability, may be obtained from the PHS SBIR/STTR Solicitation Office, phone (301) 206-9385; FAX (301) 206-9722; email a2y@cu.nih.gov. Helpful information for preparation of the application can be obtained: https://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf Applications are to be submitted on the grant application form PHS 6246-1 (1/99) (SBIR) and PHS 6246-3 (STTR) (3/99) located in the back pages of the OMNIBUS SOLICITATIONS, and will be accepted at the application deadlines as indicated on the first page of this document. THE TITLE AND NUMBER OF THIS PA MUST BE TYPED IN LINE 2 ON THE FACE PAGE OF THE APPLICATION. The OMNIBUS SOLICITATIONS give the normal levels of support and period of time for SBIR and STTR Phase I and II awards. However, these award levels are guidelines and not ceilings. Therefore, larger budgets with longer periods of time may be requested if required to complete the proposed research. As stated under MECHANISM OF SUPPORT section, Phase I applications submitted in response to this PA can have a project period of up to two years and a budget not to exceed $100,000 per year direct cost excluding subcontractor indirect costs. An annual meeting of all investigators funded through this program will be held to share progress and research insights that may further progress in the program. Applicants should request travel funds in their budgets for the principal investigator and one additional senior investigator to attend this annual meeting The second year of the Phase I budget should be included on the Budget Justification page, using categorical totals if costs deviate significantly from the first year of the budget, with narrative justifications for the increase(s). If the second year simply escalates due to cost of living factors, a statement to that effect with the escalation factor should be included rather than categorical totals. Phase II applications submitted in response to this PA have no budget limitations. The total duration (Phase I and Phase II application) cannot exceed four years. In order to apply for the FAST-TRACK option, applications for both Phase I and Phase II must be submitted together according to the instructions for FAST TRACK applications as described in the OMNIBUS SOLICITATIONS. The Phase I application must specify clear, well-defined quantifiable milestones that should be achieved prior to Phase II funding. Milestones should be located in a separate section at the end of the Research Plan of the Phase I and should be indicated in the Table of Contents. Failure to provide measurable milestones and sufficient detail may be sufficient reason for the peer review committee to exclude the Phase II application from FAST-TRACK review. If so, at a later date, the applicant may apply for Phase II support through normal application procedures. Such applications will be reviewed by a standard Study Section of the Center for Scientific Review or by a special review group convened in response to a re- issuance of this PAR, if applicable. An additional requirement of the FAST-TRACK mechanism is the Product Development Plan. The small business must submit a concise Product Development Plan (limited to five pages) as an Appendix to the Phase II application addressing the four areas described in the instructions for FAST-TRACK applications in the OMNIBUS SOLICITATIONS. In the event that an applicant feels that technology is too proprietary to disclose, applicants at a minimum should provide a demonstration (e.g., results) of the capabilities of the proposed technology. The completed original application and one legible copies must be sent or delivered 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 one additional copy of the application to: Ms. Toby Friedberg Referral Officer National Cancer Institute 6130 Executive Boulevard, Room 636a, MSC 7405 Bethesda, MS 20892-7405 Rockville, MD 20852 (for overnight/courier service) Telephone: (301) 496-3428 FAX: (301) 402-0275 Applications must be received by the receipt dates listed at the beginning of this program announcement. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the CSR for completeness and by the NCI program staff for responsiveness. Applications not adhering to application instructions described above and those applications that are incomplete or non-responsive as determined by CSR or by NCI program staff will be returned to the applicant without review. Applications that are complete and responsive to the PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the 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. Review criteria are described in the NIH Omnibus Solicitation and are as follows: 1. The soundness and technical merit of the proposed research. (Preliminary data are not required for Phase I proposals. 2. The qualifications of the proposed principal investigator, supporting staff, and consultants. 3. The scientific, technical, or technological innovation of the proposed research. 4. The potential of the proposed research for commercial application or societal impact. 5. The appropriateness of the budget requested. 6. The adequacy and suitability of the facilities and research environment. 7. Where applicable, the adequacy of assurances detailing the proposed means for safeguarding human or animal subjects and/or (b) protecting against or minimizing any adverse effect on the environment. For FAST-TRACK, Phase I application should specify clear, well defined quantifiable milestones that should be achieved prior to initiating Phase II. Failure to provide clear, measurable milestones may be sufficient reason for the study section to judge the application non-competitive. In addition to the standard review criteria as described in the NIH Omnibus Solicitation, the reviewers will comment on the six following aspects of the application in their written critiques 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 by the reviewers 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 a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a technology forward. Significance. Does this study address an important problem? 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? 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? Milestones. How appropriate are the proposed milestones against which to evaluate the demonstration of feasibility for transition to the Phase II development phase? 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? Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Environment. Does the scientific 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 evidence of institutional support? 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 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 as well as the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion (see section on NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS). AWARD CRITERIA Applications will compete for available funds with all other approved SBIR and STTR applications. Funding decisions for Phase I will be based on quality of the proposed project as determined by peer review, availability of funds, and program priority. Fast-Track Phase II applications may be funded following submission of the Phase I progress report and other documents necessary for continuation. Phase II applications will be selected for funding based on the initial priority score, NCI's assessment of the Phase I progress and determination that Phase I milestones were achieved, programmatic relevance, the project potential for commercial success, and the availability of funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Jay George Ph.D. Office of Technology and Industrial Relations National Cancer Institute 31 Center Drive, Room 11A03, MSC 2590 Bethesda, MD 20892-2590 Telephone: (301) 496-1550 FAX: (301) 496-7807 Email: jgeorge@mail.nih.gov Direct inquiries regarding fiscal matters to: Ms. Kathleen Shino National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, ext. 248 FAX: (301) 496-8601 Email: shinok@gab.nci.nih.gov Direct inquiries regarding review matters to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636 Bethesda, MD 20892-7150 Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: tf12w@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.394, Cancer Detection and Diagnosis Research. Awards are made under authorization of the Sections 301 and 405 of the Public Health Service Act, as amended (42 USC 241 and 284) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and part 92. This program is not subject to the intergovernmental review requirements of Exec The PHS strongly encourages all grant and contract recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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