EXPIRED
DEVELOPMENT OF NOVEL IMAGING TECHNOLOGIES: (SBIR/STTR) INITIATIVE Release date: April 27, 2000 PA NUMBER: PAR-00-090 National Cancer Institute National Center for Research Resources Letter of Intent Receipt Dates: June 14, 2000 and February 9, 2001 Application Receipt Dates: July 19, 2000 and March 16, 2001 PURPOSE The National Cancer Institute (NCI) invites applications on the development of novel image acquisition or enhancement methods, incorporating limited pilot or feasibility evaluations using either pre-clinical models or clinical studies. This initiative is intended to facilitate the development of novel imaging technologies for early detection, screening, diagnosis and image guided treatment of cancer and other diseases. The intent is to stimulate: (a) the development of highly innovative image acquisition and enhancement methods, including high risk/high gain research on technologies that exploit our knowledge of the molecular basis of cancer or other disease, and (b) the integration of these emerging technologies with traditional imaging methods for more effective solutions for health care delivery. The motivation for this Program Announcement (PA) is that current technologies for the molecular analysis of disease are largely restricted to in-vitro methods and need to be extended to the in-vivo situation. Furthermore, the use of molecular probes or tracers for imaging molecular events in pre-clinical or human investigations is considered essential for detection of molecular changes in-vivo. The development of innovative high- resolution imaging methods at the cellular or molecular scales is needed, with a particular emphasis on identification and characterization of either the early formation of disease processes or early molecular changes during intervention or therapy. 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 PA PAR-00-089 (see http://grants.nih.gov/grants/guide/pa-files/PAR-00-089.html). 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 NATIONAL INSTITUTES OF HEALTH, SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) GRANT APPLICATIONS (PHS 2000-2) http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf. SBIR Phase II Grant Application (PHS Form 6246-2) are available at http://grants.nih.gov/grants/funding/sbir2/index.htm. The Phase II STTR instructions and application may be found on the Internet at: http://grants.nih.gov/grants/funding/sttr2/index.html All of the instructions within the OMNIBUS SOLICITATIONS apply with the following exceptions: o Special receipt dates o Additional review considerations o Opportunity for 2 years of Phase I support 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, Development of Novel Imaging Technologies (SBIR/STTR) Initiative, is related to the priority area of cancer and several other priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. 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 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 stated in the NIH Grants Policy Statement, NIH publication 99-8 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://grants.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 plan to apply the selected technology in a pilot study of biological interest to cancer research for the Phase II R42/44 application. The FAST-TRACK must have a section labeled Milestones at the end of the Research Plan 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 total cost 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 normally not to exceed $500,000 total costs per year for R42 and $750,000 total costs per year for R44. However, the total duration (Phase I plus Phase II applications) cannot exceed four years. In any case, the Phase I application 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. Applications for Phase I grants should be prepared following the directions for Phase I SBIR/STTR applications as described in the NIH Omnibus Solicitation. The NIH Omnibus SBIR/STTR Solicitation is available on the Internet at http://grants.nih.gov/grants/funding/sbirsttr1/index.htm A limited number of hard copies of the NIH Omnibus SBIR and STTR Solicitation are available from: PHS SBIR/STTR Solicitation Office 13685 Baltimore Avenue Laurel, MD 20707-5096 Telephone: (301) 206-9385 FAX: (301) 206-9722 Email: [email protected] 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 and NCRR 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://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/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 and NCRR will entertain well-justified Phase II applications for this SBIR/STTR award with a project period up to three years with budget levels appropriate for the work proposed. Potential applicants who believe that they may be eligible for the SBIR/STTR award should consult the PHS SBIR and STTR Omnibus Solicitation prior to discussions of their eligibility with NCI and NCRR staff listed under INQUIRIES. BACKGROUND Significant advances in medical imaging technologies have been made over the last 25 years in such areas as magnetic resonance imaging (MRI), computed tomography (CT), nuclear medicine and ultrasound. However, these advances largely focused on structural or anatomic imaging at the organ or tissue level. There is clearly a need and opportunity now to stimulate the development and integration of novel imaging technologies that exploit our current knowledge of the genetic and molecular bases of cancer and other diseases and conditions. Those molecular biological discoveries have great implications for prevention, detection and targeted therapy of cancer and other diseases. Imaging technologies that can provide in vivo the same kind of cellular and molecular information that is currently available only from in vitro techniques would be very useful. This is commonly referred to as in vivo molecular imaging. Participants at several NCI-supported forums over the last few years [Imaging Sciences Working Group (ISWG) July 1997; Lung Imaging Workshop: Technology Transfer, Jan 1997; Computer Aided Diagnosis and 3D Image Analysis, Oct 1998; Quantitative In-Vivo Functional Imaging in Oncology, Jan 1999; Focus Group on Magnetic Resonance Spectroscopy (MRS) in Clinical Oncology, April 1999; and NIH BECON Symposium, June 1999] stressed the need for NCI to support bioengineering and technology development by academia and industry. The needs are to (a) promote the development of very novel (high risk, high gain) technologies, including continued support for their maturation and full exploitation, (b) promote system integration of technologies for targeted applications, and (c) improve technology transfer by promoting partnerships between academia and industry. Development of novel imaging technologies will require a multidisciplinary team approach with broad expertise in a variety of research areas. Such varied expertise, potentially including but not limited to, expertise in imaging physics, molecular and cellular biology, 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 imaging methods is considered to be a high priority. RESEARCH OBJECTIVES The intent of this PA is to stimulate: (a) the development of highly innovative image acquisition and enhancement methods, including high risk/ high gain projects that exploit our expanding knowledge of the molecular basis of cancer and other diseases, and (b) the integration of these emerging technologies with traditional imaging modalities for more effective solutions for cancer and other diseases. In particular, the development of innovative high-resolution imaging methods at the cellular or molecular scales is needed, with emphasis on identification and characterization of either the early formation of disease or early molecular changes during intervention or therapy. For many technologies that have potential for molecular imaging, the use of probes or tracers is considered essential for detection of molecular changes in-vivo. The following clinical applications are appropriate for inclusion in proposed projects: *Imaging to detect early changes. The development of innovative high-resolution imaging methods at the cellular or molecular scales is encouraged, with a particular intent to identify and characterize pre-malignant abnormalities or other early changes. Novel solutions for in-vivo microscopic imaging sensors, or microscopic implanted devices with high spatial, contrast and temporal resolution are encouraged. Similarly the use of contrast enhancement methods and imaging probes is also encouraged. The imaging methodologies proposed should emphasize analysis of molecular events on the path to disease. *Large scale screening applications for cancer and other diseases. Development and optimization of efficient low-cost imaging systems for rapid and automated large-scale screening with the intent of achieving significantly higher sensitivity and specificity for cancer and other disease detection are encouraged. Applications could address significant innovative improvements to current imaging methods or new emerging imaging sensors. Research topics of interest include, but are not limited to, technologies for molecular imaging, means to significantly reduce imaging time or motion effects, use of novel contrast agents or imaging probes, and use of technologies that do not involve ionization radiation. System integration could include a variety of image processing techniques including temporal analysis of serial studies, close to real-time image processing, novel image display methods, and related imaging informatics and information reduction methods for more cost-effective solutions for screening. *Imaging for diagnosis, staging, or monitoring the effects of therapy. This initiative encourages the development of novel imaging methods such as functional or molecular imaging or spectroscopy methods that would significantly improve the specificity of diagnosis of cancer and other diseases, allow deterministic methods or patient-specific staging, or measure early effects of therapy. Examples of system integration would include image fusion or registration from the different modalities employed, development of software methods that would estimate the probability of malignancy or other specific disease identification, quantitative information for monitoring the effects of therapy, and close to real-time image analysis. *Image guided biopsy (IGB) and therapy (IGT). Novel approaches using imaging technologies are needed to significantly improve specificity, to identify lesion extent and microscopic involvement, and to minimize the tissue damage accompanying biopsy and therapy. Of particular interest are innovative approaches to IGB or IGT that include novel imaging sensors that provide information at the cellular or molecular level. Examples of system integration that are of interest include, but are not limited to, navigational systems, registration methods for several imaging modalities, real-time feedback mechanisms for controlling therapy or the use of methods that are adaptive or allow patient-specific optimization of treatment. Partnerships of appropriate medical institutions with medical device manufacturers to facilitate the integration of system components are encouraged. 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, available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html 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. LETTER OF INTENT Prospective applicants are asked to submit, by the date listed at the beginning of this PA, a letter of intent that includes a descriptive title of the proposed research, the name, address, telephone number, and e-mail address 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 NCI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. Barbara Croft at the address listed under INQUIRIES. APPLICATION PROCEDURES The OMNIBUS SOLICITATION for the SBIR and STTR programs is available electronically through the NIH, Office of Extramural Research Small Business Funding Opportunities web site at http://grants.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 [email protected]. Helpful information for preparation of the application can be obtained: http://grants.nih.gov/grants/funding/sbir.htm Applications are to be submitted on the grant application form PHS 6246-1 (1/98) (SBIR) and PHS 6246-3 (STTR) (1/98) 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. 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 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. 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. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-004.html). The completed original application and one legible copy 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 6116 Executive Boulevard, Room 8062, MSC 8239 Bethesda, MD 20892-8239 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 PA REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the CSR for completeness and by NCI program staff for adherence to the guidelines of this PA. 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) and/or the National Advisory Research Resources Council (NARRC). Review Criteria: Review criteria are described in the NIH Omnibus Solicitation and available on the web at the following URL address: http://grants.nih.gov/grants/funding/sbirsttr1/index.htm The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the 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. 1. 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 for the targeted disease? 2. Approach. Are the conceptual framework, design, and methods 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 community's needs? How easy will it be to use the proposed technology? Are the plans for the proposed technology, its integration as an effective solution for implementation and dissemination adequate? If partnerships are proposed, how will they facilitate the development and integration of system components? 3. Milestones. How appropriate are the proposed milestones against which to evaluate the demonstration of feasibility for transition to the Phase II application? 4. Innovation. Does the project employ novel concepts, approaches or methods? 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 work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 6. 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? Additional Considerations In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project(s) proposed in the application. AWARD CRITERIA Applications will compete for available funds with all other recommended 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 and NCRR '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: Barbara Y. Croft, Ph.D. Biomedical Imaging Program National Cancer Institute 6130 Executive Plaza, Suite 800 Bethesda, MD 20892-2590 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-9531 FAX: (301) 480-5785 Email: [email protected] Abraham Levy, Ph.D. Biomedical Technology National Center for Research Resources 6705 Rockledge Drive, Room 6150 Bethesda, MD 20892-7965 Telephone: (301) 435-0755 FAX: (301)480-3659 Email: [email protected] Direct inquiries regarding fiscal matters to: Ms. Kathleen Shino Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 243 6120 Executive Boulevard Bethesda, MD 20892-7150 Telephone: (301) 496-8635 FAX: (301) 496-8601 Email: [email protected] Ms. Irene Haas Grissom Grants Management Analyst Office of Grants Management National Center for Research Resources, NIH 6705 Rockledge Drive, Room 2086 Bethesda, Maryland 20892-7965 Phone: 301-435-0848 Fax: 301-480-3777 Email: [email protected] Direct inquiries regarding review matters to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8062 Bethesda, MD 20892-7399 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No.93.394, Cancer Detection and Diagnosis Research (NCI) and No.93.371, Biomedical Technology (NCRR). 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 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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