PA-04-094: NOVEL TECHNOLOGIES FOR IN VIVO IMAGING (SBIR/STTR)

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NOVEL TECHNOLOGIES FOR IN VIVO IMAGING (SBIR/STTR) RELEASE DATE: April 19, 2004 PA NUMBER: PA-04-094 (This PA has been reissued, see PA-06-045 and PA-06-046) (Expiration date extended, see NOT-CA-05-026) EXPIRATION DATE: November 3, 2005 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Cancer Institute (NCI) (http://www.nci.nih.gov/) National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: NCI: 93.394, 93.395, 93.396; NIEHS: 93.113, 93.114, 93.115; NIDDK: 93.847, 93.848, 93.849; NINDS: 93.853 APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadline (April 1, August 1, December 1) This Program Announcement (PA) replaces PAR-03-125, which was published in the NIH Guide on May 19, 2003. THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanisms of Support o Project Period and Amount of Award o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Receipt and Review Schedule o Required Federal Citations NOTICE: This program announcement (PA) 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 [PDF] or http://grants.nih.gov/grants/funding/sbirsttr1/index.doc [MS Word] contains information about the SBIR and STTR programs, regulations governing the programs, and instructional information for submission. All of the instructions within the current SBIR/STTR Omnibus Solicitation apply. PURPOSE OF THE PA The National Cancer Institute (NCI), the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the National Institute of Neurological Disorders and Stroke (NINDS) invite applications for the development and delivery of novel in vivo image acquisition or enhancement technologies and methods for biomedical imaging and image-guided interventions and therapy. Applications may incorporate limited pilot or clinical feasibility evaluations using either pre-clinical models or clinical studies. This initiative is primarily intended to facilitate the proof-of-feasibility, development, and delivery of novel imaging technologies for early detection, screening, diagnosis, image-guided interventions and treatments of various diseases, and, secondarily, to facilitate limited evaluation studies to show proof-of-concept and functionality. The interests of NCI focus on imaging in vivo for cancer pre-conditions, cancer screening, diagnosis, progression, treatment monitoring, recurrence, and image- based surrogate end points. NCI’s interests include development and delivery of imaging technologies that are cancer specific, and optimization and validation of imaging technologies for cancer applications. The scope includes system integration, contrast agents, pre- and post-processing algorithms and software for imaging, image understanding, and related informatics that are cancer specific. The interests of NIEHS focus on detection of intracellular events including gene expression and signal transduction pathway alterations, screening or diagnosis of tissue and organ toxicities related to exposures to environmental agents. These areas of interest include initiation of toxicity or exacerbation of disease or dysfunction resulting from toxic exposure, treatment, and recovery. The interests of NIDDK focus on diabetes, digestive, and kidney diseases. The interests of NINDS focus on development and delivery of neuroimaging technologies that can be applied to diagnosis and treatment of neurological disorders. This PA is directed toward the development, optimization, and delivery of innovative image acquisition and enhancement methods, including high risk/high gain research on technologies such as: (a) novel single and multi-modality molecular imaging systems, methods, agents, and related software and informatics, including the integration of these technologies with emerging biomedical imaging methods for more effective health care delivery for cancer and other diseases and (b) novel single and multimodality anatomical and functional imaging systems, methods, agents, and related software and informatics for more effective health care delivery for cancer and other diseases. In addition, research partnerships among investigators in both academia and device and drug industries are encouraged to more rapidly translate and deliver completed imaging system developments. This PA will utilize the Small Business Innovation Research and Small Business Technology Transfer Mechanisms but will be run in parallel with a NCI program announcement of nearly identical scope PA-04-095 (http://grants.nih.gov/grants/guide/pa-files/PA-04-095.html) that utilizes the Phased Innovation Award (R21/33) and the R33 mechanisms for exploratory/developmental studies and which is open to a broad range of organizations. Fast Track applications are encouraged in this solicitation because they benefit from expedited evaluation of progress following Phase I exploratory/feasibility work for immediate decision on transition to Phase II funding for expanded developmental work. RESEARCH OBJECTIVES The overarching Research Objectives of this PA are to stimulate development, optimization, and delivery of novel imaging technologies and methods to capture, process, validate, present, interpret, or understand in vivo imaging data that support the missions of the NCI, NIEHS, NIDDK, and/or NINDS. Significant advances in medical imaging technologies have been made over the past 25 years in such areas as magnetic resonance imaging (MRI), computed tomography (CT), nuclear medicine, ultrasound, and optical imaging. These advances largely focused on structural or anatomical imaging at the organ or tissue level. Now there is an opportunity to stimulate the development and integration of novel imaging technologies that exploit our current knowledge of the genetic and molecular bases of various diseases. Molecular biological discoveries have great implications for prevention, detection, and targeted therapy. Imaging technologies able to provide similar kinds of cellular and molecular information (i.e. in vivo molecular imaging) similar to that currently available from histological or micro-array techniques use for in vitro studies would be very useful. The advances in molecular methods pose new requirements for the performance of conventional biomedical imaging systems. For example, molecular imaging systems may need to be optimized for a molecular probe (or probes) as well as for anatomical imaging. The integration of molecular imaging methods into multi- modality systems will affect data acquisition, processing, reduction, display, and archiving. Therefore, there is a need to support advances in methods for both molecular and conventional anatomical and functional imaging. The need to encourage and support biomedical imaging and imaging technology development by academic and industrial researchers was stressed by participants at several NIH- and NCI-supported forums over the past 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; NIH BECON Symposium, June 1999; Dynamic Contrast Enhancement Magnetic Resonance Imaging Workshop, Rockville, Maryland, November 2000; and NCI/ISMRM Workshop on Higher Field MR (1.5 T & Up) in Oncology: Strategic Frontiers in Cancer Diagnosis and Treatment, Glasgow, Scotland, April 2001]. The needs include: (a) promoting the development of novel, high-risk, high-gain technologies; (b) supporting these technologies to maturation, dissemination, and full exploitation; (c) integrating new technologies into commercially available imaging systems for targeted applications; (d) harmonizing imaging methods across versions of a single platform or across multiple platforms to permit the image-based surrogate outcome metrics of the kind required for multi-site pre- clinical and clinical investigations; (e) funding a small number of copies of integrated system prototypes for placement, as required, for off-site research and clinical feasibility studies; and (f) improving technology transfer, delivery, and dissemination by promoting early-stage partnerships between academia and industry to encourage sharing of research resources, including data sharing and validation studies necessary to meet Federal regulatory requirements. Therefore, the aims of this initiative and the support mechanism (SBIR/STTR, especially Fast Track applications) are also directed at encouraging the development and delivery of imaging "tools" to support biomedical imaging in general for applications in oncology and other diseases. Developments of novel imaging technologies usually require multidisciplinary approaches and teams with broad expertise in a variety of research areas. Such varied expertise might include imaging physics, chemistry, molecular and cellular biology, signal and image processing, computer vision, informatics and biostatistics, and clinical sciences. The coordination and collaboration of investigators with the necessary variety of disciplines to demonstrate the utility and applicability of new imaging methods is encouraged. The purpose of this initiative is to facilitate the development of novel imaging technologies for risk assessment, early detection, screening, diagnosis, or image-guided treatment of cancer and other diseases and to facilitate clinical evaluation and optimization studies that are specifically limited to proof-of- concept and pilot data on clinical functionality of the development. Clinical trials for clinical validation of emerging imaging technologies are beyond the scope and not responsive to this PA. Studies with pre-clinical models and clinical studies to demonstrate the feasibility of developments are encouraged, including multi-site evaluations, where appropriate. Methods that establish "ground truth" are required at appropriate levels of resolution to validate these emerging imaging methods, e.g., imaging excised tissue using protocols similar to those used in vivo, or correlation of molecular imaging results with micro-array library analyses. Developments of molecular probes or targeted contrast agents are considered important approaches to detection of molecular changes in vivo to take better advantage of many technologies with potential for molecular imaging. The following topics would make appropriate proposed projects. This list is not meant to be all-inclusive. o Early Disease Detection: Developments may address innovative high-resolution imaging methods, with a particular intent to identify and characterize abnormalities or other early changes, including molecular events on the path to disease. Novel solutions for in vivo microscopic imaging systems, or microscopic implanted devices with high spatial and/or temporal resolution that may use either intrinsic or exogenous contrast agents represent possible topics. o Disease Screening: These methods may include, but are not limited to development and optimization of efficient imaging systems for screening, with the intent of achieving improved sensitivity and specificity for disease detection. Applications could address innovative improvements to current imaging methods, including hardware and/or software upgrades, or emerging imaging sensors and methods. Research topics of interest include means to significantly reduce imaging time or effects of motion, use of novel contrast agents or imaging probes, and use of technologies that reduce or do not involve the use of ionizing radiation or novel contrast agents and imaging probes. System integration and software methods could include a variety of image processing and data reduction techniques including temporal analysis of serial studies, close to real-time image processing, novel image display methods, and related imaging informatics for more cost-effective solutions for screening. o Imaging for Diagnosis, Staging, or Monitoring the Effects of Therapy: This initiative encourages, but is not limited to, 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: multi- modality imaging; image fusion or registration of 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. o Image Guided Biopsy (IGB), Image-Guided Therapy (IGT), and Image-Guided Interventional (IGI) Procedures: This initiative encourages novel approaches using imaging technologies needed to significantly improve specificity, to identify lesion extent and microscopic involvement, and to minimize tissue damage accompanying biopsy and therapy. Of particular interest are innovative approaches to IGB, IGT, or interventional methods that include novel imaging systems that provide molecular target information or information at the cellular or molecular level sufficient for image guidance and treatment. Examples of system integration that are of interest include, but are not limited to, multi- modality imaging, navigational systems, registration methods, real-time feedback mechanisms for controlling therapy (including radiation therapy) or the use of methods that are adaptive or allow patient-specific optimization of treatment, and computer-assisted surgery. o Copies of Prototype Imaging Systems: Support may be requested to make one or more copies of the prototype for placement in collaborating facilities for research purposes, namely pre-clinical or clinical feasibility investigations, including harmonization across versions of a single platform or across multiple platforms to enable multi-center comparison studies. Collaboration with NCI funded centers may be possible, such as the NCI Network for Translational Research in Optical Imaging, http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-03-002.html, or the Lung Image Database Consortium, http://www3.cancer.gov/bip/steercom.htm. Investigators anticipating need for funds to build system copies, harmonize imaging methods, or collaborate with NCI funded centers are advised to contact the NIH program staff listed in the section of this document that is entitled Where to Send Inquiries. o Research Resources: Developments of publicly accessible research resources that facilitate a consensus process for optimization and validation of emerging imaging technologies are encouraged. Examples include the development of open source software, image processing software and related informatics that can be ported onto different platforms, methods and image databases required for validation of software performance, and other hardware or informatics methods that assist in more efficient delivery of imaging technologies for screening, diagnosis and treatment for cancer and other diseases. Investigators interested in development of research resources and related research are advised to contact NIH program staff. MECHANISMS OF SUPPORT This PA 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. This PA 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 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_2003/NIHGPS_Part2.htm#matching_or_cost_sharing. 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. 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 but not necessarily a Phase I project supported in response to this PA. PROJECT PERIOD AND AMOUNT OF AWARD: The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines on levels of funding support and periods of project duration for SBIR and STTR Phase I and Phase II awards. For this PA, budgets up to $1M total costs per year and time periods up to 3 years for Phase II Competing Continuations for NCI and NINDS grantees may be requested. For Phase I-Phase II Fast Track applications, the total duration of support cannot exceed 5 years. Total costs include direct costs, F&A, and a profit/fee. ELIGIBLE INSTITUTIONS Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation. Only small business concerns are eligible to submit 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 SBIR/STTR Omnibus Solicitation. A parallel NCI program announcement, PA-04-095 (http://grants.nih.gov/grants/guide/pa-files/PA-04-095.html), is available for institutions ineligible for small business grants. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS 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 percent) 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. WHERE TO SEND INQUIRIES We encourage inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues. o Direct your questions about scientific/research issues: For NCI Guoying Liu, Ph.D., Keyvan Farahani, Ph.D., James A. Deye, Ph.D., or Houston Baker, Ph.D. National Cancer Institute 6130 Executive Plaza, Suite 6000 Bethesda, MD 20892-7412 Rockville, MD 20852 (for express/courier service) Telephone: 301-496-9531 for GL, KF, or HB; 301-496-6111 for JAD Fax: 301-480-3507 Email: guoyingl@mail.nih.gov farahank@mail.nih.gov deyej@mail.nih.gov. bakerhou@mail.nih.gov For NIEHS Jerrold (Jerry) J. Heindel, Ph.D. Organs and Systems Toxicology Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 (for express/courier service: 79 T.W. Alexander Drive, 4401 Research Commons, 3rd Floor) Research Triangle Park, NC 27709 Telephone: 919-541-0781 Fax: 919-541-5064 Email: heindelj@niehs.nih.gov For NINDS Daofen Chen, Ph.D. National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard Bethesda, MD 20892-9523 Rockville, MD 20852 (courier service only) Telephone: (301) 496-1917 Fax: (301) 402-1501 Email: daofen.chen@nih.gov For NIDDK Sanford A. Garfield, Ph.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK/DDDN) 6707 Democracy Blvd, Room 685 Bethesda MD 20892-5450 Rockville, MD 20852 (for express/courier service) Telephone: 301-594-8803 Fax: 301-420-6271 E-mail: garfields@ep.niddk.nih.gov o Direct your questions about financial or grants management matters to: Ted Williams Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, EPS Room 243 Bethesda MD 20892 Rockville MD 20852 (for express/courier service) Telephone: 301-496-8785 Fax: 301-496-8601 Email: tw133b@nih.gov SUBMITTING AN APPLICATION 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 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. The NIH will return applications that are not submitted on the 5/2001 version of the PHS 398. For further assistance, contact GrantsInfo; Telephone: (301) 710-0267; Email: GrantsInfo@nih.gov. The title and number of this PA must be typed on line 2 of the face page of the application. SUPPLEMENTARY INSTRUCTIONS o For Phase II, if a copy or copies of a prototype will be needed for placement in one or more sites for pre-clinical or clinical testing, include a clear written justification for the funds requested in the Budget Justification Section, and make written reference to this instruction. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda MD 20892-7710 Bethesda MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described on the first page of this program announcement. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an unfunded version application already reviewed, but such application must include an Introduction addressing the previous critique. 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. PEER REVIEW PROCESS Applications submitted for this PA that are complete will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a process in which 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 second level review by the appropriate national advisory council or board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following criteria in evaluating the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigators o Environment ALL SBIR/STTR APPLICATIONS 1. Significance: Does the proposed project have commercial potential to lead to a marketable product or process? Does this study address an important problem? What may be the anticipated commercial and societal benefits of the proposed activity? If the aims of the application are achieved, how will scientific knowledge be advanced? 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 procedures appropriate? 3. Innovation: Does the project challenge existing paradigms or employ novel technologies, approaches or methodologies? Are the aims original and innovative? 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 for the work proposed? 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 applied to ALL applications in the determination of scientific merit and the priority score: 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 additional information and criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See additional information and Inclusion Criteria in the sections on Federal Citations, below). Human Subjects: 1. Protection of Human Subjects from Research Risks - for all studies involving human subjects. See instructions and "Guidance for Preparing the Human Subjects Research Section. If an exemption is claimed, is it appropriate for the work proposed? If no exemption is claimed, are the applicant's responses to the six required points appropriate? Are human subjects placed at risk by the proposed study? If so, are the risks reasonable in relation to the anticipated benefits to the subjects and others? Are the risks reasonable in relation to the importance of the knowledge that reasonably may be expected to be gained? Are the plans proposed for the protection of human subjects adequate? 2. Inclusion of Women Plan - for clinical research only. Does the applicant propose a plan for the inclusion of both genders that will provide their appropriate representation? Does the applicant provide appropriate justification when representation is limited or absent? Does the applicant propose appropriate and acceptable plans for recruitment/outreach and retention of study participants? 3. Inclusion of Minorities Plan - for clinical research only. Does the applicant propose a plan for the inclusion of minorities that will provide their appropriate representation? Does the applicant provide appropriate justification when representation is limited or absent? Does the applicant propose appropriate and acceptable plans for recruitment/outreach and retention of study participants? 4. Inclusion of Children Plan- for all studies involving human subjects. Does the applicant describe an acceptable plan in which the representation of children of all ages (under the age of 21) is scientifically appropriate and recruitment/retention is addressed realistically? If not, does the applicant provide an appropriate justification for their exclusion? 5. Data and Safety Monitoring Plan for clinical trials only. Does the applicant describe a Data and Safety Monitoring Plan that defines the general structure of the monitoring entity and mechanisms for reporting Adverse Events to the NIH and the IRB? CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the required five items described under Vertebrate Animals (section f of the Research Plan instructions) will be assessed. BIOHAZARDS: Is the use of materials or procedures that are potentially hazardous to research personnel and/or the environment proposed? Is the proposed protection adequate? ADDITIONAL REVIEW CONSIDERATIONS: The following items may be considered by reviewers but will not be included in the determination of scientific merit. SHARING RESEARCH DATA: Applicants requesting $500,000 or more in direct costs in any year of the proposed research must include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research may be considered. For all applications, is the percent effort listed for the PI appropriate for the work proposed? On applications requesting up to $100,000 total costs, is the overall budget realistic and justified in terms of the aims and methods proposed? On applications requesting over $100,000 in total costs, is each budget category realistic and justified in terms of the aims and methods? PERIOD OF SUPPORT: The appropriateness of the requested period of support in relation to the proposed research. PHASE II APPLICATIONS In addition to the above review criteria; 1. How well does the application demonstrate progress toward meeting the Phase I objectives, demonstrate feasibility and provide a solid foundation for the proposed Phase II activity? 2. Did the applicant submit a concise Commercialization Plan that adequately addresses the seven areas described in the Research Plan item J? 3. Does the project carry a high degree of commercial potential, as described in the Commercialization Plan? AMENDED APPLICATIONS In addition to the above criteria, the following criteria will be applied to revised applications. 1. Are the responses to comments from the previous SRG review adequate? 2. Are the improvements in the revised applications appropriate? PHASE I/PHASE II FAST TRACK REVIEW CRITERIA For Phase I/Phase II Fast Track applications, the following additional criteria will be applied: 1. Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II? 2. Did the applicant submit a concise Commercialization Plan that adequately addresses the seven areas described in the Research Plan, item J? 3. To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non- SBIR/ STTR funding sources that would enhance the likelihood for commercialization? 4. Does the project carry a high degree of commercial potential, as described in the Commercialization Plan? Phase I and Phase II Fast-Track applications that satisfy all of the review criteria will receive a single rating. Failure to provide clear, measurable goals may be sufficient reason for the scientific review group to exclude the Phase II application from Fast-Track review. TYPE 2 PHASE II COMPETING CONTINUATION APPLICATIONS In addition to the above criteria, the following items will be applied to ALL Type 2 Competing Continuation Phase II Applications in the determination of scientific merit and the priority score: o Does the proposed activity address issues related to Federal regulatory approval processes? o How well does the application demonstrate progress toward meeting the Phase II objectives and provide a solid foundation for the proposed Phase II competitive continuation work? o What will be the effect of these studies on the concepts, systems or methods that drive this field? AWARD CRITERIA Applications submitted in response to this PA will compete with all other recommended SBIR and STTR applications for available Small Business set aside funds. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review; o Availability of funds; and o Relevance to program priorities. For FAST-Track applications, the Phase II portion may not be funded until a Phase I final report and other documents necessary for continuation have been received and assessed by program staff that the Phase I milestones have been successfully achieved. RECEIPT AND REVIEW SCHEDULE See http://grants.nih.gov/grants/funding/sbirsttr_receipt_dates.htm. REQUIRED FEDERAL CITATIONS ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable. HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge to be gained. See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); and efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (See the NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-084.html.) SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing (http://grants.nih.gov/grants/policy/data_sharing) or state why this is not possible. Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html ); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 scientific and ethical reasons not to include them. 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A continuing education program in the protection of human participants in research is available online at http://cme.nci.nih.gov/. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law, i.e., a regulation, may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PAR is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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