DEVELOPMENT OF NOVEL TECHNOLOGIES FOR IN VIVO IMAGING (SBIR/STTR) Release Date: May 29, 2001 (see replacement PAR-03-125) PA NUMBER: PAR-01-102 National Cancer Institute National Institute of Environmental Health Sciences Letter of Intent Receipt Dates: June 11, 2001, February 11, 2002 and June 11, 2002. Application Receipt Dates: July 16, 2001, March 18, 2002, and July 16, 2002. This PAR is a reissue of PAR-00-090, which was published in the NIH Guide on April 27, 2000. PURPOSE The National Cancer Institute (NCI) and the National Institute of Environmental Health Sciences (NIEHS) invite applications for the development of novel image acquisition or enhancement methods, and which may incorporate limited pilot or clinical feasibility evaluations using either pre-clinical models or clinical studies. This initiative is intended to facilitate the proof of feasibility and development of novel imaging technologies for early detection, screening, diagnosis or image guided treatment of cancer (NCI) and environmentally induced diseases (NIEHS), and to facilitate clinical evaluation studies of the development that are specifically limited to proof of concept. The National Institute of Biomedical Imaging and Bioengineering (NIBIB) may accept assignments of grant applications that address development of novel imaging technologies that are not organ or disease specific. Specific emphasis of this PAR is directed at (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 and environmentally induced diseases, and (b) the development of other novel imaging methods and the integration of these technologies with emerging molecular imaging methods, where appropriate, for more effective 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, developments of molecular probes or tracers for imaging molecular events in pre-clinical and clinical investigations are essential for detection of molecular changes in vivo. Developments of innovative, high-resolution imaging methods at the cellular or molecular scales are needed, with particular emphasis on identification and characterization of processes in the early formation of disease or early molecular changes during intervention or therapy. Integrations of these emerging molecular imaging methods with advances in traditional imaging methods are also required for more effective in vivo investigations of environmentally induced disease and cancer. This PA (Development of Novel Technologies for in vivo Imaging (SBIR/STTR)) will utilize the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) mechanisms that are designed to encourage technology development by eligible small businesses. This PA must be read in conjunction with the current Omnibus Solicitation of the National Institutes of Health, Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Applications (http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf). An SBIR and STTR application responding to this PA may be submitted as a Phase I, Phase II or “Fast Track” pair of Phase I and Phase II applications. The Fast Track applications will benefit from expedited evaluation of progress following the Phase I feasibility study for transition to Phase II funding for expanded developmental work. Applications will undergo expedited review, and will be subject to cost and duration guidelines that are expanded over those stated in the Omnibus Solicitation of the National Institutes of Health, Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Applications (PHS 2001-2). All of the instructions in the current PHS Omnibus Solicitation for SBIR/STTR Grant Applications apply, except for the following: o Special receipt dates (see above); o Review by an NCI special study section; o Up to 2 years of Phase I feasibility study support, up to 3 years of Phase II developmental study support; but a 4 year limit of support for both Phase I and II, whether submitted separately or together as a Fast Track; o Additional review criteria.. There is a parallel NCI program announcement of identical technical and scientific scope that utilizes a new Phased Innovation Award mechanism (R21/R33) that is intended primarily for applicants other than small businesses, originally issued as PAR-00-089 (see http://grants.nih.gov/grants/guide/pa-files/PAR-00-089.html), and which is being reissued concurrently with this PA as PAR-01-101 (see http://grants.nih.gov/grants/guide/pa-files/PAR-01-101.html). BACKGROUND 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 and ultrasound. However, these advances largely focused on structural or anatomical imaging at the organ or tissue level. Now there is a clear need and opportunity to stimulate the development and integration of novel imaging technologies that exploit our current knowledge of the genetic and molecular bases of environmentally induced disease and cancer. Molecular biological discoveries have great implications for prevention, detection, and targeted therapy. Imaging technologies that can provide similar kinds of cellular and molecular information in vivo that are currently available only from techniques in vitro would be very useful. This is commonly known as in vivo molecular imaging. The need for NCI to encourage and support bioengineering and 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; and NIH BECON Symposium, June 1999]. The needs are to (a) promote the development of novel, high risk, high gain technologies, including continued support for their maturation and full exploitation, (b) promote system integration of technologies for targeted applications, including the development of a system prototype and small number of copies, as required, for research and clinical feasibility studies, and (c) improve technology transfer by promoting partnerships between academia and industry. The NIEHS has reached similar conclusions, which motivated their joining in this PA. Developments of novel imaging technologies usually will require multidisciplinary approaches to provide teams with broad expertise in a variety of research areas. Such varied expertise might include imaging physics, engineering, chemistry, molecular and cellular biology, informatics and biostatistics. The coordination and collaboration of investigators with the necessary variety of disciplines to demonstrate the utility and applicability of new imaging methods is encouraged. RESEARCH OBJECTIVES This initiative is primarily intended to facilitate the development of novel imaging technologies for early detection, screening, diagnosis or image guided treatment of cancer and environmentally induced disease, and to facilitate clinical evaluation studies of the development that are specifically limited to proof of concept. Specific emphasis of this PAR is directed at (a) developments 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 and environmentally induced disease, and (b) developments of other novel imaging methods and their integration with emerging molecular imaging methods, where appropriate, for more effective health care delivery. In particular, developments of innovative, high-resolution imaging methods at the cellular or molecular scales are needed for both pre-clinical models and clinical studies, with emphasis on identification and characterization of either the early formation of disease or early molecular changes during intervention or therapy. Methods that establish “ground truth” are required at appropriate levels of resolution to validate these emerging imaging methods. They may include the imaging of excised tissue using protocols similar to those used for imaging in vivo. Developments of probes or tracers are considered essential for detection of molecular changes in vivo to take better advantage of many technologies with potential for molecular imaging. The following objectives would make appropriate topics for proposed projects. This list is not meant to be all-inclusive. o Imaging to detect early changes. Developments of innovative high- resolution imaging methods at the cellular or molecular scales are encouraged, with a particular intent to identify and characterize pre- malignant abnormalities or early changes preceding the development of other diseases. Novel solutions for in vivo microscopic imaging systems, or microscopic implanted devices with high spatial, contrast and temporal resolution are encouraged. Similarly, developments of contrast enhancement methods and imaging probes are also encouraged. Proposed imaging methodologies that emphasize analysis of molecular events on the path to disease are encouraged. o Large scale screening applications for cancer and environmentally induced disease. 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 disease detection are encouraged. Applications could address significant innovative improvements to current imaging methods or new emerging imaging systems. 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 ionizing 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. o 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 environmentally induced disease, 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. o Image guided biopsy (IGB), therapy (IGT), and interventional procedures. 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, IGT or interventional methods that include novel imaging systems 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 and computer-assisted surgery MECHANISMS OF SUPPORT The following are points to note about the mechanism of support and its implementation: o Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. o Awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement, March 2001, available at http://grants.nih.gov/archive/grants/policy/nihgps_2001/index.htm. Hard copies are not available. Support for this program will be through the National Institutes of Health (NIH) SBIR/STTR grant program described in the “Omnibus Solicitation of the National Institutes of Health for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Applications” (http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf) o The total project period for an application submitted in response to this PA may not exceed the following durations: Phase I SBIR R43 or STTR R41, 2 years; Phase II SBIR R44 or STTR R42, 3 years; Fast Track R41/R42 or R43/R44 application, 4 years. In any case, the total project period may not exceed 4 years, whether submitted as a Fast Track or as separate Phase I and Phase II applications. ELIGIBILITY REQUIREMENTS Applications may be submitted by eligible, domestic, for-profit small business organizations, as described for SBIR and STTR grant applications in the Omnibus SBIR/STTR Solicitation. The parallel program announcement, PAR-01-101 (see http://grants.nih.gov/grants/guide/pa-files/PAR-01-101.html), has a wider range of eligibility that encompasses foreign and domestic, for- profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, companies, units of State and local governments, and eligible agencies of the Federal government.) Potential applicants are encouraged to access the PHS SBIR and STTR Omnibus Solicitation for information on eligibility requirements at the following website: http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Partnerships with medical device manufacturers to facilitate the integration of system components are encouraged, as they enable the useful pooling of resources necessary for successful execution of a project. Partnering options available to small business organizations may include subcontracts. In addition, joint ventures are eligible provided that the entity created qualifies as a small business concern as defined in the NIH SBIR/STTR Omnibus Solicitation (http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf). INQUIRIES Inquiries are encouraged. Opportunities to clarify issues and questions from potential applicants are welcome. Direct inquiries regarding programmatic issues to the following: For the NCI Houston Baker, Ph.D. Biomedical Imaging Program National Cancer Institute 6130 Executive Plaza, Suite 6000 Bethesda, MD 20892-7412 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496 9531 FAX: (301) 480 3507 Email: firstname.lastname@example.org For the 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 Research Triangle Park, NC 27709 FedEx: 79 T.W. Alexander Drive 4401 Research Commons, 3rd Floor Telephone: (919) 541 0781 FAX: (919) 541 5064 mailto: email@example.com Direct inquiries regarding fiscal matters to: For the NCI Kathleen J. Shino, M.B.A. Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, EPS 243 Bethesda, MD 20892-7150 Rockville, MD 20852-7150 (for express/courier service) Telephone: (301) 846 1016 FAX: (301) 846 5720 Email: firstname.lastname@example.org For the NIEHS Carolyn B. Winters Grants Management Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 FedEx: 79 T.W. Alexander Drive 4401 Research Commons, 3rd Floor Telephone: (919) 541 7823 FAX: (919) 541 2860 mailto: email@example.com Direct inquiries regarding review matters to: Ms. Toby Friedberg. Referral Officer National Cancer Institute 6116 Executive Boulevard, Room 8109, MSC 8236 Bethesda, MD 20892-8236 Rockville, MD 20852 (for overnight/courier service) Telephone: (301) 496 3428 FAX: (301) 402 0275 Email: tf12W@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a Letter of Intent by the date listed at the beginning of this PA and in the SCHEDULE, below. It should provide the number and title of this program announcement, a descriptive title of the proposed research, the name, address, telephone number, and e-mail address of the Principal Investigator and identify other key personnel and participating institutions. 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. Address the letter of intent to Dr. Houston Baker at the address listed under INQUIRIES, above. SCHEDULE Letter of Intent Receipt: June 11, 2001; February 11, 2002; June 11, 2002 Application Receipt Date: July 16, 2001; March 18, 2002; July 16, 2002 Peer Review Date: Oct-Nov, 2001; June-July, 2002; Oct-Nov, 2002 Review by National Cancer Advisory Board, or National Environmental Sciences Advisory Council: February, 2002; September, 2002; February, 2003 Earliest Anticipated Start Date: March 2002; October, 2002; March 2003 APPLICATION PROCEDURES SBIR and STTR application information is available at the following website: http://grants.nih.gov/grants/funding/sbir.htm, where instructions and application forms in pdf files are hyperlinked as Appendices A through E, subtopics under the SBIR/STTR Phase I Solicitation link. Application forms, requirements and procedures are the same as listed in the Omnibus Solicitation for Phase I SBIR/STTR Grant applications (http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf), with the following exceptions: o Type the title and number of this PA on line 2 on the face page of the application. o The Omnibus Solicitation states levels for Phase I and Phase II budgets that are guidelines, not ceilings. Under this PA, the NCI and NIEHS will consider larger budgets for longer periods of time that are well-justified and necessary to complete the proposed research and development. Phase I budgets are limited to project periods up to a two year ceiling, and up to a guideline of $100,000 per year, excluding subcontractor facilities and administrative costs. Include a second budget page, and expand the narrative budget justification page(s) to provide second year justification if there are significant line item differences. If second year changes reflect only cost of living factor(s), include a statement to that effect, the factor(s) used, and omit repetition of detail already provided for first year line items. o There are no dollar limitations under this PA for Phase II budgets, but requested amounts are subject to peer review recommendations, availability of funds, and Program priority. o A flexible SBIR/STTR Phase I budget period of one or two years (versus the Omnibus Solicitation guideline of 6 months for the SBIR and 1 year for the STTR). o A flexible SBIR/STTR Phase II budget period of one to three years (versus the Omnibus Solicitation guideline of up to two years). o A four year limit to funding for either a Fast Track, or a Phase I and renewal Phase II application. Specific Aims: The application must present specific aims that the applicant considers technically or scientifically appropriate for the relevant phases of the project. Since the goal of this PA is the development of innovative imaging technologies, hypothesis testing per se may not be the driving force in developing such a proposal, and therefore, may not be applicable. For the R41 or R43 phase of feasibility studies, preliminary data are not required, but should be included if they are available. Project Period and Amount of Award. Because the length of time and cost of research involving advanced technology projects may exceed that normally awarded for SBIR/STTR grants, NCI and NIEHS will entertain well-justified Phase I applications with a project period up to two years and a budget guideline that may not exceed $100,000 per year direct and indirect costs (maximum of $200,000 direct and indirect costs for up to 2 years, excluding subcontractor facilities and administrative costs). Phase II Applications. Phase II applications in response to this PA will only be accepted as competing continuations of previously funded NIH Phase I SBIR or STTR awards. The Phase II application must be for developmental work that is a logical extension of the Phase I feasibility research. Phase II budgets normally may not exceed guidelines of $500,000 total costs per year for the STTR R42 and $750,000 total costs per year for the SBIR R44. Budgets that exceed these guidelines require justification. Applications for Phase II awards should be prepared following the instructions for NIH Phase II SBIR or STTR applications. The Phase II SBIR instructions and application may be found on the Internet at: http://grants.nih.gov/grants/funding/phs398/phs398.html. The Phase II STTR instructions and application may be found on the Internet at: http://grants.nih.gov/grants/funding/phs398/phs398.html. Fast Track Applications. Applications may be submitted for the Fast Track review option. Information on the Fast Track option may be found at http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf. Project Period and Amount of Award. Because the length of time and cost of research may exceed that normally awarded for SBIR grants, NCI and NIEHS will entertain well-justified Phase II applications for this SBIR/STTR award with project periods up to three years with budget levels appropriate for the work proposed (subject to the four year funding limit for Phase I and Phase II grants). Clinical Trials: All clinical trials supported by any NIH Institute or Center require some form of safety monitoring plan. The method and degree of monitoring to be included in the plan should be commensurate with the degree of risk involved and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff to a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from and in addition to the requirement for human subject study review and approval by an Institutional Review Board (IRB). For details about the Policy of the NCI for Data Safety Monitoring of Clinical Trials, see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For additional information, see http://grants.nih.gov/grants/guide/notice-files/not98-084.html and http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for overnight express or courier service) At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Referral Officer National Cancer Institute 6116 Executive Boulevard, Room 8109, MSC 8236 Bethesda, MD 20892-8236 Rockville, MD 20852 (for overnight express or courier service) Telephone: (301) 496 3428 FAX: (301) 402 0275 The Center for Scientific Review (CSR) will not accept any application in response to this PA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCI. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. 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 applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the 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 aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will in vivo imaging technology or 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 oncology, environmental health science, or imaging that is not disease or organ specific? Does this project have commercial potential? What may be the anticipated commercial and societal benefits of the proposed activity? 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 adequate for the proposed technology, its integration as an effective solution for implementation, and dissemination? If industrial partnerships are proposed, how will they facilitate the development and integration of system components? 3. Milestones (for Phase I R41 or R43 or Fast Track applications) and Proof of Principle (for Phase II applications). For the Phase I application, how appropriate are the proposed Milestones against which to evaluate the demonstration of feasibility for transition to the R42 or R44 Phase II development work? Do they provide an objective target against which to evaluate results? For Phase II applications, how well has feasibility or proof of principle been demonstrated? 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 principal investigator appropriately trained, experienced, and well suited to direct or 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 technical and scientific environment in which the work will be performed contribute to the probability of success? Does the proposed work take advantage of unique features of the technical and scientific environment or employ useful collaborative arrangements? 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 adversely affected by the project proposed in the application. AWARD CRITERIA Applications recommended by the National Cancer Advisory Board for NCI or the National Environmental Sciences Advisory Council for NIEHS will be considered for award on the basis of (a) quality of the proposed project as determined by peer review; (b) availability of funds; and (c) program priority. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub- populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided to indicate that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the updated "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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 which is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators may also obtain copies of these policies from program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the NIH policy on education in the protection of human research participants now required for all investigators, which is published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at the following URL address http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A continuing education program on the protection of human participants in research is now available online at http://cme.nci.nih.gov/. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in a NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS led national activity for setting priority areas. This PA, Development of Novel Technologies for In Vivo Imaging (SBIR/STTR), is related to the priority areas of cancer and environmental health. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.394, Cancer Detection and Diagnosis Research (NCI), and 93.113. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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