TELEHEALTH TECHNOLOGIES DEVELOPMENT (SBIR/STTR) RELEASE DATE: November 18, 2002 PA NUMBER: PA-03-030 EXPIRATION DATE: January 1, 2004 unless reissued. National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Biomedical Imaging and Bioengineering (NIBIB) invites grant applications for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) awards to support design and development of novel telehealth instrumentation or technologies that can be applied to a broad spectrum of disorders and diseases. There is also a parallel Request for Applications (RFA) announcement on this topic RFA-EB-03- 005 (http://grants.nih.gov/grants/guide/rfa-files/RFA-EB-03-005.html). Telehealth is defined by the Federal Communications Commission and by the DHHS Office of Health Promotion and Disease Prevention as "the use of communications technologies to provide and support health care at a distance. Examples include the use of communications to provide patient treatment, often via still images or video, and the exchange and distribution of public health information." Issues amenable to technical solution arise in the diagnosis, treatment, and follow-up with a patient at a distance. The technical feasibility of telehealth applications has been well demonstrated for several specific applications in the past. The current need is to generalize remote access technology to be adaptable to a broad range of telehealth applications, to develop mechanisms in which the technology can be integrated seamlessly into the routine of the provider and the patient, and to develop technology for standardizing and incorporating state-of-the-art security protocols for verifying user identities and preserving patient confidentiality. This Program Announcement (PA) is intended to support an integrated approach on the part of biomedical engineers or imaging scientists with medical care professionals. RESEARCH OBJECTIVES The main objective of broadening the usability issues in telehealth cover but are not limited to the following application areas: One type of telehealth, store and forward, involves image-based consults, where medical diagnosis or treatment of a patient in a remote clinical care setting is accomplished through the forwarding of the locally-obtained medical images to the pertinent specialist. Examples include teleradiology, telepathology, and teledermatology. To facilitate this practice, there is a need for specialized hardware and software for image compression, storage, transmission, and display. The research objective is the development and validation of the specialized hardware or software. In addition, the quality of the workstation monitors at the receiving end is important. In this case, the research objective can range from the determination of quantitative measures of the necessary workstation image quality, or technical improvements in workstation monitors. For real-time but not necessarily image-based examinations with a distant health-care consultant, additional considerations come in to play. The research objective is to design and develop the needed easy-to-use peripheral devices that can aid in a remote interactive examination. Another type of telehealth takes place in a non-clinical setting. Home-based health care using physiological monitoring devices would benefit from development of low-cost, low-power biosensors, wireless technologies, and inexpensive interactive video for pre-operative or follow-up interactions with a health care provider. In mass casualty situations on-the-scene health professionals could do with hand-held or portable digital imaging and display devices. Additional areas in need of development are wearable patient monitors, which are lightweight and non-invasive, long-life batteries, and telemetry hardware and software. The application should make clear that the proposed research is scientifically sound, the qualifications of the investigators are appropriate, and the resources available to the investigators are adequate. Applications from groups interested in developing suitable novel approaches are encouraged. It is expected that this research will require expertise from a variety of disciplines, including engineering, computer science, physics, mathematics, and medicine. MECHANISM OF SUPPORT This PA will use the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Applications can 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 under 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 proposal must be a logical extension of the Phase I research. Information on the FAST-TRACK process and the SBIR/STTR Omnibus Solicitation is available at http://grants.nih.gov/grants/funding/sbir.htm. ELIGIBILITY REQUIREMENTS Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation. Any small business concern, independently owned and operated by United States citizens or lawfully admitted permanent resident aliens, which is located in the United States, has 500 or fewer employees and is organized for profit, may apply. 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. WHERE TO SEND INQUIRIES We encourage inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Mary S Pastel, ScD Division of Biomedical Imaging National Institute of Biomedical Imaging and Bioengineering National Institutes of Health/DHHS Democracy Two, Suite 200 Bethesda, MD 20892-5469 Telephone: (301) 451-4781 Email: pastelm@mail.nih.gov o Direct your questions about financial or grants management matters to: Mr. Nick Mitrano Grants Management Specialist National Institute of Biomedical Imaging and Bioengineering National Institutes of Health/DHHS Democracy Two, Suite 900 Bethesda, MD 20892-5469 Telephone: (301) 451-4782 Email: mitranni@mail.nih.gov SUBMITTING AN APPLICATION Detailed information regarding submitting SBIR grant applications is available on the NIH website at http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf SBIR/STTR applicants must use the PHS 398 instructions and forms for all Phase I and Phase II applications. See http://grants.nih.gov/grants/forms.htm for links to the PHS 398 Application Instructions and new Fillable Forms. IMPORTANT NOTE: Applicants should refer to Chapter VI http://grants.nih.gov/grants/funding/phs398/instructions2/ p1_preparing_SBIR_STTR_app.htm of the PHS 398 instructions (http://grants.nih.gov/grants/funding/phs398/phs398.html)prior to preparing an SBIR or STTR application. Please note that Phase I applications with budgets of $100,000 or less total costs should use the Modular Budget Page and omit Form Pages 4 and 5. See http://grants.nih.gov/grants/funding/phs398/instructions2/ p1_SBIRSTTR_general_instructions.htm. For answers to frequently asked questions about using the new fillable forms, see FAQs: Revised PHS 398 and PHS 2590 Forms and Instructions at http://grants.nih.gov/grants/forms_faq.pdf. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email:GrantsInfo@nih.gov. 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 at http://grants.nih.gov/grants/funding/submissionschedule.htm. If an application is received after that date, it will be returned to the applicant without review. 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. Please Note: As of November 27, 2001, all applications and other deliveries to the Center for Scientific Review must come via courier delivery or the USPS. Applications delivered by individuals to the Center for Scientific Review will no longer be accepted. For additional information, see the NIH Guide Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness by the CSR. 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 CSR in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Council for Biomedical Imaging and Bioengineering. 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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, you 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 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? Do you acknowledge potential problem areas and consider alternative tactics? Are the milestones and evaluation procedures appropriate? (3) INNOVATION: Does your project challenge existing paradigms or employ novel technologies, approaches or methodologies? Are the aims original and innovative? (4) INVESTIGATOR: 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 your 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? In accordance with NIH policy, all applications will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: 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 Inclusion Criteria included in the section on Federal Citations, below) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. Phase II Applications In addition to the above criteria, to what degree was progress toward the Phase I objectives met and feasibility demonstrated in providing a solid foundation for the proposed Phase II activity? Phase I/Phase II Fast-Track Applications For Phase I/Phase II Fast-Track applications, the following additional criteria will be applied: Does the Phase I application specify clear, measurable goals (milestones) that should be achieved prior to initiating Phase II? Did the applicant submit a concise Product Development Plan that adequately addresses the areas described in the Omnibus Solicitation? 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? The Phase I application should specify clear, measurable goals (milestones) that should be achieved prior to initiating Phase II. Failure to provide clear, measurable goals may be sufficient reason for the study section to judge the application non-competitive. AWARD CRITERIA Applications will compete for available funds with all other recommended SBIR and STTR applications. Funding decisions for Phase I or Phase II applications will be based on quality of the proposed project as determined by peer review, availability of funds, and relevance to program priorities. 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, NIBIB's assessment of the Phase I progress and determination that Phase I goals were achieved, the project's potential for commercial success, and the availability of funds. REQUIRED FEDERAL CITATIONS 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 AMENDMENT "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 are 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. 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 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. 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. 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 No. 93.286 and 93.287 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 administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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