SBIR INITIATIVE FOR ALCOHOL SENSING AND DATA ANALYSIS SYSTEM Release Date: March 4, 2002 RFA NUMBER: AA-02-012 National Institute on Alcohol Abuse and Alcoholism (NIAAA) ( Letter of Intent Receipt Date: March 26, 2002 Application Receipt Date: April 26, 2002. THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Mechanism Objectives o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE This Request for Applications (RFA) invites grant applications for Small Business Innovation Research (SBIR) projects on unobtrusive monitoring and continuous quantitation of alcohol (ethanol) content in humans. In recognition of the nascence and complexity of this area, the duration and amounts of individual grants awarded under this RFA may be greater than those routinely allowed under the SBIR program. Few small businesses possess the highly specialized resources needed for development of an alcohol sensor; analysis of resulting data using techniques such as spatial/temporal pattern analysis and data reduction/compression; and attendant technologies such as power supply, to enable calibrated, accurate, high-resolution continuous measurements of alcohol content. Therefore, this RFA encourages team approaches to research in the belief that a synergistic blend of expertise and resources may be needed to allow for stronger partnerships between the small businesses and other entities in Phase I than can be developed with the funds usually available through this program. Applications are encouraged from teams of investigators from commercial and other sectors of the research community. Partners to the small businesses may play important roles in these projects and may receive appropriate support for their efforts. In addition to requiring collaboration from various sectors, it is expected that this initiative will require expertise from a variety of disciplines, including alcohol research, engineering, biochemistry, physics, and mathematical sciences. RESEARCH OBJECTIVES Background NIAAA understands that achievement of program objectives will require the exercise of technologies significantly beyond the current state of the art in biomedical research and therefore requires research efforts entailing a significant level of technical risk. It is likely that these efforts will require the integration of broad spectrum of technologies and methodologies, including some not traditionally associated with biomedical applications. Therefore, proposals involving teams of investigators having expertise in key areas of sensor system design, data analysis, and/or relevant biomedical application areas are appropriate. Proposals involving individual investigators or investigator teams of narrower expertise may also be appropriate if they show strong potential applicability to the program goals and include a clear mechanism for ultimately integrating successful developments into full sensor system development. Several basic requirements can be identified for the measurement, monitoring, recording, and reporting of alcohol data. Because of the rapid uptake of alcohol upon ingestion, a rapid response and good time resolution is desirable for a measuring system. Also, any monitoring system must provide measurement data, which is detailed and reliably accurate. In order to obtain data representative of extended natural drinking behavior, a monitoring system should provide continuous measurements over extended periods (weeks). To the same end, the measurement process should be minimally obtrusive on behavior, and should be immune to accidental or intentional disruption or discontinuation of the measurement functions. Ideally the individual will act naturally during the data collection period, with essentially no awareness of the measurement process. Additional desirable features might include the ability to monitor alcohol levels in different body organs and systems simultaneously; a capability to provide other physiologic measurements such as blood pressure, temperature, and other blood chemistry measurements including glucose, enzyme and hormone levels; the ability to sense and record information about the individual's location and activity; and the ability to report data telemetrically. At a glance, the basic requirement just described seems quite commonplace and readily met with modern technology. However, even this capability is surprisingly difficult to obtain in practice. Previous methods of obtaining such data have been limited to more or less indirect evaluations of alcohol content by a variety of methods including breath tests, self-reporting surveys, and wrist-worn alcohol-diffusion measurement devices. All have proven deficient in several key regards. Research Topics A set of target performance goals and properties for an innovative blood alcohol sensor has been identified through consultation with application and technology from the alcohol research community as well as experts from other application areas in biomedical sensing. NIAAA is interested in development of integrated sensing and processing systems capable of the following: - Accurate determination of alcohol concentration every 1 to 5 minutes, with concentration resolution of (5 mg/dl) within a range of (5 -500 mg/dl), with continuous coverage over the period of at least one month. - Measurement fidelity should be robust to subject's activities up to and including active efforts at tampering. - System should provide for storage and/or telemetric exfiltration of data (without removal of the sensor). - System should provide power and data storage capabilities for at least one month of continuous activity. - Sensor system should have no deleterious effects on subject's comfort, health, and safety. Additional desirable features may include the following: - Capability to monitor alcohol levels in different body organs and systems simultaneously, with spatial resolution sufficient to study concentration variation between different organ systems and regions of the body. - Capability to provide and integrate other physiologic measurements, such as heart rate, blood pressure, temperature, galvanic skin impedance, and blood chemistry measurements, including possibly other metabolites, enzymes, and hormone levels. - Ability to sense and record information about the individual's location and activity and ability to report data telemetrically. Assessment of the current practice in sensing of various analytes present in blood has suggested that radical new approaches are required to obtain joint measurement and analysis of specific high-resolution vital data through tissue. Challenges include obtaining high-fidelity measured data out of tissue, particularly if spatial localization is to be included and multiple physiologic effects are to be monitored. This is difficult because tissue is a dispersive and scattering medium, which often foils simple methods of moving high-resolution, detailed spatiotemporal information in and out of the body. Another significant challenge will be maintaining calibration over the long operating periods and variable operating conditions anticipated for the system. In any system, power requirements for sensing and processing must be considered carefully. In each case, system output data must be stored for eventual use. One possibility would employ periodic telemetric data dumps to a small base station, possibly installed in the individual's house. There is the possibility of applying miniaturized GPS receivers in association with the sensors to provide information on subject location and movement to be incorporated into the stored physiological data. In any sensing approach, there will be a significant need of signal processing for elucidating the information contained in the raw sensor measurements. The selection of measurement features and the post-processing of these features must be matched to the physical sensor design and the ultimate application end use to ensure the production and recording of calibrated and robust information suitable to the end use. In several possible approaches, physical fields are used to probe or report the state of physical observables. As these signals pass in or out of tissue, they will be significantly modified by the transmitting medium, which must be taken into account in the design of these signals and the data processing associated with their use. Modeling of the environment for the purpose of matched field processing or physics-based processing will be appropriate to several approaches. Consideration of the challenges associated with this program indicate that advances in signal processing, data analysis, and the creation of valid and verifiable models of the basic phenomena under consideration are integral parts of any system developed in this program. Developments in this arena should be performed jointly with the development of the sensor hardware, rather than as an ancillary activity conditioned on a fixed hardware design. In any system, signal processing and physical sensing should be optimized jointly rather than independently in order to obtain maximum system performance. The desired end-to-end design and optimization of sensor systems for this program will also require an explicit consideration of the various uses for the data outputs of the system. This will include an understanding of the experiments which are likely to be conducted using the sensor, possible interventions or probing of a person, and attendant requirements of data reduction and analysis and pattern discovery. This is an essential activity, too often ignored initially, and ultimately incurring a great downstream cost in degraded system performance and resources expended in retrofit activities. Program success will require the development of not simply a physical sensor device, but rather instantiation of an integrated sensing, processing, and analysis system and methodology. The ultimate goal of such a system is to enable the elucidation of useful information patterns, rather than merely providing new means for producing enormous stores of unreduced data. MECHANISM OF SUPPORT – PHASE I Phase I applications in response to this RFA will be funded as Phase I SBIR Grants (R43) with modifications as described below. Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. Applications for Phase I grants should be prepared using the PHS 398 instructions and forms: Please refer to Chapter VI of the PHS 398 instructions prior to preparing an SBIR application. PHS 398 forms specific to SBIR applications are available. See Project Period and Amount of Award Because the duration and cost of research to develop an alcohol sensor and/or associated data analyses are likely to exceed that routinely awarded for SBIR grants, well-justified Phase I applications under this RFA will be considered with a project period up to two years and a budget not to exceed a total cost of $400,000 (i.e., an average of $200,000 per year). Consultant and Contractual Costs The total amount of all consultant costs and contractual costs normally may not exceed 33% of the total costs requested for Phase I SBIR applications. Phase I grant applications submitted under this PA may exceed this limit if the resources required for developing an alcohol sensor and data analysis system are relatively scarce, highly specialized, and multidisciplinary. Deviations must be appropriate and fully justified. Page Limitations The 25-page limitation for Phase I applications applies (see Omnibus Solicitation). MECHANISM OF SUPPORT - PHASE II Phase II applications in response to this RFA will be awarded as Phase II SBIR grants (R44) with modifications as described below. Phase II applications in response to this RFA will only be accepted as competing continuations of previously funded NIH Phase I SBIR awards. The previously funded Phase I award need not have been awarded under this RFA but the Phase II proposal must be a logical extension of the Phase I research. Applications for Phase II awards should be prepared using the PHS 398 instructions and forms: Please refer to Chapter VI of the PHS 398 instructions prior to preparing an SBIR application. PHS 398 forms specific to SBIR applications are available. See Project Period and Amount of Award Because the duration and cost of research to develop an alcohol sensor and/or data analysis system is likely to exceed that routinely awarded for SBIR grants, well-justified Phase II applications under this PA will be considered with a project period up to three years and a budget not to exceed a total cost of $1,200,000 (i.e., an average of $400,000 for each of three years). Consultant and Contractual Costs The total amount of all consultant costs and contractual costs normally may not exceed 50% of the total costs requested for Phase II SBIR applications. Phase I grant applications submitted under this PA may exceed this limit if the resources required for developing an alcohol sensor and/or data analysis system are relatively scarce, highly specialized, and multidisciplinary. Deviations must be appropriate and fully justified. The Fast-Track initiative can be utilized under this RFA. This RFA uses just-in-time concepts. It also uses the modular budgeting format. (see _general_instructions.htm. Specifically, if you are submitting an application budget of $100,000 total costs or less, use the modular format. PROGRAM OBJECTIVES The SBIR program consists of the following three phases: Phase I The objective of Phase I is to establish the technical merit and feasibility of the proposed research, or research and development efforts, and to determine the quality of performance of the small business grantee organization prior to providing further federal support in Phase II. Phase II The objective of this phase is to continue the research or research and development efforts initiated in Phase I. Phase III The objective of this phase, where appropriate, is for the small business concern to pursue the commercialization of the results of the research or research and development funded in Phases I and II. Phase III occurs without SBIR funding. FUNDS AVAILABLE The participating IC(s) intends to commit approximately $2,500,000 in FY 2002 to fund 12 to 15 new Phase I SBIR grants (R43) in response to this RFA. An applicant may request a project period of up to 2 years and a budget for total costs of up to $200,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIAAA provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS - Independently owned and operated, is not dominant in the field of operation in which it is proposing, has its principal place of business located in the United States, and is organized for profit. - At least 51% owned, or in the case of a publicly owned business, at least 51% of its voting stock is owned by United States citizens or lawfully admitted permanent resident aliens. - Must not have, including its affiliates, more than 500 employees and meets the other regulatory requirements found in 13 CFR Part 121. - Business concerns include, but are not limited to, any individual (sole proprietorship), partnership, corporation, joint venture, association, or cooperative. 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 organization 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. The primary employment of the PI must be with the small business concern at the time of award and during the conduct of the proposed project. Primary employment means that more than one half of the PI's time is spent in the employ of the small business concern. Primary employment with a small business concern precludes full-time employment at another organization. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: Direct your questions about scientific/research issues to: Michael J. Eckardt, Ph.D. Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 409 Bethesda, MD 20892-7003 Telephone: (301) 443-6107 Fax: (301) 443-6077 Email: Direct your questions about peer review issues to: Extramural Project Review Branch Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 409 Bethesda, MD 20892-7003 Telephone: (301) 443-4375 Fax: (301) 443-6077 Direct your questions about financial or grants management matters to: Ms. Judy Simons Grants Management Officer National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 504 Bethesda, MD 20892-7003 Telephone: (301) 443-2434 Fax: (301) 443-3891 Email: LETTER OF INTENT Prospective applicants are asked to submit a letter of intent by March 26, 2002 that includes the following information: Descriptive title of the proposed research Name, address, and telephone number of the Principal Investigator Names of other key personnel Participating institutions Number and title of this RFA (AA-02-012) Although a letter of intent is not required, is not binding, and does not affect the review of a subsequent application, the information that it contains allows NIAAA staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Michael J. Eckardt, Ph.D. Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism 6000 Executive Blvd., Suite 409 Bethesda, MD 20892-7003 Telephone: (301) 443-6107 Fax: (301) 443-6077 Email: SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at in an interactive format. Please refer to Chapter VI of the PHS 398 instructions prior to preparing a SBIR application. PHS 398 forms specific to SBIR applications are available: For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: Specific Instructions for Modular Grant Applications SBIR applications requesting up to $100,000 per year in total costs (direct costs, indirect costs and fee) must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Section VI of the research grant application instructions for the PHS 398 (rev. 5/2001) at includes step-by-step guidance for preparing modular grants. Additional information on SBIR modular grants is available at _general_instructions.htm. Using the RFA Label The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at Sending an Application to the NIH 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 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Extramural Project Review Branch Office of Scientific Affairs Attn: RFA-02-012 National Institute on Alcohol Abuse and Alcoholism 6000 Executive Blvd., Suite 409 Bethesda, 20892-7003 Telephone: (301) 443-4375 Fax: (301) 443-6077 Application Processing Applications must be received by the application receipt date listed in the heading of this RFA. 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 RFA 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAAA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. An appropriate peer review group convened by NIAAA in accordance with the review criteria stated below will evaluate applications that are complete and responsive to the RFA for scientific and technical merit. As part of the initial merit review, all applications will: - Receive a written critique - 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 - Receive a second level review by the NIAAA National Advisory Council. 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: Significance Approach Innovation Investigator 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 your study address an important problem? Does the proposed project have commercial potential to lead to a marketable product or process? What may be the anticipated commercial and societal benefits of the proposed activity? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? Is the proposed plan a sound approach to establishing technical and commercial feasibility? Are the milestones and evaluation procedures appropriate? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? Is the investigator capable of coordinating and managing the proposed SBIR? (5) ENVIRONMENT: Does the scientific 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? Is there evidence of institutional support? Additional Review Criteria In addition to the above criteria, your application will also be reviewed with respect to the following: 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. 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) The adequacy of the proposed plan to share data. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 26, 2002 Application Receipt Date: April 26, 2002 Peer Review Date: May-June 2002 Council Review: September 18, 2002 Earliest Anticipated Start Date: September 28, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: Scientific merit (as determined by peer review) Availability of funds Programmatic priorities Commercialization potential Applications will compete for available funds with all other favorably recommended SBIR applications. Note that applicants may achieve all Phase I goals and milestones and still not receive Phase II funding. REQUIRED FEDERAL CITATIONS Monitoring Plan and Data Safety and Monitoring Board: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 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 (; a complete copy of the updated Guidelines are available at 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 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 Human Embryonic Stem Cells (hESC): Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see It is the responsibility of the applicant to provide 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 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 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. 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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance No. 93.273 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 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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