INITIATIVE FOR ALCOHOL SENSING AND DATA ANALYSIS SYSTEM (SBIR) RELEASE DATE: September 29, 2004 RFA NUMBER: RFA-AA-05-002 EXPIRATION DATE: December 21, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.273 LETTER OF INTENT RECEIPT DATE: November 22, 2004 APPLICATION RECEIPT DATE: December 20, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Project Period and Amount of Award 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 Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations NOTICE: This Request for Applications (RFA) 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 (http://grants.nih.gov/grants/funding/sbirsttr1/index.doc or http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf) contains information about the SBIR programs, regulations governing the programs, and instructional information for submission. All of the instructions within the SBIR Omnibus Solicitation apply with the following exceptions: o Application Receipt Date: December 20, 2004 o Initial review convened by the NIAAA Division of Extramural Activities o Modified guidelines for Project Period and Amount of Award PURPOSE OF THIS RFA This Request for Applications (RFA) invites SBIR grant applications for research on unobtrusive monitoring and continuous quantitation of alcohol (ethanol) content in humans. In recognition of the complexity of the requirements, the duration and amounts of individual grants awarded under this RFA may be greater than those routinely awarded under the SBIR program. Few small businesses possess the highly specialized resources needed to develop 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, combining the expertise and resources of investigators from commercial, academic 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 relevant to alcohol research, including physiology, biochemistry, engineering, physics, and mathematical sciences. RESEARCH OBJECTIVES Background The NIAAA understands that achievement of program objectives will require the exercise of technologies 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 diverse technologies and methodologies, including some not traditionally associated with biomedical applications. Therefore, applications involving teams of investigators with expertise in key areas of sensor system design, data analysis, and/or relevant biomedical application areas are appropriate. Applications 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 are detailed and reliably accurate. 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. Other features needed depend on the particular uses intended. Some uses may be for short time periods while others may require continuous measurements over extended periods, up to a month or more. 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; a capability to provide measurements of metabolite, 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. 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 experts 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 but not limited to 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). - Measurement fidelity should be robust to subject's activities up to and including active efforts at tampering. - System should provide for either data storage or telemetric data transmission without removal of the sensor. - Sensor system should have no demonstrably deleterious effects on subject's comfort, health, and safety. With a variety of monitoring purposes possible, it is not necessary that any one system satisfy all applications. Instead, specific additional features would be desirable for specific purposes. Examples of these include but are not limited to: - Capacity for extended data monitoring, storage and reporting over time periods up to a month or more. - Capacity to monitor alcohol levels in different body organs and systems simultaneously, with spatial and temporal resolution sufficient to study concentration kinetics between different compartments of the body. - Capacity to monitor and record other physiologic measurements, such as heart rate, blood pressure, temperature, galvanic skin impedance, and blood chemistry measurements (e.g., PO2, metabolites, enzymes, and hormone levels). - Ability to sense and record information about the individual's physical activity and/or sleep-wake cycle. - Ability to monitor an individual’s geographic location. - Ability to report data telemetrically. - Ability to monitor and provide immediate feedback when alcohol concentrations exceed a predetermined cutoff (e.g., 200 mg/dL). 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 home residence. 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 indicates 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 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. MECHANISMS OF SUPPORT This RFA uses the SBIR 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 applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July 1, 2005. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW SBIR applications using the standard receipt dates for NEW applications described in the current SBIR/STTR Omnibus Solicitation. This RFA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats. Specifically, if you are submitting an application budget of $100,000 total costs (direct, F&A and fee) or less, use the modular budget format. For applications requesting more than $100,000, use the non-modular budget format. Instructions for both are described in the current SBIR/STTR Omnibus Solicitation. 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. Except as otherwise stated in this RFA, awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement, March 2001, available at http://grants.nih.gov/grants/policy/nihgps_2003/. Applications may be submitted for support as Phase I SBIR (R43) grants or Phase II SBIR (R44) grants; or the FAST-TRACK option as described in the SBIR/STTR Omnibus Solicitation. Phase II applications in response to this RFA will only be accepted as competing continuations of previously funded NIH Phase I SBIR 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 RFA. 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. PROJECT PERIODS AND AMOUNT OF AWARD Because the duration and costs of research to develop an alcohol sensor and 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). Similarly, well- justified Phase II applications under this RFA will be considered with a project period up to four 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). Total costs include direct costs, F&A, and fee/profit. Consultant and Contractual Costs The normal limits for consultant costs and contractual costs are described in the Omnibus Solicitation for SBIR/STTR applications. Grant applications submitted under this RFA, however, may exceed these limits 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. FUNDS AVAILABLE NIAAA intends to commit approximately $2,000,000 to fund approximately 3-6 Phase I and/or Phase II applications under the SBIR set-aside funding mechanism. Although the financial plans of the 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 competing renewal applications will be accepted or if this RFA will be reissued. ELIGIBLE INSTITUTIONS Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation. Only small business concerns are eligible to submit SBIR 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 current SBIR/STTR Omnibus Solicitation. 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%) with the small business at the time of award and for the duration of the project. 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 or research issues to: R. Thomas Gentry, Ph.D. Division of Metabolism and Health Effects National Institute on Alcohol Abuse and Alcoholism 5635 Fishers Lane, Room 2025, MSC 9304 Bethesda, MD 20892-9304 (For express mail delivery, use Rockville, MD 20852-1705) Telephone: 301-443-6009 Fax: 301-594-0673 Email: tgentry@niaaa.nih.gov Direct your questions about peer review issues to: Ernestine Vanderveen, Ph.D. Acting Chief, Extramural Project Review Branch Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism 5635 Fishers Lane, Room 3039, MSC 9304 Bethesda, MD 20892-9304 (For express mail delivery, use Rockville, MD 20852-1705) Telephone: 301-443-2531 Fax: 301-443-6077 Direct your questions about financial or grants management matters to: Ms. Judy Fox Chief, Grants Management Officer National Institute on Alcohol Abuse and Alcoholism 5635 Fishers Lane, Room 3023, MSC 9304 Bethesda, MD 20892-9304 (For express mail delivery, use Rockville, MD 20852-1705) Telephone: 301-443-4704 Fax: 301-443-3891 Email: jfox@niaaa.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent by November 22, 2004 that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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: Karen P. Peterson, Ph.D. Acting Chief, Research Policy and Special Projects Branch Office of Scientific Affairs, NIAAA 5635 Fishers Lane Room 2017, MSC 9304 Bethesda, MD 20892-9304 Federal Express: Rockville, MD 20852-1705 Telephone 301-451-3883 Fax 301-480-2358 Email: kpeterso@mail.nih.gov SUBMITTING AN APPLICATION The PHS 398 research grant application must be used for all SBIR 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 D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The D&B 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. USING THE RFA LABEL: The RFA label available in the PHS 398 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: http://grants1.nih.gov/grants/funding/phs398/labels.doc or http://grants.nih.gov/grants/funding/phs398/labels.pdf. 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 (for USPS EXPRESS OR REGULAR MAIL) Bethesda, MD 20817 (for EXPRESS/COURIER NON-USPS SERVICE) To expedite the review process, 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-AA-05-002 National Institute on Alcohol Abuse and Alcoholism 5635 Fishers Lane, Room 3039, MSC 9304 Bethesda, MD 20892-9304 (For express mail delivery, use Rockville, MD 20852-1705) Telephone: 301-443-2531 Fax: 301-443-6077 RECEIPT OF APPLICATIONS. Applications must be received on or before the receipt date listed on the first page of this announcement. If an application is received after that date, it will be returned to the applicant without review. 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. The Center for Scientific Research (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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAAA. Incomplete and/or nonresponsive applications will not be reviewed. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAAA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: 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 written critique o Receive a second level review by the NIAAA 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 evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals within the context of the SBIR Program. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score: o Significance o Approach o Innovation o Investigator o Environment ALL SBIR 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 or research methods 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? 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? 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). 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. If vertebrate animals are involved, are adequate plans proposed for their care and use? Are the applicant's responses to the five required points appropriate? Will the procedures be limited to those that are unavoidable in the conduct of scientifically sound research? 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 also 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. Information on NIH data sharing policy and procedures can be found at: http://grants.nih.gov/grants/policy/data_sharing/index.htm. BUDGET: The reasonableness of the proposed budget 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 did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity? 2. Did the applicant submit a concise Commercialization Plan [formerly Product Development 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 application appropriate? TYPE 2 PHASE II COMPETING CONTINUATION APPLICATIONS In addition to the above review 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 activity as proposed address issues related to Federal regulatory approval processes? o What will be the effect of these studies on the concepts or methods that drive this field? PHASE I/PHASE II FAST-TRACK APPLICATION REVIEW CRITERIA For Phase I/Phase II Fast Track applications, the following criteria also 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 [formerly Product Development 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 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: November 22, 2004 Application Receipt Date: December 20, 2004 Peer Review Date: March/April, 2005 Council Review: May, 2005 Earliest Anticipated Start Date: July 1, 2005 AWARD CRITERIA Applications submitted in response to an RFA will compete for available funds with all other recommended SBIR applications. 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 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. 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 gained or to be gained. 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); 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. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 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 or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing. 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 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. 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. 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 RFA 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). 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 RFA 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 inter governmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the 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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