DEVELOPMENT OF TECHNOLOGY-DRIVEN PRODUCTS/DEVICES/BIOMARKERS FOR MEASURING EXPOSURE TO ENVIRONMENTAL AGENTS: SBIR INITIATIVE Release Date: September 11, 2000 RFA: ES-00-009 National Institute of Environmental Health Sciences (http://www.niehs.nih.gov) Letter of Intent Receipt Date: October 1, 2000 Application Receipt Date: November 16, 2000 PURPOSE The mission of the National Institute of Environmental Health Sciences (NIEHS) is to reduce the burden of human illness and dysfunction from environmental exposures to chemical agents by understanding the interaction between environmental exposures, individual susceptibility, and time. Exposure assessment, the quantification of human contact with chemicals or other exposures, is an essential component of environmental, epidemiologic, and risk assessment studies aimed at reducing the burden of environmentally induced diseases. It is often the most criticized part of the research, as it is difficult to gather reliable and valid measures of exposures, especially when they have occurred in the past. The exposure-disease relationship is subject to misclassification and recall bias when surrogate exposure measures, such as self-report of exposures, are used. Historically, tools available to epidemiologists were questionnaire and survey methods, which included asking subjects about their exposures on the job or at home. Improvements in exposure assessment have been made in occupational and environmental studies over time, but new tools are necessary to include improved biomonitoring strategies into such research. The current explosion in biotechnology and bioengineering is ripe for exploitation by exposure assessment and analysis researchers. A unique opportunity exists to infuse the discipline with new strategies and approaches in chemical measurement, bioimaging and sensing, and miniaturization, that are currently being utilized in the defense, agriculture, and security industries. The application of these methods will improve our ability to measure environmental pollutants in the air, soil, water, and in human tissues and body fluids. Refinements in exposure assessment strategies using new technology will aid in the quantification of the disposition of these agents, including the metabolism and clearance in the body. The development of more sensitive and specific monitoring devices, more sophisticated biomonitoring scenarios, and novel imaging techniques will help generate much needed data. Information from these new devices and products will provide more valid estimates of body burden and more precise pharmacokinetic data needed to expand our understanding of the toxic effects of these exposures and aid in the improved conduct of epidemiologic studies and risk assessment exercises. The purpose of this Request for Applications (RFA) is to foster the integration of biotechnology with bioengineering, imaging techniques, and advances in molecular biology in order to revolutionize the field of exposure assessment. It is anticipated that the improvement in exposure assessment methodologies that result from this RFA will have a major impact on epidemiology and community-based environmental health studies and thereby on the risk assessment process and our ability to protect the public health. Because this initiative deals with a subset of the exposure assessment area, that of the development of technology driven commercial products, this initiative will use the Small Business Innovation Research (SBIR) program. This RFA provides a flexible system within the SBIR program to cover the extensive needs and complex development processes needed to develop and validate products and devices that will measure exposure to environmental agents. 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 Request for Applications, "Development of Products/Devices/Biomarkers for Assessment of Exposure to Environmental Agents: SBIR Initiative," is related to the priority areas of environmental health. Potential applicants may obtain a copy of "Healthy People 2010" at http://health.gov/healthypeople/ ELIGIBILITY REQUIREMENTS Eligibility requirements are described in the Omnibus SBIR Solicitation. Each organization submitting an SBIR grant application must qualify as a small business concern in accordance with the definition given in Section III of the Omnibus SBIR Solicitation (http://grants.nih.gov/grants/funding/sbirsttr1/index.htm) MECHANISM OF SUPPORT This RFA invites grant applications for Small Business Innovation Research (SBIR) projects with award duration and amounts greater than those routinely allowed under the SBIR program. This RFA must be read in conjunction with the Omnibus Solicitation of the Public Health Service (Omnibus Solicitation) for Phase I SBIR Grant Applications (PHS 2000-2) and the instructions for Phase II Grant Applications revised March 1998. All instructions and information in these documents also apply to applications in response to this RFA. The NIH has announced that applicants may request a larger budget and period of support if necessary for completion of the project. See NIH Guide for Grants and Contracts, February 13, 1998 at: http://grants.nih.gov/grants/guide/notice-files/not98-014.html This RFA is a one-time solicitation. Responsibility for the planning, direction and execution of the proposed project will be solely that of the applicant. Awards will be administered under NIH grants policy stated in the NIH Grants Policy Statement, NIH publication 99-8 October 1998. A. FAST-TRACK APPLICATIONS. Applications may be submitted for the FAST-TRACK review option. Information on the FAST-TRACK process may be found at: http://grants.nih.gov/grants/funding/sbir.htm To be eligible for the FAST-TRACK option, the Phase I SBIR application must include well defined quantifiable milestones that will be used to judge the success of the proposed research, as well as a credible plan to apply the selected technology in a pilot study of interest to exposure assessment research for the Phase II R44 application. The FAST-TRACK must have a section labeled Milestones at the end of the Research Plan Phase I. This section must include well-defined quantifiable milestones for completion of Phase I, a discussion of the suitability of the proposed milestones for assessing the success in Phase I, and a discussion of the implications of successful completion of these milestones on the proposed Phase II. Applications submitted through the FAST-TRACK option are subject to the same total cost limits per year as when submitted outside of the FAST-TRACK option: Phase I R43, not to exceed $200,000 per year total direct costs excluding subcontractor indirect costs, Phase II normally not to exceed $500,000 total costs per year. The total duration (Phase I plus Phase II applications) cannot exceed four years. In any case, the Phase I application cannot exceed two years duration. B. INDIVIDUAL PHASE I APPLICATIONS. Phase I applications in response to this RFA will be funded as Phase I SBIR Grants (R43) with modifications as described below. STTR applications will not be accepted under this solicitation. Applications for Phase I grants should be prepared following the directions for Phase I SBIR applications as described in the NIH Omnibus Solicitation. The NIH Omnibus SBIR Solicitation is available on the Internet at http://grants.nih.gov/grants/funding/sbirsttr1/index.htm A limited number of hard copies of the NIH Omnibus SBIR Solicitation are available from: PHS SBIR/STTR Solicitation Office 13685 Baltimore Avenue Laurel, MD 20707-5096 Telephone: (301) 206-9385 FAX: (301) 206-9722 Email: a2y@cu.nih.gov Page Limitations. The requirements for Phase I applications apply (see NIH OMNIBUS Solicitation). C. INDIVIDUAL PHASE II APPLICATIONS Phase II applications will not be accepted in response to this RFA unless they are part of the FAST-TRACK. They will only be accepted as competing continuations of Phase I SBIR awards funded under this initiative. PROJECT PERIOD AND AMOUNT OF AWARD PHASE I: Because the length of time and cost of research involving development and evaluation of products/devices/biomarkers for the assessment of exposure to environmental agents may exceed that routinely awarded for SBIR grants, the NIEHS will entertain well-justified Phase I applications for an SBIR award with a project period up to two years and a budget not to exceed a total cost of $200,000 per year. PHASE I BUDGET PERIOD REQUESTS THAT EXCEED THE 6-MONTH GUIDELINES Phase I SBIR Applicants requesting a budget period of more than 1 year should follow the following procedures: Photocopy Form Page 3 "Budget for Phase I-Direct Costs Only", number it Form Page"3a" o Use Form Page 3 for the first year budget and title Form Page 3a "Phase I - 2nd year budget." This page will not be counted against the "25-page" total. o Provide the appropriate/requested information in the narrative justification (Form Page 4) for years 1 and 2. o Indicate on the Phase I Face page in Field 6, Dates of Project Period, the dates for the ENTIRE project period (e.g., Nov, 15, 2000- Nov. 15, 2002) o Indicate on the Phase I Face Page in Field 7, the requested Direct Costs for the entire project period and the Total Costs for the entire project period (e.g. 2 years). The summary statement will reflect the recommended budget for the -01 year and 02 year. Consultant and contractual costs associated with Phase I: The total amount of all consultant costs and contractual costs normally may not exceed 33 percent of the total costs requested for Phase I SBIR applications. However, the NIEHS will entertain well-justified Phase I applications for an SBIR award with greater than 33 percent contractual costs when those costs are necessary to support development and evaluation of a product/device/biomarker for the assessment of exposure to environmental agents. Page Limitations: The 25-page limitation for Phase I applications applies (see Omnibus Solicitation). PHASE II: This solicitation is only for Phase I or FAST-TRACK SBIR applications. Phase II applications that result from funded Phase I studies under this RFA, will be awarded as Phase II SBIR grants (R44) with modifications as described below. In addition, FAST-TRACK Phase I and Phase II applications will be accepted as described above. Project Period and Amount of Award: Because the length of time and cost of research involving exposure assessment products/devices/biomarkers often exceeds that routinely awarded for SBIR grants, the NIEHS will entertain well-justified Phase II applications that result from Phase I funded projects from this RFA for an SBIR award with a project period up to three years and a budget not to exceed $600,000 per year total cost. The increased time and cost are allowed because of the time and cost associated with the evaluation and validation on the products/devices/ biomarkers developed in Phase II. It is anticipated that the Phase II applications that result from successful Phase I applications funded under this RFA will have a significant partnership component with epidemiologists and statisticians in order to evaluate and validate the products developed in human populations. Consultant and contractual costs: The total amount of all consultant costs and contractual costs normally may not exceed 50 percent of the total costs requested for Phase II SBIR applications. However, NIEHS will entertain well-justified Phase II applications for an SBIR award with greater than 50 percent contractual costs when those costs are necessary to support the development, evaluation and validation of exposure assessment products/devices/biomarkers. FUNDS AVAILABLE It is expected that 10-12 awards will be made in FY 2001, and $3 million from the SBIR set-aside of the NIEHS will be designated for this purpose. The number of awards will be dependent upon receipt of a sufficient number and diversity of applications with high scientific merit. RESEARCH OBJECTIVES Background The goal of this proposed research initiative is to develop new tools, products and devices that will enhance our ability to measure a wider variety of chemical contaminants in our environment and in humans. The integration of biotechnology with bioengineering, imaging techniques, and advances in molecular biology will revolutionize the field of exposure assessment by producing new and innovative commercial products that will aid the detection of exposure to environmental agents and improve the detection of the toxicity resulting from exposure. It is anticipated that the improvement in exposure assessment methodologies that result from this initiative will have a major impact on epidemiology studies and thereby on the risk assessment process and our ability to protect the public health. This initiative invites technology-driven applications to develop commercially viable products in order to improve existing analytic methods to quantify chemical exposures. The technological tools should be integrated with biology, chemistry, computer science, engineering, mathematics, and physics to achieve a systems science approach for the analysis of biological information useful for assessing exposure to environmental agents and the biological consequences of that exposure. The use of this emerging technology could very likely change the face of exposure assessment making it increasingly possible to noninvasively detect recent and past exposures, diagnose the associated toxicity, and guide intervention therapies. Technology-driven product development appropriate for this initiative include but are not limited to the following: IMPROVED ANALYTIC METHODS TO QUANTIFY EXPOSURE o Development of sensitive and inexpensive field kits which use nanotechniques to detect and quantitatively assay environmental agents and their metabolites in small samples of air, tears, tissues, blood, saliva, or urine (blood,saliva or urinary dip-sticks for example) that could be used for screening large populations for exposure to specific environmental agents. o Development of field-capable methods to determine body burdens or environmental chemicals in the population especially children with a focus on improved exposures in homes, school, and in motor vehicles. o Quantitation of exposures found in food (i.e., mycotoxins in corn) which may pose a hazard to children and sensitive populations. INSTRUMENTS TO MEASURE BIOMARKERS OF EXPOSURE o Development of high throughput fingerprinting of genetic polymorphisms for use in large-scale human studies. o Miniaturization of high throughput technology for gene/protein expression for the detection of toxicant exposure in field studies. o Development and validation of instruments that can measure biomarkers or surrogate markers of tissue function that can be measured either noninvasively or in small blood, saliva or urine samples and that can be used to determine tissue toxicity after exposure to environmental agents. o Development and validation of biomarkers that reflect exposures to specific environmental agents or classes of agents (acute exposures and long term chronic exposures) and predict disease risk in individuals. o Development of instruments that can detect and quantify past exposures (months to years) to environmental agents singly or combined by similar mechanism, based on changes in metabolism, biochemical endpoints or molecular endpoints. This could include improved gene expression profiling assays that detect chemical signatures from exposure to specific toxicants that can be standardized to be used in large scale epidemiology studies. o Development of instruments that can measure chemical specific biomarkers for identifying stages in the development of the toxic effects of environmental agents from initial exposure to early toxicity to disease or dysfunction. o Development of an instrument that can measure a battery of biomarkers that would quantify exposures to mixtures of chemicals with a similar mechanism of action. IMPROVED BIOMONITORING OF EXPOSURE o Development of sensitive miniaturized user-friendly personal exposure assessment monitors for use with children as well as adults. o Development of novel technology to monitor daily activity patterns and exposure of children (i.e., continuous sampling over time). o Sensitive and specific personal monitors to detect exposure to various environmental agents, especially low dose environmental exposures (for example a home collection kit for house dust or mites or biomonitors that could be worn to school that can detect metals, solvents, particulates, air toxics, water pollutants etc). o Use of nanotechnology and integration of complex functionality for a new class of biomedical devices that will be useful for real-time biomonitoring and imaging of exposure. This includes the development of improved contrast enhancement agents and probes specific for molecular, cellular, and physiological processes that can detect exposure by alteration in physiological processes. o Development of screens of cord blood or placenta detect in utero exposure to environmental agents along with methods to assess the effects of the exposure on organ function at birth and throughout life. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the "NIH Guide for Grants and Contracts," March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIEHS staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the letter of intent receipt date listed to: Dr. Ethel Jackson, D.D.S. Chief, Scientific Review Branch Office of Program Operations Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-30 111 T.W. Alexander Drive Research Triangle Park, N.C. 27709 Phone: (919) 541-7826 Fax: (919) 541-2503 E-mail: jackson4@niehs.nih.gov APPLICATION PROCEDURES Applicants should follow the instructions for SBIR Phase I submission with the modifications as noted in this RFA. A sample Phase I SBIR application can be found at http://www.nhlbi.nih.gov/nhlbi/sbir/modelsbi.htm This RFA must be read in conjunction with the OMNIBUS SOLICITATION OF THE PUBLIC HEALTH SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH GRANT (SBIR) APPLICATIONS (PHS 2000-2). All of the instructions within the Omnibus Solicitation apply with the following exceptions: - Special receipt date - Additional award considerations - Increased award amount and duration Applications received in response to this RFA are to be prepared as described in the Omnibus Solicitations for the SBIR program. Omnibus Solicitations are available electronically through the NIH, Office of Extramural Research "Small Business Funding Opportunities" at http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf Hard copies, subject to availability, may be obtained from the PHS SBIR/STTR Solicitation Office, phone (301) 206-9385, Fax (301) 206-9722, Email: a2y@cu.nih.gov. Helpful information in preparation of the application can be obtained at http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf Applications in response to this RFA are to be submitted on the applicable grant application forms as follows: SBIR Phase I - PHS 6246-1 (1/98) http://grants.nih.gov/grants/funding/sbirsttr1/index.htm The application forms are also located in the back pages of the Omnibus SBIR Solicitation. The RFA title and number must be typed in line 2 on the face page of the application form. 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 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. SBIR projects submitted in response to this RFA must contain a Phase I feasibility segment that must be successful prior to a Phase II award. Applications can be submitted for Phase I support, or as a combined Phase I and II (FAST-TRACK). Phase II applications will be accepted April 1, August 1, and December 1 after completion of the Phase I applications supported by this RFA or as part of a FAST-TRACK application. Projects may be presented for SBIR support at all stages of exposure assessment methodology discovery and development process. Projects will be evaluated on overall innovation and success potential of the product/device or biomarker of exposure to environmental agents. Larger budgets could be considered for Phase I if required for conduct of the research and appropriately justified in the application. The second year of support will be contingent upon NIEHS programmatic evaluation to ensure that investigators are accomplishing milestones and time lines presented in the original application. FAST-TRACK: Due to the complex nature of the development of products/devices and biomarkers of exposure, it is recommended that only well defined and more advanced projects be proposed for support through this mechanism. FAST-TRACK applications must specify clear, measurable goals for Phase I that should be achieved prior to Phase II funding. Failure to provide measurable goals in the Phase I application and/or sufficient detail in the Phase II application may be sufficient reason for the peer review committee to exclude the Phase II from consideration. If so, the applicant may apply later for Phase II support. Special provisions described in this RFA pertaining to Phase I and Phase II also apply to FAST-TRACK applications. Submit a signed, typewritten original of the application, including the Checklist, and one signed, photocopy, 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) For purposes of identification and processing, the title and number of this RFA must be shown in item 2 on the face page of the SBIR Phase I applications. Follow the mailing instructions in the Omnibus Solicitation for Phase I or FAST-TRACK applications. At the time of submission, one additional copy of the application must be sent to: Dr. Ethel Jackson, D.D.S. Chief, Scientific Review Branch Office of Program Operations Division of Extramural Research and Training National Institute of Environmental Health Sciences 79 T.W. Alexander Drive Bldg. 4401, Rm 116 Research Triangle Park, NC 27709 Phone: (919) 541-7826 Fax: (919) 541-2503 E-mail: jackson4@niehs.nih.gov REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the NIEHS Scientific Review Branch. Incomplete applications will be returned to the applicant without further consideration. Applications will be reviewed for scientific and technical merit by an initial review group convened by the NIEHS, in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. REVIEW CRITERIA Review criteria are described in the Omnibus SBIR Solicitation. Additional review criteria are that the proposal must produce a product, device or biomarker that will improve the exposure assessment process and that the applications must address the evaluation and validation of the product using humans. The Phase I application should specify clear, measurable goals (milestones) that should be achieved prior to initiating Phase II. Review criteria are described in the NIH Omnibus Solicitation and available on the web at the following URL address: http://grants.nih.gov/grants/funding/sbirsttr1/index.htm The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? To what degree does the product rely on state-of-the-art technology? 2. Approach. Are the conceptual framework, design, and methods adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? What is the time frame for developing the proposed technologies and suitability of this time frame for meeting the research needs? How easy will it be to use the proposed technology? Are the plans for the proposed technology, its integration as an effective solution for implementation and dissemination adequate? If partnerships are proposed, how will they facilitate the development and integration of system components? 3. Milestones. How appropriate are the proposed milestones against which to evaluate the demonstration of feasibility for transition to the Phase II application? 4. Innovation. Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? What is the throughput and cost effectiveness of the proposed technology? What additional uses can be projected for the proposed technology? 5. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 6. Environment. Does the scientific 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? Is there evidence of institutional support? Additional Considerations In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project(s) proposed in the application. AWARD CRITERIA The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among research areas of the announcement, the availability of funds, and the commercialization status where the small business concern has received more than 15 Phase II awards in the prior five fiscal years, if applicable (see this application requirement under "Prior SBIR Phase II Awards" found in the "Introduction and Application Instructions" portion of the Omnibus Solicitation). ADVICE ON SUBMITTING APPLICATIONS Potential applicants are strongly encouraged to contact program staff for pre- application guidance and/or for more specific information on the research topics described in this RFA. They are also encouraged to read the advice and information on SBIR programs located on the Internet at: http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf SCHEDULE Letter of Intent Date: October 1, 2000 Application Receipt Date: November 16, 2000 Review by NAEHSC: June, 2001 Earliest Award Date: August, 2001 INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants are welcome. Inquiries regarding programmatic issues may be directed to: Jerrold Heindel, Ph.D. Scientific Program Administrator Organ and Systems Toxicology Branch Office of Program Development Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 111 T.W. Alexander Drive, MD EC-23 Research Triangle Park, NC 27709 Telephone: (919) 541-0781 Fax: (919) 541-5064 E-mail: heindelj@niehs.nih.gov Direct inquiries regarding fiscal matters to: Ms. Carolyn Winters Grants Management Branch Office of Program Operations National Institute of Environmental Health Sciences P.O. Box 12233 111 T.W. Alexander Drive, MD EC-22 Research Triangle Park, NC 27709 Telephone: (919) 541-7823 Fax: (919) 541-2860 E-mail: winters@niehs.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.113 and 93.115. Awards are made under authorization of the Public Health Service Act, Title IV part A (Public Law 78-419 as amended by Public Law 99- 158, 42USC 241 and 285) and administered under NIH grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. PHS98-2 is not the current SBIR Solicitation. Change to: This RFA must be read in conjunction with the current calendar year 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) Phase I Grant Applications (http://grants.nih.gov/grants/funding/sbirsttr1/index.htm). Phase II SBIR application forms and instructions may be may be found on the Internet at: http://grants.nih.gov/grants/funding/sbir2/index.htm. Add the following text about budget requests greater than 1 year.

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