RFA-DA-01-012: TOOLS FOR INSERTIONAL MUTAGENESIS IN THE MOUSE: SBIR/STTR INITIATIVE

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

TOOLS FOR INSERTIONAL MUTAGENESIS IN THE MOUSE: SBIR/STTR INITIATIVE Release Date: January 25, 2001 RFA: RFA-DA-01-012 National Institute on Drug Abuse (http://www.nida.nih.gov) National Institute on Aging (http://www.nih.gov/nia/) National Institute on Dental and Craniofacial Research (http://www.nidcr.nih.gov) National Institute on General Medical Sciences (http://www.nigms.nih.gov) National Institute of Mental Health (http://www.nimh.nih.gov) National Eye Institute (http://www.nei.nih.gov) National Institute on Deafness and Other Communication Disorders (http://www.nidcd.nih.gov) National Human Genome Research Institute (http://www.nhgri.nih.gov) National Center for Research Resources (http://www.ncrr.nih.gov) National Institute of Diabetes and Digestive and Kidney Diseases (http://www.niddk.nih.gov) National Institute on Alcohol Abuse and Alcoholism (http://www.niaaa.nih.gov) National Institute of Child Health and Human Development (http://www.nichd.nih.gov) National Institute of Environmental Health Sciences (http://www.niehs.nih.gov) National Institute of Allergy and Infectious Diseases (http://www.niaid.nih.gov) National Institute of Neurological Disorders and Stroke (http://www.ninds.nih.gov) Letter of Intent Receipt Date: March 11, 2001 Application Receipt Date: April 11, 2001 PURPOSE This Request for Applications (RFA) solicits proposals for development of tools and techniques for the establishment of random and targeted sequence- tagged insertion libraries of embryonic stem (ES) cells that can be used to generate mutant mice in which the expression of the tagged gene could be controlled temporally and spatially. The development of such a resource for wide distribution to the scientific community would make it possible to scan the sequence database for any gene of interest and order the corresponding targeted ES cell line. Ideally, the insertional mutagenesis system developed would permit a wide range of genetic analyses and manipulations, including enhancer-trapping, conditional knockouts, conditional expression or overexpression, etc. It also would permit the larger community of investigators to utilize genomic resources efficiently. This effort complements ongoing National Institutes of Health (NIH) efforts to create and characterize induced point mutations in mice using ethylnitrosourea (ENU) and provides a functional genomics tool to translate the information from the Mouse Genome Sequencing Project. Further information about NIH initiatives on mouse genomics and genetics resources is available at http://www.nih.gov/science/mouse. Because this initiative deals with the development of technology-driven commercial products, this initiative will use the Small Business Innovation Research/Small Business Technology Transfer Research (SBIR/STTR) programs. This RFA provides a flexible system within the SBIR/STTR programs to cover the research steps needed to develop and validate technology to generate insertional mutations in mouse ES cells. It will be run in parallel with a program of identical scientific scope utilizing the research project grant (R01) and for exploratory/development grant (R21) (see http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-01-011.html) mechanisms. 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, "Tools for Insertional Mutagenesis in the Mouse: SBIR/STTR Initiative," is related to several of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Eligibility requirements are described in the Omnibus Solicitation of the Public Health Service, Centers for Disease Control and Prevention, and Food and Drug Administration for Phase I SBIR/STTR Grant Applications (PHS 2000-2) (Omnibus Solicitation) (http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf). Each organization submitting an SBIR/STTR grant application must qualify as a small business concern in accordance with the definition given in Section III of the Omnibus Solicitation. MECHANISM OF SUPPORT This RFA invites grant applications for Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) 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 (http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf) and with the instructions for Phase II SBIR/STTR Grant Applications http://grants.nih.gov/grants/funding/sbir2/index.htm and http://grants.nih.gov/grants/funding/sttr2/index.html). 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/sbirsttr1/index.pdf. To be eligible for the Fast-Track option, the Phase I SBIR/STTR 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 or R42 application. The Fast-Track application 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, as described below in the PROJECT PERIOD AND AMOUNT OF AWARD section. B. Individual Phase I Applications. Phase I applications in response to this RFA will be funded as Phase I SBIR Grants (R43) or STTR Grants (R41) with modifications as described below. Applications for Phase I grants should be prepared following the directions for Phase I SBIR/STTR applications as described in the Omnibus Solicitation. The Omnibus Solicitation is available on the Internet at http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf. C. Individual Phase II Applications. Phase II applications will not be accepted in response to this RFA unless they are submitted for Fast-Track review. They will only be accepted as competing continuations of Phase I SBIR awards funded under this initiative. PROJECT PERIOD AND AMOUNT OF AWARD Applicants planning to propose research in excess of the limits (duration and amount) stated below must obtain agreement from Institute staff (named under INQUIRIES below) that the application will be accepted for consideration. The applicant must identify, in the cover letter that is sent with the application, the staff member and Institute who agreed to accept the application. Phase I: Because of the challenges that may be involved in the development and evaluation of insertional mutagenesis technology, the participating Institutes will entertain well-justified Phase I applications for an SBIR/STTR award with a project period up to two years and a budget not to exceed a total cost of $100,000 per 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/STTR applications. However, well-justified Phase I applications for an SBIR/STTR award with greater than 33 percent contractual costs will be considered when those costs are necessary to support the development and evaluation of tools for insertional mutagenesis. 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 (R44) or STTR (R42) grants 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 of the challenges that may be involved in the development and evaluation of insertional mutagenesis technology, the participating Institutes will entertain well-justified Phase II applications for an SBIR/STTR award with a project period up to two years and a budget of no more than $500,000 per year for STTR and $750,000 for SBIR awards. Consultant and contractual costs: For SBIR projects, the total amount of all contractual costs and consultant fees normally may not exceed 33 percent of the total costs requested for Phase I projects and 50 percent of total costs requested for Phase II projects. However, well-justified Phase II applications for an SBIR award with greater contractual costs will be considered when those costs are necessary to support the development, evaluation, and validation of tools for insertional mutagenesis. FUNDS AVAILABLE It is expected that 10-20 awards will be made during FY 2001 and FY 2002, and approximately $3.15 million from the SBIR set-aside of the participating NIH Institutes and Centers 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 use of transposon tagging and retroviral insertional mutagenesis in model organisms such as Drosophila, C. elegans, and zebrafish has greatly facilitated the characterization of gene function and permitted rapid cloning of the mutated gene. This approach has complemented analysis of gene function using chemically and X-ray-induced mutations where great effort is expended in positional cloning of the mutant gene. Insertional mutagenesis in mice is made practical by the availability of efficient methods of transfecting ES cells, the production of a 2.5 to 3.5X draft of the mouse genome using C57BL/6 by February 2001, polymerase chain reaction (PCR), and automated sequencing methods. The development of both random and targeted sequence-tagged insertion libraries in mouse ES cells would greatly facilitate analysis of gene function in mice and permit the rapid development of mouse models for human genetic disease. Not only would such an approach create induced mutation methodologies, but it would also permit analysis of patterns of gene expression. The value of this resource would be greatly enhanced by the use of site-specific gene recombination systems or trans-acting factor binding sites that would allow the expression of the tagged gene to be controlled temporally and spatially. Two recombination systems currently used to create conditional mutations or knockouts in mice are the cre-lox and FLP-FRT site-specific recombination systems. The usefulness of these recombination systems in vertebrate systems is dependent on the activity of the recombinase and the ability to drive the expression of the recombinase with non-mammalian promoters, such as ecdysone or tetracycline-sensitive promoters. The ability to control the spatial expressions of the recombinase is limited by the lack of well-characterized enhancers that control gene expression. To overcome these obstacles, modifications of these recombinase systems, as well as the development of new ones, are needed. In addition, the flexibility of existing systems can be enhanced through the use of inducible promoters or fusion-protein recombinases that are activated by ligands such as steroids. The creation of appropriate insertional mutagenesis vectors containing site- specific recombination targets will also aid in the generation of chromosomal deletions, duplications, and inversions when another genetic locus is tagged with a vector containing the same target sequence. Chromosomal aberrations are an important tool for selecting and mapping mutations in a specific chromosomal region and for positional cloning, as well as for the study of position effects and contiguous gene syndromes. In addition, inversions can be combined to produce balancer chromosomes. Balancer chromosomes carrying dominant phenotypic markers simplify the maintenance of recessive mutations and combinations of alleles from generation to generation because the balancer prevents recombination. Balancer chromosomes also facilitate isolation and high-throughput screening for new recessive mutations. Current estimates are that a total of 500,000 ES cell lines may be needed to tag every single mouse gene. Thus, high-throughput methods are needed to automate the processing of large numbers of clones and to identify the site of insertion. The use of C57BL/6 ES cells will speed the distribution of mice in a defined isogenic background by eliminating the need to cross sv129 mice over successive generations into C57BL/6. Many of the current sv129 cell lines in use are derived from different strains of sv129 mice, making comparisons among the various targeted mutations difficult until transferred to a defined genetic background. Moreover, much of the public chemical mutagenesis and sequencing effort is being done in C57BL/6. Thus, crosses between C57BL/6 mice carrying mutations created by ENU and C57BL/6 mice carrying a targeted deletion can be performed in a single generation without concern about the effects of genetic background. It is anticipated that the results of funded research projects will eventually lead to production of new libraries of ES cells with random or targeted insertional mutations for wide distribution to the research community. Examples of research that may be considered responsive to this RFA include, but are not limited to, those listed below. o Feasibility studies for the establishment of sequence-tagged insertional libraries of C57BL/6 ES cells in which the expression of the tagged gene can be controlled temporally and spatially. o The development of new or modified site-specific recombination systems for efficient random and targeted insertional mutagenesis and enhanced control of conditional expression. o The development of novel vectors that allow imaging of specific cell types or tissues, metabolic activity, or other cellular or physiological functions. o The invention of efficient systems for transposon tagging in mammalian systems for the wide use of the scientific community. o The development of vectors for identification ("trapping") of promoters and enhancers that could be used for tissue-specific and temporal expression of recombinases and for the study of gene expression patterns. o Methods to automate the processing of large numbers of clones and to identify the sites of insertion. SPECIAL REQUIREMENTS It is the policy of the NIH to make available to the public the results and accomplishments of the activities it funds [NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps, Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, December 1999 (http://www.nih.gov/od/ott/RTguide_final.htm)]. Biomaterials and other patentable research resources (e.g., mutagenesis protocols, vectors, embryonic cell lines, etc.) produced in projects funded by this RFA are expected to be made available and distributed to the broader scientific community. The NIH encourages the commercialization of research products and allows grantee organizations to make materials available to others for commercial purposes with appropriate restrictions and licensing terms. Where the product of research developed with federal funding is a patentable but unpatented research product, the terms of a license must be no more restrictive than they would have been if the product had been patented. Plan to Share Resources and Handle Intellectual Property Rights NIH is interested in ensuring that the research resources developed through this RFA become readily available to the research community. Therefore, applicants are required to include in their applications a specific plan by which they will make research resources available to the wider scientific community. The plan must also address how they will exercise their intellectual property rights while making available to the broader scientific community patentable research resources. The scientific review group will evaluate the adequacy of the proposed plan for access and for handling intellectual property rights. Comments on the plan and any concerns will be presented in an administrative note in the Summary Statement. The adequacy of the plan will be considered by NIH program staff and will be important in determining whether the grant shall be awarded. The plan as approved, after negotiation with the applicant when necessary, will be a condition of the award. Evaluation of non-competing continuation applications will include assessment of the effectiveness of research resource release and of the awardee’s adherence to the proposed plan to handle intellectual property rights. Disclosure of Invention Applicants also are reminded that the grantee institution is required to disclose each subject invention to NIH within two months after the inventor discloses it in writing to grantee institutional personnel responsible for patent matters. The awarding Institute reserves the right to monitor awardee activity in this area to ascertain if patents or patent applications on mutagenesis protocols, cell lines, vectors, or other patentable subject matter are adversely affecting the goals of this RFA. 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 phone 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 NIH 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. Rebekah S. Rasooly Division of Neuroscience and Behavioral Research National Institute on Drug Abuse/NIH 6001 Executive Boulevard, Room 4260, MSC 9555 Bethesda, MD 20892-9555 Phone: 301-443-6300 Fax: 301-594-6043 APPLICATION PROCEDURES Applicants should follow the instructions for SBIR/STTR 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/funding/sbir/modelsbi.htm. This RFA must be read in conjunction with the Omnibus Solicitation of the Public Health Service for SBIR/STTR 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 Solicitation for the SBIR/STTR 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. 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) or STTR Phase I PHS 6346-3 (http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf). The application forms are also located in the back pages of the Omnibus SBIR/STTR 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/STTR 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/STTR support at all stages of insertional mutagenesis tool development. Projects will be evaluated on overall innovation and success potential of the product/technology. Larger budgets and longer project periods may be considered if required for conduct of the research and appropriately justified in the application. Applicants planning to propose research in excess of the limits (duration and amount) listed earlier in this RFA must obtain agreement from Institute staff (named under INQUIRIES below) that the application will be accepted for consideration. The applicant must identify, in the cover letter that is sent with the application, the staff member and Institute who agreed to accept the application. Fast-Track Applications: 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 application 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 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. Rebekah S. Rasooly Division of Neuroscience and Behavioral Research National Institute on Drug Abuse/NIH 6001 Executive Boulevard, Room 4260, MSC 9555 Bethesda, MD 20892-9555 Phone: 301-443-6300 Fax: 301-594-6043 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review and for responsiveness by NIDA staff. 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 Center for Scientific Review, in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and may 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 or technology that will improve mouse insertional mutagenesis and that the applications must address the evaluation and validation of the product using C57BL/6 ES cells. 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 are available on the Web at the following URL address: http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf. 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? 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 the application are achieved, how will scientific knowledge be advanced? Does the proposal lead to enabling technologies (e.g., instrumentation, software) for further discoveries? Will the technology have a competitive advantage over existing/alternate technologies that can meet the market needs? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Is the proposed plan a sound approach for establishing technical and commercial feasibility? 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/STTR? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers, including consultants and subawardees (if any)? (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? In accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of the proposed protection for animals or the environment to the extent they may be adversely affected by the project proposed in the application. o The appropriateness of the proposed budget and duration in relation to the proposed research. The following evaluation criterion will be presented in an administrative note in the Summary Statement and will not factor into the numerical score: o The adequacy of plans to make the methods and materials generated in the project widely available in a timely fashion to the scientific community, given the proposed plan to exercise (or not to exercise) intellectual property rights. Phase II Applications In addition to the above criteria, to what degree was progress toward the Phase I objectives met and feasibility demonstrated in providing a solid foundation for the proposed Phase II activity? Phase I/Phase II Fast-Track Applications For Phase I/Phase II Fast-Track applications, the following additional criteria will be applied: Does the Phase I application specify clear, measurable goals (milestones) that should be achieved prior to initiating Phase II? Did the applicant submit a concise Product Development Plan that adequately addresses the four areas described in Section VI, item G, of the Omnibus Solicitation? To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/STTR funding sources that would enhance the likelihood for commercialization? AWARD CRITERIA When making funding decisions, the awarding components take into consideration the following: (1) ratings resulting from the scientific and technical evaluation process, (2) areas of high program relevance, (3) program balance (that is, balance among areas of research), (4) available funds, (5) 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), (6) adequacy of plans to make widely available to the research community all research resources developed during this project, and (7) adequacy of plans to exercise (or not exercise) intellectual property rights while permitting wide availability to the research community of patentable research resources developed during this project. The awarding component will notify the Principal Investigator and the applicant small business concern of the final disposition of the application. The National Institute of Mental Health will support only SBIR grants under this RFA. 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: March 11, 2001 Application Receipt Date: April 11, 2001 Review by Council: September 2001 Earliest Award Date: September 30, 2001 INQUIRIES Written and phone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Dr. Rebekah S. Rasooly Division of Neuroscience and Behavioral Research National Institute on Drug Abuse/NIH 6001 Executive Boulevard, Room 4260, MSC 9555 Bethesda, MD 20892-9555 Phone: 301-443-6300 Fax: 301-594-6043 Email: rr185i@nih.gov Dr. Cathrine Sasek SBIR/STTR Coordinator Office of Science Policy and Communications National Institute on Drug Abuse/NIH 6001 Executive Boulevard, Room 5237, MSC 9591 Bethesda, MD 20892-9591 Phone: 301-443-6071 Fax: 301-443-6277 Email: csasek@nih.gov Dr. Rochelle K. Small Craniofacial Anomalies and Injuries Branch National Institute of Dental and Craniofacial Research/NIH Natcher Building, Room 4AN-24K Bethesda, MD 20892 Phone: 301-594-9898 Fax: 301-480-8318 Email: rochelle.small@nih.gov Dr. Bernard Janicki SBIR/STTR Coordinator National Institute of Dental and Craniofacial Research/NIH Building 45/4AN-12B Bethesda, MD 20892-2190 Phone: 301-594-4861 Fax: 301-480-8318 Email: bj68j@nih.gov Dr. Anna M. McCormick Chief, Genetics and Cell Biology Branch Genetics Program Director Biology of Aging Program National Institute on Aging/NIH Gateway Building, Suite 2C231 7201 Wisconsin Avenue Bethesda, Maryland 20892 (20814 for express deliveries) Phone: 301-496-6402 Fax: 301-402-0010 Email: mccormia@exmur.nia.nih.gov Dr. Miriam F. Kelty National Institute on Aging/NIH Gateway Building, Rm 218C 7201 Wisconsin Avenue Bethesda, MD 20892 Phone: 301-496-9322 Fax: 301-402-2945 Email: mk46u@nih.gov Dr. Judith H. Greenberg Director, Division of Genetics and Developmental Biology National Institute of General Medical Sciences/NIH Natcher Building, Room 2As25 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Phone: 301-594-0943 Fax: 301-480-2228 Email: greenbej@nigms.nih.gov Dr. Paul Wolfe SBIR Program Administrator and Program Contact National Institute of General Medical Sciences/NIH Natcher Building, Room 2As25 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Phone: 301-594-0943 Fax: 301-480-2228 Email: wolfep@nigms.nih.gov Dr. Michael F. Huerta Associate Director Division of Neuroscience and Basic Behavioral Science SBIR/STTR Coordinator National Institute of Mental Health/NIH 6001 Executive Boulevard, Room 7202, MSC 9645 Bethesda, MD 20892-9645 Phone: 301-443-3563 Fax: 301-443-1731 Email: mhuerta@helix.nih.gov Dr. Bettie Graham Division of Extramural Research SBIR/STTR Coordinator National Human Genome Research Institute/NIH Building 31, Room B2B07 Bethesda, MD 20892-2033 Phone: 301-496-7531 Fax: 301-480-2770 Email: bettie_graham@nih.gov Dr. Thomas M. Johnson Program Director Scientific Programs Branch National Institute on Deafness and Other Communication Disorders/NIH Executive Plaza South-400C 6120 Executive Boulevard Bethesda, MD 20892-7180 Phone: 301-402-3461 Fax: 301-402-6251 Email: tj65y@nih.gov Dr. Lynn E. Luethke SBIR/STTR Coordinator National Institute on Deafness and Other Communication Disorders/NIH 6120 Executive Boulevard, MSC 7180 Bethesda, MD 20892-7180 Phone: 301-402-3458 Fax: 301-402-6251 Email: lynn_luethke@nih.gov Dr. Sheryl Sato Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases/NIH 6707 Democracy Plaza, Room 601 Bethesda, MD 20892-5460 Phone: 301-594-8811 Fax: 301-480-3503 Email: satos@extra.nddk.nih.gov Dr. Judy Podskalny SBIR/STTR Coordinator National Institute of Diabetes and Digestive and Kidney Diseases/NIH 6707 Democracy Plaza, Room 667 Bethesda, MD 20892-5450 Phone: 301-594-8876 Fax: 301-480-8300 Email: jp53s@nih.gov Dr. Peter A. Dudley Division of Extramural Research National Eye Institute/NIH 6120 Executive Boulevard, Suite 350, MSC 7164 Bethesda, MD 20892-7164 Phone: 301-496-0484 Fax: 301-402-0528 Email: pad@nei.nih.gov Dr. Ralph Helmsen SBIR/STTR Coordinator National Eye Institute/NIH 6120 Executive Boulevard, Suite 350, MSC 7164 Bethesda, MD 20892-7164 Phone: 301-496-5301 Fax: 301-402-0528 Email: rjh@nei.nih.gov Dr. Franziska Grieder Comparative Medicine SBIR/STTR Coordinator National Center for Research Resources/NIH One Rockledge Center 6705 Rockledge Drive, Suite 6050 Bethesda, MD 20892-7965 Phone: 301-435-0744 Fax: 301-480-3819 Email: GriederF@ncrr.nih.gov Dr. Robert W. Karp Division of Basic Research National Institute on Alcohol Abuse and Alcoholism/NIH 6000 Executive Boulevard, Suite 402, MSC 7003 Bethesda, MD 20892-7003 Phone: 301-443-2239 Fax: 301-594-0673 Email: rkarp@willco.niaaa.nih.gov Dr. Michael Eckardt SBIR/STTR Coordinator National Institute on Alcohol Abuse and Alcoholism/NIH 6000 Executive Boulevard, Suite 409, MSC 7003 Bethesda, MD 20892-7003 Phone: 301-443-6107 Fax: 301-443-6077 E-mail: meckardt@willco.niaaa.nih.gov Dr. Steven Klein Developmental Biology, Genetics and Teratology Branch National Institute of Child Health and Human Development/NIH 6100 Executive Boulevard, Room 4B01 Bethesda, MD 20892 Phone: 301-496-5541 Fax: 301-480-0303 Email: KleinS@Exchange.nih.gov Dr. Louis A. Quatrano Director, Behavioral Science and Rehabilitation Engineering Program SBIR Coordinator National Institute of Child and Health and Human Development/NIH 6100 Executive Boulevard, Room 2A-03 Bethesda, MD 20892 Phone: 301-402-4221 Fax: 301-402-0832 Email: lq2n@nih.gov Dr. Jerry Heindel Scientific Program Administrator SBIR/STTR Coordinator Division of Extramural Research and Training National Institute of Environmental Health Sciences/NIH P.O.B. 12233 101 T. W. Alexander Drive Research Triangle Park, NC 27709 Phone: 919-541-0781 Fax: 919-541-5064 Email: heindelj@niehs.nih.gov Dr. Alison Deckhut Basic Immunology Branch Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases/NIH 6700-B Rockledge Drive, Room 5138, MSC 7640 Bethesda, MD 20892-7640 Phone: 301-496-7551 Fax: 301-402-2571 Email: adeckhut@niaid.nih.gov Dr. Greg Milman Director, Innovation and Special Programs Division of Extramural Activities National Institute of Allergy and Infectious Diseases/NIH 6700-B Rockledge Drive, Room 2140, MSC 7610 Bethesda, MD 20892-7610 Phone: 301-496-8666 Fax: 301-402-0369 Email: gm16s@nih.gov Thomas Miller, Ph.D. SBIR Program Analyst Technology Development National Institute of Neurological Disorders and Stoke/NIH 6001 Executive Boulevard, Room 2139 Bethesda, MD 20892 Phone: 301-496-1779 Fax: 301-402-1501 Email: tm208y@nih.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse/NIH 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Phone: 301-443-6710 Fax: 301-443-6847 Email: gf6s@nih.gov Mr. Martin Rubinstein Grants Management Branch National Institute of Dental and Craniofacial Research/NIH 45 Center Drive, Room 4AN-44 Bethesda, MD 20892-6402 Phone: 301-594-4800 Fax: 301-480-8301 Email: Martin.Rubinstein@nih.gov Ms. Linda Whipp Grants and Contracts Management Office National Institute on Aging/NIH Gateway Building, Suite 2N212, MSC 9205 7201 Wisconsin Avenue Bethesda, MD 20892-9205 (20814 for Express deliveries) Phone: 301-496-1472 Fax: 301-402-3672 Email: whippl@nia.nih.gov Ms. Marcia Cohn National Institute of General Medical Sciences/NIH Building 45, Room 2An24 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Phone: 301-594-3918 Fax: 301-480-2554 Email: cohnm@nigms.nih.gov Ms. Diana S. Trunnell Grants Management Branch National Institute of Mental Health/NIH 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Phone: 301-443-2805 Fax: 301-443-6885 Email: Diana_Trunnell@nih.gov Ms. Jean Cahill Grants Administration Branch National Human Genome Research Institute/NIH Building 31, Room B2-B34 Bethesda, MD 20892-2031 Phone: 301-402-0733 Fax: 301-402-1951 Email: jc166o@nih.gov Ms. Sara Stone Chief, Grants Management Office Division of Extramural Research National Institute on Deafness and Other Communication Disorders/NIH Executive Plaza South-400B 6120 Executive Boulevard Bethesda, MD 20892-7180 Phone: 301-402-0909 Fax: 301-402-1758 Email: stones@nidcd.nih.gov Mr. George Tucker Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases/NIH 6707 Democracy Boulevard, Rm. 654, MSC 5456 Bethesda, MD 20892-5456 Phone: 301-594-8853 Fax: 301-480-3504 Email: gt35v@nih.gov Mr. William Darby Grants Management Officer National Eye Institute/NIH Executive Plaza South, Suite 350 Bethesda, MD 20892-7164 Phone: 301-496-5884 Fax: 301-496-9997 Email: wwd@nei.nih.gov Mr. Bryan Clark Office of Grants Management National Center for Research Resources/NIH One Rockledge Center, Suite 6174 6705 Rockledge Drive Bethesda, MD 20892 Tel: 301-435-0835 Fax: 301-480-3777 Email: ClarkB@ncrr.nih.gov Ms. Linda Hilley Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism/NIH 6000 Executive Boulevard, Suite 504, MSC 7003 Bethesda, MD 20892-7003 Phone: 301-443-4703 Fax: 301-443-3891 Email: lhilley@willco.niaaa.nih.gov Mr. Edgar D. Shawver Grants Management Branch National Institute of Child Health and Human Development/NIH 6100 Executive Boulevard, Rm. 8A07 Bethesda, MD 20892 Phone: 301-496-5001 Fax: 301-496-0915 Email: ShawverD@exchange.nih.gov Ms. Carolyn Winters Grants Management Specialist, SBIR/STTR Division of Extramural Research and Training National Institute of Environmental Health Sciences/NIH P.O.B. 12233 101 T.W. Alexander Drive Research Triangle Park, NC 27709 Phone: 919-541-7823 Fax: 919-541-2860 Email: mwinters@niehs.nih.gov Ms. Pamela Fleming Division of Extramural Activities National Institute of Allergy and Infectious Diseases/NIH 6700-B Rockledge Drive, Room 2119, MSC 7614 Bethesda, MD 20892-7614 (Regular Mail) Bethesda, MD 20817 (Express Mail) Phone: 301-402-6580 Fax: 301-493-0597 Email: pf49e@nih.gov Ms. Joellen Harper Grants Management Branch National Institute of Neurological Disorders and Stoke/NIH 6001 Executive Boulevard, Room 3290 Bethesda, MD 20892 Phone: 301-496-9231 Fax: 301-402-0219 Email: jh41m@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.279 (NIDA), 93.866 (NIA), 93.862 (NIGMS), 93.121 (NIDCR), 93.242 (NIMH), 93.172 (NHGRI), 93.371 (NCRR), 93.173 (NIDCD), 93.273 (NIAAA), 93.847 (NIDDK), 93.867 (NEI), 93.864 and 93.865 (NICHD), 93.113 (NIEHS), 93.855 (NIAID), and 93.853 (NINDS). 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.

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