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Kay Etzler NIH SBIR

Agenda. SBIR/STTR Overview NIH SBIR/STTR Overview What's new Latest funding opportunities. $$$$$. . Small Business Innovation Research (SBIR) Set-aside program for small businessconcerns to engage in federal R

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Kay Etzler NIH SBIR

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    2. Agenda SBIR/STTR Overview NIH SBIR/STTR Overview What’s new Latest funding opportunities

    3. Small Business Innovation Research (SBIR) Set-aside program for small business concerns to engage in federal R&D -- with potential for commercialization. Small Business Technology Transfer (STTR) Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions -- with potential for commercialization.

    4. SBIR/STTR: 3-Phase Program PHASE I Feasibility Study $100K and 6-month (SBIR) or 12-month (STTR) Award

    5. SBIR AND STTR PROGRAMS CRITICAL DIFFERENCES Research Partner SBIR: Permits research institution partners [Outsource ~ 33% Phase I and 50% Phase II R&D] STTR: Requires research institution partners (e.g., universities) [40% small business concerns (for-profit) and 30% U.S. research institution (non-profit)]

    6. Principal Investigator SBIR: Primary (>50%) employment must be with small business concern STTR: Primary employment not stipulated [PI can be from research institution and/or from small business concern*] SBIR AND STTR PROGRAMS CRITICAL DIFFERENCES

    10. DOD SBIR/STTR HHS SBIR/STTR NASA SBIR/STTR DOE SBIR/STTR NSF SBIR/STTR DHS SBIR USDA SBIR DOC SBIR ED SBIR EPA SBIR DOT SBIR SBIR / STTR Participating Agencies

    11. Agency SBIR Differences

    12. NIH Mission

    14. DOD SBIR/STTR NASA SBIR/STTR DOE SBIR/STTR NSF SBIR/STTR DHS SBIR USDA SBIR DOC SBIR ED SBIR EPA SBIR DOT SBIR SBIR/STTR Participating Agencies

    15. NIH SBIR/STTR FUNDING RATES FISCAL YEAR 2004 (Preliminary)

    21. APPLICATION, REVIEW, and AWARD TIMELINE

    23. Phase II Review Criteria Same as Phase I Demonstrated Feasibility in Phase I High Degree of Commercial Potential based on Commercialization Plan

    24. SBIR “FAST-TRACK”

    25. NIH SBIR “FAST-TRACK” Best Option For Everyone?

    26. Updated PHS-398 Submission Forms (9/04) Phase II Competing Continuations Executive Order 13329 – Encouraging Innovation in Manufacturing Technical Assistance Programs What’s New?

    27. Updated PHS-398 Forms (9/04) Form Page 2 – now two pages Description Performance Sites Key Personnel Other Significant Contributors Human Embryonic Stem Cells Budget Pages Modified to implement new policy on Direct Cost Limitations (affects only those funding opportunities which limit the amount requested based on Total Direct Costs) Font size Arial-11 or Helvetica-11 point required

    28. Phase II Competing Continuations Goal: Provide additional research funds to move already identified drugs or devices requiring regulatory approval into clinical trials Stipulations: Available only to Phase II grantees preparing for clinical trials Focus -- Diagnostics, devices, tissue engineering, drug development, biologics Funding level: $750K to $1M per year for maximum of 3 years IC must have announced the opportunity

    29. Technical Assistance Programs Commercialization Assistance

    30. Executive Order 13329 Requires SBIR/STTR Agencies to give high priority to manufacturing-related research and development

    31. Latest Funding Opportunities (Samples) http://grants.nih.gov/grants/funding/sbir_announcements.htm RFA-06-005: Innovative Technologies for Molecular Analysis of Cancer PA-04-156: Bioengineering Approaches to Energy Balance and Obesity PAR-03-119: Innovations in Biomedical Computational Science and Technology PA-04-161: Manufacturing Processes of Medical, Dental, & Biological Technologies PA--05-014: Molecular Libraries Screening Instrumentation

    32. PAR-03-119: Innovations in Biomedical Computational Science and Technology Unique Features: Special receipt dates (Oct ’04, Feb ’05, Oct ’05, Feb ’06) Trans-NIH opportunity Flexible budget and project durations Phase I: 2 yrs, $100K direct costs each year Phase II: 3 yrs, no official budget limit Parallel Announcement (PAR-03-106)

    33. RFA-AT-05-005: Improving Measurement Tools for Sternal Skin Conductance & Hot Flashes Unique Features: Special receipt date (Jan 25, 2005) Letter of Intent Receipt Date: (Dec 20, 2004) Only SBIR Phase I apps. accepted Flexible budget and project durations 1 yr, $200K total costs Multiple IC participation (NCCAM, NIA, NIBIB)

    35. Applications Submitted to NIH Center for Scientific Review

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