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The SBIR and STTR Programs at the National Institutes of Health General Information and Nuances.

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Presentation on theme: "The SBIR and STTR Programs at the National Institutes of Health General Information and Nuances."— Presentation transcript:

1 The SBIR and STTR Programs at the National Institutes of Health General Information and Nuances

2 Agenda Basics of the SBIR & STTR programs NIH SBIR/STTR programs  Overview  What’s new  Latest funding opportunities  University participation/involvement

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. Program Descriptions 2.5% 0.3%

4 SBIR/STTR: 3-Phase Program PHASE I Ü Feasibility Study Ü $100K and 6-month (SBIR) or 12-month (STTR) Award PHASE II Ü Full Research/R&D Ü $750K and 2-year Award (SBIR/STTR) PHASE III Ü Commercialization Stage Ü Use of non-SBIR/STTR Funds

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)] AWARD ALWAYS MADE TO SMALL BUSINESS

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*] *Varies Among Agencies SBIR AND STTR PROGRAMS CRITICAL DIFFERENCES

7 Organized for- profit U.S. business At least 51% U.S.- owned and independently operated Small Business located in the U.S. 500 or fewer employees P.I.’s primary employment with small business during project SBIR PROGRAM ELIGIBILITY CHECKPOINTS

8 Applicant is Small Business Concern Formal Cooperative R&D Effort Ü Minimum 40% by small business Ü Minimum 30% by U.S. research institution U.S. Research Institution Ü College or University; other non-profit research organization; Federal R&D center Intellectual Property Agreement Ü Allocation of Rights in IP and Rights to Carry out Follow-on R&D and Commercialization STTR PROGRAM ELIGIBILITY CHECKPOINTS

9 DODSBIR/STTR HHSSBIR/STTR NASA SBIR/STTR DOE SBIR/STTR NSF SBIR/STTR DHSSBIR USDASBIR DOCSBIR EDSBIR EPASBIR DOTSBIR SBIR / STTR Participating Agencies TOTAL ~ $2.0 B Est. FY 2004 New

10 We’re all just a little bit different...

11 Agency SBIR Differences Number and Timing of Solicitations R&D Topic Areas -- (Broad vs. Focused) Dollar Amount of Award (Phase I and II) Proposal Preparation Instructions Financial details (e.g., Indirect Cost Rates, Gap Funding) Receipt Dates Proposal Review Process Proposal Success Rates Type of Award (Contract or Grant)

12 Agency SBIR Differences Granting Agencies Ü Investigator initiates approach Ü Less-specified topics Ü Assistance mechanism Ü More flexibility DOD HHS/NIH NASAED EPADOT DOC Contracting Agencies Ü Agency establishes plans, protocols, requirements Ü Highly focused topics Ü Procurement mechanism for DOD and NASA Ü More fiscal requirements HHS/NIH NSF ED USDA DOE

13 NIH Mission IMPROVE HUMAN HEALTH through biomedical and behavioral research, research training and communications.

14 Small Companies Can Help NIH meet its mission Conduct innovative R/R&D that results in product, process, or service that will... l Improve patient health l Speed process of discovery l Reduce cost of medical care/cost of research l Improve research & communication tools

15 DODSBIR/STTR NASASBIR/STTR DOESBIR/STTR NSFSBIR/STTR DHSSBIR USDASBIR DOCSBIR EDSBIR EPASBIR DOTSBIR SBIR/STTR Participating Agencies NIH: $ 564 M SBIR $ 67 M STTR $631 M Total CDC: $ 8.0 M SBIR FDA: ~ $ 0.8 M SBIR AHRQ: ~$ 2.1 M SBIR HHS SBIR/STTR TOTAL ~ $2.0 B FY 2004

16 NIH SBIR/STTR FUNDING RATES FISCAL YEAR 2003 Success Rate (%) 24% 44% 27% 43% 28% 22% $563 M SBIR/STTR (set aside $556M) 95 5

17 NUANCES NIH SBIR & STTR Programs l SBIR and STTR Program l Multiple Award Mechanisms l Multiple Receipt Date l Budget ~$100K/ $750K l External Peer Review Critiques sent to all applicants l Phase III è Single Solicitation è ~ 95% Awards are grants è April 1, Aug 1, Dec 1 è Realistic & appropriate è Academia and industry è NIH: rarely your customer

18 Examples of Cross-Cutting Areas of Interest l Nanotechnologies l Bioinformatics l Biodefense l Proteomics / Genomics l Genetically engineered proteins l Biosensors l Biosilicon devices l Biocompatible materials l Acousto-optics and opto-electronics l Imaging technologies l Education/communication tools l Computational biology l Behavioral research

19 Our Ideas …  SBIR/STTR Omnibus Grant Solicitation (NIH, CDC and FDA) Release: JanuaryOpen for entire Calendar Year  SBIR Contract Solicitation (NIH, CDC) Release: AugustOpen for ~ 3 months  NIH Guide for Grants and Contracts Release: WeeklyOpen as noted

20 l Investigator-initiated R&D l Research projects related to the NIH mission l “Other” areas of research within the mission of an awarding component Your Ideas …

21 SBIR/STTR Award Type l l Multiple Mechanisms, GRANTS, Contracts, Cooperative Agreements l l Award Amount and Project Period  Phase I~$100,0006 months  Phase II~$750,0002 years Realistic and appropriate

22 Application Assignments Institutes/Centers Scientific Review Group Center for Scientific Review Receipt & Referral Office Match between proposed research and IC’s mission for funding Match between proposed research and review groups for scientific/technical merit

23 Small Business Concern Applicant Initiates Research Idea Grantee Conducts Research IC Staff Prepare funding Plan for IC Director NIH Center for Scientific Review Assign to IC and IRG Scientific Review Groups Evaluate Scientific Merit Advisory Council or Board Recommend approval IC Allocates Funds Submits SBIR/STTR Grant Application to NIH ~2-3 months after submission ~2-3 months after review NIH SBIR/STTR PROGRAM NIH SBIR/STTR PROGRAM Review Process for Research Grant

24 APPLICATION, REVIEW, and AWARD TIMELINE SBIR/STTR Scientific/TechnicalAdv Council Awd Receipt Dates Peer ReviewBoard Review Date Apr 1 June/JulySept/Oct Nov Aug 1 Oct/NovJan/Feb Mar Dec 1 Feb/MarchMay/June July 90-Day pre-award costs are allowable: At your own risk….. 7 to 9 months

25 REVIEW CRITERIA (Phase I) l Significance (Real Problem/Real People) l Approach (Research Design, Feasible) l Innovation (New or Improved?) l Investigators (PI and team) l Environment (Facilities/Resources) … Protection of Human Subjects … Animal Welfare … Budget

26 Phase II Review Criteria l Same as Phase I l Demonstrated Feasibility in Phase I l Commercialization Plan l High Degree of Commercial Potential based on plan … Protection of Human Subjects … Animal Welfare … Budget

27 SBIR “FAST-TRACK” Standard application, review, award process Fast-Track review option Satisfactory Phase I Final Report Phase I 7-9 months Simultaneous submission/review Phase I + Phase II 7-9 months Phase II 6 months 24 months 6 months Phase II 7-9 months

28 NIH SBIR “FAST-TRACK” Best Option For Everyone? l Convincing preliminary data? l Clear, measurable, achievable milestones? l Well-conceived Commercialization Plan? l Letters of Phase III support/interest? l Track record for commercializing? No! Speak with Program Staff Prior to Submission

29 Phase II Competing Continuations What’s New? Technical Assistance Programs Executive Order – Encouraging Innovation in Manufacturing

30 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 Funding level: $750K to $1M per year for maximum of 3 years IC must have announced the opportunity Speak with Program Staff Prior to Submission

31 Phase II Competing Continuations PAs & RFAs NIMH PA NICHD PA NCI PA NIAAA PA NHLBI PA NIAID RFA-AI NIDA PA Omnibus Solicitation NIA NIDCD NINDS

32 Technical Assistance Programs Commercialization Assistance Business & strategic planning Builds alliances and investor partnerships Pilot Niche Assessment Identify other uses of technology Determines competitive advantages Develops market entry strategy (Phase II awardees) (Phase I awardees)

33 Executive Order Requires SBIR/STTR Agencies to give high priority to manufacturing-related research and development …relating to manufacturing processes, equipment and systems; or manufacturing workforce skills and protection

34 Latest Funding Opportunities (Samples) RFA-CA : Innovative Technologies for Molecular Analysis of Cancer (SBIR/STTR) PAR : Innovations in Biomedical Computational Science and Technology PA : Novel Technologies for In Vivo Imaging

35 RFA-CA : Innovative Technologies for Molecular Analysis of Cancer Unique Features: Special receipt dates (Mar, Jun, Oct) Initial review convened by NCI Parallel in scope with RFA-CA Flexible budget and project durations Phase I: 2 yrs, $100K direct costs each year Phase II: 3 yrs, no official budget limit Annual meeting of investigators Objective: To develop highly innovative cancer- related methods and tools that enable research

36 PAS : Small Business Biodefense Program Unique Features: ~ $35M “set-aside” in FY 2003 Flexible budget and project durations Phase I: 2 yrs, $500K total costs per year Phase II: 3 yrs, $2M total costs per year Mandatory milestone – approval of the final clinical protocol by NIAID prior to start of clinical trial Objective: To rapidly develop specific products for biodefense

37 University Partnerships (Provide analytical and other service support) Consultants on SBIR/STTR Subcontracts on SBIR/STTR Senior Personnel on SBIR/STTR Principal Investigator (with official permission from University) Own small firms (assign someone else PI) Applicant must be the small business!

38 Alerts Solicitations Targeted Research Opportunities Sample Application Award Information Collaborative Opportunities Success Stories

39 I’m from the Government, and I’m here to help you….

40 Jo Anne Goodnight NIH SBIR/STTR Program Coordinator Phone: Fax: Kay Etzler SBIR/STTR Program Phone: Fax:


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