National Institutes of Health Small Business Innovation Research (SBIR) Program Small Business Technology Transfer (STTR) Program 8 th Annual NIH SBIR/STTR Conference Renaissance Cleveland Hotel Cleveland, Ohio July 13, 2006 Jo Anne Goodnight NIH SBIR/STTR Program Coordinator Office of Extramural Research National Institutes of HealthSlide 2
Extramural Programs Reserved for Small Business SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM "The most ideal approach to foresee what\'s to come… is to make it."Slide 3
SBIR/STTR PROGRAM GENERAL FEATURESSlide 4
SBIR/STTR Program Mission Supporting logical fabulousness and mechanical development through the venture of government exploration stores in basic American needs to assemble a solid national economy … one little business at once .Slide 5
Program Descriptions Small Business Innovation Research (SBIR) Set-aside program for little business concerns to take part in government R&D - with potential for commercialization. Little Business Technology Transfer (STTR) Set-aside program to encourage agreeable R&D between little business concerns and U.S. research organizations - with potential for commercialization. 2.5% 0.3%Slide 6
WHY SBIR???? Little Business Innovation Development Act of 1982 Congress assigned 4 noteworthy objectives Stimulate mechanical advancement Use little business to meet government R&D needs Foster and energize support by minorities and impeded persons in mechanical advancement Increase private-segment commercialization developments got from elected R&DSlide 7
2000 REAUTHORIZATION MAJOR PROVISIONS OF P.L. 106-554; Signed 12/21/00 Program Extension until 9/30/2008 Output and Outcome Data - Public Database: essential honor data (Tech-Net- - http://technet.sba.gov) - Government Database: program assessment (Phase II awardees - e.g., new item deal incomes; other venture financing sources)Slide 8
WHY STTR???? Little Business Research and Development Enhancement Act of 1992 Stimulate and encourage exploratory and mechanical advancement through helpful innovative work did between little business concerns and research organizations Foster innovation exchange between little business concerns and research establishmentsSlide 9
2001 STTR REAUTHORIZATION Reauthorized through FY2009 Set-aside expanded from 0.15% to 0.30% in FY 2004 Phase II recompense levels expanded from $500,000 to $750,000 in FY 2004 Participating offices to execute comparable effort endeavors as SBIRSlide 10
"Never, ever, conceive brand new ideas."Slide 11
SBIR/STTR: 3-Phase Program PHASE I Feasibility Study $100K and 6-month (SBIR) or 12-month (STTR) Award PHASE II Full Research/R&D $750K and 2-year Award (SBIR/STTR) PHASE III Commercialization Stage Use of non-SBIR/STTR FundsSlide 12
SBIR PROGRAM ELIGIBILITY CHECKPOINTS Organized revenue driven U.S. business 500 representatives or less, including subsidiaries PI\'s essential work must be with the little business worry at the season of grant and for the length of the venture period.Slide 13
SBIR PROGRAM ELIGIBILITY CHECKPOINTS Small business concern must be: At slightest 51% U.S.- claimed by people and freely worked or if nothing else 51% possessed and controlled by another (one) revenue driven business worry that is no less than 51% possessed and controlled by one or more peopleSlide 14
STTR PROGRAM ELIGIBILITY CHECKPOINTS Applicant is Small Business Concern Subsidiaries are NOT qualified for STTR program Formal Cooperative R&D Effort Minimum 40% by little business Minimum 30% by U.S. research organization U.S. Research Institution College or University; other non-benefit research association; Federal R&D focus Intellectual Property Agreement Allocation of Rights in IP and Rights to Carry out Follow-on R&D and CommercializationSlide 15
SBIR/STTR ELIGIBILITY OWNERSHIP AND CONTROL got questions? Contact the SBA Size Specialists Request a qualification determination http://www.sba.gov/size/indexcontacts.htmlSlide 16
PERFORMANCE of RESEARCH ACTIVITIES "All exploration/R&D must be performed completely in the U.S." Rare cases to lead testing of particular patient populaces outside U.S. is passable Travel to experimental meeting in remote nation reasonable Foreign specialists/teammates admissible, yet should perform counseling in U.S.Slide 17
FEE/PROFIT Up to 7% of aggregate direct and F&A expenses might be asked for charge Must be REQUESTED/JUSTIFIED in application/proposition Only SBC qualified ; no agreements, consortium or other outsider are qualified for charge Not immediate or circuitous expense *DISCUSS WITH AGENCIESSlide 18
TOTAL $2.0 + B FY 2006 SBIR/STTR Participating Agencies DOD SBIR/STTR HHS SBIR/STTR NASA SBIR/STTR DOE SBIR/STTR NSF SBIR/STTR DHS SBIR/STTR USDA SBIR DOC SBIR ED SBIR EPA SBIR DOT SBIRSlide 19
We\'re all only a smidgen diverse ...Slide 20
About 6-9 months Standard Phase I Process Solicitation Topics Agencies portray R&D themes in requesting. Little Business Concerns get ready short (as a rule 25-page)proposals . Spontaneous recommendations not acknowledged. Proposition Submission Evaluation Agencies assess in light of specialized legitimacy , association\'s capabilities , and business potential/societal advantage . Ph I grant Agencies make Phase I honors .Slide 21
Agency SBIR Differences Number and Timing of Solicitations R&D Topic Areas - (Broad versus Centered) Dollar Amount of Award (Phase I and II) Proposal Preparation Instructions Financial points of interest (e.g., Indirect Cost Rates, Gap Funding) Receipt Dates Proposal Review Process Proposal Success Rates Type of Award (Contract or Grant)Slide 22
SBIR AND STTR PROGRAMS CRITICAL DIFFERENCES Research Partner SBIR: Permits research organization accomplices [Outsource ~ 33% Phase I and half Phase II R&D] STTR: Requires research establishment accomplices (e.g., colleges) [40% little business worries (for-benefit) and 30% U.S. research foundation (non-profit)] AWARD ALWAYS MADE TO SMALL BUSINESSSlide 23
SBIR AND STTR PROGRAMS CRITICAL DIFFERENCES Principal Investigator SBIR: Primary (>50%) vocation must be with little business concern STTR: Primary livelihood not stipulated [PI can be from examination organization and/or from little business concern*] *DISCUSS WITH AGENCIESSlide 24
Important Facts to Remember Eligibility is resolved at time of grant No reference sections permitted in Phase I The PI is not required to have a Ph.D. on the other hand M.D. The PI is required to have skill to manage extend deductively and in fact Applications might be submitted to various offices for comparable work Awards may not be acknowledged from various organizations for duplicative activitiesSlide 25
Advice from Awardees Don\'t pass judgment on an office\'s advantages by its " name " Understand office\'s central goal & needs Get to know your office Program Manager Read requesting and take after instructionsSlide 26
Advice from Awardees Don\'t depend entirely on SBIR subsidizing Don\'t go only it - use emotionally supportive networks Have a result Win or lose - get and audit assessments Be PERSISTENTSlide 27
NIH SBIR/STTR PROGRAM FEATURES and NUANCESSlide 28
The Secretary Deputy Secretary Administration for Children and Families (ACF) Administration on Aging (AoA) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Centers for Medicare And Medicaid Services (CMS) Agency for Healthcare Research and Quality (AHRQ) Indian Health Services (IHS) National Institutes of Health (NIH) Centers for Disease Control and Prevention (CDC) Agency for Toxic Substances and Disease Registry (ATSDR) Substance Abuse and Mental Health Services Administration (SAMHSA) Program Support Center (PSC) U. S. Bureau of Health and Human ServicesSlide 29
Improve human wellbeing through biomedical and behavioral exploration, research preparing and correspondences. NIH MissionSlide 30
SBIR Program: Importance to NIH Transforming pharmaceutical through development The SBIR system is incorporated inside the NIH research motivation. Enhance human strength of the Nation (aversion, identification, finding and treatment of infection or handicap). Speed procedure of disclosure. Diminish expense of restorative consideration. Enhance research instruments/diminish expense of exploration. Expand wellbeing information base.Slide 31
SBCs can utilize SBIR/STTR help NIH meet its central goal Conduct creative R/R&D that outcomes in item, process, or administration that will... Enhance quiet wellbeing (aversion, recognition, determination and treatment of sickness or handicap) Speed procedure of revelation Reduce expense of medicinal consideration Improve research apparatuses/diminish expense of examination Help in preparing of exploration agents Increase wellbeing information baseSlide 32
DHHS Budget and Award Amount $640M ****Propose a Realistic and Appropriate Budget for the Research**** Take Home Message #1Slide 33
Types of SBIR/STTR Awards ~95% GRANTS: you choose the exploration and item to be composed or created (SBIR/STTR) CONTRACTS: The administration chooses the exploration and general item to fill their apparent need (SBIR just) COOPERATIVE AGREEMENTS: Similar to stipends, yet recompensing IC has significant association in completing the task\'s exercises. ~4-5% <1%Slide 34
NIH ISSUES MULTIPLE SOLICITATIONS SBIR/STTR Omnibus Grant Solicitation (NIH, CDC, and FDA) = Parent FOA Release: January April 1, Aug 1, Dec 1 receipt dates SBIR Contract Solicitation (NIH, CDC) Relea
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