1. National Institutes of Health Small Business Innovation Research (SBIR) ProgramSmall Business Technology Transfer (STTR) Program 8th Annual NIH SBIR/STTR Conference Renaissance Cleveland HotelCleveland, OhioJuly 13, 2006 Jo Anne Goodnight NIH SBIR/STTR Program Coordinator Office of Extramural Research National Institutes of Health

2. Extramural Programs Reserved for Small Business SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM “The best way to predict the future… is to create it.”

3. SBIR/STTR PROGRAM GENERAL FEATURES

4. SBIR / STTR Program Mission Supporting scientific excellence and technological innovation through the investment of federal research funds in critical American priorities to build a strong national economy… onesmallbusinessatatime.

5. Program Descriptions 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. 2.5% 0.3%

6. WHY SBIR???? Small Business Innovation Development Act of 1982 Congress designated 4 major goals • Stimulate technological innovation • Use small business to meet federal R&D needs • Foster and encourage participation by minorities and disadvantaged persons in technological innovation • Increase private-sector commercialization innovations derived from federal R&D

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: basic award information (Tech-Net-- http://technet.sba.gov) - Government Database: program evaluation (Phase II awardees -- e.g., new product sale revenues; other investment funding sources)

8. WHY STTR???? Small Business Research and Development Enhancement Act of 1992 • Stimulate and foster scientific and technological innovation through cooperative research and development carried out betweensmall business concerns andresearch institutions • Foster technology transfer between small business concerns and research institutions

9. 2001 STTR REAUTHORIZATION • Reauthorized through FY2009 • Set-aside increased from 0.15% to 0.30% in FY 2004 • Phase II award levels increased from $500,000 to $750,000 in FY 2004 • Participating agencies to implement similar outreach efforts as SBIR

10. “Never, ever, think outside the box.”

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 Funds

12. SBIR PROGRAM ELIGIBILITY CHECKPOINTS • Organized for- profit U.S. business • 500 employees or fewer, including affiliates • PI’s primary employment must be with the small business concern at the time of award and for the duration of the project period.

13. SBIR PROGRAM ELIGIBILITY CHECKPOINTS Small business concern must be: • At least 51% U.S.- owned by individuals and independently operated or • At least 51% owned and controlled by another (one) for-profit business concern that is at least 51% owned and controlled by one or more individuals

14. STTR PROGRAM ELIGIBILITY CHECKPOINTS • Applicantis Small Business ConcernSubsidiaries are NOT eligible for STTR program • Formal Cooperative R&D Effort • Minimum 40% by small business • Minimum 30% by U.S. research institution • U.S. Research Institution • College or University; other non-profit research organization; Federal R&D center • Intellectual Property Agreement • Allocation of Rights in IP and Rights to Carry out Follow-on R&D and Commercialization

15. SBIR / STTR ELIGIBILITY OWNERSHIP AND CONTROL got questions? • Contact the SBA Size Specialists • Request an eligibility determination • http://www.sba.gov/size/indexcontacts.html

16. PERFORMANCE of RESEARCH ACTIVITIES • “All research/R&D must be performed in its entirety in the U.S.” • Rare cases to conduct testing of specific • patient populations outside U.S. is allowable • Travel to scientific meeting in foreign • country allowable • Foreign consultants/collaborators allowable, • but must perform consulting in U.S.

17. FEE/PROFIT Up to 7% of total direct and F&A costs may be requested for fee • Must be REQUESTED/JUSTIFIED in application/proposal • Only SBC eligible; no contracts, consortium or other third party are eligible for fee • Not direct or indirect cost *DISCUSS WITH AGENCIES

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 SBIR

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

20. About 6-9 months Standard Phase I Process Solicitation Topics • Agencies describe R&D topics in solicitations. • Small Business Concerns prepare • short (usually 25-page)proposals. • Unsolicited proposals not accepted. Proposal Submission Evaluation • Agencies evaluate based on technical • merit, firm’s qualifications, and • commercial potential / societal benefit. Ph I award • Agenciesmake Phase I awards.

21. 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)

22. SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES • Research Partner SBIR:Permits research institution partners [Outsource ~ 33% Phase I and 50% Phase II R&D] STTR:Requiresresearch 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

23. SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES • 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*] *DISCUSS WITH AGENCIES

24. Important Facts to Remember • Eligibility is determined at time of award • Noappendices allowed in Phase I • The PI is not required to have a Ph.D. or M.D. • The PI is required to have expertise to oversee project scientifically and technically • Applications may be submitted to different agencies for similar work • Awards may not be accepted from different agencies for duplicative projects

25. Advice from Awardees • Don’t judge an agency’s interests by its “name ” • Understand agency’s mission & needs • Get to know your agency Program Manager • Read solicitation and follow instructions

26. Advice from Awardees • Don’t depend solely on SBIR funding • Don’t go it alone - use support systems • Have an outcome • Win or lose - get and review evaluations • Be PERSISTENT

27. NIH SBIR/STTR PROGRAM FEATURES and NUANCES

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. Department of Health and Human Services

29. Improve human health through biomedical and behavioral research, research training and communications. NIH Mission

30. SBIR Program:Importance to NIHTransforming medicine through innovation The SBIR program is integrated within the NIH research agenda. • Improve human health of the Nation (prevention, detection, diagnosis and treatment of disease or disability). • Speed process of discovery. • Reduce cost of medical care. • Improve research tools/reduce cost of research. • Increase health knowledge base.

31. SBCs can use SBIR/STTR • help NIH meet its mission Conduct innovative R/R&D that results in product, process, or service that will... • Improve patient health • (prevention, detection, diagnosis and treatment • of disease or disability) • Speed process of discovery • Reduce cost of medical care • Improve research tools/ reduce cost of research • Help in training of research investigators • Increase health knowledge base

32. DHHS Budget and Award Amount $640M ****Propose a Realistic and Appropriate Budget for the Research**** Take Home Message #1

33. Types of SBIR / STTR Awards ~95% • GRANTS: you decide the research and product to be designed or developed (SBIR / STTR) • CONTRACTS: The government decides the research and general product to fill their perceived need (SBIR only) • COOPERATIVE AGREEMENTS: Similar to grants, but awarding IC has substantial involvement in carrying out the project's activities. ~4-5% <1%

34. NIH ISSUES MULTIPLE SOLICITATIONS SBIR/STTR Omnibus Grant Solicitation (NIH, CDC, and FDA) = Parent FOARelease: January April 1, Aug 1, Dec 1 receipt dates SBIR Contract Solicitation (NIH, CDC) Release: August Early November receipt date NIH Guide for Grants and Contracts Release: Weekly Various receipt dates http://grants.nih.gov/grants/funding/sbir.htm

35. SBIR/STTR Omnibus Solicitation • SBIR Parent Funding Opportunity Announcement • (PA-06-120) • STTR Parent Funding Opportunity Announcement  • (PA-06-121) • SBIR/STTR Program Descriptions and Research Topics (PDF or MS Word) http://grants1.nih.gov/grants/funding/sbir.htm

36. NIH Guide for Grants & ContractsSpecial SBIR/STTR Opportunities http://grants.nih.gov/grants/guide/index.html Go Beyond the SBIR/STTR Omnibus Solicitation….

37. NIH GUIDE: FOAs SBIR/STTR Opportunities (cont.)

38. Parent SBIR FOA

39. SBIR/STTR RESEARCH GRANT TOPICS Our Ideas…. examples Biodefense Biosensors Nanotechnologies Bioinformatics Behavioral research Computational Biology Cell and Gene Therapy Biosilicon devices Biocompatible materials Acousto-optics / opto-electronics Imaging technologies Genetically engineered proteins Proteomics / Genomics Complementary & Alt. Med (CAM) …

40. SBIR/STTR RESEARCH GRANT TOPICS Your ideas... • Investigator-initiated R&D • Research topics related to the NIH mission • “Other” areas of research within the • mission of an awarding component • … Take-home Message #2

41. NIH SBIR/STTR RESEARCH AREAS Angioscopes to Zebrafish

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

43. Grant Application Process E Are you R ady?

44. Submitting an Application Electronically • Find out at http://era.nih.gov/ElectronicReceipt/. •  New electronic Grants.gov application SF424 (R&R) • Check the Timeline • Register EARLY…http://grants.gov/

45. Electronic Submission Information: http://era.nih.gov/ElectronicReceipt/

46. Grants.gov: How It Works Before an applicant can Apply 1) Complete these registration steps: a) Go to http://grants.gov/GetStarted • Obtain a DUNS number (DUNS=Data Universal Numbering System). • Register in Central Contractor Registry (CCR). • Register with Grants.gov. b) Go to https://commons.era.nih.gov/commons/ • Set up institution and PI profiles in eRA Commons.

47. Grants.gov: How It Works Before an applicant can Apply 2) Establish capacity to fill out applications: • Download PureEdge Viewer (from Grants.gov site) OR • Establish an electronic system that allows the applicant to submit to Grants.gov using system-to-system (XML) datastream • Can be created by institution OR • Institution can establish an agreement with a commercial Service Provider to develop the system

48. APPLICATION TO AWARD TIMELINE 2-tiered review process SBIR/STTR Scientific/Technical Adv Council Est.Award Receipt Dates Peer Review Board Review Date Apr 1 June/July Sept/Oct Nov Aug 1 Oct/Nov Jan/Feb Mar Dec 1 Feb/March May/June July 90-Day pre-award costs are allowable: At applicant’s own risk…..

49. Common Problems with Applications • Inadequately defined test of feasibility • Diffuse, superficial, or unfocused research plan • Lack of sufficient experimental detail • Questionable reasoning in experimental approach • Uncritical approach • Failure to consider potential pitfalls and alternatives • Lack of innovation • Unconvincing case for commercial potential or societal impact • Lack of experience with essential methodologies • Unfamiliar with relevant published work • Unrealistically large amount of work proposed

50. Gap Funding Options Phase I Phase II