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The SBIR and STTR Programsat the
National Institutes of Health
General Information and Nuances
Agenda
Basics of the SBIR & STTR programs NIH SBIR/STTR programs
Overview What’s new Latest funding opportunities University participation/involvement
Small Business Innovation Research (SBIR) Set-aside program for small businessconcerns 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%
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
SBIR AND STTR PROGRAMSCRITICAL 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
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 PROGRAMSCRITICAL DIFFERENCES
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
Applicant is Small Business Concern
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
STTR PROGRAMELIGIBILITY CHECKPOINTS
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
TOTAL ~ $2.0 BEst. FY 2004
New
We’re all just a little bit different ...
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)
Agency SBIR Differences
Granting Agencies Investigator initiates approach Less-specified topics Assistance mechanism
More flexibility
DOD HHS/NIHNASA EDEPA DOT
DOC
Contracting Agencies Agency establishes plans, protocols, requirements Highly focused topics Procurement mechanism for DOD and NASA More fiscal requirements
HHS/NIH NSF ED USDA DOE
NIH Mission
IMPROVE HUMAN HEALTHthrough biomedical and behavioral
research, research trainingand communications.
Small Companies Can Help NIH meet its mission
Conduct innovative R/R&D that results in product, process, or service that will...
Improve patient health Speed process of discovery Reduce cost of medical care/cost of research Improve research & communication tools
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
NIH: $ 564 M SBIR $ 67 M STTR
$631 M Total
CDC: $ 8.0 M SBIRFDA: ~ $ 0.8 M SBIRAHRQ: ~$ 2.1 M SBIR
HHS SBIR/STTR
TOTAL ~ $2.0 B FY 2004
NIH SBIR/STTR FUNDING RATESFISCAL YEAR 2003
0
5
10
15
20
25
30
35
40
45
SBIR STTR
Phase I
Phase II
Fast-Track
Su
cces
s R
ate
(%)
24%
44%
27%
43%
28%
22%
981
327 18
61
$563 M SBIR/STTR(set aside $556M)
955
NUANCESNIH SBIR & STTR Programs
SBIR and STTR Program
Multiple Award Mechanisms
Multiple Receipt Date
Budget ~$100K/ $750K
External Peer Review Critiques sent to all applicants
Phase III
Single Solicitation
~ 95% Awards are grants
April 1, Aug 1, Dec 1
Realistic & appropriate
Academia and industry
NIH: rarely your customer
Examples ofCross-Cutting Areas of Interest Nanotechnologies Bioinformatics Biodefense Proteomics / Genomics Genetically engineered proteins Biosensors Biosilicon devices Biocompatible materials Acousto-optics and opto-electronics Imaging technologies Education/communication tools Computational biology Behavioral research
Our Ideas …
SBIR/STTR Omnibus Grant Solicitation (NIH, CDC and FDA) Release: January Open for entire Calendar Year
SBIR Contract Solicitation (NIH, CDC) Release: August Open for ~ 3 months
NIH Guide for Grants and Contracts Release: Weekly Open as noted
Investigator-initiated R&D Research projects related to the NIH mission “Other” areas of research within the mission of an awarding component
Your Ideas …
SBIR/STTR Award Type
Multiple Mechanisms GRANTS, , Contracts, Cooperative Agreements
Award Amount and Project Period
Phase I ~$100,000 6 months Phase II ~$750,000 2 years
Realistic and appropriate
Application Assignments
Institutes/Centers
Scientific Review Group
Center for Scientific ReviewReceipt & Referral Office
Match between proposed research and
IC’s mission
for funding
Match between proposed research and review
groups
for scientific/technical merit
Small Business Concern
Applicant InitiatesResearch Idea
Grantee Conducts Research
IC Staff Prepare funding Planfor IC Director
NIH Center for Scientific ReviewAssign to IC and IRG
Scientific Review GroupsEvaluate Scientific Merit
Advisory Council or BoardRecommend approval
IC Allocates
Funds
SubmitsSBIR/STTR Grant Application to NIH
~2-3 monthsafter submission
~2-3 months
after review
NIH SBIR/STTR PROGRAMNIH SBIR/STTR PROGRAMReview Process for Research Grant
APPLICATION, REVIEW, and
AWARD TIMELINE
SBIR/STTR Scientific/Technical Adv Council Awd
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 your own risk…..
7 to 9 months
REVIEW CRITERIA (Phase I)
Significance (Real Problem/Real People) Approach (Research Design, Feasible) Innovation (New or Improved?) Investigators (PI and team) Environment (Facilities/Resources)
… Protection of Human Subjects… Animal Welfare… Budget
Phase II Review Criteria
Same as Phase I Demonstrated Feasibility in Phase I Commercialization Plan High Degree of Commercial Potential based on plan
… Protection of Human Subjects… Animal Welfare… Budget
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 II6 months
24 months
6 months
Phase II
7-9 months
NIH SBIR “FAST-TRACK” Best Option For Everyone?
Convincing preliminary data? Clear, measurable, achievable milestones? Well-conceived Commercialization Plan? Letters of Phase III support/interest? Track record for commercializing?
No!
Speak with Program Staff Prior to Submission
Phase II Competing Continuations
What’s New?
Technical Assistance Programs
Executive Order 13329 – Encouraging Innovation in Manufacturing
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
Phase II Competing Continuations
PAs & RFAs
• NIMH PA-01-173• NICHD PA-03-085• NCI PA-04-047• NIAAA PA-03-129• NHLBI PA-04-028• NIAID RFA-AI-04-005• NIDA PA-03-154
OmnibusSolicitation
• NIA• NIDCD• NINDS
Technical Assistance Programs
Commercialization Assistance
Business & strategic planning
Builds alliances and investor partnerships
Pilot NicheAssessment
Identify other uses of technology
Determines competitive advantages
Develops market entry strategy
(Phase II awardees)
(Phase I awardees)
Executive Order 13329
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
Latest Funding Opportunities (Samples)http://grants.nih.gov/grants/funding/sbir_announcements.htm
RFA-CA-05-006: Innovative Technologies for Molecular Analysis of Cancer (SBIR/STTR)
PAR-03-119: Innovations in Biomedical Computational Science and Technology
PA-04-094: Novel Technologies for In Vivo Imaging
RFA-CA-05-006: 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-05-002• Flexible budget and project durations
Phase I: 2 yrs, $100K direct costs each yearPhase II: 3 yrs, no official budget limit
• Annual meeting of investigators
Objective: To develop highly innovative cancer-related methods and tools that enable research
PAS-02-149: 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
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!
Applicant must be the
small business!
• Alerts
• Solicitations
• Targeted Research Opportunities
• Sample Application
• Award Information
• Collaborative Opportunities
• Success Stories
http://grants.nih.gov/grants/funding/sbir.htm
I’m from the Government,
and I’m here to help you….
Jo Anne GoodnightNIH SBIR/STTR Program Coordinator
Phone: 301-435-2688Fax: 301-480-0146
Email: [email protected]
Kay EtzlerSBIR/STTR ProgramPhone: 301-435-2713
Fax: 301-480-0146 Email: [email protected]