The SBIR and STTR Programs at the National Institutes of Health

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

• Basics of the SBIR STTR programs
• NIH SBIR/STTR programs
• Overview
• Whats new
• Latest funding opportunities
• University participation/involvement

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Program Descriptions

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

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SBIR/STTR 3-Phase Program

• PHASE I
• Feasibility Study
• 100K and 6-month (SBIR)
• or 12-month (STTR) Award

• PHASE II
• Full Research/RD
• 750K and 2-year Award
• (SBIR/STTR)

• PHASE III
• Commercialization Stage
• Use of non-SBIR/STTR Funds

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SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES

• Research Partner
• SBIR Permits research institution partners
• Outsource 33 Phase I and 50
  Phase II RD
• 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
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SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES

• Principal Investigator
• SBIR Primary (gt50) 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
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SBIR PROGRAM ELIGIBILITY CHECKPOINTS

• 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

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STTR PROGRAM ELIGIBILITY CHECKPOINTS

• Applicant is Small Business Concern
• Formal Cooperative RD 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 RD center
• Intellectual Property Agreement
• Allocation of Rights in IP and Rights to Carry
  out
• Follow-on RD and Commercialization

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SBIR / STTR Participating Agencies

• 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

New
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Were all just a little bit different ...
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Agency SBIR Differences

• Number and Timing of Solicitations
• RD 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)

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Agency SBIR Differences

• Granting Agencies
• Investigator initiates
• approach
• Less-specified topics
• Assistance mechanism
• More flexibility

• Contracting Agencies
• Agency establishes plans,
• protocols, requirements
• Highly focused topics
• Procurement mechanism
• for DOD and NASA
• More fiscal requirements

DOD HHS/NIH NASA ED EPA DOT DOC
HHS/NIH NSF ED USDA DOE
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NIH Mission
IMPROVE HUMAN HEALTH through biomedical and
behavioral research, research training and
communications.
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Small Companies Can Help NIH meet its mission

• Conduct innovative R/RD 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

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SBIR/STTR Participating Agencies
TOTAL 2.0 B FY 2004

• DOD SBIR/STTR
• NASA SBIR/STTR
• DOE SBIR/STTR
• NSF SBIR/STTR
• DHS SBIR
• USDA SBIR
• DOC SBIR
• ED SBIR
• EPA SBIR
• DOT SBIR

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

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NIH SBIR/STTR FUNDING RATESFISCAL YEAR 2003
327
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563 M SBIR/STTR (set aside 556M)
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43
5
95
981
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61
Success Rate ()
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NUANCES NIH 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

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Examples of Cross-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

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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

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Your Ideas

• Investigator-initiated RD
• Research projects related to the NIH
• mission
• Other areas of research within the
• mission of an awarding component

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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
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Application Assignments
Center for Scientific ReviewReceipt Referral
Office

• Institutes/Centers

• Scientific Review Group

• Match between proposed research and ICs mission
• for funding

Match between proposed research and review groups
for scientific/technical merit
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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
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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
7 to 9 months
90-Day pre-award costs are allowable At your
own risk..
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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

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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

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SBIR FAST-TRACK
Standard application, review, award process
Fast-Track review option
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NIH SBIR FAST-TRACK Best Option For Everyone?
No!

• Convincing preliminary data?
• Clear, measurable, achievable milestones?
• Well-conceived Commercialization Plan?
• Letters of Phase III support/interest?
• Track record for commercializing?

Speak with Program Staff Prior to Submission
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Whats New?

• Phase II Competing Continuations

• Technical Assistance Programs

• Executive Order 13329 Encouraging Innovation
  in Manufacturing

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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
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Phase II Competing Continuations

• Omnibus
• Solicitation
• NIA
• NIDCD
• NINDS

• 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

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Technical Assistance Programs
Business strategic planning Builds alliances
and investor partnerships

• Commercialization
• Assistance

(Phase II awardees)
Identify other uses of technology Determines
competitive advantages Develops market entry
strategy
Pilot Niche Assessment
(Phase I awardees)
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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
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Latest Funding Opportunities (Samples)http//gran
ts.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

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RFA-CA-05-006 Innovative Technologies for
Molecular Analysis of Cancer
Objective To develop highly innovative
cancer-related methods and tools that enable
research

• 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 year
• Phase II 3 yrs, no official budget limit
• Annual meeting of investigators

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PAS-02-149 Small Business Biodefense Program
Objective To rapidly develop specific products
for biodefense

• 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

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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!
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http//grants.nih.gov/grants/funding/sbir.htm

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

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Im from the Government, and Im here to help
you.
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Jo Anne Goodnight NIH SBIR/STTR Program
Coordinator Phone [phone] Fax
301-480-0146 Email goodnigj_at_od.nih.gov Kay
Etzler SBIR/STTR Program Phone
301-435-2713 Fax [phone] Email
etzlerk_at_od.nih.gov