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					The SBIR and STTR Programs
            at 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
         Program Descriptions

 Small Business Innovation Research (SBIR)
       Set-aside program for small business
2.5%   concerns to engage in federal R&D --
       with potential for commercialization.

 Small Business Technology Transfer (STTR)
     Set-aside program to facilitate cooperative
0.3% R&D between small business concerns
     and U.S. research institutions -- with
     potential for commercialization.
      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 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
      SBIR AND STTR PROGRAMS
       CRITICAL 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*]


              *Varies Among Agencies
       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
        STTR 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
     SBIR / STTR Participating
             Agencies
                    DOD    SBIR/STTR
                    HHS    SBIR/STTR
                    NASA   SBIR/STTR
                    DOE    SBIR/STTR
                    NSF    SBIR/STTR
                    DHS    SBIR        New
                    USDA   SBIR
                    DOC    SBIR
                    ED     SBIR
                    EPA    SBIR
TOTAL ~ $2.0 B      DOT    SBIR
 Est. FY 2004
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
Contracting Agencies            Granting Agencies
   Agency establishes plans,      Investigator initiates
     protocols, requirements          approach
   Highly focused topics          Less-specified topics
   Procurement mechanism          Assistance mechanism
     for DOD and NASA
   More fiscal requirements       More flexibility


    DOD          HHS/NIH
                                 HHS/NIH NSF
    NASA         ED              ED USDA DOE
    EPA          DOT
           DOC
         NIH Mission


    IMPROVE HUMAN HEALTH
through biomedical and behavioral
    research, research training
       and 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
      SBIR/STTR Participating Agencies
            TOTAL ~ $2.0 B FY 2004
   DOD    SBIR/STTR
   HHS    SBIR/STTR   NIH: $ 564 M SBIR
   NASA   SBIR/STTR        $ 67 M STTR
   DOE    SBIR/STTR        $631 M Total
   NSF    SBIR/STTR
   DHS    SBIR
                       CDC:   $ 8.0 M SBIR
   USDA   SBIR
                       FDA: ~ $ 0.8 M SBIR
   DOC    SBIR
                       AHRQ: ~$ 2.1 M SBIR
   ED     SBIR
   EPA    SBIR
   DOT    SBIR
NIH SBIR/STTR FUNDING RATES
FISCAL YEAR 2003
             327               18          $563 M
  45
  40         44%               43%
                                           SBIR/STTR
  35                                       (set aside $556M)
                                      5
  30                     95
       981
  25                61               28%       Phase I
                         27%
  20   24%                                     Phase II
  15               22%                         Fast-Track
  10
   5
   0
         SBIR              STTR
                     NUANCES
             NIH SBIR & STTR Programs
   SBIR and STTR Program                  Single Solicitation

   Multiple Award Mechanisms              ~ 95% Awards are grants

   Multiple Receipt Date                  April 1, Aug 1, Dec 1

   Budget                                 Realistic & appropriate
    ~$100K/ $750K

   External Peer Review                   Academia and industry
     Critiques sent to all applicants
                                           NIH: rarely your customer
   Phase III
        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
                    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
            Your Ideas …


 Investigator-initiated R&D
 Research projects related to the NIH
  mission
 “Other” areas of research within the
   mission of an awarding component
      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
            Center for Scientific Review
             Receipt & Referral Office


   Application Assignments

 Scientific Review          Institutes/Centers
      Group

Match between proposed          Match between
  research and review       proposed research and
        groups                   IC’s mission
 for scientific/technical         for funding
          merit
       NIH SBIR/STTR PROGRAM
     Review Process for Research Grant
                                             NIH Center for Scientific Review
                           Submits                Assign to IC and IRG
Small Business
                      SBIR/STTR Grant
  Concern
                      Application to NIH

Applicant Initiates
                                               Scientific Review Groups
 Research Idea                                 Evaluate Scientific Merit
                           ~2-3 months
                         after submission

                                               Advisory Council or Board
                                ~2-3             Recommend approval
                              months
                            after review
                                     IC      IC Staff Prepare funding Plan
 Grantee Conducts                Allocates           for IC Director
     Research                     Funds
       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…..
         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
                                                 7-9 months
Phase I 7-9 months
                                      Phase II
                     6 months
                                                       24 months
Fast-Track review option
 Phase I + Phase II 7-9 months              Satisfactory Phase I
                                                Final Report
  Simultaneous                   6 months
submission/review
                      Phase II
        NIH SBIR “FAST-TRACK”                  No!

        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?

    Speak with Program Staff Prior to Submission
             What’s New?


   Phase II Competing Continuations

   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                  Omnibus
                            Solicitation
•   NIMH    PA-01-173
•   NICHD   PA-03-085       • NIA
•   NCI     PA-04-047       • NIDCD
•   NIAAA   PA-03-129       • NINDS
•   NHLBI   PA-04-028
•   NIAID   RFA-AI-04-005
•   NIDA    PA-03-154
     Technical Assistance Programs

                      Business & strategic
Commercialization
                      planning
Assistance
                      Builds alliances and
(Phase II awardees)   investor partnerships


                      Identify other uses of
                      technology
Pilot Niche
                      Determines competitive
Assessment            advantages
(Phase I awardees)
                      Develops market entry
                      strategy
    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

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
      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
                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
                                          Applicant
    (assign someone else PI)
                                         must be the
                                            small
                                          business!
http://grants.nih.gov/grants/funding/sbir.htm


                          • Alerts
                          • Solicitations
                          • Targeted Research
                          Opportunities
                          • Sample Application
                          • Award Information
                          • Collaborative Opportunities
                          • Success Stories
 I’m from the
 Government,
and I’m here to
 help you….
        Jo Anne Goodnight
NIH SBIR/STTR Program Coordinator
       Phone: 301-435-2688
         Fax: 301-480-0146
    Email: goodnigj@od.nih.gov


           Kay Etzler
      SBIR/STTR Program
      Phone: 301-435-2713
       Fax: 301-480-0146
    Email: etzlerk@od.nih.gov

				
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