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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.

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slide1

The SBIR and STTR Programs

at the

National Institutes of Health

General Information and Nuances

agenda
Agenda
  • Basics of the SBIR & STTR programs
  • NIH SBIR/STTR programs
    • Overview
    • What’s new
    • Latest funding opportunities
    • University participation/involvement

$$$$$

slide3

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%

sbir sttr 3 phase program
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
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

sbir and sttr programs critical differences6
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*]

*Varies Among Agencies

slide7

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

businessduring project

slide8

STTR PROGRAM

ELIGIBILITY CHECKPOINTS

  • Applicantis 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

TOTAL ~ $2.0 B

Est. FY 2004

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

agency sbir differences
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 differences12
Agency SBIR Differences

Contracting Agencies

  • Agency establishes plans,

protocols, requirements

  • Highly focused topics
  • Procurement mechanism

for DOD and NASA

  • More fiscal requirements

Granting Agencies

  • Investigator initiates

approach

  • Less-specified topics
  • Assistance mechanism
  • More flexibility

DOD HHS/NIH

NASA ED

EPA DOT

DOC

HHS/NIH NSF

ED USDA DOE

nih mission
NIH Mission

IMPROVE HUMAN HEALTH

through biomedical and behavioral research, research training

and communications.

slide14

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 agencies15
SBIR/STTR Participating Agencies

TOTAL ~ $2.0 B FY 2004

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

  • DOD SBIR/STTR
  • NASA SBIR/STTR
  • DOE SBIR/STTR
  • NSF SBIR/STTR
  • DHS SBIR
  • USDA SBIR
  • DOC SBIR
  • ED SBIR
  • EPA SBIR
  • DOT SBIR
  • HHS SBIR/STTR
nih sbir sttr funding rates fiscal year 2003
NIH SBIR/STTR FUNDING RATESFISCAL YEAR 2003

327

18

$563 M

SBIR/STTR

(set aside $556M)

44%

43%

5

95

981

61

28%

Success Rate (%)

27%

24%

22%

slide17

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
slide18

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
slide19

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
slide20

Your Ideas …

  • Investigator-initiated R&D
  • Research projects related to the NIH

mission

  • “Other” areas of research within the

mission of an awarding component

slide21

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

Center for Scientific ReviewReceipt & Referral Office

Application Assignments

Institutes/Centers

Scientific Review Group

Match between proposed research and review groups

for scientific/technical merit

Match between proposed research and IC’s mission

for funding

slide23

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

application review and award timeline
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…..

slide25

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
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

7-9 months

7-9 months

Phase I

Phase II

6 months

6 months

24 months

Satisfactory Phase I

Final Report

7-9 months

Phase I + Phase II

Simultaneous

submission/review

Phase II

SBIR “FAST-TRACK”

Standard application, review, award process

Fast-Track review option

nih sbir fast track best option for everyone

No!

NIH SBIR “FAST-TRACK”Best Option For Everyone?
  • Convincing preliminary data?
  • Clear, measurable, achievable milestones?
  • Well-conceivedCommercialization Plan?
  • Letters of Phase III support/interest?
  • Track record for commercializing?

Speak with Program Staff Prior to Submission

what s new
What’s New?
  • Phase II Competing Continuations
  • Technical Assistance Programs
  • Executive Order 13329 – Encouraging Innovation in Manufacturing
phase ii competing continuations
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 continuations31
Phase II Competing Continuations
  • Omnibus
  • Solicitation
  • NIA
  • NIDCD
  • NINDS
  • PAs & RFAs
  • NIMHPA-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
technical assistance programs
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)

executive order 13329
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
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
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
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
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!

slide38

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

  • Alerts
  • Solicitations
  • Targeted Research Opportunities
  • Sample Application
  • Award Information
  • Collaborative Opportunities
  • Success Stories
slide40

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