# Presentation: 184416

## The SBIR and STTR Programs

**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

- $$$$$

## 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.

**	****	****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.**

**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 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**

## 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*]

**	****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 PROGRAMS*****CRITICAL DIFFERENCES***

## SBIR PROGRAM

**   ****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**

## STTR PROGRAM

**   ****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 PROGRAM**
**ELIGIBILITY 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

**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***

**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/NIH**
**NASA****	****ED**
**EPA****	****	****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****** 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**

## DOD	SBIR/STTR

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

- 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 SBIR**
**FDA:   ~ $ 0.8 M SBIR**
**AHRQ: ~$ 2.1 M SBIR**

**  ****HHS       SBIR/STTR**

**TOTAL ~ ****	****$2.0 B  FY 2004**

## NIH SBIR/STTR FUNDING RATESFISCAL YEAR 2003

**Success Rate (%)**

**24%**

**44%**

**27%**

**43%**

**28%**

**22%**

**981**

**327**

**18**

**61**

**$563 M **
**SBIR/STTR**
**(set aside $556M)**

**95**

**5**

## 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**

## Examples of

**Examples of**
**Cross-Cutting Areas of Interest**

** ****Nanotechnologies**
**  ****Bio****informatics**
**  ****Biodefense**
**  ****Proteomics / Genomics**
**  ****Genetically engineered proteins**
**  ****Bio****sensors**
**  ****Biosilicon devices**
**  ****Biocompatible ****materials**
**  ****Acousto-****optics**** and opto-****electronics**
**  ****Imaging**** technologies**
**  ****Education****/communication tools**
**  ****Computational biology**
**  ****Behavioral research**

##  Our Ideas ...

** ****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**

** ****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 Review****Receipt & Referral Office**

**Match between proposed research and IC’s mission **
***for funding***

**Match between proposed research and review groups **
***for scientific/technical merit***

##  NIH SBIR/STTR PROGRAM

**Grantee Conducts **
**Research**

**IC Staff Prepare funding Plan**
**for IC Director**

**Submits**
**SBIR/STTR Grant **
**Application to NIH**

**~2-3 months**
**after submission**

**~2-3 months after review**

** ****NIH SBIR/STTR PROGRAM**
***Review 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**

## 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

**Omnibus**
_**Solicitation**_
-   NIA
-   NIDCD
-   NINDS

## Technical Assistance Programs

**Commercialization **
**Assistance**
**	**

**Business & strategic   planning**
**Builds alliances and investor partnerships**

_***Pilot***_** Niche**
**Assessment**
**	**

**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 year
- Phase 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!*

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

-  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....

**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**