# Presentation: 817235

## OPPORTUNIHTIES

**OPPORTU****NIH****TIE****S**

**Jo Anne Goodnight**
**SBIR/STTR Program Coordinator**
**National Institutes of Health**
**6701 Rockledge Drive       Room 6186 - MSC 7910**
**     ****Bethesda, MD  20892        Phone:  301-435-2688         **
** ****Email:  jg128w@nih.gov**

## SMALL  BUSINESS  INNOVATION 

**SMALL  BUSINESS  INNOVATION **
**RESEARCH (SBIR) PROGRAM**
** **
**SMALL BUSINESS TECHNOLOGY **
**TRANSFER (STTR) PROGRAM**
***“******The best way to predict the future...***
***is to create it.”***

## SBIR:  Set-aside Program for Small Business
Concerns to engage in Federal R&D--
 with potential for commercialization.

STTR: Set-aside Program to facilitate
cooperative R&D between Small Business
Concerns and U.S. Research Institutions--
with potential for commercialization.

**Concerns to engage in Federal R&D--**
** ****with potential for commercialization.**
**STTR:**** Set-aside Program to facilitate**
**cooperative R&D between Small Business**
**Concerns and U.S. Research Institutions--**
**with potential for commercialization.**

**Extramural Programs **
_**Reserved**_** for Small Business**

## WHY SBIR????

**Congress designated 4 major goals**
**Stimulate technological innovation**
**Use small business to meet federal R&D needs**
**Foster and encourage participation by minority and disadvantaged persons in technological innovation**
**Increase private-sector commercialization innovations derived from federal R&D**

- Small Business Innovation Development Act of 1982

## REAUTHORIZATION of SBIR PROGRAM

**Expand and improve SBIR Program**
**Emphasize goal of increasing private sector commercialization**
**Increase small business participation in Federal R&D**
**Improve dissemination of information on SBIR Program**

- PURPOSES OF P.L. 102-564, SIGNED 10/28/92

## SBIR PROGRAM

**Program re-authorized through FY 2000**
**10 agencies with R&D budgets greater than $100 Million participate**
_**Amounts to be Set-aside of R&D Budget:**_
**    ****	****FY 1987-92:****	****	****       1.25%**
**    ****	****FY 1993-94:****	****	****        1.5 %**
**    ****	****FY 1995-96:  ****	****	****        2.0 %**
**    ****	****FY 1997 and Beyond:    ****2.5 %**

## SBIR/STTR: 3-Phase Program

_**PHASE I**_
**Feasibility study **
**(*****no preliminary data needed*****)**
**$100K and 6 months (SBIR) or 12 months(STTR)**
**    **
_**PHASE II**_
**Full R/R&D**
**2-Year Award and $750K (SBIR) or $500K (STTR)**** **
_**PHASE III**_
**Commercialization Stage**
**Without SBIR Support**

## SBIR PROGRAM ELIGIBILITY CHECKPOINT

**  ****For- profit U.S. business firm **
**  ****At least 51% U.S.- owned and independently operated **
**  ****Small Business located in the U.S. **
**  ****P.I.’s primary employment with small business during project **
**  ****500 employees or fewer **_**	**_

**SBIR PROGRAM ELIGIBILITY CHECKPOINT**

## STTR PROGRAM

**   ****FORMAL COOPERATIVE R&D EFFORT**** **
**  ****Minimum 40% by small business**
**  ****Minimum 30% by research institution**
**   ****U.S. RESEARCH INSTITUTION**
**  ****College or University;  other non-profit research**
**    ****organization;  federal R&D center (GOCO)**
**   ****PRINCIPAL INVESTIGATOR FROM SMALL**
**        ****BUSINESS or RESEARCH INSTITUTION**
**   ****GRANT AWARDED TO SMALL BUSINESS**

**STTR PROGRAM**

## SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES

**SBIR:  2/3 by small business - Phase I**
**	****	****      ****1/2 by small business - Phase II**
**	****	****      ****     **
**STTR:  40% by small business ****and**
**                ****30% by research institution**
**SBIR:   PI’s primary employment ****must**** be with **
**                ****small business concern**
**STTR:  PI can be from research institution ****or**
**                ****small business concern**

## Faculty Partnership Opportunities

-  Own small firms (assign *someone else* PI)
-  Senior Personnel on SBIR
-  Consultants on SBIR
-  Principal Investigator (w/ official permission from University)
- Subcontract on SBIR
- University facilities can provide analytical and other service support

## PUBLIC  HEALTH AGENCIESSBIR/STTR SET-ASIDE REQUIREMENT(dollars in millions)

**Agency      FY 1999****	**** FY 2000**

**NIH**		   **$     307****	****	****$ 352.1 (SBIR)**
**	****	****	****    ****18****	****	****     21.1 (STTR)****	**
**AHRQ**	         ** 1.5 ** 	       **2.1 (SBIR)**
- Agency for Healthcare Research and Quality
**CDC**		 	  **4.0 ****	****	****    ~5.0 (SBIR)**
**FDA**		          **0.5** 	 	    ~**0.5** **(SBIR)**

## Major Changes for FY 2000

**  ****Single SBIR/STTR Solicitation**
**  ****Coincident Grant Receipt Dates**
***April 1, August 1, December 1***
**  ****Special Announcements : **
***   ******NIH Guide for Grants and Contracts***
**  ****Review Criteria**** **

- NATIONAL INSTITUTES OF HEALTH
**SBIR/STTR PROGRAM**

## SBIRs vs. STTRs

**UNIQUE FEATURES**
- 					_**SBIR**_ 		   _**STTR**__**	**_
**% Set-Aside of  NIH Budget**	2.5% 		   0.15%
**FY00 NIH SBIR/STTR Budget**	**$351.5 M ****	****   $21 Million**
**Award Guidelines ****	****Phase I**    	$100K/6mos  $100K/12 mos.		      	**Phase II**    	$750K/2 yrs   $500K/2 yrs
**Subcontracts**	**Phase I**	 <33% 	    <60%
- 			**Phase II**	 <50% 	    <60%
**Academic Component**		 Not Required   >30%
**Business Employment of PI**	 >50% 	      n/a

## Program’s success is dependent upon...

**  ****Flexibility**

** ****Communication**

## SBIR/STTR PROGRAM

** ****Grants **_**and**_** contracts**
** ****Three receipt dates for grants**
**SBIR/STTR: April 1; August 1; December 1**
** ****One receipt date for contracts:**
** ****First  week in November**** **

- NATIONAL INSTITUTES OF HEALTH
**SBIR/STTR PROGRAM**

## SBIR/STTR PROGRAM

**SBIR/STTR PROGRAM**

**  ****Flexibility (cont.)**
**  ****Areas of interest **_**not**_** intended to be exhaustive for grant applications**
**  ****Propose budget and award period **_**appropriate**_** for your project**
**  ****Revise and resubmit two times**
**  ****Special Announcements for **
**   ****Small Business Research Projects    **

## SBIR/STTR PROGRAM

**SBIR/STTR PROGRAM**

**  ****Communication**
** ****Pre-application advice/guidance**
** ****Post-review advice/guidance**
** ****Post-award advice/guidance**
** ****Success stories**

## NATIONAL INSTITUTES OF HEALTHSBIR/STTR AWARD DATA(dollars in millions)

- 		**       ****FY 1998           FY 1999 **
- 		**Number****	**** Dollars****	****Number Dollars**

**SBIR**
**   ****Fast-Track**
**STTR**
**Totals**

**   ****1,313**
**      ****(23)**
**    ****  ****123**

**1,436**

**$ 265.6**
**   ****($ 6.2)**
**$  17. 2**

**$282.8**

**1,439**
**   ****(58)**
**  **** ****119**
** **

**1,558**

**$ 307.0**
** ****($ 10.2)**
**$   19.7**** **

**$326.7**

## NATIONAL INSTITUTES OF HEALTHSBIR/STTR COMPETING AWARD DATA

## NATIONAL INSTITUTES OF HEALTHSBIR/STTR FUNDING RATES for FISCAL YEAR 1999

**Success Rate (%)**

**27.2**

**45.4**

**23.1**

**27.9**

**/****14.3**

**34.9**

## NATIONAL INSTITUTES OF HEALTH

## Slide 23

## Who Speaks for NIH?

**Who Speaks for NIH?**

## Cutting-Edge Technologies

**Cutting-Edge Technologies**

**  ****Nanotechnologies**
**  ****Bioinformatics**
**  ****Proteomics  **
**  ****Caged molecules**
**  ****Genetically engineered proteins**
**  ****Combinatorial approaches**
**  ****Biosilicon devices**
**  ****Biocompatible biomaterials**
**  ****Acousto-optics and opto-electronics**
**  ****Imaging technologies**

## Examples of Nanotechnologies

**  ****Nanoplumbing components****.... valves, microfluidic channels, motors.... that can be operated from a distance**
**  ****Logic Circuits****... based on quantum dots which carry out computing functions without current flow**
**  ****Fluorescent probes**** at nanometer scale for monitoring biochemical processes on the surface and inside the cell**

## Examples of Nanotechnologies

**  ****Nanofabricated barriers**** to control rejection of implantable materials**
**  ****Nanoparticles and nanospheres**** that enable controlled release of therapeutic agents, antibodies, genes, and vaccines **
**  ****Biotemplates and sensor technologies**** for detection and analysis of DNA and RNA targets in body fluid samples**

**Examples of Nanotechnologies**
**(cont.)**

## SBIR AND STTR PROGRAMSAPPLICATION PROCEDURES

** ****Up to $100,000 Total Costs**
** ****No Budget Detail**
** ****Narrative Justification For:**
** ****Personnel**
** ****Fixed Fee**
** ****Consultant Costs**
** ****Contractual Costs**

## SBIR AND STTR PROGRAMSAPPLICATION PROCEDURE (cont.)

** ****Above $100,000 Total Costs**
**  ****Budget Detail **
**  ****Narrative Justifications**
**  ****Same as Current Practice**

## Cover Letter:  A Valuable Tool

**Cover Letter:  A Valuable Tool**

- Suggest funding component(s)
- Suggest study section(s)
- Indicate individual(s) or organization(s) that would be in conflict
- Discuss areas of expertise appropriate for the application’s review

## Slide 31

## NATIONAL INSTITUTES OF HEALTHSBIR/STTR REVIEW PROCESS

** ****Grants to Center for Scientific Review, NIH**
** ****Two-step review process**** **
**I.  External Peer Review **
**(~10-20 scientists from academia and industry)**
**II. National Advisory Council or Board **
** ****Contracts to Contracting Officers**
** ****Technical Evaluation Panel**

## NATIONAL INSTITUTES OF HEALTHSBIR “FAST-TRACK” PARALLEL REVIEW OPTION

**   ****Two major advantages**
** ****Concurrent submission and review of SBIR Phase I and Phase II projects**
**  ****Funding gap eliminated or reduced**
**  ****Clear, measurable milestones in Phase I**
**  ****Product Development Plan: Ph II Appendix**

## NATIONAL INSTITUTES OF HEALTHOther possibilities to bridge the funding gap 

**  ****No-cost extensions**
** ****Contact Program Director**** **
** ****Extension with funds**
** ****Administrative supplements:  Within scope of **_**current**_** project**
** ****Varies among ICs: Discuss with your Program Director**

## Streamlined Procedures of NIH Review

**Streamlined Procedures of NIH Review**

**Reviewers**
- Identify/Discuss applications in the upper half
- Score these applications between 100 and 300
-  UNscore applications (300-500).... generally
**Summary Statements sent to every applicant**
- Unscored applications receive unedited critiques prepared by assigned reviewers
- Scored applications receive unedited critiques and a summary of the discussion

## NIH SBIR Review Criteria

**NIH SBIR Review Criteria**

**Significance**
**Approach**** **
**Innovation**
**Investigators**
**Environment**
**Safeguards for animal and human subjects**
**Appropriateness of the budget**

## NIH SBIR Review Criteria (cont.)

**NIH SBIR Review Criteria (cont.)**

**Phase II: Standard review criteria **_***and***_** degree to which Phase I feasibility was  demonstrated**
**Fast Track (Phase I/Phase II)**
**Specification of clear, measurable goals to be achieved prior to initiating Phase II**
**Concise Product Development Plan **
**Extent to which applicant was able to obtain letters of interest, additional funding commitments and/or resources from non-SBIR/STTR funding sources that would enhance the likelihood for commercialization**

## Common Problems with Applications

**Common Problems with Applications**

**Inadequately **_**defined**_** test of feasibility**
**Diffuse, superficial, or unfocused research plan**
**Lack of sufficient experimental detail**
**Questionable reasoning in experimental approach**
**Uncritical approach **
**Failure to consider potential pitfalls and alternatives**
**Lack of innovation**
**Unconvincing case for commercial potential or societal impact**
**Lack of experience with essential methodologies**
**Unfamiliar with relevant published work**
**Unrealistically large amount of work proposed**

## NIH Allows Amended Applications

**NIH Allows Amended Applications**

**Two amended applications allowed**
**Generally half of the reviewers are new**
**Request for change of reviewers must be supported**
**An opportunity to revise and improve your application**

## BECOME AN NIH CONSULTANT

**Request Consultant Information**
**                   ****Form (CIF)**
**  ****E-mail:  ****cn3@cu.nih.gov**
**  ****Fax:      ****(301) 907-9655**
**  ****Write:   ****NIH Consultant File**
**                 ****7101 Wisconsin Ave.**
**                 ****Suite 1125**
**                 ****Bethesda, MD  20814-5228**

## Congratulations!The check is in the mail...

**(almost)**

## WHERE’S THE MONEY?

**WHERE’S THE MONEY**?

**WHY THE AWARD MAY BE DELAYED**
**OPRR Issues**
** ****IRB (Human Subjects)**
** ****IACUC (Animal Involvement)**
**EIN **(Entity Identification Number)
**Third Party Involvement**
** ****Contracts, Consortia, Consultants**

## NOTICE OF GRANT AWARD

**LEGALLY BINDING DOCUMENT**
- Establishes funding level
- Establishes period of support
- Sets forth terms and conditions of award
- NIH Contact Information
**Program Director**
**Grants Management Specialist**

## REPORTING REQUIREMENTS

**PHASE I**
- Final Progress Report if Phase II application is not submitted
-  Financial Status Report at end of project period
-  Inventions:  IEdison http://www.iedison.gov

## REPORTING REQUIREMENTS 

**FINAL REPORTS**
- Due within 90 days of the project end date
-  SF 269     Financial Status Report
-  Final Progress Report  (no form)
-  HHS 568  Final Invention Statement
-  SF 272     Federal Cash Transaction Report

## NIH SMALL BUSINESS FUNDING OPPORTUNITIES WEBSITE

## http://grants.nih.gov/grants/

**funding/sbir.htm**

-   SBIR and STTR Solicitation and Forms/Instructions
-   SBIR/STTR Policy Information
-   Invention Reporting Requirements
-   Information For New Grantees
-   SBIR and STTR Award Data (Including Abstracts)
-   Special Announcements (PAs and RFAs)
-   Other Small Business Sites of Interest
-   Financial Questionnaire: Evaluation of Financial
-       Management System
-   NIH SBIR/STTR Conferences
-   NIH SBIR/STTR Success Stories
-   Review of Small Business Research Applications

## Special Announcements for 

**Special Announcements for **
**Small Business **
**Research Projects**
***To emphasize the importance of research topics***
- http://grants.nih.gov/grants/funding/sbir.htm

## Reasons to Seek NIH 

**SBIR/STTR Funding Opportunities**

** ****Over $350 Million dollars available**
** ****Seed money to fund high risk projects**
** ****Not a loan-- no repayment of awards**
** ****Intellectual property rights retained by small business**
** ****Recognition and visibility**

## Reasons to Seek NIH 

**SBIR/STTR Funding Opportunities**
**(cont.)**

** ****Potential leveraging tool to attract venture capital/other sources of $$$**
**Small Business Concerns are principal source of technological innovation**

## When opportunity doesn’t knock...

**Build doorways.**

## NIH Program Activities and Areas of Research

**NCI****-- cancer cause, prevention, detection, diagnosis, treatment and control**

**NHLBI****-- diseases of heart, blood vessels, lungs, blood, and transfusion medicine**

**NINDS****-- diagnosis, treatment, and prevention of disorders of the nervous system, neuromuscular apparatus, and special senses of touch/pain**

**NIDDK****-- diabetes, endocrinology, and metabolic diseases; digestive diseases and nutrition; kidney, urologic and hematologic diseases**

**NIAID****-- understand, treat and prevent infectious, immunologic, and allergic diseases**

**NIDCR****-- understand, treat and prevent infectious and inherited craniofacial-oral-dental diseases and disorders**

## NIH Program Activities and Areas of Research

**(cont.)**

**NICHD****-- fertility, pregnancy, growth, development, and medical rehabilitation **

**NEI****-- blinding eye diseases, visual disorders, mechanisms of visual function, preservation of sight, requirements of the blind**

**NIEHS****-- identification, assessment, and mechanism of action of environmental agents that are potentially harmful to human health**

**NIA****-- biomedical, social, and behavioral aspects of aging process; prevention of age-related diseases and disabilities; promotion of better QOL for older Americans**

**NIGMS****-- basic biomedical research not targeted to diseases or disorders; recombinant DNA technology**

## NIH Program Activities and Areas of Research  (cont.)

**NIDCD****-- normal mechanisms diseases, and disorders of hearing, balance, smell, taste, voice, speech and language **

**NIMH****-- understanding, treating, preventing behavioral and mental disorders (including HIV prevention, neuro-AIDS research)**

**NIDA****-- treatment of drug addiction; behavioral strategies for treatment medication; training in drug abuse treatment techniques; drug abuse treatment **

**NIAAA****-- treatment and prevention of alcoholism and alcohol-related problems**

**NIAMS****-- arthritis/rheumatic diseases, connective tissue diseases, musculoskeletal and skin disorders**

**NINR****-- understand effects of acute and chronic illness, improving QOL, approaches to promote health and prevent disease, improving clinical environments**

## NIH Program Activities and Areas of Research   (cont.)

**NIHGRI****-- efforts toward achieving the goals of the Human Genome Project  **
***(Science vol. 262, pp.43-46; Oct. 1, 1993)***

**NCRR****-- R&D in instrumentation and specialized technologies for biomedical research; R&D in comparative medicine; discovery-oriented software for science education**

**NCCAM****-- complementary and alternative treatment, diagnostic, and prevention modalities, disciplines and systems: education and public information; patient management; botanical products; research-related issues (e.g., models, methods)  **

**NLM****-- innovative methods, systems, and services for managing health knowledge and information **