overview of the nih sbir/sttr programs

National Institutes of HealthOffice of Extramural Research

Overview of the NIH SBIR/STTR Programs

June 26, 2014

Betty Royster

NIH SBIR/STTR Communications Specialist

Office of Extramural Research, NIH


Agenda

• Overview of NIH SBIR and STTR Programs• Technical Assistance/Reauthorization Updates • Electronic Submission • Peer Review Overview• Case Studies • Questions and Answers!


SBIR/STTR Programs Overview

SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMSet-aside program for small business concerns to engage in Federal R&D – with potential for commercialization

SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMSet-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions – with potential for commercialization

2.8%

0.40%


SBIR/STTR Programs

The largest, most accessible source of

SEED CAPITAL in the nation

for innovative small businesses

Over 2 Billion $$$$ in FY 14

NIH SBIR $663 M

NIH STTR $ 95 M

NIH FY 14 TOTAL $758M


And…..

The seed capital is in the form of grants and contracts….

• Not a loan - no repayment• No debt service

• Non-dilutive funding• Maintain IP rights


SBIR Purpose and Goals

Small Business Innovation Development Act of 1982P.L. 112-81 Re-Authorizes program through FY2017

• Stimulate technological innovation• Use small business to meet Federal R&D

needs• Foster and encourage participation by

minorities and disadvantaged persons in technological innovation

• Increase private-sector commercialization innovations derived from Federal R&D


STTR Purpose and Goals

Small Business Research and Development Enhancement Act of 1992

P.L. 112-81 Re-Authorizes program through FY2017

• Stimulate and foster scientific and technological innovation through cooperative research and development carried out between small business concerns and research institutions

• Foster technology transfer between small business concerns and research institutions


SBIR/STTR Budgets by Agency, FY 2013

Agencies with SBIR and STTR Programs

Department of Defense (DOD) $ 1.0 B

Department of Health and Human Services: National Institutes of Health (NIH)

$697.0 M

Department of Energy (DOE), including ARPA-E $183.9M

National Science Foundation (NSF) $153.0 M

National Aeronautics and Space Administration (NASA)

$ 148.8 M

Agencies with SBIR Programs

U.S. Department of Agriculture (USDA) $18.4M

Department of Homeland Security (DHS): Science and Technology Directorate (S&T) and Domestic Nuclear Detection Office (DNDO)

$15.7 M

Department of Education (ED) $13.4 M

Department of Transportation (DOT) $7.6 M

Department of Commerce: National Oceanic and Atmospheric Administration (NOAA) and National Institute of Standards and Technology (NIST)

$7.4 M

Environmental Protection Agency (EPA) $3.8 M

DOD

NIH

DOENSF NASA All

Others

~ $2.3B in FY13Across all agencies


NIH Mission

To seek fundamental knowledge about the

nature and behavior of living systems and the

application of that knowledge to enhance

health, lengthen life, and reduce illness and

disability.


Office of the Director

National Institute on Minority Health

and Health Disparities

National Institutes of Health

http://www.nih.gov/icd

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis and

Musculoskeletaland Skin Diseases

National CancerInstitute

National Instituteon Aging

National Instituteof Child Health

and HumanDevelopment

National Instituteof Allergy and

Infectious Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Dental andCraniofacial

Research

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National HumanGenome Research

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical Sciences

National Instituteof Nursing Research

National Libraryof Medicine

National Centerfor Complementary

and AlternativeMedicine

FogartyInternational

Center

National Centerfor Advancing

Translational Sciences

National Instituteof Biomedical

Imaging and

Bioengineering

No funding authority

Center for Information Technology

Center for Scientific Review

NIH Clinical Center

Office of Research Infrastructure Programs


PHASE II Full Research/R&D $1M (SBIR), $1M (STTR) over two years

PHASE IIB Competing Renewal/R&D Clinical R&D; Complex Instrumentation/Tools to FDA Many, but not all, ICs participate Varies ~$1M/year; 3 years

PHASE III Commercialization Stage NIH, generally, not the “customer” Consider partnering and exit strategy early

PHASE I Feasibility Study Budget Guide: $150K (SBIR); $150K (STTR) Total Costs Project Period: 6 months (SBIR); 1 year (STTR)

NIH SBIR/STTR3-Phase Program


SBIR Eligibility Criteria

Organized as for-profit U.S. business

Small: 500 or fewer employees, including affiliates

PD/PI’s primary employment must be with small business concern at time of award and for duration of project period

Greater than 50% U.S.- owned by individuals and independently operated or

Greater than 50% owned and controlled by other business concern/s that is/are greater than 50% owned and controlled by one or more individuals

OR

Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these


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 Eligibility Criteria


PD/PI Eligibility on STTR

• PD/PI is not required to be employed by SBC

• PD/PI at RI must establish contract between RI and SBC describing PD/PI’s involvement

• PD/PI must commit a minimum of 10% effort

• PD/PI’s “signature” on application is agreement to conforming to Solicitation requirements


• Research Partner SBIR: Permits partnering

33% Phase I and 50% Phase II

STTR: Requires partnering with research institution.

Small business (40%) and U.S. research institution (30%)

Award is always made to Small Business Concern

SBIR and STTR Critical Differences

• Principal Investigator SBIR: Primary (>50%)

employment must be with small business concern

STTR: PI may be employed by either research institution or small business concern

NCI

NIAID

NHLBINIGMSNIDDKNINDS

NIMH

NICHD

NIA

NIDA

NEI

NCATS

NIEHSNIAMS

NHGRI

NIAAA

NIDCD

NIDCR NIBIB NIMHD ORIP NINR NCCAMNLM

NIH SBIR/STTR Budget Allocations FY20132.7% SBIR $617M0.35% STTR $80MTotal FY2013 $697M


NIH-wide SBIR/STTR Success Rates

Fiscal Year SBIR/STTR PhaseNumber of

Applications Reviewed

Number of Applications

AwardedSuccess

Rate Total Funding

2012 SBIR Fast Track 358 57 15.9% $13,985,8022012 SBIR Phase 1 4,287 667 15.6% $154,237,8902012 SBIR Phase 2 557 222 39.9% $153,650,1622012 STTR Fast Track 32 11 34.4% $2,840,6322012 STTR Phase 1 542 110 20.3% $23,857,7002012 STTR Phase 2 71 28 39.4% $18,240,4182012 FY TOTAL 5,847 1,095 18.7% $366,812,6042013 SBIR Fast Track 313 49 15.7% $13,981,3862013 SBIR Phase I 3,738 495 13.2% $114,040,1572013 SBIR Phase II 542 178 32.8% $136,348,8462013 STTR Fast Track 42 12 28.6% $2,542,1282013 STTR Phase I 583 109 18.7% $24,138,6292013 STTR Phase II 72 19 26.4% $10,985,3732013 FY TOTAL 5,290 862 16.3% $302,036,519

Success Rates Posted Online: http://report.nih.gov/success_rates/index.aspx


HHS/NIH Program Funding

2014 Budget SBIR STTRNIH $663M $95M

CDC FDAACF

$8.97M$1.29M$81K

N/A

Phase I $150K*6 months*

$150K*1 year*

Phase II $1M* 2 years*

$1M* 2 years*


Biodefense

Biosensors

Nanotechnologies

Bioinformatics

Diagnostic and Therapeutic Devices

Telehealth

Proteomics / Genomics

Biosilicon devices

Biocompatible materials

Acousto-optics / opto-electronics

Health IT

Imaging devices

Genetically engineered proteins

…

Our Ideas: Suggested topic areas*

SBIR/STTR Program Descriptions & Research Topics


Biodefense

Biosensors

Nanotechnologies

Bioinformatics

Diagnostic and Therapeutic Devices

Telehealth

Proteomics / Genomics

Biosilicon devices

Biocompatible materials

Acousto-optics / opto-electronics

Health IT

Imaging devices

Genetically engineered proteins

…

Our Ideas: Suggested topic areas*

SBIR/STTR ProgramDescriptions and Research Topics

Your Ideas: Investigator-initiated R&D

Research projects related to the NIH mission

“Other” areas of research within the

mission of an awarding component Keyword search the Solicitation

Ctrl - F


Solicitations and Due Dates

• NIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation

Release: January Standard Due Dates: April 5, August 5, December 5(AIDS/AIDS-related: May 7, September 7, January 7)

• SBIR Contract Solicitation (NIH, CDC)Release: August November 2014 close date

• NIH Guide for Grants and ContractsRelease: Weekly Receipt dates specified in each FOA

(http://grants.nih.gov/grants/guide/index.html)

“Parent” FOAs: SBIR: PA-14-071 STTR: PA-14-072

http://grants.nih.gov/grants/guide/index.html

http://grants.nih.gov/grants/guide/index.html

http://grants.nih.gov/grants/guide/pa-files/PA-14-071.html

http://grants.nih.gov/grants/guide/pa-files/PA-14-072.html


NIH SBIR/STTR FOAs

SBIR/STTR Omnibus Solicitation

NIH SBIR Direct Phase II

Targeted FOAs

NIH SBIR Contract Solicitation

Located on the NIH SBIR/STTR Homepage: http://sbir.nih.gov

http://sbir.nih.gov/


Targeted FOAs

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

Over 60 IC Specific Targeted FOAs


NIH SBIR/STTR FOAs

Which FOA is best for you?

SBIR vs STTR?

Phase I vs Fast-track vs Direct Phase II?

**Contact your NIH SBIR/STTR Program Officer!**


Technical Assistance Programs

Phase I Phase II Phase III

Mt. “FDA”???

Commercialization Assistance Program

Niche Assessment Program

Helping Companies cross the “Valley of Death”


Technical Assistance Programs

Commercialization Assistance

“Menu” of technical assistance/training programs in:

• Strategic/business planning• FDA requirements• Technology valuation• Manufacturing issues• Patent and licensing issues

Helps build strategic alliances

Facilitates investor partnerships

Individualized mentoring/consulting

(Phase II or IIB awardees)

Niche Assessment Identifies other uses of technology

Determines competitive advantages

Performs market research(Active Phase I awardees)


Gap Funding Programs

Additional Commercialization Resources

• No-cost extension− Extends project period by 6 months or 1 year

• Fast-track application− One application for Phase I and Phase II that is submitted

and reviewed together• Phase IIB awards

− $1M per year for up to 3 years; not offered by all ICs• Administrative supplements

− Adds money to parent grant• Commercialization Readiness Pilot Program

− Additional gap funding opportunity – stay tuned for details!

Always talk to Program Officer!


Reauthorization Changes – Budget Hard Caps

• Reauthorization required that budgets over the hard cap ($225,000 for Phase I and $1,500,000 for Phase II) Agencies (not applicants) apply for waiver from SBA

• SBA has recently approved a topics list, which allows budgets to exceed the hard caps as long as the project topics are on the list

• Pre-approved topics list is Appendix A in regular topics document: http://1.usa.gov/1iUa5Kh

• The approval is good for the 2014 SBIR/STTR Omnibus, and any FOA that falls on the topic list, including the Direct Phase II FOA

http://1.usa.gov/1iUa5Kh

http://1.usa.gov/1iUa5Kh


Other Reauthorization Changes

• Majority-owned venture capital provision

• Switching between SBIR and STTR

• SBIR Direct Phase II

• SBA Company Registry

Full list of changes located here:

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

Questions? – Talk to your NIH IC Program Officer!




Gap Funding Programs Phase IIB Competing Renewals Phase I/Phase II Fast Track Administrative Supplements

NIH SBIR/STTR Program Summary of Key Features

SBIR and STTR Program Single SBIR/STTR grant solicitation Investigator-initiated research ideas Special Funding Opportunities (NIH Guide for Grants & Contracts) Electronic Submission (grants only) Awards: Grants, Contracts, Cooperative Agreements

Budget and Project Period $150K/6 - 12 months (Phase I) $1M/2 years (Phase II)

External Peer Review Option to request review group Experts from academia/industry Five Criteria: Significance,

Approach, PI(s), Innovation, Environment

Summary statement for all applicants

Revise & resubmit

Technical Assistance Programs Technology Niche Assessment Commercialization Assistance

Multiple Receipt Dates (Grants) April 5, August 5, December 5 May 7, Sept 7, Jan 7 (AIDS) Contracts: November


Next Steps

You’ve convinced me to apply……

NOW WHAT?!?!


Small Business Concern

Applicant Initiates

Research Idea

Grantee Conducts Research

IC Staff Prepare funding Planfor IC Director

NIH Center for Scientific ReviewAssign to IC and IRG

Scientific Review GroupsEvaluate Scientific Merit

Advisory Council or BoardRecommend approval

IC Allocates

Funds

SubmitsSBIR/STTR Grant Application to NIH

Electronically

~2-3 monthsafter submission

~2-3 months after review

Application & Review Process


Timeline: New Applications

DueDate

April 5

August 5

December 5

ScientificReview

July

November

March

CouncilReview

October

January

May

AwardDate (earliest)

December

April

July

2 2 4 4 5 5

<……………….……6-9 months…………………….>


Electronic Submission

SBIR/STTR grant applications must be submitted electronically. SBIR contract proposals still in paper form.

Registrations are required!!!

DUNS Number (Company) System for Award Management (SAM)Grants.gov (Company) eRA Commons (Company and all PD/PIs)SBA Company Registry at SBIR.gov

http://era.nih.gov/ElectronicReceipt/index.htm


WOSB

What is a Women-Owned Small Business?

• A firm must be at least 51% owned and controlled by one or more women, and primarily managed by one or more women (who must be US citizens).

• The firm must be “small” in its primary industry in accordance with SBA’s size standards for that industry.

• SBCs self certify on the SF 424 (R&R) Form.

• http://1.usa.gov/1d10b5q

http://1.usa.gov/1d10b5q

http://1.usa.gov/1d10b5q


SDB

What is a Socially and Economically Disadvantaged Business (SDB)?

• The firm must be 51% or more owned and control by one or more disadvantaged persons.

• The disadvantaged person or persons must be socially disadvantaged and economically disadvantaged,

• The firm must be small, according to SBA’s size standards.

• You must self-certify by registering your business in the System for Award Management.

• http://1.usa.gov/1mKnU0a

http://www.sba.gov/category/navigation-structure/contracting/contracting-officials/eligibility-size-standards

http://www.sba.gov/category/navigation-structure/contracting/contracting-officials/eligibility-size-standards

https://www.sam.gov/

https://www.sam.gov/

http://1.usa.gov/1mKnU0a

http://1.usa.gov/1mKnU0a


Most Important Piece of Advice

• Talk to an NIH Program Officer about your application and SUBMIT EARLY (days not hours and minutes)!

– Program Officer contact information found in the NIH SBIR/STTR Solicitation on http://sbir.nih.gov

– Questions about who to contact? Email [email protected]


mailto:[email protected]


Other Presentations to Check Out

• NIH Peer Review Process– By:

• How Well Do You Know the eRA Commons? – By:


Case Study

• Case Study – SBIR or STTR?

• An SBC is developing a novel therapeutic for hepatitis B.

• The PI has primary employment at the SBC, and the SBC wants to partner with a university to complete the animal studies?

• Would SBIR or STTR be most appropriate?


Case Study

• Case Study – SBIR or STTR?

• It depends! For both SBIR and STTR, the SBC can partner with a research institution, but an STTR requires that a research partner complete at least 30% of the overall work

• No research partner is required for SBIR

Which one is right for you? Talk to your Program Officer!


Case Study

• Case Study – PI Eligibility for SBIR?

• A researcher has primary employment at a university, but wants to lead the research project for an SBIR award.

• Would the SBC be eligible to apply for an SBIR?


Case Study

• Case Study – PI Eligibility for SBIC?

• No, not under current circumstances. The PI must have primary employment at the SBC at the time of award to be eligible for an SBIR.

• Before Notice of Award is sent out, SBC will be asked to submit Just-in-Time information, which will access the PI’s employment status.

• What about an STTR?


Case Study

• Case Study – PI Eligibility for STTR?

• Yes, as long as the SBC completes at least 40% of the overall work for a Phase I and Phase II, and the partnering non-profit research institution completes at least 30% of the work.

• The remaining 30% can go to the SBC, the RI or another third party organization.


Case Study

• Case Study – Budget Hard Caps?

• An SBC wants to submit a Phase I budget for $300,000 to develop the proof-of-concept for a tool to improve diabetes care.

• Is this permitted?


Case Study

• Case Study – Budget Hard Caps?

• Perhaps! Look on Appendix A of the 2014 SBIR/STTR Topics Document to see if this topic has been granted a waiver by the Small Business Administration (SBA).

• Either way – Seek the advice of your Program Officer!


For More Information

Matthew Portnoy, PhDNIH SBIR/STTR Program Coordinator

Phone: 301- 435-2688Email: [email protected]

Lenka Fedorkova, PhDSBIR/STTR Program Analyst

Phone: 301-435-0921Email: [email protected]

Robert VinsonSBIR/STTR Program Analyst


Betty RoysterSBIR/STTR Communications Specialist


Julie BeaverSBIR/STTR StatisticianPhone: 301-496-8807

Email: [email protected]







More Information

Get Connected!• Subscribe to the SBIR/STTR Listserv:

• Email [email protected] with the following text in the message body: subscribe SBIR-STTR your name

• NIH Guide for Grants and Contracts (weekly notification) http://grants.nih.gov/grants/guide/listserv.htm

• Follow us on Twitter: @NIHsbir

• Submit your SBIR/STTR Success Story at: http://sbir.nih.gov

• Email: [email protected]







Save the Date

16th Annual NIH SBIR/STTR Conference• October 21 – 23, 2014

• Albuquerque, New Mexico

• Host: University of New Mexico Health Sciences Center

• Stay tuned – details to come!


More Information

Questions and Answers!

overview of the nih sbir/sttr programs

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