2014 national sbir conference · 2014 national sbir conference gaylord national resort &...

1

National Institutes of Health Office of Extramural Research

Overview of the

NIH SBIR/STTR Programs

2014 National SBIR Conference

Gaylord National Resort & Convention Center

June 16 - 18, 2014

Robert Vinson

NIH SBIR/STTR Assistant Program Manager


SBIR/STTR Programs Overview

SMALL BUSINESS INNOVATION

RESEARCH (SBIR) PROGRAM Set-aside program for small business concerns to

engage in Federal R&D – with potential for

commercialization

SMALL BUSINESS TECHNOLOGY

TRANSFER (STTR) PROGRAM Set-aside program to facilitate cooperative R&D

between small business concerns and U.S. research

institutions – with potential for commercialization

2.8%

0.40%

2


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

DOE NSF NASA All

Others

~ $2.3B in FY13

Across all agencies


HHS/NIH Program Funding

2014 Budget SBIR STTR

NIH $663M $95M

CDC

FDA

ACF

$8.97M

$1.29M

$81K

N/A

Phase I

$150K*

6 months*

$150K*

1 year*

Phase II $1M*

2 years*

$1M*

2 years*

3


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 Institute

on Alcohol Abuse

and Alcoholism

National Institute

of Arthritis and

Musculoskeletal

and Skin Diseases

National Cancer

Institute

National Institute

on Aging

National Institute

of Child Health

and Human

Development

National Institute

of Allergy and

Infectious Diseases

National Institute

of Diabetes and

Digestive and

Kidney Diseases

National Institute

of Dental and

Craniofacial

Research

National Institute

on Drug Abuse

National Institute

of Environmental

Health Sciences

National Institute on

Deafness and Other

Communication

Disorders

National Eye

Institute

National Human

Genome Research

Institute

National Heart,

Lung, and Blood

Institute

National Institute

of Mental Health

National Institute

of Neurological

Disorders and

Stroke

National Institute

of General

Medical Sciences

National Institute

of Nursing Research

National Library

of Medicine

National Center

for Complementary

and Alternative

Medicine

Fogarty

International

Center

National Center

for Advancing

Translational Sciences

National Institute

of Biomedical

Imaging

and

Bioengineering

No funding

authority

Center for

Information

Technology

Center for

Scientific Review NIH Clinical Center

Office of Research

Infrastructure Programs

4


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.

NCI

NIAID

NHLBI

NIGMS NIDDK

NINDS

NIMH

NICHD

NIA

NIDA NEI

NCATS

NIEHS

NIAMS

NHGRI

NIAAA

NIDCD

NIDCR NIBIB

NIMHD

ORIP NINR NCCAM

NLM

NIH SBIR/STTR Budget Allocations FY2014 2.8% SBIR $663M

0.40% STTR $95M

Total FY2014 $758M

5


Success Rate of SBIR/STTR

2012 and 2013 by Phase

9

15.9% 15.6%

39.9%

15.7% 13.2%

32.8%

Fast Track Phase I Phase II

34.4%

20.3%

39.4%

28.6%

18.7%

26.4%

Fast Track Phase I Phase II

2012

2013

STTR

Success Rates Posted Online:

http://report.nih.gov/success_rates/index.aspx

SBIR


NIH-wide SBIR/STTR Success Rates

Fiscal Year SBIR/STTR Phase Number of

Applications Reviewed

Number of Applications

Awarded

Success Rate

Total Funding

2012 SBIR Fast Track 358 57 15.9% $13,985,802

2012 SBIR Phase 1 4,287 667 15.6% $154,237,890

2012 SBIR Phase 2 557 222 39.9% $153,650,162

2012 STTR Fast Track 32 11 34.4% $2,840,632

2012 STTR Phase 1 542 110 20.3% $23,857,700

2012 STTR Phase 2 71 28 39.4% $18,240,418

2012 FY TOTAL 5,847 1,095 18.7% $366,812,604

2013 SBIR Fast Track 313 49 15.7% $13,981,386

2013 SBIR Phase I 3,738 495 13.2% $114,040,157

2013 SBIR Phase II 542 178 32.8% $136,348,846

2013 STTR Fast Track 42 12 28.6% $2,542,128

2013 STTR Phase I 583 109 18.7% $24,138,629

2013 STTR Phase II 72 19 26.4% $10,985,373

2013 FY TOTAL 5,290 862 16.3% $302,036,519

Success Rates Posted Online:

http://report.nih.gov/success_rates/index.aspx

6


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 Program

Descriptions 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

7


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 Contracts

Release: 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

National Institutes of Health Office of Extramural Research 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://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://sbir.nih.gov/

8


New NIH SBIR/STTR Homepage

15


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)

9


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


Other Reauthorization Changes

• Majority-owned venture capital provision

• Switching between SBIR and STTR

• SBIR Direct Phase II

Full list of changes located here:

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

.htm

Questions? – Talk to your NIH IC Program Officer!

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

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

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

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

10


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


Small Business

Concern

Applicant

Initiates

Research Idea

Grantee Conducts

Research

IC Staff Prepare funding Plan

for IC Director

NIH Center for Scientific

Review/Assign to IC and IRG

Scientific Review Groups

Evaluate Scientific Merit

Advisory Council or Board

Recommend approval

IC

Allocates

Funds

Submits

SBIR/STTR Grant

Application to NIH

Electronically

~2-3 months

after submission

~2-3 months

after review

Application & Review Process

11


Timeline: New Applications

Due Date

April 5

August 5

December 5

Scientific Review

July

November

March

Council Review

October

January

May

Award Date (earliest)

December

April

July

2 4 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

12


For More Information

Matthew Portnoy, PhD NIH SBIR/STTR Program Coordinator

Phone: 301- 435-2688

Email: [email protected]

Lenka Fedorkova, PhD SBIR/STTR Asst. Program Manager

Phone: 301-435-0921


Robert Vinson SBIR/STTR Asst. Program Manager

Phone: 301-435-2713


Betty Royster SBIR/STTR Communications Specialist

Phone: 301-402-1632


Julie Beaver SBIR/STTR Statistician

Phone: 301-496-8807



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]

mailto:[email protected]










13


Save the Date

16th Annual NIH SBIR/STTR

Conference

• October 21 – 23, 2014

• Albuquerque, New Mexico

• Host: University of New Mexico

Health Sciences Center

• Conference website: sbir2014.com

2014 national sbir conference · 2014 national sbir conference gaylord national resort &...

Documents