-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

HHS SBIRSTTR PHS 2017-2 GRANT OMNIBUS WEBINAR

Thursday June 29 2017

200-330PM

Matthew Portnoy PhD

SBIRSTTR Program Coordinator

Director of the Division of Special Programs

Office of Extramural Research NIH

1

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (SITR

AGE AGENDA DA

Ji ~ ~

middotmiddotmiddotrGJ

Introductions

Reauthorizations

SBIR 101

New Omnibus Solicitations

2017 Deadlines

Questions amp Answers

Closing

2

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

SAVE THE DATE November 7-9 2017

Milwaukee Wisconsin

httpsctsimcwedueventnih-sbir-milwaukee-2017

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (SITR

AGE AGENDA DA

Ji ~ ~

middotmiddotmiddotrGJ

Introductions

Reauthorizations

SBIR 101

New Omnibus Solicitations

2017 Deadlines

Questions amp Answers

Closing

2

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

SAVE THE DATE November 7-9 2017

Milwaukee Wisconsin

httpsctsimcwedueventnih-sbir-milwaukee-2017

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

SAVE THE DATE November 7-9 2017

Milwaukee Wisconsin

httpsctsimcwedueventnih-sbir-milwaukee-2017

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

_ _ _

NIH SBIRSTTR Website

httpssbirnihgov

4

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (SITR NIH SBIRSTTR Website

WhWhat at are are SBIR and SBIR and STTSTTR R PPrograms rograms

SBISBIR R The NIH SBIR program funds early stage small businesses

that are seeking to commercialize innovative biomedical

technologies This competitive program helps small

businesses participate in federal research and

development develop life-saving technologies and create

jobs

The NIH STTR program is similar to the NIH SBIR program

STTR but requires that the small business formally collaborate with

a research institution in Phase I and Phase II Learn

more about the NIH SBIR and STTR programs including

their critical differences

httpssbirnihgov

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (SITR New to SBIRSTTR

SBIRSTTR Application Process lnfographic

Use this interactive chart that contains helpful information to guide you through the NIH SBIRSTTR application process Click though the chart for answers to your related questions

START THE SBIRSTTR APPLICATION PROCESS

INFOGRAPHIC

Confirm Your Small Business Meets Eligibility Requirements

Research Idea r Develop an Innovative 0

-SBIR Omnibus - -

(PA-16-302) V V STTR Omnibus

(PA-16-303)

Five Required Registrations (Overview)

Targeted SBIRSTTR FOAs

httpsbirnihgovinfographic

Congressionally Mandated

Programs

SET ASIDE

32

(FY17)

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (SITR

SMALL BUSINESS INNOVATION

RESEARCH (SBIR) PROGRAM

Set-aside program for small business concerns

to engage in federal RampD -- with potential for

commercialization

45

(FY17)

SMALL BUSINESS TECHNOLOGY

TRANSFER (STTR) PROGRAM

Set-aside program to facilitate cooperative

RampD between small business concerns and US

research institutions -- with potential for

commercialization

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer SBIR Purpose and Goals

8

bull Stimulate technological innovation

bull Use small business to meet federal RampD needs

bull Foster and encourage participation by minorities and disadvantaged persons in technological innovation

bull Increase private-sector commercialization innovations

derived from federal RampD

Small Business Innovation Development Act of 1982 PL 114-328 Re-Authorizes program through FY2022

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer STTR Purpose and Goals

9

bull Stimulate and foster scientific and technological

innovation through cooperative research and

development carried out between small business

concerns and research institutions

bull Foster technology transfer between small business

concerns and research institutions

Small Business Research and Development Enhancement Act of 1992

PL 114-328 Re-Authorizes program through FY2022

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

SBIRSTTR Reauthorization

update

10

bull Congress passed a 5 year SBIRSTTR Reauthorization as

part of S2943 the 2017 National Defense Authorization

Act (NDAA)

bull SBIRSTTR programs reauthorized for 5 year FY18

through FY22

bull Simple one line reauthorization

bull No pilot programs extended all expire 93017

o Direct Phase II

o CRP

o 3 Agency SBIR Admin funds

o NIH Phase 0 Proof of Concept Centers

bull Bills circulating in Congress as we speak on these and other areas ndash Stay tuned

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (SITR

SBIRSTTR Budgets by Agency

FY15

bull bull

DOD

HHS

DOE NASA NSF All

Others

~ $25B in FY2015

across all agencies

Grants

Contracts

I bull bull e middotmiddot~middot -

middot bull-r middotmiddot middot SBIR middot STTR ~ -middot~middot ~1bull middotmiddotmiddot A mericas Seed Fund middot

Agencies with SBIR and STTR Programs Budget

Department of Defense (DOD) $1070B

Department of Health and Human Services (HHS)

including the National Institutes of Health (NIH)

$7970M

Department of Energy (DOE) including Advanced

Research Projects Agency ndash Energy (ARPA-E)

$2061M

National Aeronautics and Space Administration

(NASA)

$1801M

National Science Foundation (NSF) $1760M

Agencies with SBIR Programs Budget

US Department of Agriculture (USDA) $253M

Department of Homeland Security (DHS)

Science and Technology Directorate (SampT) and

Domestic Nuclear Detection Office (DNDO)

$177M

Department of Commerce National Oceanic and

Atmospheric Administration (NOAA) and National

Institute of Standards and Technology (NIST)

$84M

Department of Transportation (DOT) $79M

Department of Education (ED) $75M

Environmental Protection Agency (EPA) $42M

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer HHS Program Funding

2017 Budget SBIR STTR

NIH

CDC

ACL (NIDILRR)

FDA

$861M

~$110M

~$3M

~$1M

$121M

NA

NA

NA

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer Program Eligibility Criteria

bull Organized as for-profit US business

bull Small 500 or fewer employees including affiliates

bull Work must be done in the US (with few exceptions)

bull Individual Ownership

o Greater than 50 US-owned by individuals and independently operated

OR

o Greater than 50 owned and controlled by other business concerns

that isare greater than 50 owned and controlled by one or more

individuals OR

o 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 (For FOAs after 1282013 NIH 71014 CDC)

Determined at Time of Award

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer STTR Eligibility Criteria

14

bull Applicant is a Small Business Concern

bull Formal Cooperative RampD Effort

o Minimum 40 by small business

o Minimum 30 by US research institution

bull US Research Institution

o College or university other non-profit research organization Federal RampD center

bull Intellectual Property Agreement

o Allocation of rights in IP and rights to carry out follow-on

RampD and commercialization

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

NIH SBIRSTTR

3-Phase Program

Discovery

Phase

I Phase I Feasibility Study Budget Guide $150K for SBIR and STTR

Project Period 6 months (SBIR) 1 year (STTR)

Development

Phase

II

Phase

IIB

Phase II Full ResearchRampD $1M for SBIR and STTR over two years

Phase IIB Competing RenewalRampD Clinical RampD Complex Instrumentationto FDA

Many but not all ICrsquos participate

Varies~$1M per year up to 3 years

Commercialization

Phase

III Phase III Commercialization NIH generally not the ldquocustomerrdquo

Consider partnering and exit strategy early

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

SBIR and STTR Critical

Differences

SBIR STTR

Partnering

Requirement

Permits partnering

Guidelines May outsource

33 (Phase I) 50 (Phase II)

Primary employment (gt50)

must be with the small

business

Requires a non-profit research

institution partner

(eg university)

Minimum Work Requirements

40 small business

30 research institution

partner

PI may be employed by either

the research institution

partner or small business

Work

Requirement

Principal

Investigator

Award is always made to the small business

No SBIRSTTR funding authority

Office of Research

Infrastructure Programs

National

Institute

on Aging

National Institute

on Alcohol Abuse

and Alcoholism

National Institute

of Allergy and

Infectious Diseases

National Institute of

Arthritis and

Musculoskeletal and

Skin Diseases

National

Cancer

Institute

National Institute

of Child Health

and Human

Development

National Institute

on Deafness and

Other

Communication

Disorders

National Institute

of Dental and

Craniofacial

Research

National Institute

of Diabetes and

Digestive and

Kidney Diseases

National

Institute

on Drug Abuse

National Institute

of Environmental

Health Sciences

National

Eye

Institute

National Institute

of General

Medical Sciences

National Heart

Lung and Blood

Institute

National Human

Genome Research

Institute

National

Institute

of Mental Health

National Institute of

Neurological

Disorders and Stroke

National Institute

of Nursing

Research

National Institute

on Minority

Health and Health

Disparities

National Center for

Complementary and

Integrative Health

Fogarty

International

Center

National Center

for Advancing

Translational Sciences

National

Library

of Medicine

National Institute

of Biomedical

Imaging and

Bioengineering

Office of the Director

NIH Clinical Center Center for Information

Technology Center for Scientific Review

httpwwwnihgovicd

- Small Business Innovation Research (SBIR Small Business Technology Transfer National Institutes of Health

NIH SBIRSTTR Budget Allocations FY2017

NIDCD NIMHD NINR

NIBIB ORIP NCCIH

32 SBIR $8614M

045 STTR $1211M

Total FY17 $9825M

NIAAA NIDCR NLM NHGRI NIAMS

NIEHS NCI NCATS

NEI

NIDA

NIAID NIA

NICHD

NIMH NHLBI

NINDS

NIDDK NIGMS

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

----------------------~~

NIH SBIRSTTR

3-Phase Program

I

I

---------------------~-

I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Only Some ICs

Participate

Direct to Phase II

$3M for up to 3 years

Commercialization

Readiness Pilot (CRP) Congressional

authority expired

Congressional

authority expired

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Fast-Track

----------------------~~ I

I

---------------------~-

I I I I I I

I I I I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II

bull Simultaneous submission

and review of Phase I and II

bull Phase I is awarded

bull Milestonesaims of Phase I

are assessed by program

staff BEFORE Phase II is

awarded

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Direct to Phase II

----------------------~~ I

I

I I I I I I

---------------------~-

I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II bull SBIR only

bull Bypass Phase I grant

bull Congressional authority EXPIRED

Discovery Development Commercialization Competing Renewal Phase I Phase II Phase III

$3M for up to 3 years

Phase IIB

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

Phase IIB Competing

Renewal Award

bull SBIRSTTR Phase II awardee

bull Technologies that require extraordinary timeeffort to develop

and often require FDA regulatory approval

bull Awards up to $1Myear for up to 3 years

bull IC must accept Competing Renewal applications (NIA NIAAA

NIAID NICHD NIDA NIDCD NIDDK NEI NIGMS NHLBI NIMH

NINDS NCATS ORIP NCI NHLBI NINDS)

Contact NIH Program Staff to discuss

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR NIH SBIRSTTR FOAs

FunFunding ding OpportOpportunities unities AnAnnouncements nouncements (FO(FOAs) As) a publicly available document by which a federal agency makes

known its intentions to award discretionary grants or cooperative agreements usually as a result of competition for funds

Targeted SBIIUSTTR Solicitations

bull SBIR omnbus Fu nd ing Opportun ity

Announcement (PA-17 -302)

bull STTR Omnib u s FundinQ Opportu nity

Announcement (PA-17-303)

bull 2017 Program Oescnptions and Researc h

Topics Document

II (1 6 M B) CHI (479 KB)

bull 2017 SBA a p proved topics list for budget

waivers

II (1 6 M B) Clil (479 KB)

rJ NIH SBIRSTTR Grant Forms

The Co ng ressio na l a utho rity for SBIR D ire ct

Ph as e II has e xpired

See individual SBIR STTR targeted

soI1cita ho ns

Standard Due Dates

eJ Janu a ry5

eJ April 5

eJ Septembe r 5

Standard Due Oates

eJ Janu a ry 5

eJ April 5

eJ Septembe r 5

Due dates v ary

See individual a nnouncem ents ror dates Top of Page

httpssbirnihgovfunding

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer SBIR Purpose and Goals

8

bull Stimulate technological innovation

bull Use small business to meet federal RampD needs

bull Foster and encourage participation by minorities and disadvantaged persons in technological innovation

bull Increase private-sector commercialization innovations

derived from federal RampD

Small Business Innovation Development Act of 1982 PL 114-328 Re-Authorizes program through FY2022

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer STTR Purpose and Goals

9

bull Stimulate and foster scientific and technological

innovation through cooperative research and

development carried out between small business

concerns and research institutions

bull Foster technology transfer between small business

concerns and research institutions

Small Business Research and Development Enhancement Act of 1992

PL 114-328 Re-Authorizes program through FY2022

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

SBIRSTTR Reauthorization

update

10

bull Congress passed a 5 year SBIRSTTR Reauthorization as

part of S2943 the 2017 National Defense Authorization

Act (NDAA)

bull SBIRSTTR programs reauthorized for 5 year FY18

through FY22

bull Simple one line reauthorization

bull No pilot programs extended all expire 93017

o Direct Phase II

o CRP

o 3 Agency SBIR Admin funds

o NIH Phase 0 Proof of Concept Centers

bull Bills circulating in Congress as we speak on these and other areas ndash Stay tuned

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (SITR

SBIRSTTR Budgets by Agency

FY15

bull bull

DOD

HHS

DOE NASA NSF All

Others

~ $25B in FY2015

across all agencies

Grants

Contracts

I bull bull e middotmiddot~middot -

middot bull-r middotmiddot middot SBIR middot STTR ~ -middot~middot ~1bull middotmiddotmiddot A mericas Seed Fund middot

Agencies with SBIR and STTR Programs Budget

Department of Defense (DOD) $1070B

Department of Health and Human Services (HHS)

including the National Institutes of Health (NIH)

$7970M

Department of Energy (DOE) including Advanced

Research Projects Agency ndash Energy (ARPA-E)

$2061M

National Aeronautics and Space Administration

(NASA)

$1801M

National Science Foundation (NSF) $1760M

Agencies with SBIR Programs Budget

US Department of Agriculture (USDA) $253M

Department of Homeland Security (DHS)

Science and Technology Directorate (SampT) and

Domestic Nuclear Detection Office (DNDO)

$177M

Department of Commerce National Oceanic and

Atmospheric Administration (NOAA) and National

Institute of Standards and Technology (NIST)

$84M

Department of Transportation (DOT) $79M

Department of Education (ED) $75M

Environmental Protection Agency (EPA) $42M

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer HHS Program Funding

2017 Budget SBIR STTR

NIH

CDC

ACL (NIDILRR)

FDA

$861M

~$110M

~$3M

~$1M

$121M

NA

NA

NA

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer Program Eligibility Criteria

bull Organized as for-profit US business

bull Small 500 or fewer employees including affiliates

bull Work must be done in the US (with few exceptions)

bull Individual Ownership

o Greater than 50 US-owned by individuals and independently operated

OR

o Greater than 50 owned and controlled by other business concerns

that isare greater than 50 owned and controlled by one or more

individuals OR

o 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 (For FOAs after 1282013 NIH 71014 CDC)

Determined at Time of Award

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer STTR Eligibility Criteria

14

bull Applicant is a Small Business Concern

bull Formal Cooperative RampD Effort

o Minimum 40 by small business

o Minimum 30 by US research institution

bull US Research Institution

o College or university other non-profit research organization Federal RampD center

bull Intellectual Property Agreement

o Allocation of rights in IP and rights to carry out follow-on

RampD and commercialization

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

NIH SBIRSTTR

3-Phase Program

Discovery

Phase

I Phase I Feasibility Study Budget Guide $150K for SBIR and STTR

Project Period 6 months (SBIR) 1 year (STTR)

Development

Phase

II

Phase

IIB

Phase II Full ResearchRampD $1M for SBIR and STTR over two years

Phase IIB Competing RenewalRampD Clinical RampD Complex Instrumentationto FDA

Many but not all ICrsquos participate

Varies~$1M per year up to 3 years

Commercialization

Phase

III Phase III Commercialization NIH generally not the ldquocustomerrdquo

Consider partnering and exit strategy early

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

SBIR and STTR Critical

Differences

SBIR STTR

Partnering

Requirement

Permits partnering

Guidelines May outsource

33 (Phase I) 50 (Phase II)

Primary employment (gt50)

must be with the small

business

Requires a non-profit research

institution partner

(eg university)

Minimum Work Requirements

40 small business

30 research institution

partner

PI may be employed by either

the research institution

partner or small business

Work

Requirement

Principal

Investigator

Award is always made to the small business

No SBIRSTTR funding authority

Office of Research

Infrastructure Programs

National

Institute

on Aging

National Institute

on Alcohol Abuse

and Alcoholism

National Institute

of Allergy and

Infectious Diseases

National Institute of

Arthritis and

Musculoskeletal and

Skin Diseases

National

Cancer

Institute

National Institute

of Child Health

and Human

Development

National Institute

on Deafness and

Other

Communication

Disorders

National Institute

of Dental and

Craniofacial

Research

National Institute

of Diabetes and

Digestive and

Kidney Diseases

National

Institute

on Drug Abuse

National Institute

of Environmental

Health Sciences

National

Eye

Institute

National Institute

of General

Medical Sciences

National Heart

Lung and Blood

Institute

National Human

Genome Research

Institute

National

Institute

of Mental Health

National Institute of

Neurological

Disorders and Stroke

National Institute

of Nursing

Research

National Institute

on Minority

Health and Health

Disparities

National Center for

Complementary and

Integrative Health

Fogarty

International

Center

National Center

for Advancing

Translational Sciences

National

Library

of Medicine

National Institute

of Biomedical

Imaging and

Bioengineering

Office of the Director

NIH Clinical Center Center for Information

Technology Center for Scientific Review

httpwwwnihgovicd

- Small Business Innovation Research (SBIR Small Business Technology Transfer National Institutes of Health

NIH SBIRSTTR Budget Allocations FY2017

NIDCD NIMHD NINR

NIBIB ORIP NCCIH

32 SBIR $8614M

045 STTR $1211M

Total FY17 $9825M

NIAAA NIDCR NLM NHGRI NIAMS

NIEHS NCI NCATS

NEI

NIDA

NIAID NIA

NICHD

NIMH NHLBI

NINDS

NIDDK NIGMS

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

----------------------~~

NIH SBIRSTTR

3-Phase Program

I

I

---------------------~-

I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Only Some ICs

Participate

Direct to Phase II

$3M for up to 3 years

Commercialization

Readiness Pilot (CRP) Congressional

authority expired

Congressional

authority expired

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Fast-Track

----------------------~~ I

I

---------------------~-

I I I I I I

I I I I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II

bull Simultaneous submission

and review of Phase I and II

bull Phase I is awarded

bull Milestonesaims of Phase I

are assessed by program

staff BEFORE Phase II is

awarded

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Direct to Phase II

----------------------~~ I

I

I I I I I I

---------------------~-

I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II bull SBIR only

bull Bypass Phase I grant

bull Congressional authority EXPIRED

Discovery Development Commercialization Competing Renewal Phase I Phase II Phase III

$3M for up to 3 years

Phase IIB

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

Phase IIB Competing

Renewal Award

bull SBIRSTTR Phase II awardee

bull Technologies that require extraordinary timeeffort to develop

and often require FDA regulatory approval

bull Awards up to $1Myear for up to 3 years

bull IC must accept Competing Renewal applications (NIA NIAAA

NIAID NICHD NIDA NIDCD NIDDK NEI NIGMS NHLBI NIMH

NINDS NCATS ORIP NCI NHLBI NINDS)

Contact NIH Program Staff to discuss

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR NIH SBIRSTTR FOAs

FunFunding ding OpportOpportunities unities AnAnnouncements nouncements (FO(FOAs) As) a publicly available document by which a federal agency makes

known its intentions to award discretionary grants or cooperative agreements usually as a result of competition for funds

Targeted SBIIUSTTR Solicitations

bull SBIR omnbus Fu nd ing Opportun ity

Announcement (PA-17 -302)

bull STTR Omnib u s FundinQ Opportu nity

Announcement (PA-17-303)

bull 2017 Program Oescnptions and Researc h

Topics Document

II (1 6 M B) CHI (479 KB)

bull 2017 SBA a p proved topics list for budget

waivers

II (1 6 M B) Clil (479 KB)

rJ NIH SBIRSTTR Grant Forms

The Co ng ressio na l a utho rity for SBIR D ire ct

Ph as e II has e xpired

See individual SBIR STTR targeted

soI1cita ho ns

Standard Due Dates

eJ Janu a ry5

eJ April 5

eJ Septembe r 5

Standard Due Oates

eJ Janu a ry 5

eJ April 5

eJ Septembe r 5

Due dates v ary

See individual a nnouncem ents ror dates Top of Page

httpssbirnihgovfunding

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer STTR Purpose and Goals

9

bull Stimulate and foster scientific and technological

innovation through cooperative research and

development carried out between small business

concerns and research institutions

bull Foster technology transfer between small business

concerns and research institutions

Small Business Research and Development Enhancement Act of 1992

PL 114-328 Re-Authorizes program through FY2022

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

SBIRSTTR Reauthorization

update

10

bull Congress passed a 5 year SBIRSTTR Reauthorization as

part of S2943 the 2017 National Defense Authorization

Act (NDAA)

bull SBIRSTTR programs reauthorized for 5 year FY18

through FY22

bull Simple one line reauthorization

bull No pilot programs extended all expire 93017

o Direct Phase II

o CRP

o 3 Agency SBIR Admin funds

o NIH Phase 0 Proof of Concept Centers

bull Bills circulating in Congress as we speak on these and other areas ndash Stay tuned

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (SITR

SBIRSTTR Budgets by Agency

FY15

bull bull

DOD

HHS

DOE NASA NSF All

Others

~ $25B in FY2015

across all agencies

Grants

Contracts

I bull bull e middotmiddot~middot -

middot bull-r middotmiddot middot SBIR middot STTR ~ -middot~middot ~1bull middotmiddotmiddot A mericas Seed Fund middot

Agencies with SBIR and STTR Programs Budget

Department of Defense (DOD) $1070B

Department of Health and Human Services (HHS)

including the National Institutes of Health (NIH)

$7970M

Department of Energy (DOE) including Advanced

Research Projects Agency ndash Energy (ARPA-E)

$2061M

National Aeronautics and Space Administration

(NASA)

$1801M

National Science Foundation (NSF) $1760M

Agencies with SBIR Programs Budget

US Department of Agriculture (USDA) $253M

Department of Homeland Security (DHS)

Science and Technology Directorate (SampT) and

Domestic Nuclear Detection Office (DNDO)

$177M

Department of Commerce National Oceanic and

Atmospheric Administration (NOAA) and National

Institute of Standards and Technology (NIST)

$84M

Department of Transportation (DOT) $79M

Department of Education (ED) $75M

Environmental Protection Agency (EPA) $42M

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer HHS Program Funding

2017 Budget SBIR STTR

NIH

CDC

ACL (NIDILRR)

FDA

$861M

~$110M

~$3M

~$1M

$121M

NA

NA

NA

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer Program Eligibility Criteria

bull Organized as for-profit US business

bull Small 500 or fewer employees including affiliates

bull Work must be done in the US (with few exceptions)

bull Individual Ownership

o Greater than 50 US-owned by individuals and independently operated

OR

o Greater than 50 owned and controlled by other business concerns

that isare greater than 50 owned and controlled by one or more

individuals OR

o 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 (For FOAs after 1282013 NIH 71014 CDC)

Determined at Time of Award

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer STTR Eligibility Criteria

14

bull Applicant is a Small Business Concern

bull Formal Cooperative RampD Effort

o Minimum 40 by small business

o Minimum 30 by US research institution

bull US Research Institution

o College or university other non-profit research organization Federal RampD center

bull Intellectual Property Agreement

o Allocation of rights in IP and rights to carry out follow-on

RampD and commercialization

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

NIH SBIRSTTR

3-Phase Program

Discovery

Phase

I Phase I Feasibility Study Budget Guide $150K for SBIR and STTR

Project Period 6 months (SBIR) 1 year (STTR)

Development

Phase

II

Phase

IIB

Phase II Full ResearchRampD $1M for SBIR and STTR over two years

Phase IIB Competing RenewalRampD Clinical RampD Complex Instrumentationto FDA

Many but not all ICrsquos participate

Varies~$1M per year up to 3 years

Commercialization

Phase

III Phase III Commercialization NIH generally not the ldquocustomerrdquo

Consider partnering and exit strategy early

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

SBIR and STTR Critical

Differences

SBIR STTR

Partnering

Requirement

Permits partnering

Guidelines May outsource

33 (Phase I) 50 (Phase II)

Primary employment (gt50)

must be with the small

business

Requires a non-profit research

institution partner

(eg university)

Minimum Work Requirements

40 small business

30 research institution

partner

PI may be employed by either

the research institution

partner or small business

Work

Requirement

Principal

Investigator

Award is always made to the small business

No SBIRSTTR funding authority

Office of Research

Infrastructure Programs

National

Institute

on Aging

National Institute

on Alcohol Abuse

and Alcoholism

National Institute

of Allergy and

Infectious Diseases

National Institute of

Arthritis and

Musculoskeletal and

Skin Diseases

National

Cancer

Institute

National Institute

of Child Health

and Human

Development

National Institute

on Deafness and

Other

Communication

Disorders

National Institute

of Dental and

Craniofacial

Research

National Institute

of Diabetes and

Digestive and

Kidney Diseases

National

Institute

on Drug Abuse

National Institute

of Environmental

Health Sciences

National

Eye

Institute

National Institute

of General

Medical Sciences

National Heart

Lung and Blood

Institute

National Human

Genome Research

Institute

National

Institute

of Mental Health

National Institute of

Neurological

Disorders and Stroke

National Institute

of Nursing

Research

National Institute

on Minority

Health and Health

Disparities

National Center for

Complementary and

Integrative Health

Fogarty

International

Center

National Center

for Advancing

Translational Sciences

National

Library

of Medicine

National Institute

of Biomedical

Imaging and

Bioengineering

Office of the Director

NIH Clinical Center Center for Information

Technology Center for Scientific Review

httpwwwnihgovicd

- Small Business Innovation Research (SBIR Small Business Technology Transfer National Institutes of Health

NIH SBIRSTTR Budget Allocations FY2017

NIDCD NIMHD NINR

NIBIB ORIP NCCIH

32 SBIR $8614M

045 STTR $1211M

Total FY17 $9825M

NIAAA NIDCR NLM NHGRI NIAMS

NIEHS NCI NCATS

NEI

NIDA

NIAID NIA

NICHD

NIMH NHLBI

NINDS

NIDDK NIGMS

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

----------------------~~

NIH SBIRSTTR

3-Phase Program

I

I

---------------------~-

I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Only Some ICs

Participate

Direct to Phase II

$3M for up to 3 years

Commercialization

Readiness Pilot (CRP) Congressional

authority expired

Congressional

authority expired

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Fast-Track

----------------------~~ I

I

---------------------~-

I I I I I I

I I I I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II

bull Simultaneous submission

and review of Phase I and II

bull Phase I is awarded

bull Milestonesaims of Phase I

are assessed by program

staff BEFORE Phase II is

awarded

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Direct to Phase II

----------------------~~ I

I

I I I I I I

---------------------~-

I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II bull SBIR only

bull Bypass Phase I grant

bull Congressional authority EXPIRED

Discovery Development Commercialization Competing Renewal Phase I Phase II Phase III

$3M for up to 3 years

Phase IIB

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

Phase IIB Competing

Renewal Award

bull SBIRSTTR Phase II awardee

bull Technologies that require extraordinary timeeffort to develop

and often require FDA regulatory approval

bull Awards up to $1Myear for up to 3 years

bull IC must accept Competing Renewal applications (NIA NIAAA

NIAID NICHD NIDA NIDCD NIDDK NEI NIGMS NHLBI NIMH

NINDS NCATS ORIP NCI NHLBI NINDS)

Contact NIH Program Staff to discuss

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR NIH SBIRSTTR FOAs

FunFunding ding OpportOpportunities unities AnAnnouncements nouncements (FO(FOAs) As) a publicly available document by which a federal agency makes

known its intentions to award discretionary grants or cooperative agreements usually as a result of competition for funds

Targeted SBIIUSTTR Solicitations

bull SBIR omnbus Fu nd ing Opportun ity

Announcement (PA-17 -302)

bull STTR Omnib u s FundinQ Opportu nity

Announcement (PA-17-303)

bull 2017 Program Oescnptions and Researc h

Topics Document

II (1 6 M B) CHI (479 KB)

bull 2017 SBA a p proved topics list for budget

waivers

II (1 6 M B) Clil (479 KB)

rJ NIH SBIRSTTR Grant Forms

The Co ng ressio na l a utho rity for SBIR D ire ct

Ph as e II has e xpired

See individual SBIR STTR targeted

soI1cita ho ns

Standard Due Dates

eJ Janu a ry5

eJ April 5

eJ Septembe r 5

Standard Due Oates

eJ Janu a ry 5

eJ April 5

eJ Septembe r 5

Due dates v ary

See individual a nnouncem ents ror dates Top of Page

httpssbirnihgovfunding

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

SBIRSTTR Reauthorization

update

10

bull Congress passed a 5 year SBIRSTTR Reauthorization as

part of S2943 the 2017 National Defense Authorization

Act (NDAA)

bull SBIRSTTR programs reauthorized for 5 year FY18

through FY22

bull Simple one line reauthorization

bull No pilot programs extended all expire 93017

o Direct Phase II

o CRP

o 3 Agency SBIR Admin funds

o NIH Phase 0 Proof of Concept Centers

bull Bills circulating in Congress as we speak on these and other areas ndash Stay tuned

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (SITR

SBIRSTTR Budgets by Agency

FY15

bull bull

DOD

HHS

DOE NASA NSF All

Others

~ $25B in FY2015

across all agencies

Grants

Contracts

I bull bull e middotmiddot~middot -

middot bull-r middotmiddot middot SBIR middot STTR ~ -middot~middot ~1bull middotmiddotmiddot A mericas Seed Fund middot

Agencies with SBIR and STTR Programs Budget

Department of Defense (DOD) $1070B

Department of Health and Human Services (HHS)

including the National Institutes of Health (NIH)

$7970M

Department of Energy (DOE) including Advanced

Research Projects Agency ndash Energy (ARPA-E)

$2061M

National Aeronautics and Space Administration

(NASA)

$1801M

National Science Foundation (NSF) $1760M

Agencies with SBIR Programs Budget

US Department of Agriculture (USDA) $253M

Department of Homeland Security (DHS)

Science and Technology Directorate (SampT) and

Domestic Nuclear Detection Office (DNDO)

$177M

Department of Commerce National Oceanic and

Atmospheric Administration (NOAA) and National

Institute of Standards and Technology (NIST)

$84M

Department of Transportation (DOT) $79M

Department of Education (ED) $75M

Environmental Protection Agency (EPA) $42M

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer HHS Program Funding

2017 Budget SBIR STTR

NIH

CDC

ACL (NIDILRR)

FDA

$861M

~$110M

~$3M

~$1M

$121M

NA

NA

NA

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer Program Eligibility Criteria

bull Organized as for-profit US business

bull Small 500 or fewer employees including affiliates

bull Work must be done in the US (with few exceptions)

bull Individual Ownership

o Greater than 50 US-owned by individuals and independently operated

OR

o Greater than 50 owned and controlled by other business concerns

that isare greater than 50 owned and controlled by one or more

individuals OR

o 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 (For FOAs after 1282013 NIH 71014 CDC)

Determined at Time of Award

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer STTR Eligibility Criteria

14

bull Applicant is a Small Business Concern

bull Formal Cooperative RampD Effort

o Minimum 40 by small business

o Minimum 30 by US research institution

bull US Research Institution

o College or university other non-profit research organization Federal RampD center

bull Intellectual Property Agreement

o Allocation of rights in IP and rights to carry out follow-on

RampD and commercialization

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

NIH SBIRSTTR

3-Phase Program

Discovery

Phase

I Phase I Feasibility Study Budget Guide $150K for SBIR and STTR

Project Period 6 months (SBIR) 1 year (STTR)

Development

Phase

II

Phase

IIB

Phase II Full ResearchRampD $1M for SBIR and STTR over two years

Phase IIB Competing RenewalRampD Clinical RampD Complex Instrumentationto FDA

Many but not all ICrsquos participate

Varies~$1M per year up to 3 years

Commercialization

Phase

III Phase III Commercialization NIH generally not the ldquocustomerrdquo

Consider partnering and exit strategy early

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

SBIR and STTR Critical

Differences

SBIR STTR

Partnering

Requirement

Permits partnering

Guidelines May outsource

33 (Phase I) 50 (Phase II)

Primary employment (gt50)

must be with the small

business

Requires a non-profit research

institution partner

(eg university)

Minimum Work Requirements

40 small business

30 research institution

partner

PI may be employed by either

the research institution

partner or small business

Work

Requirement

Principal

Investigator

Award is always made to the small business

No SBIRSTTR funding authority

Office of Research

Infrastructure Programs

National

Institute

on Aging

National Institute

on Alcohol Abuse

and Alcoholism

National Institute

of Allergy and

Infectious Diseases

National Institute of

Arthritis and

Musculoskeletal and

Skin Diseases

National

Cancer

Institute

National Institute

of Child Health

and Human

Development

National Institute

on Deafness and

Other

Communication

Disorders

National Institute

of Dental and

Craniofacial

Research

National Institute

of Diabetes and

Digestive and

Kidney Diseases

National

Institute

on Drug Abuse

National Institute

of Environmental

Health Sciences

National

Eye

Institute

National Institute

of General

Medical Sciences

National Heart

Lung and Blood

Institute

National Human

Genome Research

Institute

National

Institute

of Mental Health

National Institute of

Neurological

Disorders and Stroke

National Institute

of Nursing

Research

National Institute

on Minority

Health and Health

Disparities

National Center for

Complementary and

Integrative Health

Fogarty

International

Center

National Center

for Advancing

Translational Sciences

National

Library

of Medicine

National Institute

of Biomedical

Imaging and

Bioengineering

Office of the Director

NIH Clinical Center Center for Information

Technology Center for Scientific Review

httpwwwnihgovicd

- Small Business Innovation Research (SBIR Small Business Technology Transfer National Institutes of Health

NIH SBIRSTTR Budget Allocations FY2017

NIDCD NIMHD NINR

NIBIB ORIP NCCIH

32 SBIR $8614M

045 STTR $1211M

Total FY17 $9825M

NIAAA NIDCR NLM NHGRI NIAMS

NIEHS NCI NCATS

NEI

NIDA

NIAID NIA

NICHD

NIMH NHLBI

NINDS

NIDDK NIGMS

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

----------------------~~

NIH SBIRSTTR

3-Phase Program

I

I

---------------------~-

I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Only Some ICs

Participate

Direct to Phase II

$3M for up to 3 years

Commercialization

Readiness Pilot (CRP) Congressional

authority expired

Congressional

authority expired

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Fast-Track

----------------------~~ I

I

---------------------~-

I I I I I I

I I I I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II

bull Simultaneous submission

and review of Phase I and II

bull Phase I is awarded

bull Milestonesaims of Phase I

are assessed by program

staff BEFORE Phase II is

awarded

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Direct to Phase II

----------------------~~ I

I

I I I I I I

---------------------~-

I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II bull SBIR only

bull Bypass Phase I grant

bull Congressional authority EXPIRED

Discovery Development Commercialization Competing Renewal Phase I Phase II Phase III

$3M for up to 3 years

Phase IIB

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

Phase IIB Competing

Renewal Award

bull SBIRSTTR Phase II awardee

bull Technologies that require extraordinary timeeffort to develop

and often require FDA regulatory approval

bull Awards up to $1Myear for up to 3 years

bull IC must accept Competing Renewal applications (NIA NIAAA

NIAID NICHD NIDA NIDCD NIDDK NEI NIGMS NHLBI NIMH

NINDS NCATS ORIP NCI NHLBI NINDS)

Contact NIH Program Staff to discuss

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR NIH SBIRSTTR FOAs

FunFunding ding OpportOpportunities unities AnAnnouncements nouncements (FO(FOAs) As) a publicly available document by which a federal agency makes

known its intentions to award discretionary grants or cooperative agreements usually as a result of competition for funds

Targeted SBIIUSTTR Solicitations

bull SBIR omnbus Fu nd ing Opportun ity

Announcement (PA-17 -302)

bull STTR Omnib u s FundinQ Opportu nity

Announcement (PA-17-303)

bull 2017 Program Oescnptions and Researc h

Topics Document

II (1 6 M B) CHI (479 KB)

bull 2017 SBA a p proved topics list for budget

waivers

II (1 6 M B) Clil (479 KB)

rJ NIH SBIRSTTR Grant Forms

The Co ng ressio na l a utho rity for SBIR D ire ct

Ph as e II has e xpired

See individual SBIR STTR targeted

soI1cita ho ns

Standard Due Dates

eJ Janu a ry5

eJ April 5

eJ Septembe r 5

Standard Due Oates

eJ Janu a ry 5

eJ April 5

eJ Septembe r 5

Due dates v ary

See individual a nnouncem ents ror dates Top of Page

httpssbirnihgovfunding

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (SITR

SBIRSTTR Budgets by Agency

FY15

bull bull

DOD

HHS

DOE NASA NSF All

Others

~ $25B in FY2015

across all agencies

Grants

Contracts

I bull bull e middotmiddot~middot -

middot bull-r middotmiddot middot SBIR middot STTR ~ -middot~middot ~1bull middotmiddotmiddot A mericas Seed Fund middot

Agencies with SBIR and STTR Programs Budget

Department of Defense (DOD) $1070B

Department of Health and Human Services (HHS)

including the National Institutes of Health (NIH)

$7970M

Department of Energy (DOE) including Advanced

Research Projects Agency ndash Energy (ARPA-E)

$2061M

National Aeronautics and Space Administration

(NASA)

$1801M

National Science Foundation (NSF) $1760M

Agencies with SBIR Programs Budget

US Department of Agriculture (USDA) $253M

Department of Homeland Security (DHS)

Science and Technology Directorate (SampT) and

Domestic Nuclear Detection Office (DNDO)

$177M

Department of Commerce National Oceanic and

Atmospheric Administration (NOAA) and National

Institute of Standards and Technology (NIST)

$84M

Department of Transportation (DOT) $79M

Department of Education (ED) $75M

Environmental Protection Agency (EPA) $42M

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer HHS Program Funding

2017 Budget SBIR STTR

NIH

CDC

ACL (NIDILRR)

FDA

$861M

~$110M

~$3M

~$1M

$121M

NA

NA

NA

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer Program Eligibility Criteria

bull Organized as for-profit US business

bull Small 500 or fewer employees including affiliates

bull Work must be done in the US (with few exceptions)

bull Individual Ownership

o Greater than 50 US-owned by individuals and independently operated

OR

o Greater than 50 owned and controlled by other business concerns

that isare greater than 50 owned and controlled by one or more

individuals OR

o 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 (For FOAs after 1282013 NIH 71014 CDC)

Determined at Time of Award

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer STTR Eligibility Criteria

14

bull Applicant is a Small Business Concern

bull Formal Cooperative RampD Effort

o Minimum 40 by small business

o Minimum 30 by US research institution

bull US Research Institution

o College or university other non-profit research organization Federal RampD center

bull Intellectual Property Agreement

o Allocation of rights in IP and rights to carry out follow-on

RampD and commercialization

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

NIH SBIRSTTR

3-Phase Program

Discovery

Phase

I Phase I Feasibility Study Budget Guide $150K for SBIR and STTR

Project Period 6 months (SBIR) 1 year (STTR)

Development

Phase

II

Phase

IIB

Phase II Full ResearchRampD $1M for SBIR and STTR over two years

Phase IIB Competing RenewalRampD Clinical RampD Complex Instrumentationto FDA

Many but not all ICrsquos participate

Varies~$1M per year up to 3 years

Commercialization

Phase

III Phase III Commercialization NIH generally not the ldquocustomerrdquo

Consider partnering and exit strategy early

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

SBIR and STTR Critical

Differences

SBIR STTR

Partnering

Requirement

Permits partnering

Guidelines May outsource

33 (Phase I) 50 (Phase II)

Primary employment (gt50)

must be with the small

business

Requires a non-profit research

institution partner

(eg university)

Minimum Work Requirements

40 small business

30 research institution

partner

PI may be employed by either

the research institution

partner or small business

Work

Requirement

Principal

Investigator

Award is always made to the small business

No SBIRSTTR funding authority

Office of Research

Infrastructure Programs

National

Institute

on Aging

National Institute

on Alcohol Abuse

and Alcoholism

National Institute

of Allergy and

Infectious Diseases

National Institute of

Arthritis and

Musculoskeletal and

Skin Diseases

National

Cancer

Institute

National Institute

of Child Health

and Human

Development

National Institute

on Deafness and

Other

Communication

Disorders

National Institute

of Dental and

Craniofacial

Research

National Institute

of Diabetes and

Digestive and

Kidney Diseases

National

Institute

on Drug Abuse

National Institute

of Environmental

Health Sciences

National

Eye

Institute

National Institute

of General

Medical Sciences

National Heart

Lung and Blood

Institute

National Human

Genome Research

Institute

National

Institute

of Mental Health

National Institute of

Neurological

Disorders and Stroke

National Institute

of Nursing

Research

National Institute

on Minority

Health and Health

Disparities

National Center for

Complementary and

Integrative Health

Fogarty

International

Center

National Center

for Advancing

Translational Sciences

National

Library

of Medicine

National Institute

of Biomedical

Imaging and

Bioengineering

Office of the Director

NIH Clinical Center Center for Information

Technology Center for Scientific Review

httpwwwnihgovicd

- Small Business Innovation Research (SBIR Small Business Technology Transfer National Institutes of Health

NIH SBIRSTTR Budget Allocations FY2017

NIDCD NIMHD NINR

NIBIB ORIP NCCIH

32 SBIR $8614M

045 STTR $1211M

Total FY17 $9825M

NIAAA NIDCR NLM NHGRI NIAMS

NIEHS NCI NCATS

NEI

NIDA

NIAID NIA

NICHD

NIMH NHLBI

NINDS

NIDDK NIGMS

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

----------------------~~

NIH SBIRSTTR

3-Phase Program

I

I

---------------------~-

I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Only Some ICs

Participate

Direct to Phase II

$3M for up to 3 years

Commercialization

Readiness Pilot (CRP) Congressional

authority expired

Congressional

authority expired

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Fast-Track

----------------------~~ I

I

---------------------~-

I I I I I I

I I I I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II

bull Simultaneous submission

and review of Phase I and II

bull Phase I is awarded

bull Milestonesaims of Phase I

are assessed by program

staff BEFORE Phase II is

awarded

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Direct to Phase II

----------------------~~ I

I

I I I I I I

---------------------~-

I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II bull SBIR only

bull Bypass Phase I grant

bull Congressional authority EXPIRED

Discovery Development Commercialization Competing Renewal Phase I Phase II Phase III

$3M for up to 3 years

Phase IIB

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

Phase IIB Competing

Renewal Award

bull SBIRSTTR Phase II awardee

bull Technologies that require extraordinary timeeffort to develop

and often require FDA regulatory approval

bull Awards up to $1Myear for up to 3 years

bull IC must accept Competing Renewal applications (NIA NIAAA

NIAID NICHD NIDA NIDCD NIDDK NEI NIGMS NHLBI NIMH

NINDS NCATS ORIP NCI NHLBI NINDS)

Contact NIH Program Staff to discuss

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR NIH SBIRSTTR FOAs

FunFunding ding OpportOpportunities unities AnAnnouncements nouncements (FO(FOAs) As) a publicly available document by which a federal agency makes

known its intentions to award discretionary grants or cooperative agreements usually as a result of competition for funds

Targeted SBIIUSTTR Solicitations

bull SBIR omnbus Fu nd ing Opportun ity

Announcement (PA-17 -302)

bull STTR Omnib u s FundinQ Opportu nity

Announcement (PA-17-303)

bull 2017 Program Oescnptions and Researc h

Topics Document

II (1 6 M B) CHI (479 KB)

bull 2017 SBA a p proved topics list for budget

waivers

II (1 6 M B) Clil (479 KB)

rJ NIH SBIRSTTR Grant Forms

The Co ng ressio na l a utho rity for SBIR D ire ct

Ph as e II has e xpired

See individual SBIR STTR targeted

soI1cita ho ns

Standard Due Dates

eJ Janu a ry5

eJ April 5

eJ Septembe r 5

Standard Due Oates

eJ Janu a ry 5

eJ April 5

eJ Septembe r 5

Due dates v ary

See individual a nnouncem ents ror dates Top of Page

httpssbirnihgovfunding

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer HHS Program Funding

2017 Budget SBIR STTR

NIH

CDC

ACL (NIDILRR)

FDA

$861M

~$110M

~$3M

~$1M

$121M

NA

NA

NA

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer Program Eligibility Criteria

bull Organized as for-profit US business

bull Small 500 or fewer employees including affiliates

bull Work must be done in the US (with few exceptions)

bull Individual Ownership

o Greater than 50 US-owned by individuals and independently operated

OR

o Greater than 50 owned and controlled by other business concerns

that isare greater than 50 owned and controlled by one or more

individuals OR

o 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 (For FOAs after 1282013 NIH 71014 CDC)

Determined at Time of Award

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer STTR Eligibility Criteria

14

bull Applicant is a Small Business Concern

bull Formal Cooperative RampD Effort

o Minimum 40 by small business

o Minimum 30 by US research institution

bull US Research Institution

o College or university other non-profit research organization Federal RampD center

bull Intellectual Property Agreement

o Allocation of rights in IP and rights to carry out follow-on

RampD and commercialization

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

NIH SBIRSTTR

3-Phase Program

Discovery

Phase

I Phase I Feasibility Study Budget Guide $150K for SBIR and STTR

Project Period 6 months (SBIR) 1 year (STTR)

Development

Phase

II

Phase

IIB

Phase II Full ResearchRampD $1M for SBIR and STTR over two years

Phase IIB Competing RenewalRampD Clinical RampD Complex Instrumentationto FDA

Many but not all ICrsquos participate

Varies~$1M per year up to 3 years

Commercialization

Phase

III Phase III Commercialization NIH generally not the ldquocustomerrdquo

Consider partnering and exit strategy early

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

SBIR and STTR Critical

Differences

SBIR STTR

Partnering

Requirement

Permits partnering

Guidelines May outsource

33 (Phase I) 50 (Phase II)

Primary employment (gt50)

must be with the small

business

Requires a non-profit research

institution partner

(eg university)

Minimum Work Requirements

40 small business

30 research institution

partner

PI may be employed by either

the research institution

partner or small business

Work

Requirement

Principal

Investigator

Award is always made to the small business

No SBIRSTTR funding authority

Office of Research

Infrastructure Programs

National

Institute

on Aging

National Institute

on Alcohol Abuse

and Alcoholism

National Institute

of Allergy and

Infectious Diseases

National Institute of

Arthritis and

Musculoskeletal and

Skin Diseases

National

Cancer

Institute

National Institute

of Child Health

and Human

Development

National Institute

on Deafness and

Other

Communication

Disorders

National Institute

of Dental and

Craniofacial

Research

National Institute

of Diabetes and

Digestive and

Kidney Diseases

National

Institute

on Drug Abuse

National Institute

of Environmental

Health Sciences

National

Eye

Institute

National Institute

of General

Medical Sciences

National Heart

Lung and Blood

Institute

National Human

Genome Research

Institute

National

Institute

of Mental Health

National Institute of

Neurological

Disorders and Stroke

National Institute

of Nursing

Research

National Institute

on Minority

Health and Health

Disparities

National Center for

Complementary and

Integrative Health

Fogarty

International

Center

National Center

for Advancing

Translational Sciences

National

Library

of Medicine

National Institute

of Biomedical

Imaging and

Bioengineering

Office of the Director

NIH Clinical Center Center for Information

Technology Center for Scientific Review

httpwwwnihgovicd

- Small Business Innovation Research (SBIR Small Business Technology Transfer National Institutes of Health

NIH SBIRSTTR Budget Allocations FY2017

NIDCD NIMHD NINR

NIBIB ORIP NCCIH

32 SBIR $8614M

045 STTR $1211M

Total FY17 $9825M

NIAAA NIDCR NLM NHGRI NIAMS

NIEHS NCI NCATS

NEI

NIDA

NIAID NIA

NICHD

NIMH NHLBI

NINDS

NIDDK NIGMS

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

----------------------~~

NIH SBIRSTTR

3-Phase Program

I

I

---------------------~-

I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Only Some ICs

Participate

Direct to Phase II

$3M for up to 3 years

Commercialization

Readiness Pilot (CRP) Congressional

authority expired

Congressional

authority expired

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Fast-Track

----------------------~~ I

I

---------------------~-

I I I I I I

I I I I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II

bull Simultaneous submission

and review of Phase I and II

bull Phase I is awarded

bull Milestonesaims of Phase I

are assessed by program

staff BEFORE Phase II is

awarded

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Direct to Phase II

----------------------~~ I

I

I I I I I I

---------------------~-

I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II bull SBIR only

bull Bypass Phase I grant

bull Congressional authority EXPIRED

Discovery Development Commercialization Competing Renewal Phase I Phase II Phase III

$3M for up to 3 years

Phase IIB

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

Phase IIB Competing

Renewal Award

bull SBIRSTTR Phase II awardee

bull Technologies that require extraordinary timeeffort to develop

and often require FDA regulatory approval

bull Awards up to $1Myear for up to 3 years

bull IC must accept Competing Renewal applications (NIA NIAAA

NIAID NICHD NIDA NIDCD NIDDK NEI NIGMS NHLBI NIMH

NINDS NCATS ORIP NCI NHLBI NINDS)

Contact NIH Program Staff to discuss

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR NIH SBIRSTTR FOAs

FunFunding ding OpportOpportunities unities AnAnnouncements nouncements (FO(FOAs) As) a publicly available document by which a federal agency makes

known its intentions to award discretionary grants or cooperative agreements usually as a result of competition for funds

Targeted SBIIUSTTR Solicitations

bull SBIR omnbus Fu nd ing Opportun ity

Announcement (PA-17 -302)

bull STTR Omnib u s FundinQ Opportu nity

Announcement (PA-17-303)

bull 2017 Program Oescnptions and Researc h

Topics Document

II (1 6 M B) CHI (479 KB)

bull 2017 SBA a p proved topics list for budget

waivers

II (1 6 M B) Clil (479 KB)

rJ NIH SBIRSTTR Grant Forms

The Co ng ressio na l a utho rity for SBIR D ire ct

Ph as e II has e xpired

See individual SBIR STTR targeted

soI1cita ho ns

Standard Due Dates

eJ Janu a ry5

eJ April 5

eJ Septembe r 5

Standard Due Oates

eJ Janu a ry 5

eJ April 5

eJ Septembe r 5

Due dates v ary

See individual a nnouncem ents ror dates Top of Page

httpssbirnihgovfunding

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer Program Eligibility Criteria

bull Organized as for-profit US business

bull Small 500 or fewer employees including affiliates

bull Work must be done in the US (with few exceptions)

bull Individual Ownership

o Greater than 50 US-owned by individuals and independently operated

OR

o Greater than 50 owned and controlled by other business concerns

that isare greater than 50 owned and controlled by one or more

individuals OR

o 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 (For FOAs after 1282013 NIH 71014 CDC)

Determined at Time of Award

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer STTR Eligibility Criteria

14

bull Applicant is a Small Business Concern

bull Formal Cooperative RampD Effort

o Minimum 40 by small business

o Minimum 30 by US research institution

bull US Research Institution

o College or university other non-profit research organization Federal RampD center

bull Intellectual Property Agreement

o Allocation of rights in IP and rights to carry out follow-on

RampD and commercialization

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

NIH SBIRSTTR

3-Phase Program

Discovery

Phase

I Phase I Feasibility Study Budget Guide $150K for SBIR and STTR

Project Period 6 months (SBIR) 1 year (STTR)

Development

Phase

II

Phase

IIB

Phase II Full ResearchRampD $1M for SBIR and STTR over two years

Phase IIB Competing RenewalRampD Clinical RampD Complex Instrumentationto FDA

Many but not all ICrsquos participate

Varies~$1M per year up to 3 years

Commercialization

Phase

III Phase III Commercialization NIH generally not the ldquocustomerrdquo

Consider partnering and exit strategy early

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

SBIR and STTR Critical

Differences

SBIR STTR

Partnering

Requirement

Permits partnering

Guidelines May outsource

33 (Phase I) 50 (Phase II)

Primary employment (gt50)

must be with the small

business

Requires a non-profit research

institution partner

(eg university)

Minimum Work Requirements

40 small business

30 research institution

partner

PI may be employed by either

the research institution

partner or small business

Work

Requirement

Principal

Investigator

Award is always made to the small business

No SBIRSTTR funding authority

Office of Research

Infrastructure Programs

National

Institute

on Aging

National Institute

on Alcohol Abuse

and Alcoholism

National Institute

of Allergy and

Infectious Diseases

National Institute of

Arthritis and

Musculoskeletal and

Skin Diseases

National

Cancer

Institute

National Institute

of Child Health

and Human

Development

National Institute

on Deafness and

Other

Communication

Disorders

National Institute

of Dental and

Craniofacial

Research

National Institute

of Diabetes and

Digestive and

Kidney Diseases

National

Institute

on Drug Abuse

National Institute

of Environmental

Health Sciences

National

Eye

Institute

National Institute

of General

Medical Sciences

National Heart

Lung and Blood

Institute

National Human

Genome Research

Institute

National

Institute

of Mental Health

National Institute of

Neurological

Disorders and Stroke

National Institute

of Nursing

Research

National Institute

on Minority

Health and Health

Disparities

National Center for

Complementary and

Integrative Health

Fogarty

International

Center

National Center

for Advancing

Translational Sciences

National

Library

of Medicine

National Institute

of Biomedical

Imaging and

Bioengineering

Office of the Director

NIH Clinical Center Center for Information

Technology Center for Scientific Review

httpwwwnihgovicd

- Small Business Innovation Research (SBIR Small Business Technology Transfer National Institutes of Health

NIH SBIRSTTR Budget Allocations FY2017

NIDCD NIMHD NINR

NIBIB ORIP NCCIH

32 SBIR $8614M

045 STTR $1211M

Total FY17 $9825M

NIAAA NIDCR NLM NHGRI NIAMS

NIEHS NCI NCATS

NEI

NIDA

NIAID NIA

NICHD

NIMH NHLBI

NINDS

NIDDK NIGMS

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

----------------------~~

NIH SBIRSTTR

3-Phase Program

I

I

---------------------~-

I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Only Some ICs

Participate

Direct to Phase II

$3M for up to 3 years

Commercialization

Readiness Pilot (CRP) Congressional

authority expired

Congressional

authority expired

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Fast-Track

----------------------~~ I

I

---------------------~-

I I I I I I

I I I I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II

bull Simultaneous submission

and review of Phase I and II

bull Phase I is awarded

bull Milestonesaims of Phase I

are assessed by program

staff BEFORE Phase II is

awarded

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Direct to Phase II

----------------------~~ I

I

I I I I I I

---------------------~-

I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II bull SBIR only

bull Bypass Phase I grant

bull Congressional authority EXPIRED

Discovery Development Commercialization Competing Renewal Phase I Phase II Phase III

$3M for up to 3 years

Phase IIB

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

Phase IIB Competing

Renewal Award

bull SBIRSTTR Phase II awardee

bull Technologies that require extraordinary timeeffort to develop

and often require FDA regulatory approval

bull Awards up to $1Myear for up to 3 years

bull IC must accept Competing Renewal applications (NIA NIAAA

NIAID NICHD NIDA NIDCD NIDDK NEI NIGMS NHLBI NIMH

NINDS NCATS ORIP NCI NHLBI NINDS)

Contact NIH Program Staff to discuss

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR NIH SBIRSTTR FOAs

FunFunding ding OpportOpportunities unities AnAnnouncements nouncements (FO(FOAs) As) a publicly available document by which a federal agency makes

known its intentions to award discretionary grants or cooperative agreements usually as a result of competition for funds

Targeted SBIIUSTTR Solicitations

bull SBIR omnbus Fu nd ing Opportun ity

Announcement (PA-17 -302)

bull STTR Omnib u s FundinQ Opportu nity

Announcement (PA-17-303)

bull 2017 Program Oescnptions and Researc h

Topics Document

II (1 6 M B) CHI (479 KB)

bull 2017 SBA a p proved topics list for budget

waivers

II (1 6 M B) Clil (479 KB)

rJ NIH SBIRSTTR Grant Forms

The Co ng ressio na l a utho rity for SBIR D ire ct

Ph as e II has e xpired

See individual SBIR STTR targeted

soI1cita ho ns

Standard Due Dates

eJ Janu a ry5

eJ April 5

eJ Septembe r 5

Standard Due Oates

eJ Janu a ry 5

eJ April 5

eJ Septembe r 5

Due dates v ary

See individual a nnouncem ents ror dates Top of Page

httpssbirnihgovfunding

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer STTR Eligibility Criteria

14

bull Applicant is a Small Business Concern

bull Formal Cooperative RampD Effort

o Minimum 40 by small business

o Minimum 30 by US research institution

bull US Research Institution

o College or university other non-profit research organization Federal RampD center

bull Intellectual Property Agreement

o Allocation of rights in IP and rights to carry out follow-on

RampD and commercialization

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

NIH SBIRSTTR

3-Phase Program

Discovery

Phase

I Phase I Feasibility Study Budget Guide $150K for SBIR and STTR

Project Period 6 months (SBIR) 1 year (STTR)

Development

Phase

II

Phase

IIB

Phase II Full ResearchRampD $1M for SBIR and STTR over two years

Phase IIB Competing RenewalRampD Clinical RampD Complex Instrumentationto FDA

Many but not all ICrsquos participate

Varies~$1M per year up to 3 years

Commercialization

Phase

III Phase III Commercialization NIH generally not the ldquocustomerrdquo

Consider partnering and exit strategy early

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

SBIR and STTR Critical

Differences

SBIR STTR

Partnering

Requirement

Permits partnering

Guidelines May outsource

33 (Phase I) 50 (Phase II)

Primary employment (gt50)

must be with the small

business

Requires a non-profit research

institution partner

(eg university)

Minimum Work Requirements

40 small business

30 research institution

partner

PI may be employed by either

the research institution

partner or small business

Work

Requirement

Principal

Investigator

Award is always made to the small business

No SBIRSTTR funding authority

Office of Research

Infrastructure Programs

National

Institute

on Aging

National Institute

on Alcohol Abuse

and Alcoholism

National Institute

of Allergy and

Infectious Diseases

National Institute of

Arthritis and

Musculoskeletal and

Skin Diseases

National

Cancer

Institute

National Institute

of Child Health

and Human

Development

National Institute

on Deafness and

Other

Communication

Disorders

National Institute

of Dental and

Craniofacial

Research

National Institute

of Diabetes and

Digestive and

Kidney Diseases

National

Institute

on Drug Abuse

National Institute

of Environmental

Health Sciences

National

Eye

Institute

National Institute

of General

Medical Sciences

National Heart

Lung and Blood

Institute

National Human

Genome Research

Institute

National

Institute

of Mental Health

National Institute of

Neurological

Disorders and Stroke

National Institute

of Nursing

Research

National Institute

on Minority

Health and Health

Disparities

National Center for

Complementary and

Integrative Health

Fogarty

International

Center

National Center

for Advancing

Translational Sciences

National

Library

of Medicine

National Institute

of Biomedical

Imaging and

Bioengineering

Office of the Director

NIH Clinical Center Center for Information

Technology Center for Scientific Review

httpwwwnihgovicd

- Small Business Innovation Research (SBIR Small Business Technology Transfer National Institutes of Health

NIH SBIRSTTR Budget Allocations FY2017

NIDCD NIMHD NINR

NIBIB ORIP NCCIH

32 SBIR $8614M

045 STTR $1211M

Total FY17 $9825M

NIAAA NIDCR NLM NHGRI NIAMS

NIEHS NCI NCATS

NEI

NIDA

NIAID NIA

NICHD

NIMH NHLBI

NINDS

NIDDK NIGMS

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

----------------------~~

NIH SBIRSTTR

3-Phase Program

I

I

---------------------~-

I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Only Some ICs

Participate

Direct to Phase II

$3M for up to 3 years

Commercialization

Readiness Pilot (CRP) Congressional

authority expired

Congressional

authority expired

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Fast-Track

----------------------~~ I

I

---------------------~-

I I I I I I

I I I I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II

bull Simultaneous submission

and review of Phase I and II

bull Phase I is awarded

bull Milestonesaims of Phase I

are assessed by program

staff BEFORE Phase II is

awarded

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Direct to Phase II

----------------------~~ I

I

I I I I I I

---------------------~-

I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II bull SBIR only

bull Bypass Phase I grant

bull Congressional authority EXPIRED

Discovery Development Commercialization Competing Renewal Phase I Phase II Phase III

$3M for up to 3 years

Phase IIB

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

Phase IIB Competing

Renewal Award

bull SBIRSTTR Phase II awardee

bull Technologies that require extraordinary timeeffort to develop

and often require FDA regulatory approval

bull Awards up to $1Myear for up to 3 years

bull IC must accept Competing Renewal applications (NIA NIAAA

NIAID NICHD NIDA NIDCD NIDDK NEI NIGMS NHLBI NIMH

NINDS NCATS ORIP NCI NHLBI NINDS)

Contact NIH Program Staff to discuss

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR NIH SBIRSTTR FOAs

FunFunding ding OpportOpportunities unities AnAnnouncements nouncements (FO(FOAs) As) a publicly available document by which a federal agency makes

known its intentions to award discretionary grants or cooperative agreements usually as a result of competition for funds

Targeted SBIIUSTTR Solicitations

bull SBIR omnbus Fu nd ing Opportun ity

Announcement (PA-17 -302)

bull STTR Omnib u s FundinQ Opportu nity

Announcement (PA-17-303)

bull 2017 Program Oescnptions and Researc h

Topics Document

II (1 6 M B) CHI (479 KB)

bull 2017 SBA a p proved topics list for budget

waivers

II (1 6 M B) Clil (479 KB)

rJ NIH SBIRSTTR Grant Forms

The Co ng ressio na l a utho rity for SBIR D ire ct

Ph as e II has e xpired

See individual SBIR STTR targeted

soI1cita ho ns

Standard Due Dates

eJ Janu a ry5

eJ April 5

eJ Septembe r 5

Standard Due Oates

eJ Janu a ry 5

eJ April 5

eJ Septembe r 5

Due dates v ary

See individual a nnouncem ents ror dates Top of Page

httpssbirnihgovfunding

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

NIH SBIRSTTR

3-Phase Program

Discovery

Phase

I Phase I Feasibility Study Budget Guide $150K for SBIR and STTR

Project Period 6 months (SBIR) 1 year (STTR)

Development

Phase

II

Phase

IIB

Phase II Full ResearchRampD $1M for SBIR and STTR over two years

Phase IIB Competing RenewalRampD Clinical RampD Complex Instrumentationto FDA

Many but not all ICrsquos participate

Varies~$1M per year up to 3 years

Commercialization

Phase

III Phase III Commercialization NIH generally not the ldquocustomerrdquo

Consider partnering and exit strategy early

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

SBIR and STTR Critical

Differences

SBIR STTR

Partnering

Requirement

Permits partnering

Guidelines May outsource

33 (Phase I) 50 (Phase II)

Primary employment (gt50)

must be with the small

business

Requires a non-profit research

institution partner

(eg university)

Minimum Work Requirements

40 small business

30 research institution

partner

PI may be employed by either

the research institution

partner or small business

Work

Requirement

Principal

Investigator

Award is always made to the small business

No SBIRSTTR funding authority

Office of Research

Infrastructure Programs

National

Institute

on Aging

National Institute

on Alcohol Abuse

and Alcoholism

National Institute

of Allergy and

Infectious Diseases

National Institute of

Arthritis and

Musculoskeletal and

Skin Diseases

National

Cancer

Institute

National Institute

of Child Health

and Human

Development

National Institute

on Deafness and

Other

Communication

Disorders

National Institute

of Dental and

Craniofacial

Research

National Institute

of Diabetes and

Digestive and

Kidney Diseases

National

Institute

on Drug Abuse

National Institute

of Environmental

Health Sciences

National

Eye

Institute

National Institute

of General

Medical Sciences

National Heart

Lung and Blood

Institute

National Human

Genome Research

Institute

National

Institute

of Mental Health

National Institute of

Neurological

Disorders and Stroke

National Institute

of Nursing

Research

National Institute

on Minority

Health and Health

Disparities

National Center for

Complementary and

Integrative Health

Fogarty

International

Center

National Center

for Advancing

Translational Sciences

National

Library

of Medicine

National Institute

of Biomedical

Imaging and

Bioengineering

Office of the Director

NIH Clinical Center Center for Information

Technology Center for Scientific Review

httpwwwnihgovicd

- Small Business Innovation Research (SBIR Small Business Technology Transfer National Institutes of Health

NIH SBIRSTTR Budget Allocations FY2017

NIDCD NIMHD NINR

NIBIB ORIP NCCIH

32 SBIR $8614M

045 STTR $1211M

Total FY17 $9825M

NIAAA NIDCR NLM NHGRI NIAMS

NIEHS NCI NCATS

NEI

NIDA

NIAID NIA

NICHD

NIMH NHLBI

NINDS

NIDDK NIGMS

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

----------------------~~

NIH SBIRSTTR

3-Phase Program

I

I

---------------------~-

I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Only Some ICs

Participate

Direct to Phase II

$3M for up to 3 years

Commercialization

Readiness Pilot (CRP) Congressional

authority expired

Congressional

authority expired

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Fast-Track

----------------------~~ I

I

---------------------~-

I I I I I I

I I I I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II

bull Simultaneous submission

and review of Phase I and II

bull Phase I is awarded

bull Milestonesaims of Phase I

are assessed by program

staff BEFORE Phase II is

awarded

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Direct to Phase II

----------------------~~ I

I

I I I I I I

---------------------~-

I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II bull SBIR only

bull Bypass Phase I grant

bull Congressional authority EXPIRED

Discovery Development Commercialization Competing Renewal Phase I Phase II Phase III

$3M for up to 3 years

Phase IIB

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

Phase IIB Competing

Renewal Award

bull SBIRSTTR Phase II awardee

bull Technologies that require extraordinary timeeffort to develop

and often require FDA regulatory approval

bull Awards up to $1Myear for up to 3 years

bull IC must accept Competing Renewal applications (NIA NIAAA

NIAID NICHD NIDA NIDCD NIDDK NEI NIGMS NHLBI NIMH

NINDS NCATS ORIP NCI NHLBI NINDS)

Contact NIH Program Staff to discuss

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR NIH SBIRSTTR FOAs

FunFunding ding OpportOpportunities unities AnAnnouncements nouncements (FO(FOAs) As) a publicly available document by which a federal agency makes

known its intentions to award discretionary grants or cooperative agreements usually as a result of competition for funds

Targeted SBIIUSTTR Solicitations

bull SBIR omnbus Fu nd ing Opportun ity

Announcement (PA-17 -302)

bull STTR Omnib u s FundinQ Opportu nity

Announcement (PA-17-303)

bull 2017 Program Oescnptions and Researc h

Topics Document

II (1 6 M B) CHI (479 KB)

bull 2017 SBA a p proved topics list for budget

waivers

II (1 6 M B) Clil (479 KB)

rJ NIH SBIRSTTR Grant Forms

The Co ng ressio na l a utho rity for SBIR D ire ct

Ph as e II has e xpired

See individual SBIR STTR targeted

soI1cita ho ns

Standard Due Dates

eJ Janu a ry5

eJ April 5

eJ Septembe r 5

Standard Due Oates

eJ Janu a ry 5

eJ April 5

eJ Septembe r 5

Due dates v ary

See individual a nnouncem ents ror dates Top of Page

httpssbirnihgovfunding

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

SBIR and STTR Critical

Differences

SBIR STTR

Partnering

Requirement

Permits partnering

Guidelines May outsource

33 (Phase I) 50 (Phase II)

Primary employment (gt50)

must be with the small

business

Requires a non-profit research

institution partner

(eg university)

Minimum Work Requirements

40 small business

30 research institution

partner

PI may be employed by either

the research institution

partner or small business

Work

Requirement

Principal

Investigator

Award is always made to the small business

No SBIRSTTR funding authority

Office of Research

Infrastructure Programs

National

Institute

on Aging

National Institute

on Alcohol Abuse

and Alcoholism

National Institute

of Allergy and

Infectious Diseases

National Institute of

Arthritis and

Musculoskeletal and

Skin Diseases

National

Cancer

Institute

National Institute

of Child Health

and Human

Development

National Institute

on Deafness and

Other

Communication

Disorders

National Institute

of Dental and

Craniofacial

Research

National Institute

of Diabetes and

Digestive and

Kidney Diseases

National

Institute

on Drug Abuse

National Institute

of Environmental

Health Sciences

National

Eye

Institute

National Institute

of General

Medical Sciences

National Heart

Lung and Blood

Institute

National Human

Genome Research

Institute

National

Institute

of Mental Health

National Institute of

Neurological

Disorders and Stroke

National Institute

of Nursing

Research

National Institute

on Minority

Health and Health

Disparities

National Center for

Complementary and

Integrative Health

Fogarty

International

Center

National Center

for Advancing

Translational Sciences

National

Library

of Medicine

National Institute

of Biomedical

Imaging and

Bioengineering

Office of the Director

NIH Clinical Center Center for Information

Technology Center for Scientific Review

httpwwwnihgovicd

- Small Business Innovation Research (SBIR Small Business Technology Transfer National Institutes of Health

NIH SBIRSTTR Budget Allocations FY2017

NIDCD NIMHD NINR

NIBIB ORIP NCCIH

32 SBIR $8614M

045 STTR $1211M

Total FY17 $9825M

NIAAA NIDCR NLM NHGRI NIAMS

NIEHS NCI NCATS

NEI

NIDA

NIAID NIA

NICHD

NIMH NHLBI

NINDS

NIDDK NIGMS

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

----------------------~~

NIH SBIRSTTR

3-Phase Program

I

I

---------------------~-

I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Only Some ICs

Participate

Direct to Phase II

$3M for up to 3 years

Commercialization

Readiness Pilot (CRP) Congressional

authority expired

Congressional

authority expired

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Fast-Track

----------------------~~ I

I

---------------------~-

I I I I I I

I I I I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II

bull Simultaneous submission

and review of Phase I and II

bull Phase I is awarded

bull Milestonesaims of Phase I

are assessed by program

staff BEFORE Phase II is

awarded

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Direct to Phase II

----------------------~~ I

I

I I I I I I

---------------------~-

I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II bull SBIR only

bull Bypass Phase I grant

bull Congressional authority EXPIRED

Discovery Development Commercialization Competing Renewal Phase I Phase II Phase III

$3M for up to 3 years

Phase IIB

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

Phase IIB Competing

Renewal Award

bull SBIRSTTR Phase II awardee

bull Technologies that require extraordinary timeeffort to develop

and often require FDA regulatory approval

bull Awards up to $1Myear for up to 3 years

bull IC must accept Competing Renewal applications (NIA NIAAA

NIAID NICHD NIDA NIDCD NIDDK NEI NIGMS NHLBI NIMH

NINDS NCATS ORIP NCI NHLBI NINDS)

Contact NIH Program Staff to discuss

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR NIH SBIRSTTR FOAs

FunFunding ding OpportOpportunities unities AnAnnouncements nouncements (FO(FOAs) As) a publicly available document by which a federal agency makes

known its intentions to award discretionary grants or cooperative agreements usually as a result of competition for funds

Targeted SBIIUSTTR Solicitations

bull SBIR omnbus Fu nd ing Opportun ity

Announcement (PA-17 -302)

bull STTR Omnib u s FundinQ Opportu nity

Announcement (PA-17-303)

bull 2017 Program Oescnptions and Researc h

Topics Document

II (1 6 M B) CHI (479 KB)

bull 2017 SBA a p proved topics list for budget

waivers

II (1 6 M B) Clil (479 KB)

rJ NIH SBIRSTTR Grant Forms

The Co ng ressio na l a utho rity for SBIR D ire ct

Ph as e II has e xpired

See individual SBIR STTR targeted

soI1cita ho ns

Standard Due Dates

eJ Janu a ry5

eJ April 5

eJ Septembe r 5

Standard Due Oates

eJ Janu a ry 5

eJ April 5

eJ Septembe r 5

Due dates v ary

See individual a nnouncem ents ror dates Top of Page

httpssbirnihgovfunding

No SBIRSTTR funding authority

Office of Research

Infrastructure Programs

National

Institute

on Aging

National Institute

on Alcohol Abuse

and Alcoholism

National Institute

of Allergy and

Infectious Diseases

National Institute of

Arthritis and

Musculoskeletal and

Skin Diseases

National

Cancer

Institute

National Institute

of Child Health

and Human

Development

National Institute

on Deafness and

Other

Communication

Disorders

National Institute

of Dental and

Craniofacial

Research

National Institute

of Diabetes and

Digestive and

Kidney Diseases

National

Institute

on Drug Abuse

National Institute

of Environmental

Health Sciences

National

Eye

Institute

National Institute

of General

Medical Sciences

National Heart

Lung and Blood

Institute

National Human

Genome Research

Institute

National

Institute

of Mental Health

National Institute of

Neurological

Disorders and Stroke

National Institute

of Nursing

Research

National Institute

on Minority

Health and Health

Disparities

National Center for

Complementary and

Integrative Health

Fogarty

International

Center

National Center

for Advancing

Translational Sciences

National

Library

of Medicine

National Institute

of Biomedical

Imaging and

Bioengineering

Office of the Director

NIH Clinical Center Center for Information

Technology Center for Scientific Review

httpwwwnihgovicd

- Small Business Innovation Research (SBIR Small Business Technology Transfer National Institutes of Health

NIH SBIRSTTR Budget Allocations FY2017

NIDCD NIMHD NINR

NIBIB ORIP NCCIH

32 SBIR $8614M

045 STTR $1211M

Total FY17 $9825M

NIAAA NIDCR NLM NHGRI NIAMS

NIEHS NCI NCATS

NEI

NIDA

NIAID NIA

NICHD

NIMH NHLBI

NINDS

NIDDK NIGMS

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

----------------------~~

NIH SBIRSTTR

3-Phase Program

I

I

---------------------~-

I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Only Some ICs

Participate

Direct to Phase II

$3M for up to 3 years

Commercialization

Readiness Pilot (CRP) Congressional

authority expired

Congressional

authority expired

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Fast-Track

----------------------~~ I

I

---------------------~-

I I I I I I

I I I I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II

bull Simultaneous submission

and review of Phase I and II

bull Phase I is awarded

bull Milestonesaims of Phase I

are assessed by program

staff BEFORE Phase II is

awarded

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Direct to Phase II

----------------------~~ I

I

I I I I I I

---------------------~-

I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II bull SBIR only

bull Bypass Phase I grant

bull Congressional authority EXPIRED

Discovery Development Commercialization Competing Renewal Phase I Phase II Phase III

$3M for up to 3 years

Phase IIB

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

Phase IIB Competing

Renewal Award

bull SBIRSTTR Phase II awardee

bull Technologies that require extraordinary timeeffort to develop

and often require FDA regulatory approval

bull Awards up to $1Myear for up to 3 years

bull IC must accept Competing Renewal applications (NIA NIAAA

NIAID NICHD NIDA NIDCD NIDDK NEI NIGMS NHLBI NIMH

NINDS NCATS ORIP NCI NHLBI NINDS)

Contact NIH Program Staff to discuss

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR NIH SBIRSTTR FOAs

FunFunding ding OpportOpportunities unities AnAnnouncements nouncements (FO(FOAs) As) a publicly available document by which a federal agency makes

known its intentions to award discretionary grants or cooperative agreements usually as a result of competition for funds

Targeted SBIIUSTTR Solicitations

bull SBIR omnbus Fu nd ing Opportun ity

Announcement (PA-17 -302)

bull STTR Omnib u s FundinQ Opportu nity

Announcement (PA-17-303)

bull 2017 Program Oescnptions and Researc h

Topics Document

II (1 6 M B) CHI (479 KB)

bull 2017 SBA a p proved topics list for budget

waivers

II (1 6 M B) Clil (479 KB)

rJ NIH SBIRSTTR Grant Forms

The Co ng ressio na l a utho rity for SBIR D ire ct

Ph as e II has e xpired

See individual SBIR STTR targeted

soI1cita ho ns

Standard Due Dates

eJ Janu a ry5

eJ April 5

eJ Septembe r 5

Standard Due Oates

eJ Janu a ry 5

eJ April 5

eJ Septembe r 5

Due dates v ary

See individual a nnouncem ents ror dates Top of Page

httpssbirnihgovfunding

NIH SBIRSTTR Budget Allocations FY2017

NIDCD NIMHD NINR

NIBIB ORIP NCCIH

32 SBIR $8614M

045 STTR $1211M

Total FY17 $9825M

NIAAA NIDCR NLM NHGRI NIAMS

NIEHS NCI NCATS

NEI

NIDA

NIAID NIA

NICHD

NIMH NHLBI

NINDS

NIDDK NIGMS

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

----------------------~~

NIH SBIRSTTR

3-Phase Program

I

I

---------------------~-

I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Only Some ICs

Participate

Direct to Phase II

$3M for up to 3 years

Commercialization

Readiness Pilot (CRP) Congressional

authority expired

Congressional

authority expired

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Fast-Track

----------------------~~ I

I

---------------------~-

I I I I I I

I I I I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II

bull Simultaneous submission

and review of Phase I and II

bull Phase I is awarded

bull Milestonesaims of Phase I

are assessed by program

staff BEFORE Phase II is

awarded

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Direct to Phase II

----------------------~~ I

I

I I I I I I

---------------------~-

I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II bull SBIR only

bull Bypass Phase I grant

bull Congressional authority EXPIRED

Discovery Development Commercialization Competing Renewal Phase I Phase II Phase III

$3M for up to 3 years

Phase IIB

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

Phase IIB Competing

Renewal Award

bull SBIRSTTR Phase II awardee

bull Technologies that require extraordinary timeeffort to develop

and often require FDA regulatory approval

bull Awards up to $1Myear for up to 3 years

bull IC must accept Competing Renewal applications (NIA NIAAA

NIAID NICHD NIDA NIDCD NIDDK NEI NIGMS NHLBI NIMH

NINDS NCATS ORIP NCI NHLBI NINDS)

Contact NIH Program Staff to discuss

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR NIH SBIRSTTR FOAs

FunFunding ding OpportOpportunities unities AnAnnouncements nouncements (FO(FOAs) As) a publicly available document by which a federal agency makes

known its intentions to award discretionary grants or cooperative agreements usually as a result of competition for funds

Targeted SBIIUSTTR Solicitations

bull SBIR omnbus Fu nd ing Opportun ity

Announcement (PA-17 -302)

bull STTR Omnib u s FundinQ Opportu nity

Announcement (PA-17-303)

bull 2017 Program Oescnptions and Researc h

Topics Document

II (1 6 M B) CHI (479 KB)

bull 2017 SBA a p proved topics list for budget

waivers

II (1 6 M B) Clil (479 KB)

rJ NIH SBIRSTTR Grant Forms

The Co ng ressio na l a utho rity for SBIR D ire ct

Ph as e II has e xpired

See individual SBIR STTR targeted

soI1cita ho ns

Standard Due Dates

eJ Janu a ry5

eJ April 5

eJ Septembe r 5

Standard Due Oates

eJ Janu a ry 5

eJ April 5

eJ Septembe r 5

Due dates v ary

See individual a nnouncem ents ror dates Top of Page

httpssbirnihgovfunding

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

----------------------~~

NIH SBIRSTTR

3-Phase Program

I

I

---------------------~-

I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Only Some ICs

Participate

Direct to Phase II

$3M for up to 3 years

Commercialization

Readiness Pilot (CRP) Congressional

authority expired

Congressional

authority expired

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Fast-Track

----------------------~~ I

I

---------------------~-

I I I I I I

I I I I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II

bull Simultaneous submission

and review of Phase I and II

bull Phase I is awarded

bull Milestonesaims of Phase I

are assessed by program

staff BEFORE Phase II is

awarded

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Direct to Phase II

----------------------~~ I

I

I I I I I I

---------------------~-

I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II bull SBIR only

bull Bypass Phase I grant

bull Congressional authority EXPIRED

Discovery Development Commercialization Competing Renewal Phase I Phase II Phase III

$3M for up to 3 years

Phase IIB

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

Phase IIB Competing

Renewal Award

bull SBIRSTTR Phase II awardee

bull Technologies that require extraordinary timeeffort to develop

and often require FDA regulatory approval

bull Awards up to $1Myear for up to 3 years

bull IC must accept Competing Renewal applications (NIA NIAAA

NIAID NICHD NIDA NIDCD NIDDK NEI NIGMS NHLBI NIMH

NINDS NCATS ORIP NCI NHLBI NINDS)

Contact NIH Program Staff to discuss

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR NIH SBIRSTTR FOAs

FunFunding ding OpportOpportunities unities AnAnnouncements nouncements (FO(FOAs) As) a publicly available document by which a federal agency makes

known its intentions to award discretionary grants or cooperative agreements usually as a result of competition for funds

Targeted SBIIUSTTR Solicitations

bull SBIR omnbus Fu nd ing Opportun ity

Announcement (PA-17 -302)

bull STTR Omnib u s FundinQ Opportu nity

Announcement (PA-17-303)

bull 2017 Program Oescnptions and Researc h

Topics Document

II (1 6 M B) CHI (479 KB)

bull 2017 SBA a p proved topics list for budget

waivers

II (1 6 M B) Clil (479 KB)

rJ NIH SBIRSTTR Grant Forms

The Co ng ressio na l a utho rity for SBIR D ire ct

Ph as e II has e xpired

See individual SBIR STTR targeted

soI1cita ho ns

Standard Due Dates

eJ Janu a ry5

eJ April 5

eJ Septembe r 5

Standard Due Oates

eJ Janu a ry 5

eJ April 5

eJ Septembe r 5

Due dates v ary

See individual a nnouncem ents ror dates Top of Page

httpssbirnihgovfunding

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Fast-Track

----------------------~~ I

I

---------------------~-

I I I I I I

I I I I I I I I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II

bull Simultaneous submission

and review of Phase I and II

bull Phase I is awarded

bull Milestonesaims of Phase I

are assessed by program

staff BEFORE Phase II is

awarded

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Direct to Phase II

----------------------~~ I

I

I I I I I I

---------------------~-

I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II bull SBIR only

bull Bypass Phase I grant

bull Congressional authority EXPIRED

Discovery Development Commercialization Competing Renewal Phase I Phase II Phase III

$3M for up to 3 years

Phase IIB

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

Phase IIB Competing

Renewal Award

bull SBIRSTTR Phase II awardee

bull Technologies that require extraordinary timeeffort to develop

and often require FDA regulatory approval

bull Awards up to $1Myear for up to 3 years

bull IC must accept Competing Renewal applications (NIA NIAAA

NIAID NICHD NIDA NIDCD NIDDK NEI NIGMS NHLBI NIMH

NINDS NCATS ORIP NCI NHLBI NINDS)

Contact NIH Program Staff to discuss

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR NIH SBIRSTTR FOAs

FunFunding ding OpportOpportunities unities AnAnnouncements nouncements (FO(FOAs) As) a publicly available document by which a federal agency makes

known its intentions to award discretionary grants or cooperative agreements usually as a result of competition for funds

Targeted SBIIUSTTR Solicitations

bull SBIR omnbus Fu nd ing Opportun ity

Announcement (PA-17 -302)

bull STTR Omnib u s FundinQ Opportu nity

Announcement (PA-17-303)

bull 2017 Program Oescnptions and Researc h

Topics Document

II (1 6 M B) CHI (479 KB)

bull 2017 SBA a p proved topics list for budget

waivers

II (1 6 M B) Clil (479 KB)

rJ NIH SBIRSTTR Grant Forms

The Co ng ressio na l a utho rity for SBIR D ire ct

Ph as e II has e xpired

See individual SBIR STTR targeted

soI1cita ho ns

Standard Due Dates

eJ Janu a ry5

eJ April 5

eJ Septembe r 5

Standard Due Oates

eJ Janu a ry 5

eJ April 5

eJ Septembe r 5

Due dates v ary

See individual a nnouncem ents ror dates Top of Page

httpssbirnihgovfunding

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi

NIH SBIRSTTR

Direct to Phase II

----------------------~~ I

I

I I I I I I

---------------------~-

I I

I

Feasibility

Discovery

Phase I

Full RD

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase II Commercialization

Phase III Competing Renewal Award

Phase IIB

Additional RD

Direct to Phase II bull SBIR only

bull Bypass Phase I grant

bull Congressional authority EXPIRED

Discovery Development Commercialization Competing Renewal Phase I Phase II Phase III

$3M for up to 3 years

Phase IIB

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

Phase IIB Competing

Renewal Award

bull SBIRSTTR Phase II awardee

bull Technologies that require extraordinary timeeffort to develop

and often require FDA regulatory approval

bull Awards up to $1Myear for up to 3 years

bull IC must accept Competing Renewal applications (NIA NIAAA

NIAID NICHD NIDA NIDCD NIDDK NEI NIGMS NHLBI NIMH

NINDS NCATS ORIP NCI NHLBI NINDS)

Contact NIH Program Staff to discuss

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR NIH SBIRSTTR FOAs

FunFunding ding OpportOpportunities unities AnAnnouncements nouncements (FO(FOAs) As) a publicly available document by which a federal agency makes

known its intentions to award discretionary grants or cooperative agreements usually as a result of competition for funds

Targeted SBIIUSTTR Solicitations

bull SBIR omnbus Fu nd ing Opportun ity

Announcement (PA-17 -302)

bull STTR Omnib u s FundinQ Opportu nity

Announcement (PA-17-303)

bull 2017 Program Oescnptions and Researc h

Topics Document

II (1 6 M B) CHI (479 KB)

bull 2017 SBA a p proved topics list for budget

waivers

II (1 6 M B) Clil (479 KB)

rJ NIH SBIRSTTR Grant Forms

The Co ng ressio na l a utho rity for SBIR D ire ct

Ph as e II has e xpired

See individual SBIR STTR targeted

soI1cita ho ns

Standard Due Dates

eJ Janu a ry5

eJ April 5

eJ Septembe r 5

Standard Due Oates

eJ Janu a ry 5

eJ April 5

eJ Septembe r 5

Due dates v ary

See individual a nnouncem ents ror dates Top of Page

httpssbirnihgovfunding

Discovery Development Commercialization Competing Renewal Phase I Phase II Phase III

$3M for up to 3 years

Phase IIB

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

Phase IIB Competing

Renewal Award

bull SBIRSTTR Phase II awardee

bull Technologies that require extraordinary timeeffort to develop

and often require FDA regulatory approval

bull Awards up to $1Myear for up to 3 years

bull IC must accept Competing Renewal applications (NIA NIAAA

NIAID NICHD NIDA NIDCD NIDDK NEI NIGMS NHLBI NIMH

NINDS NCATS ORIP NCI NHLBI NINDS)

Contact NIH Program Staff to discuss

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR NIH SBIRSTTR FOAs

FunFunding ding OpportOpportunities unities AnAnnouncements nouncements (FO(FOAs) As) a publicly available document by which a federal agency makes

known its intentions to award discretionary grants or cooperative agreements usually as a result of competition for funds

Targeted SBIIUSTTR Solicitations

bull SBIR omnbus Fu nd ing Opportun ity

Announcement (PA-17 -302)

bull STTR Omnib u s FundinQ Opportu nity

Announcement (PA-17-303)

bull 2017 Program Oescnptions and Researc h

Topics Document

II (1 6 M B) CHI (479 KB)

bull 2017 SBA a p proved topics list for budget

waivers

II (1 6 M B) Clil (479 KB)

rJ NIH SBIRSTTR Grant Forms

The Co ng ressio na l a utho rity for SBIR D ire ct

Ph as e II has e xpired

See individual SBIR STTR targeted

soI1cita ho ns

Standard Due Dates

eJ Janu a ry5

eJ April 5

eJ Septembe r 5

Standard Due Oates

eJ Janu a ry 5

eJ April 5

eJ Septembe r 5

Due dates v ary

See individual a nnouncem ents ror dates Top of Page

httpssbirnihgovfunding

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR NIH SBIRSTTR FOAs

FunFunding ding OpportOpportunities unities AnAnnouncements nouncements (FO(FOAs) As) a publicly available document by which a federal agency makes

known its intentions to award discretionary grants or cooperative agreements usually as a result of competition for funds

Targeted SBIIUSTTR Solicitations

bull SBIR omnbus Fu nd ing Opportun ity

Announcement (PA-17 -302)

bull STTR Omnib u s FundinQ Opportu nity

Announcement (PA-17-303)

bull 2017 Program Oescnptions and Researc h

Topics Document

II (1 6 M B) CHI (479 KB)

bull 2017 SBA a p proved topics list for budget

waivers

II (1 6 M B) Clil (479 KB)

rJ NIH SBIRSTTR Grant Forms

The Co ng ressio na l a utho rity for SBIR D ire ct

Ph as e II has e xpired

See individual SBIR STTR targeted

soI1cita ho ns

Standard Due Dates

eJ Janu a ry5

eJ April 5

eJ Septembe r 5

Standard Due Oates

eJ Janu a ry 5

eJ April 5

eJ Septembe r 5

Due dates v ary

See individual a nnouncem ents ror dates Top of Page

httpssbirnihgovfunding

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer Omnibus vs Targeted FOAs

Omnibus Targeted

Due Dates Standard Due Dates

SBIRSTTR panels at CSR

Follow SF424 RampR

SBIRSTTR Application Guide

amp Annotated Form Set

Standard or

Customized Due Dates

SBIRSTTR panels at CSR ltORgt

SBIRSTTR panel at IC

Follow SF424 RampR

SBIRSTTR Application Guide

amp Annotated Form Set ltANDgt

any additional instructions in

FOA

Review

Application

Instructions

Read FOA very carefully

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer Solicitations and Due Dates

bull NIH CDC FDA amp ACF SBIRSTTR Grant Solicitation

ldquoParentrdquo FOAs SBIR PA-17-302 STTR PA-17-303 Release June 5 2017 Standard Due Dates September 5th January 5th

o These FOAs are being issued with limited due dates to accommodate

the transition from FORMS-D to FORMS-E application packages

o HHS expects to re-issue these Omnibus after the January 5 2018

due date

bull SBIR Contract Solicitation (NIH CDC) ndash Program

Solicitation PHS 2017-2 (SBIR Only)

NIH Guide Notice NOT-OD-17-070 Release PHS 2018-1hellipsoon

bull NIH Guide for Grants and Contracts

Release Weekly receipt dates specified in each FOA

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer Solicitations and Due Dates

bull NIH CDC FDA amp ACF SBIRSTTR Grant Solicitation

ldquoParentrdquo FOAs SBIR PA-17-302 STTR PA-17-303 Release June 5 2017 Standard Due Dates September 5th January 5th

o These FOAs are being issued with limited due dates to accommodate

the transition from FORMS-D to FORMS-E application packages

o HHS expects to re-issue these Omnibus after the January 5 2018

due date

bull SBIR Contract Solicitation (NIH CDC) ndash Program

Solicitation PHS 2017-2 (SBIR Only)

NIH Guide Notice NOT-OD-17-070 Release PHS 2018-1hellipsoon

bull NIH Guide for Grants and Contracts

Release Weekly receipt dates specified in each FOA

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

Institutes NOT accepting

Clinical Trials under Omnibus

26

bull National Eye Institute (NEI)

bull National Human Genome Research Institute (NHGRI)

bull National Institute of Allergy and Infectious Diseases (NIAID)

bull National Institute of Arthritis Musculoskeletal and Skin Diseases (NIAMS)

bull National Institute of Dental and Craniofacial Research (NIDCR)

bull National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

bull National Institute of Environmental Health Sciences (NIEHS)

bull National Institute of Neurological Disorders and Stroke (NINDS)

bull National Library of Medicine (NLM)

bull National Center for Advancing Translational Sciences (NCATS)

bull Division of Program Coordination Planning and Strategic Initiatives Office

of Research Infrastructure Programs (ORIP)

bull US Food and Drug Administration (FDA)

bull If your proposed work includes an NIH-defined clinical trial that would be

assigned to one of these NIH InstitutesCenters you should contact

relevant program staff to discuss alternatives for support of those studies

Our Ideas Suggested topic areas

bull Biodefense bull Biosilicon devices

bull Biosensors bull Biocompatible

materialsbull Nanotechnologies

bull Acousto-optics opto-bull Bioinformatics electronics

bull Diagnostic and bull Health IT Therapeutic Devices

bull Imaging devices bull Telehealth

bull Genetically engineered bull Proteomics Genomics proteins

bull hellip

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

SBIRSTTR Program

Descriptions and Research Topics

27

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

SBIRSTTR Program

Descriptions and Research Topics

34

YOUR Ideas Investigator-initiated RampD

bull Research projects related to the NIH mission

bull ldquoOtherrdquo areas of research within the mission

of an awarding component

Keyword Search the Solicitation

Ctrl + F

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (SITR

bull bull 29

NIH 2016 SBIRSTTR Grants

Success Rate by Phase

32

13 13

31

17

22

15 14

31

Fast Track Phase I Regular Phase II Phase IIB Direct Phase II CRP

SBIR STTR STTR PHIIB 1 Application and 1 Award

ID)

labs

30

National Institutes of Health Office of Extramural Research

When is SBIRSTTR appropriate

Lift Labs

bull Develops new technologies to

provide proactive care for people

with essential tremor and

Parkinsons Disease

bull Acquired by Google in September

2014 Anupam Pathak PhD

Founder amp CEO NINDS SBIR Awardee

httpwwwliftlabsdesigncom

Our Ideas Suggested topic areas

bull Biodefense bull Biosilicon devices

bull Biosensors bull Biocompatible

materialsbull Nanotechnologies

bull Acousto-optics opto-bull Bioinformatics electronics

bull Diagnostic and bull Health IT Therapeutic Devices

bull Imaging devices bull Telehealth

bull Genetically engineered bull Proteomics Genomics proteins

bull hellip

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

SBIRSTTR Program

Descriptions and Research Topics

27

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

SBIRSTTR Program

Descriptions and Research Topics

34

YOUR Ideas Investigator-initiated RampD

bull Research projects related to the NIH mission

bull ldquoOtherrdquo areas of research within the mission

of an awarding component

Keyword Search the Solicitation

Ctrl + F

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (SITR

bull bull 29

NIH 2016 SBIRSTTR Grants

Success Rate by Phase

32

13 13

31

17

22

15 14

31

Fast Track Phase I Regular Phase II Phase IIB Direct Phase II CRP

SBIR STTR STTR PHIIB 1 Application and 1 Award

ID)

labs

30

National Institutes of Health Office of Extramural Research

When is SBIRSTTR appropriate

Lift Labs

bull Develops new technologies to

provide proactive care for people

with essential tremor and

Parkinsons Disease

bull Acquired by Google in September

2014 Anupam Pathak PhD

Founder amp CEO NINDS SBIR Awardee

httpwwwliftlabsdesigncom

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

SBIRSTTR Program

Descriptions and Research Topics

34

YOUR Ideas Investigator-initiated RampD

bull Research projects related to the NIH mission

bull ldquoOtherrdquo areas of research within the mission

of an awarding component

Keyword Search the Solicitation

Ctrl + F

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (SITR

bull bull 29

NIH 2016 SBIRSTTR Grants

Success Rate by Phase

32

13 13

31

17

22

15 14

31

Fast Track Phase I Regular Phase II Phase IIB Direct Phase II CRP

SBIR STTR STTR PHIIB 1 Application and 1 Award

ID)

labs

30

National Institutes of Health Office of Extramural Research

When is SBIRSTTR appropriate

Lift Labs

bull Develops new technologies to

provide proactive care for people

with essential tremor and

Parkinsons Disease

bull Acquired by Google in September

2014 Anupam Pathak PhD

Founder amp CEO NINDS SBIR Awardee

httpwwwliftlabsdesigncom

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (SITR

bull bull 29

NIH 2016 SBIRSTTR Grants

Success Rate by Phase

32

13 13

31

17

22

15 14

31

Fast Track Phase I Regular Phase II Phase IIB Direct Phase II CRP

SBIR STTR STTR PHIIB 1 Application and 1 Award

ID)

labs

30

National Institutes of Health Office of Extramural Research

When is SBIRSTTR appropriate

Lift Labs

bull Develops new technologies to

provide proactive care for people

with essential tremor and

Parkinsons Disease

bull Acquired by Google in September

2014 Anupam Pathak PhD

Founder amp CEO NINDS SBIR Awardee

httpwwwliftlabsdesigncom

ID)

labs

30

National Institutes of Health Office of Extramural Research

When is SBIRSTTR appropriate

Lift Labs

bull Develops new technologies to

provide proactive care for people

with essential tremor and

Parkinsons Disease

bull Acquired by Google in September

2014 Anupam Pathak PhD

Founder amp CEO NINDS SBIR Awardee

httpwwwliftlabsdesigncom

SenesTech

bull Limits rodent fertility in a non-lethal and environmentally-friendly way

bull Works with NYC Subway System

and Chicago Transit Authority

Loretta Mayer PhD

Founder amp CSO NIEHS SBIR Awardee

ID When is SBIRSTTR appropriate

31

National Institutes of Health Office of Extramural Research

httpsenestechcom

When is SBIRSTTR appropriate

Be Prepared to Resubmit

g

Laverne Morrow

Carter PhD

Founder amp President REESSI

NIMHD SBIR Awardee

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (SITR

RESEARCH EVALUATION amp SOCIAL SOLUTIONS INC IH FORMA TIOH lltHOW IEOOE ACTION POW ER

ldquo[SBIR] has been a long trying but worthwhile

journeyfrom multiple submissions that were not

discussedto applications that scored below the fundin

levelsto concurrent applications (one Phase II and a

Phase I) emerging from the rigorous peer review

process with impact scores in the ldquoExcellent rangerdquo

httpwwwreessicom

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (STTi When is SBIRSTTR appropriate

irisEdreg

Jessie Marquez Instructional Designer at

IRIS Educational Media

ldquoAs a native Spanish-speaking curriculum designer with

a background in literary and performing arts I work as a

principal investigator on a number of NIH-funded

projects The SBIR and STTR programs allow me to

translate evidence-based practices into web-based

multimedia programs that offer skill-building tools for

improving health and educational outcomes among

Latino audiencesrdquo

httpwwwirisedcom

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (SITR

A ~shy~-

Electronic Submission

SBIRSTTR grant applications and SBIR contract proposals

must be submitted electronically

Registrations are required

o DUNS Number (Company)

o System for Award Management (SAM)

o Grantsgov (Company)

o eRA Commons (Company and all PDPIs)

o SBA Company Registry at SBIRgov

bull Helpful NIH Grants Registration Infographic

bull For contracts submit proposals with electronic Contract Proposal

Submission (eCPS) website

- Small Business Innovation Research (SBIR

Small Business Technology Transfer (STTi

Tllere are several options ava1latgtle to sutgtITllt your application tllrougll Grantsgov to NIH and Department of Healtll and Human Services partners

S1knil u JILi-pnbulljtcl gr1ul 1J)y caLur s ele-roiicallv t ) ~IH and otter Pmiddot_lic Healtl StgtTviltf 4gr~dAi

Check with your

L -gtHAlJJ= _1 aNleff ~ (O

- middot bulliovr S-011( gt- V P I ~ (a (ICltI~ ~ MTO CgtVllU nfl- cbullrAJOC M at~-middot

~ middot middot- L_

Cw11H _ bull110-bullbullbull11 lgt-1bulltbullbullbull~bull1wm--4 _ c bullbullbull - - nNMl~ut1_ 11_ fl)-9 -11_oo )-TU-fIIOl~-Q--ltl

bull 1Ml l91tMIUt tNTaJAilllM 1111ltlAMI bullbull bullbull _ ____ _1ouwnT1oo_ ___ -Mio ar ___ u =1=-r-=middotn=k~~=-~~ow~i~~1-=i~~remiddot~~tz-

Submit via ASSIST or Forms

Excerpt from single-project FOA in NIH Guidehellip

bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull bull bull

Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddot bull bull

Timeline New Applications

Scientific Council Award Due Date

Review Review Date (earliest)

Sept 5th OctNov JanFeb March

Jan 5th FebMar MayJune July

I bull

bull

I bull bull bull

bull bull bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (SITR

a ===m========~a ---------bull ------

__ bull bull bull bull bull bull bull bull bull bull bull bull bull bull bull bull middot bullbullbullbullbull middot

~==============~bull

bull bull bull bull bull bull bull bull bull bull bull bull bull bull bull bull middot bullbullbullbullbull middot

NIH Application amp Review Process

Applicant initiates

research idea

Small Business

Concern confirms

Eligibility

Submits SBIRSTTR

grant application to

NIH electronically

Scientific Review

Group evaluates

scientific merit

Advisory Council or

Board recommend

Approval

IC staff prepare

funding plan for

IC Director

NIH Center for

Scientific Review

assigns to IC and IRG

1-2 Months

3 Months

2-4 Months

IC allocates Grantee conducts

funds research

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer Review Criteria

38

Overall Impact Score

Scored Review Criteria (score 1-9)

bull Significance (Real ProblemCommercial Potential)

bull Investigators (PI and team)

bull Innovation (New or Improved)

bull Approach (Research Design Feasible)

bull Environment (FacilitiesResources)

Additional Review Criteria (not scored individually)

bull Protection of Human Subjects

bull Inclusion of Women Minorities amp Children

bull Vertebrate Animals

bull Biohazards

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR

SBIRSR Horre gt IC Program Contacts

A lcoholism

httr middotAwwniaaa nih ryw

National 1nstw te or A llerg ano 1nrecoous

Diseases

httpIAWwniaidnihgov

rgthonc 30 1-443-4220

F mtilmiddot mryrn 1mril nih gm

ur Nata 1a Krucnrnn

Phone 240-GG3-2915

Fax 240-E27-3162

Email kruchilinnW1iaidn hQCV

PDF Versicn

Em 3il Lindawnpinihg01

M S Juay FOX

rgthonc 301-443-4 704

Fff ~O 1-44 ~-~fll 1

Em 3il JudyFoxnihg ov

Ms vananana Knurana MtJA

Phone 240-GC9-29GG

Fax 301-493-0597

Em 3il khuranavlniaidnihgov

J3son Lundgren

inone l 4lJ-bt~-~~3

r ax 301-49)-0597

Em ail Jasonlundgrennihgov

Most Important Piece of Advice

Talk to a HHS Program Officer at least a month before a deadline for application specific advice

Click here for the list of HHS SBIR Program Managers

Not sure who to contact Email sbirodnihgov

bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull bull bull

Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddot bull bull

Timeline New Applications

Scientific Council Award Due Date

Review Review Date (earliest)

Sept 5th OctNov JanFeb March

Jan 5th FebMar MayJune July

I bull

bull

I bull bull bull

bull bull bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (SITR

a ===m========~a ---------bull ------

__ bull bull bull bull bull bull bull bull bull bull bull bull bull bull bull bull middot bullbullbullbullbull middot

~==============~bull

bull bull bull bull bull bull bull bull bull bull bull bull bull bull bull bull middot bullbullbullbullbull middot

NIH Application amp Review Process

Applicant initiates

research idea

Small Business

Concern confirms

Eligibility

Submits SBIRSTTR

grant application to

NIH electronically

Scientific Review

Group evaluates

scientific merit

Advisory Council or

Board recommend

Approval

IC staff prepare

funding plan for

IC Director

NIH Center for

Scientific Review

assigns to IC and IRG

1-2 Months

3 Months

2-4 Months

IC allocates Grantee conducts

funds research

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer Review Criteria

38

Overall Impact Score

Scored Review Criteria (score 1-9)

bull Significance (Real ProblemCommercial Potential)

bull Investigators (PI and team)

bull Innovation (New or Improved)

bull Approach (Research Design Feasible)

bull Environment (FacilitiesResources)

Additional Review Criteria (not scored individually)

bull Protection of Human Subjects

bull Inclusion of Women Minorities amp Children

bull Vertebrate Animals

bull Biohazards

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR

SBIRSR Horre gt IC Program Contacts

A lcoholism

httr middotAwwniaaa nih ryw

National 1nstw te or A llerg ano 1nrecoous

Diseases

httpIAWwniaidnihgov

rgthonc 30 1-443-4220

F mtilmiddot mryrn 1mril nih gm

ur Nata 1a Krucnrnn

Phone 240-GG3-2915

Fax 240-E27-3162

Email kruchilinnW1iaidn hQCV

PDF Versicn

Em 3il Lindawnpinihg01

M S Juay FOX

rgthonc 301-443-4 704

Fff ~O 1-44 ~-~fll 1

Em 3il JudyFoxnihg ov

Ms vananana Knurana MtJA

Phone 240-GC9-29GG

Fax 301-493-0597

Em 3il khuranavlniaidnihgov

J3son Lundgren

inone l 4lJ-bt~-~~3

r ax 301-49)-0597

Em ail Jasonlundgrennihgov

Most Important Piece of Advice

Talk to a HHS Program Officer at least a month before a deadline for application specific advice

Click here for the list of HHS SBIR Program Managers

Not sure who to contact Email sbirodnihgov

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer (SITR

a ===m========~a ---------bull ------

__ bull bull bull bull bull bull bull bull bull bull bull bull bull bull bull bull middot bullbullbullbullbull middot

~==============~bull

bull bull bull bull bull bull bull bull bull bull bull bull bull bull bull bull middot bullbullbullbullbull middot

NIH Application amp Review Process

Applicant initiates

research idea

Small Business

Concern confirms

Eligibility

Submits SBIRSTTR

grant application to

NIH electronically

Scientific Review

Group evaluates

scientific merit

Advisory Council or

Board recommend

Approval

IC staff prepare

funding plan for

IC Director

NIH Center for

Scientific Review

assigns to IC and IRG

1-2 Months

3 Months

2-4 Months

IC allocates Grantee conducts

funds research

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer Review Criteria

38

Overall Impact Score

Scored Review Criteria (score 1-9)

bull Significance (Real ProblemCommercial Potential)

bull Investigators (PI and team)

bull Innovation (New or Improved)

bull Approach (Research Design Feasible)

bull Environment (FacilitiesResources)

Additional Review Criteria (not scored individually)

bull Protection of Human Subjects

bull Inclusion of Women Minorities amp Children

bull Vertebrate Animals

bull Biohazards

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR

SBIRSR Horre gt IC Program Contacts

A lcoholism

httr middotAwwniaaa nih ryw

National 1nstw te or A llerg ano 1nrecoous

Diseases

httpIAWwniaidnihgov

rgthonc 30 1-443-4220

F mtilmiddot mryrn 1mril nih gm

ur Nata 1a Krucnrnn

Phone 240-GG3-2915

Fax 240-E27-3162

Email kruchilinnW1iaidn hQCV

PDF Versicn

Em 3il Lindawnpinihg01

M S Juay FOX

rgthonc 301-443-4 704

Fff ~O 1-44 ~-~fll 1

Em 3il JudyFoxnihg ov

Ms vananana Knurana MtJA

Phone 240-GC9-29GG

Fax 301-493-0597

Em 3il khuranavlniaidnihgov

J3son Lundgren

inone l 4lJ-bt~-~~3

r ax 301-49)-0597

Em ail Jasonlundgrennihgov

Most Important Piece of Advice

Talk to a HHS Program Officer at least a month before a deadline for application specific advice

Click here for the list of HHS SBIR Program Managers

Not sure who to contact Email sbirodnihgov

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer Review Criteria

38

Overall Impact Score

Scored Review Criteria (score 1-9)

bull Significance (Real ProblemCommercial Potential)

bull Investigators (PI and team)

bull Innovation (New or Improved)

bull Approach (Research Design Feasible)

bull Environment (FacilitiesResources)

Additional Review Criteria (not scored individually)

bull Protection of Human Subjects

bull Inclusion of Women Minorities amp Children

bull Vertebrate Animals

bull Biohazards

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR

SBIRSR Horre gt IC Program Contacts

A lcoholism

httr middotAwwniaaa nih ryw

National 1nstw te or A llerg ano 1nrecoous

Diseases

httpIAWwniaidnihgov

rgthonc 30 1-443-4220

F mtilmiddot mryrn 1mril nih gm

ur Nata 1a Krucnrnn

Phone 240-GG3-2915

Fax 240-E27-3162

Email kruchilinnW1iaidn hQCV

PDF Versicn

Em 3il Lindawnpinihg01

M S Juay FOX

rgthonc 301-443-4 704

Fff ~O 1-44 ~-~fll 1

Em 3il JudyFoxnihg ov

Ms vananana Knurana MtJA

Phone 240-GC9-29GG

Fax 301-493-0597

Em 3il khuranavlniaidnihgov

J3son Lundgren

inone l 4lJ-bt~-~~3

r ax 301-49)-0597

Em ail Jasonlundgrennihgov

Most Important Piece of Advice

Talk to a HHS Program Officer at least a month before a deadline for application specific advice

Click here for the list of HHS SBIR Program Managers

Not sure who to contact Email sbirodnihgov

- Small Business Innovation Research (SBIR Small Business Technology Transfer (SITR

SBIRSR Horre gt IC Program Contacts

A lcoholism

httr middotAwwniaaa nih ryw

National 1nstw te or A llerg ano 1nrecoous

Diseases

httpIAWwniaidnihgov

rgthonc 30 1-443-4220

F mtilmiddot mryrn 1mril nih gm

ur Nata 1a Krucnrnn

Phone 240-GG3-2915

Fax 240-E27-3162

Email kruchilinnW1iaidn hQCV

PDF Versicn

Em 3il Lindawnpinihg01

M S Juay FOX

rgthonc 301-443-4 704

Fff ~O 1-44 ~-~fll 1

Em 3il JudyFoxnihg ov

Ms vananana Knurana MtJA

Phone 240-GC9-29GG

Fax 301-493-0597

Em 3il khuranavlniaidnihgov

J3son Lundgren

inone l 4lJ-bt~-~~3

r ax 301-49)-0597

Em ail Jasonlundgrennihgov

Most Important Piece of Advice

Talk to a HHS Program Officer at least a month before a deadline for application specific advice

Click here for the list of HHS SBIR Program Managers

Not sure who to contact Email sbirodnihgov

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer WOSB and SDB Definitions

40

What is a Women-Owned Small

Business (WOSB)

bull 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)

bull The firm must be ldquosmallrdquo in its primary industry in accordance

with SBArsquos size standards for that

industry

bull SBCs self certify on the SF 424

(RampR) Form

What is a Socially and Economically

Disadvantaged Business (SDB)

bull The firm must be 51 or more

owned and control by one or

more disadvantaged persons

bull The disadvantaged person or

persons must be socially

disadvantaged and economically

disadvantaged

bull The firm must be small

according to SBArsquos size standards

bull You must self-certify by

registering your business in

the System for Award

Management

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer Budget Hard Caps

bull SBIRSTTR award budget HARD caps in place

bull Pre-approved topics list can be found on funding page

httpssbirnihgovfunding

Award Guidelines

Program Phase I Phase II

SBIR $150000 $1000000

STTR $150000 $1000000

Award Hard Caps ndash cannot exceed

Program Phase I Phase II

SBIR $225000 $1500000

STTR $225000 $1500000

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer

Multi-IC Technology Development Programs (open to eligible Awardees from participating ICs)

I-CorpsTM at NIH

An intensive Entrepreneurial

Immersion course for scientists

12 Participating ICs + CDC

Investor

Forum Facilitating

Partnerships

Niche Assessment

Program-Foresight SampT

(Phase I Awardees)

Commercialization

Accelerator Program -

Larta Inc

(Phase II Awardees)

bull Helps jump start commercialization

efforts

bull Determines competitive advantages

bull Develops market entry strategy

bull Technical AssistanceTraining in

o Strategicbusiness planning

requirements o FDA

o Technology evaluation

o Manufacturing issues

o Patent and licensing issues

bull Helps build strategic alliances

bull Facilitates investor partnerships

bull Individualized mentoringconsulting

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer NIH Technical Assistance Programs

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer More Information

Get Connected

bull Subscribe to the SBIRSTTR Listserv

o Email LISTSERVLISTNIHGOV with the following text in the

message body subscribe SBIR-STTR your name

bull NIH Guide for Grants and Contracts (weekly notification)

bull Follow us o n Twitter NIHsbir

bull Read our NIH SBIRSTTR Success Stories

bull Connect with Us

bull Email sbirodnihgov

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer More Information

Get Connected

bull Subscribe to the SBIRSTTR Listserv

o Email LISTSERVLISTNIHGOV with the following text in the

message body subscribe SBIR-STTR your name

bull NIH Guide for Grants and Contracts (weekly notification)

bull Follow us o n Twitter NIHsbir

bull Read our NIH SBIRSTTR Success Stories

bull Connect with Us

bull Email sbirodnihgov

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer For More Information

45

Matthew Portnoy PhD NIH SBIRSTTR Program Coordinato

Phone 301-435-2688

Email mportnoymailnihgov

Julie Beaver MD MS SBIRSTTR Statistician

Phone 301-496-8807

Email juliebeavernihgov

Robert Vinson r SBIRSTTR Program Manager

Phone 301-435-2713

Email vinsonrmailnihgov

JP Kim JD MBA MSc SBIRSTTR Program Manager

Phone 301-435-0189

Email jpkimnihgov

Patricia Swayne SBIRSTTR Communications

Specialist

Phone 301-402-1632

Email patriciaswaynenihgov

-

Small Business Innovation Research (SBIR V Small Business Technology Transfer Pre-submitted questions

46

bull Is it required to have a company to apply

bull Will SBIR Direct Phase II return why did it go away

bull Are there significant technical changes to the Omnibus solicitation since the last round

bull How long is approval process assuming everything is submitted correctly

bull Is there any special preference for Socially or Economically Disadvantaged- or Minority-owned

Small Business

bull We are planning a fast track submission for Sept 5 deadline can you tell us more about it

bull What is the easiest way to submit through grantsgov or using NIH assist Are updates allowed

after submission

bull I would like to know the importance of preliminary results Our project is in its infancy We

have proof of concept in the literature but our proposal is fa r more extensive and risky than

what has been demonstrated in the literature

bull What helps to ensure a qualifying score What are reviewers l ooking for in a submission Does

academic partnership increase the odds of funding

bull Do we need to apply through a specific branch of the NIH

bull Interested in CDCNIOSH and NIEHS RFPs and whether multiple grants of different topics can

be applied in the same grant cycle

bull If an application is submitted to a specific FOA in phase 1 can it be renewed and submitted to

another FOA for phase 2

bull Do I need an indirect cost rate agreement before applying for sbir grants

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Small Business Innovation Research (SBIR V Small Business Technology Transfer Preparing for 2017-2018

SAVE THE DATE November 7-9 2017

Milwaukee Wisconsin

httpsctsimcwedueventnih-sbir-milwaukee-2017 Early Bird Registration ends Sept 28