NIH Regional Seminar on Program Funding & Grants Administration
June 27-28, 2013
Robert Vinson, Jr.
Assistant Program Manager
NIH SBIR/STTR Program Office
Baltimore, MD
Topics to Discuss Today
* NIH SBIR/STTR Program Specifics
* Red Lights and Yellow Lights
* Answer Your Questions!
SBIR/STTR Programs
The largest, most accessible source of
SEED CAPITAL
for the nation’s innovative small
businesses
$2.5 Billion in FY 2012
SBIR/STTR Set-Aside
NIH SBIR: $632 M
NIH STTR: $ 85 M
Total:
$717M
NIH
$717M
$2.5B
and….
This capital is in the form of
grants and contracts
•
•
•
•
no repayment
no debt service
no equity forfeiture
no IP forfeiture
SBIR/STTR Program Overview
SMALL BUSINESS INNOVATION
RESEARCH (SBIR) PROGRAM
2.7%*
Set-aside program for small business
concerns to engage in Federal R&D -- with
potential for commercialization.
SMALL BUSINESS TECHNOLOGY
TRANSFER (STTR) PROGRAM
0.35%* Set-aside program to facilitate cooperative
R&D between small businesses and research
institutions -- with potential for
commercialization.
The best way to predict the future…is to create it.
SBIR Purpose and Goals
* Stimulate technological innovation
* Use small business to meet Federal R&D needs
* Foster and encourage participation by
minorities and disadvantaged persons in
technological innovation
* Increase private-sector commercialization
innovations derived from Federal R&D
Small Business Innovation Development Act of 1982
P.L. 112-81 Re-Authorizes program through FY2017
SBIR/STTR Program Overview
STTR Purpose and Goals
* Stimulate and foster scientific and technological
innovation through cooperative research and
development between small business concerns
and research institutions
* Foster technology transfer between small
business concerns and research institutions
Small Business Research and Development
Enhancement Act of 1992
P.L. 112-81 Re-Authorizes program through FY2017
SBIR/STTR Program Overview
NIH Mission
Improve human
health through
biomedical and
behavioral research,
research training and
communications.
Organizational Structure of NIH
Office of Research
Infrastructure Programs
Office of the Director
http://www.nih.gov/icd
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 Alternative
Medicine
Fogarty
International
Center
National Center
for Advancing
Translational Sciences
NIH Clinical Center
Center for
Information
Technology
National Library
of Medicine
Center for
Scientific Review
National Institute
of Biomedical
Imaging
and
Bioengineering
No funding
authority
NIH SBIR/STTR: 3-Phase Program
PHASE I Feasibility Study
 Budget Guide: $150K (SBIR); $150K (STTR) Total Costs
 Project Period: 6 months (SBIR); 1 year (STTR)
PHASE II Full Research/R&D
 $1M (STTR), $1M (SBIR) over two years
PHASE IIB Competing Renewal/R&D
 Clinical R&D; Complex Instrumentation/Tools to FDA
 Many, but not all, ICs participate
 Varies ~$1M/year; 3 years
PHASE III Commercialization Stage
 NIH, generally, not the “customer”
 Consider partnering and exit strategy early
SBIR/STTR Eligibility Criteria
Subject to change per new SBA Policy Directive pending
 Organized as for-profit U.S. business

Small: 500 or fewer employees, including affiliates

PD/PI’s primary employment must be with small
business concern at time of award and for duration of
project period

At least 51% U.S.- owned by individuals and
independently operated or
At least 51% owned and controlled by another (one)
business concern that is at least 51% owned and
controlled by one or more individuals
more Eligibility Checkpoints

STTR: Formal collaborative effort means:
* Minimum 40% by small business
* Minimum 30% by U.S. research institution

STTR: Intellectual Property Agreement Needed
Allocation of Rights in IP and Rights to Carry out
Follow-on R&D and Commercialization

SBIR/STTR: Applicant is Small Business Concern

SBIR/STTR: All of the work must be done in the US
SBIR/STTR Program Overview
SBIR and STTR:
Critical Differences
* Research Partner
* Principal Investigator
Employment
 SBIR: Permits partnering
 SBIR: Primary employment
(>50%) must be with small
business concern
 STTR: PI may be employed by
either research institution or
small business concern
 Multiple PD/PI allowable
33% Phase I and 50% Phase II
 STTR: Requires partnering with
Research Institution
Small business (40%) and U.S.
research institution (30%)
Award is always made to Small Business Concern
Important Facts to Remember
* Eligibility is determined at time of award
* No appendices allowed in Phase I
* The PD/PI is not required to have a PhD/MD
* The PD/PI is required to have expertise to
oversee project scientifically and technically
* Applications may be submitted to different
agencies for similar work
* Awards may not be accepted from different
agencies for duplicative projects
NIH SBIR/STTR Budget Allocations FY2012
NIAAA
NCATS
NHGRI
NIEHS NIAMS
NIBIB NIMHD
NIDCR
ORIP
NIDCD
NCCAM
NINR
NLM
NCI
NEI
NIDA
NIAID
NIA
NICHD
NIMH
NHLBI
NINDS
NIDDK
2.6% SBIR $632M
0.35% STTR $85M
Total FY2012 $717M
NIGMS
NIH SBIR/STTR Success Rates
Fiscal Year
SBIR/STTR
Phase
2010
2010
2010
2010
2010
2010
2010
2011
2011
2011
2011
2011
2011
SBIR
SBIR
SBIR
STTR
STTR
STTR
FY TOTAL
SBIR
SBIR
SBIR
STTR
STTR
STTR
Fast Track
Phase 1
Phase 2
Fast Track
Phase 1
Phase 2
2011
FY TOTAL
Fast Track
Phase 1
Phase 2
Fast Track
Phase 1
Phase 2
Number of
Applications
Reviewed
Number of
Applications
Awarded
Success
Rate
Total Funding
430
4,496
734
47
539
92
6,338
409
4,672
681
42
508
103
67
614
246
11
109
32
1,079
42
536
203
4
80
37
15.6%
13.7%
33.5%
23.4%
20.2%
34.8%
17.0%
10.3%
11.5%
29.8%
9.5%
15.7%
35.9%
$16,795,150
$129,218,371
$146,228,959
$2,300,971
$21,620,399
$18,207,113
$334,370,963
$10,059,904
$123,802,074
$137,152,687
$813,900
$18,321,516
$20,977,584
6,415
902
14.1%
$311,127,665
HHS/NIH Program Funding
2012 Budget
SBIR
STTR
NIH
$632M
$85M
CDC
FDA
ACF
Phase I
$8.3M
$1M
~350K
$150K*
6 months*
$1M*
2 years*
Phase II
N/A
$150K*
1 year*
$1M*
2 years*
Gap Funding Programs
Phase IIB Competing
Renewal Award
Mt. “FDA”
Phase I
Phase II
Phase III
• No-Cost Extension
• Phase I / Phase II Fast Track
• Administrative / Competitive
Supplements
NIH SBIR/STTR Program Specifics
NIH Phase I/Phase II Fast-Track
Bridging the Phase I - II Funding Gap
SBIR/STTR Phase I + Phase II
7-9 months
(Simultaneous Submission
and Concurrent Review)
Completion of Phase I
Go?
Phase I Award
Phase I Final Report
Program Staff assess
completion of specific
aims and milestones
Aims/Milestones
Met
Phase II award
No Go?
Aims/Milestones
NOT Met
Phase II award
“In-NIH-vative” Approaches
Phase IIB Competing Renewals
Purpose
* To take existing, promising compounds or devices
developed under a Phase II through the next step of
drug discovery / medical device refinement and
development (see SBIR/STTR Solicitation)
or…NCI, NHLBI, NINDS specific announcements, ex:
* Competing Renewal Awards of SBIR Phase IIB
Grants for Brain and Behavior Tools (R44)
(see PA-11-135)
“In-NIH-vative” Approaches
Phase IIB Competing Renewals
Eligibility
Contact NIH Program Staff to discuss
* SBIR/STTR Phase II awardee
* Promising pharmacologic compound identified in original Phase II
* Device prototype developed in original Phase II
* Instrumentation/Interventional technologies not subject to FDA
regulatory approval but require extraordinary time/effort to develop
Parameters
* Maximum of $1M/year for up to 3 years
* IC must accept Competing Renewal applications
(NIA, NIAAA, NIAID, NICHD, NIDA, NIDCD, NIDDK, NIGMS, NEI,
NHLBI, NIMH, NINDS, NCI, NCATS, and ORIP)
“In-NIH-vative” Approaches
Solicitations & Due Dates
http://sbir.nih.gov
Solicitations & Due Dates
http://grants.nih.gov/grants/funding/sbir.htm
* NIH, CDC, FDA & ACF Omnibus Solicitation for
SBIR/STTR Grant Applications
Parent FOAs:
SBIR: (PA-13-088) STTR: (PA-13-089)
Release: January
Due Dates: April 5, Aug 5, Dec 5
(AIDS: May 7, Sept 7, Jan 7)
* NIH & CDC SBIR Contract Solicitation
Release: August
NIH (24 ICs) – SBIR & STTR
Receipt Date: November
FDA – SBIR only
CDC – SBIR only
ACF– SBIR only
NIH SBIR/STTR Program Specifics
Descriptions & Research Topics
Suggested topic areas
Biodefense
Biosilicon devices
Investigator-initiated
R&D
Biosensors
Biocompatible materials
Nanotechnologies
/ opto* Research projectsAcousto-optics
related to the NIH
electronics
mission
Bioinformatics
Imaging devices
Diagnostic and
*
“Other” areas of research within the
Therapeutic Devices
Genetically engineered
mission of an awarding
component
proteins
Telehealth
Keyword search the Solicitation
Proteomics / Genomics
… - F
Ctrl
Cover Letter: A Valuable Tool
*Suggest potential awarding component(s):
NIH Institutes/Centers
* Request SBIR/STTR study section
http://www.csr.nih.gov/Roster_proto/sbir_section.asp
* Suggest key areas of expertise required
* Indicate individual(s) or organization(s) in
conflict
* For resubmission, indicate review history
* Justify your requests
Targeted SBIR/STTR FOA
http://grants.nih.gov/grants/funding/sbir_announcements.htm
* NIH Guide for Grants and Contracts
- High priority areas for ICs
- Various IC participation
- Nuances:
a) Various due dates
b) Additional review criteria
c) Limited funds and project duration periods
d) Etc.
Electronic Submission
• SBIR/STTR grant applications must be
submitted electronically.
(SBIR contract proposals still in paper
form)
• Registrations are required!!!
– Grants.gov (company)
– eRA Commons (company and all PD/PIs)
http://era.nih.gov/ElectronicReceipt/index.htm
Important Application Changes
(Effective January 25, 2010)
• Research Plan Restructure
Research Plan
Research Strategy
Background & Significance
Preliminary Studies/Progress Report
Research Design and Methods
Significance
Innovation
Approach
• Page Limits
– Introduction (resubmission or revision) – 1page
– Specific Aims – 1page
– Research Strategy
• Phase I – 6 pages
• Phase II – 12 pages
• Phase II Commercialization Plan – 12 pages
Guide Notice: NOT-OD-09-149
Updates
1. Error correction window:
•
Eliminated effective January 25, 2011. (NIH Guide Notice NOTOD-10-123)
•
Until January 25, 2011, two business days to correct errors and
warnings.
2. Resubmissions: Must be submitted no later than 37 months after
initial receipt date. (NIH Guide Notice NOT-OD-10-140)
3. New Reporting Requirement: Transparency Act requires reporting
on subawards over $25K & executive compensation (NIH Guide
Notice NOT-OD-11-005)
4. Annotated forms:
http://grants.nih.gov/grants/ElectronicReceipt/files/small_bus_annotated_app_form.pdf
Application & Review Process
Remember: First get registered in Grants.gov AND eRA Commons!
Small Business
Concern
Applicant
Initiates
Research Idea
Submits
SBIR/STTR Grant
Application to NIH
Electronically
NIH Center for Scientific Review
Assign to IC and IRG
Scientific Review Groups
Evaluate Scientific Merit
~2-3 months
after submission
~2-3
months
after review
Grantee Conducts
Research
IC
Allocates
Funds
Advisory Council or Board
Recommend approval
IC Staff Prepare funding Plan
for IC Director
NIH SBIR/STTR Program Specifics
Review Criteria
•
Overall Impact Score
•
Scored Review Criteria (score 1-9)
•





Significance (Real Problem/Commercial Potential)
Investigators (PI and team)
Innovation (New or Improved?)
Approach (Research Design, Feasible)
Environment (Facilities/Resources)
Additional Review Criteria (not scored individually)



Protection of Human Subjects
Inclusion of Women, Minorities & Children
Vertebrate Animals

Biohazards
Competing Successfully
∙Understand our mission.
∙Review Funding Opportunity Announcements (FOAs).
∙Propose innovative ideas with significance as well as
scientific and technical merit.
∙Give yourself ample time to prepare application.
∙Communication, Communication, Communication!
∙Contact NIH Staff to discuss:
a) your research idea.
b) outcome of your review.
c) challenges and opportunities.
Technical Assistance Programs
Helping Companies cross the “Valley of Death”
Niche Assessment Program
Mt. “FDA”
???
Commercialization
Assistance
Program
Phase I
Phase II
Phase III
“In-NIH-vative” Approaches
Technical Assistance Programs
Niche Assessment
Identifies other uses of technology
(Phase I awardees)
Determines competitive advantages
Develops market entry strategy
Commercialization
Assistance
(Phase II awardees)
“Menu” of technical assistance/training
programs in:
•Strategic/business planning
•FDA requirements
•Technology valuation
•Manufacturing issues
•Patent and licensing issues
Helps build strategic alliances
Facilitates investor partnerships
Individualized mentoring/consulting
Summary of Key Features
* SBIR and STTR Program
 Single SBIR/STTR grant solicitation
 Investigator-initiated research ideas
 Special Funding Opportunities
(NIH Guide for Grants and Contracts)
 Electronic Submission (grants only)
 Awards: Grants, Contracts,
Cooperative Agreements
* External Peer Review
 Option to request review group
 Experts from Academia/Industry
 5 Criteria: Significance, Approach,
PI(s), Innovation, Environment
 Summary Statement for all
applicants
 Revise & resubmit
* Gap Funding Programs
* Multiple Receipt Dates (Grants)
 Phase IIB Competing Renewals
 April 5, August 5, December 5
 Ph I/Ph II Fast Track
 May 7, September 7, January 7 (AIDS)
 Administrative Supplements
 Contracts: Early November
* Budget and Project Period
 $150K/6 -12months (Ph I)
 $1M/2 yrs (Ph II)
* Technical Assistance Programs
 Technology Niche Assessment
 Commercialization Assistance
 Pipeline to Partnerships (P2P)
Summary
Topics to Discuss Today
* NIH SBIR/STTR Program Specifics
* Red Lights and Yellow Lights
* Answer Your Questions!
Eligibility Criteria
Subject to change
* Ownership: US-owned, independently operated
* Affiliations: Research Institutions,
Foundations, Foreign “Parents”
* Size: 500 employees maximum
* Business Structure: Inc., LLP, LLC, ...
* Principal Investigator: Employment
Ownership And Affiliations
Subject to change
Eligibility of wholly-owned subsidiary
* Owners of the SBIR organization must be
"individuals" who are "citizens of, or
permanent resident aliens in, the United
States."
* The regulations nowhere provide that
corporations or artificial entities may qualify
as "individuals" who are U.S. citizens.
Ownership and Affiliations
* Parent of wholly-owned subsidiary is
FOREIGN
* Sum TOTAL of ALL employees
more than 500 (parent + subsidiary)
* Sharing of officers on Board of Directors
PD/PI Eligibility on SBIR
* PI must have primary employment
with SBC (unless waiver is granted)
* More than 50% of PI’s time spent in
employ of SBC
* Primary employment w/SBC precludes
full-time employment at another
organization
Eligibility is determined at the time of award
STTR Eligibility Criteria
* Applicant Organization
* Research Institution Partner
* Project Director/Principal Investigator
STTR Applicant Organization
Small Business Concern is
ALWAYS
the applicant/awardee organization
STTR Research Institution Partner
* Must establish formal collaborative relationship
with SBC
* Must perform minimum of 30% of the
research/R&D (maximum 60%)
* Non-profit organization owned and operated
exclusively for scientific or educational purposes
* Non-profit medical and surgical hospitals

eligible as partner as long as these institutions are
exclusively engaged in scientific research and/or
application of scientific principles and techniques
PD/PI Eligibility on STTR
* PD/PI: Not required to be employed by SBC
* PD/PI: Must commit 10% effort (minimum)
* PD/PI at RI: Must establish contract between
RI and SBC describing PD/PI’s involvement
PD/PI’s “signature” on Face Page represents
agreement to conforming to Solicitation
requirements
PD/PI Role on STTR
BUDGET PAGE
* PI must be on SBC or RI budget,
but NOT BOTH
* PI and co-PI must be paid at either SBC or RI,
but NOT BOTH
* PI oversees all research activities on behalf of
SBC
PD/PI Role on STTR
* Is PD/PI also business official for SBC?
* Type of appointment does PD/PI have at RI?
* If Owner/Business Official, s/he should also
appear as employee of SBC (co-Investigator)
and forego RI appointment during Phase II
PI Role on STTR
* NIH requires documentation from original
employer/RI confirming change in employment
status (e.g., sabbatical) for duration of
SBIR/STTR project
* PI cannot serve as consultant on same project
Tips for Potential Applicants
* Explore the OER website – a wealth of information there!
http://grants.nih.gov/grants/oer.htm
* Explore Institute/Center (IC) websites - to find the most likely
home for your project
* Explore the CSR website - identify potential study sections
http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription/
* Contact appropriate program staff – they can help you!
* Include a cover letter with your application - to request IC and
study section assignments
* Be persistent and don’t get discouraged: NIH extramural
staff are your links with the ICs and are there to help you.
Top 10 Reasons
Top 10 Reasons
10. Over $2.5 Billion available annually
9. NOT A LOAN - no repayment
8. Provides recognition, verification
and visibility
7. Potential leveraging tool to attract
venture capital/other sources of
$$$$$
Top 10 Reasons
6. Foster partnerships (universities, large
corporations) that enhance
competitiveness of small businesses in
marketplace
5. Creates jobs / stimulates local and state
economies – stronger National Economy
4. Provides seed money to fund high
risk projects
Top 10 Reasons
3. Intellectual property rights normally
retained by the small business
2. Small business concerns recognized
as a unique national resource of
technological innovation
Top 10 Reasons
Intralase Corporation
Cardiac Assist, Inc.
Design Continuum, Inc.
1. Opportunity to improve
GlycoFi, Inc.
the health of America
Xilas Medical, Inc.
Altea Therapeutics Corporation
Merck pays $400 million in cash for small New Hampshire
company … largest sum ever reported for a privately held
biotech.
Cyberkinetics Neurotechnology
Systems, Inc.
For More Information
Matthew Portnoy, PhD
NIH SBIR/STTR Program Coordinator
Phone: 301-435-2688
Email: mportnoy@mail.nih.gov
Lenka Fedorkova, PhD
Assistant Program Manager
Phone: 301-435-0921
Email: fedorkoval@mail.nih.gov
Robert Vinson, Jr.
Assistant Program Manager
Phone: 301-435-2713
Email: vinsonr@mail.nih.gov
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