National Institutes of Health
SBIR/STTR Program:
Features and Nuances
Jo Anne Goodnight
SBIR/STTR Program Coordinator
National Institutes of Health
6701 Rockledge Drive Room 6186 - MSC 7910
Bethesda, MD 20892 Phone: 301-435-2688
Email: jg128w@nih.gov
SBIR/STTR: 3-Phase Program
PHASE I
Feasibility study
(no preliminary data needed)
$100K and 6 months (SBIR) or 12 months(STTR)
PHASE II
Full R/R&D
2-Year Award and $750K (SBIR) or $500K (STTR)
PHASE III
Commercialization Stage
Without SBIR Support
SBIR PROGRAM
ELIGIBILITY CHECKPOINTS
Organized for- profit U.S. business
At least 51% U.S.-owned and
independently operated
Small Business located in the U.S.
P.I.’s primary employment with small
business during project
500 or fewer employees
STTR PROGRAM
FORMAL COOPERATIVE R&D EFFORT
Minimum 40% by small business
Minimum 30% by research institution
U.S. RESEARCH INSTITUTION (RI)
College or University; other non-profit research
organization; federal R&D center
PRINCIPAL INVESTIGATOR FROM SMALL
BUSINESS and/or RESEARCH INST.
AWARD MADE TO SMALL BUSINESS
SBIR AND STTR PROGRAMS
CRITICAL DIFFERENCES
Research Partner
SBIR: Allows for, but does not require,
research institution partners
STTR: Requires partners from research
institutions (e.g., universities)
= 40% work by small business
and 30% work by research institution
SBIR AND STTR PROGRAMS
CRITICAL DIFFERENCES
Principal Investigator
SBIR: PI’s primary (>50%) employment
must be with small business concern
STTR: Primary employment not
stipulated
= PI can be from research institution or
from small business concern
Faculty Partnership Opportunities
Own small firms (assign someone else PI)
Principal Investigator (w/ official permission
from University)
Senior Personnel on SBIR
Consultants on SBIR
Subcontract on SBIR
University facilities can provide analytical
and other service support
The NIH SBIR/STTR Application
Process: A closer look …..
NATIONAL INSTITUTES OF HEALTH
SBIR/STTR REVIEW/AWARD PROCESS
SBIR/STTR Scientific/Technical Adv Council Awd
Receipt Dates Peer Review Board Review Date
Apr 1, 2000 June/July Sept/Oct Nov
Aug 1, 2000 Oct/Nov Jan/Feb Mar
Dec 1, 2000 Feb/March May/June July
90-Day pre-award costs are allowable:
At your own risk…..
NATIONAL INSTITUTES OF HEALTH
SBIR/STTR PROGRAM
Communication
NIH Program Director
Advice and Guidance
What’s Hot: New initiatives
Answer your questions
Review Issues: Dos and Don’ts
Discuss funding alternatives
NIH SBIR/STTR
APPLICATION PROCEDURES
Up to $100,000 Total Costs
– Omit Detailed Budget Form Pg. 3
– Include Narrative Justification:
Personnel
Budget Justification
Fixed Fee Narrative ONLY
Consultant Costs
Contractual Costs Form Page 4
Applications Submitted to NIH
Center for Scientific Review
Approximately 40,000
grant applications are
submitted to NIH each
year, of which 25-30%
are funded
Competing grant
applications are
received for three
review cycles per year
Cover Letter: A Valuable Tool
Suggest potential awarding
component(s)
Discuss areas of expertise
appropriate for the application’s
review
Indicate individual(s) or
organization(s) that would be in
conflict
NIH SBIR Review Criteria
Scientific and Technical Merit based on….
Significance
Commercial Potential?
Anticipated commercial and societal benefits?
Advancement of scientific knowledge?
Approach
Innovation
Investigators
Environment
NIH SBIR Review Criteria
Other factors considered….
Safeguards for animal and human subjects
Appropriateness of the budget
Justify costs that deviate from the
guidelines!
NIH SBIR Review Criteria
(cont.)
Phase II: Standard review criteria and degree to
which Phase I feasibility was demonstrated
Fast Track (Phase I/Phase II)
Specification of measurable goals to be
achieved prior to initiating Phase II
Concise Product Development Plan
Extent to which applicant was able to obtain
letters of interest, additional funding
commitments and/or other
non-SBIR/STTR resources
Streamlined Procedures of
NIH Grant Application Review
Reviewers
– Rate applications: 100-500 priority score
– Discuss at review applications identified
between 100 and 300
– “Triage”/ UNscore applications between
300-500…. generally
Applicants: ALL
– Automatically receive essentially verbatim
written critiques (Summary Statements)
NIH Allows Amended
Applications
Two amended applications allowed
Generally half of the reviewers are new
Request for change of reviewers must
be supported
An opportunity to revise and improve
your application
Common Problems with Applications
Inadequately defined test of feasibility
Diffuse, superficial, or unfocused research plan
– Lack of sufficient experimental detail
Questionable reasoning in experimental approach
– Uncritical approach
– Failure to consider potential pitfalls and alternatives
Lack of innovation
Unconvincing case for commercial potential or societal
impact
Lack of experience with essential methodologies
Unfamiliar with relevant published work
Unrealistically large amount of work proposed
What Reviewers Say About
Outstanding Phase II Applications
“principals … highly experienced in their respective
roles”
“ detailed Ph I Data Summary Report was included”
Ph I effort was substantial and addressed reservations
of the Ph I review solidly”
“…product promises to fill a long-felt need in
neuroscience and in the larger community”
“… resources are outstanding”
“limitations of the project have been realistically
addressed”
What Reviewers Say About
Outstanding Phase II Applications
“A prototype has been developed… pre-tested in
Phase I… good feasibility results
“…well-defined goals presented in the work plan… to
address required improvements that arose during
testing in Phase I”
“clearly stated rationale for developing such a program
is a major strength”
“commercial applications for the … are significant”
“innovative with high promise of producing a major
advance in…”
What Reviewers Say About
Outstanding Ph II Applications
“strengths include satisfactory feasibility demonstration
of prototype during Ph I, innovation and technical
merit of the concept…expertise of staff”
“Ph I aims were met as was proof of feasibility… ”
“Ph I data are presented to support their claims that a
successful Ph II effort will be accomplished”
“..one of the best this reviewer has seen.. Data
presented from Ph I are convincing, proposed
research is very sound. And PI and staff are well-
versed..”
WHERE’S THE MONEY?
WHY THE AWARD MAY BE DELAYED
OPRR Issues
IRB (Human Subjects)
http://ohrp.osophs.dhhs.gov/index.htm
IACUC (Animal Involvement)
http://grants.nih.gov/grants/olaw/olaw.htm
EIN (Entity Identification Number)
Third Party Involvement
Contracts, Consortia, Consultants
SBIR/STTR TIPS CHECKLIST
Get to know your agency Program Manager
Understand agency’s mission & needs
Read solicitation and follow instructions
Do not depend solely on SBIR funding
Don’t go it alone
Have an outcome
Be PERSISTENT
NIH Program Activities and Areas of
Research
NCI-- cancer cause, prevention, detection, diagnosis, treatment and
control
NHLBI-- diseases of heart, blood vessels, lungs, blood, and
transfusion medicine
NIDCR-- understand, treat and prevent infectious and inherited
craniofacial-oral-dental diseases and disorders
NINDS-- diagnosis, treatment, and prevention of disorders of the
nervous system, neuromuscular apparatus, and special senses of
touch/pain
NIDDK-- diabetes, endocrinology, and metabolic diseases; digestive
diseases and nutrition; kidney, urologic and hematologic diseases
NIAID-- understand, treat and prevent infectious, immunologic, and
allergic diseases
NIH Program Activities and Areas of
Research
(cont.)
NIGMS-- basic biomedical research not targeted to diseases or
disorders; recombinant DNA technology
NICHD-- fertility, pregnancy, growth, development, and medical
rehabilitation
NEI-- blinding eye diseases, visual disorders, mechanisms of visual
function, preservation of sight, requirements of the blind
NIEHS-- identification, assessment, and mechanism of action of
environmental agents that are potentially harmful to human health
NIA-- biomedical, social, and behavioral aspects of aging process;
prevention of age-related diseases and disabilities; promotion of
better QOL for older Americans
NIH Program Activities and Areas of
Research (cont.)
NIAMS-- arthritis/rheumatic diseases, connective tissue diseases,
musculoskeletal and skin disorders
NIDCD-- normal mechanisms diseases, and disorders of hearing,
balance, smell, taste, voice, speech and language
NIMH-- understanding, treating, preventing behavioral and mental
disorders (including HIV prevention, neuro-AIDS research)
NIDA-- treatment of drug addiction; behavioral strategies for treatment
medication; training in drug abuse treatment techniques; drug abuse
treatment
NIAAA-- treatment and prevention of alcoholism and alcohol-related
problems
NINR-- understand effects of acute and chronic illness, improving
QOL, approaches to promote health and prevent disease, improving
clinical environments
NIH Program Activities and Areas of
Research (cont.)
NIHGRI-- efforts toward achieving the goals of the Human Genome
Project
(Science vol. 262, pp.43-46; Oct. 1, 1993)
NCRR-- R&D in instrumentation and specialized technologies for
biomedical research; R&D in comparative medicine; discovery-
oriented software for science education
NCCAM-- complementary and alternative treatment, diagnostic, and
prevention modalities, disciplines and systems: education and public
information; patient management; botanical products; research-
related issues (e.g., models, methods)
NLM-- innovative methods, systems, and services for managing
health knowledge and information