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National Institutes of National Institutes of HealthHealth
SBIR/STTR Program:SBIR/STTR Program:Features and NuancesFeatures and Nuances
Jo Anne GoodnightSBIR/STTR Program Coordinator
National Institutes of Health
6701 Rockledge Drive Room 6186 - MSC 7910 Bethesda, MD 20892 Phone: 301-435-2688
Email: [email protected]
SBIR/STTR: 3-Phase ProgramSBIR/STTR: 3-Phase ProgramPHASE 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
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
SBIR PROGRAM SBIR PROGRAM ELIGIBILITY CHECKPOINTSELIGIBILITY CHECKPOINTS
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
STTR PROGRAMSTTR PROGRAM
SBIR AND STTR PROGRAMSCRITICAL DIFFERENCESCRITICAL 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 PROGRAMSCRITICAL DIFFERENCESCRITICAL DIFFERENCES
Principal InvestigatorSBIR: 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 OpportunitiesFaculty 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 The NIH SBIR/STTR Application
Process: A closer look …..Process: A closer look …..
NATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH
SBIR/STTR REVIEW/AWARD PROCESSSBIR/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 HEALTHSBIR/STTR PROGRAMSBIR/STTR PROGRAM
Communication
NIH Program Director
AAdvice and GGuidanceWWhat’s Hot: New initiativesAAnswer your questions RReview Issues: Dos and Don’tsDDiscussiscuss funding alternatives
NIH SBIR/STTR APPLICATION PROCEDURESAPPLICATION PROCEDURES
Up to $100,000 Total Costs
– Omit Detailed Budget Form Pg. 3
– Include Narrative Justification: Personnel Fixed Fee Consultant Costs Contractual Costs
Budget JustificationNarrative ONLY
Form Page 4
Applications Submitted to NIHApplications Submitted to NIHCenter for Scientific ReviewCenter 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 budgetJustify 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 What Reviewers Say About Outstanding Ph II ApplicationsOutstanding 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 MONEYWHERE’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 CHECKLISTSBIR/STTR TIPS CHECKLIST
Get to know your agency Program Manageragency Program Manager
Understand agency’s mission & needsagency’s mission & needs
Read solicitation and follow instructionsfollow instructions
Do not depend solelysolely on SBIR funding
Don’t go it alonealone
Have an outcomeoutcome
Be PERSISTENTPERSISTENT
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
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
NIDCR-- understand, treat and prevent infectious and inherited craniofacial-oral-dental diseases and disorders
NIH Program Activities and Areas of Research
(cont.)
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
NIGMS-- basic biomedical research not targeted to diseases or disorders; recombinant DNA technology
NIH Program Activities and Areas of Research (cont.)
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
NIAMS-- arthritis/rheumatic diseases, connective tissue diseases, musculoskeletal and skin disorders
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