SBIRSTTR quick view

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A Quick Look at the NIH SBIR/STTR Programs For
Small Businesses Only
Society for Research Administrators
Conference Milwaukee, Wisconsin October 2005

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Topics

• Review of NIH SBIR/STTR Nuances
• NIH Evaluation/Review/Selection Process
• Identifying Funding Opportunities
• Communication Other Tips
• Technical Assistance Program
• NIH Resources
• QA

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NIH Mission
IMPROVE HUMAN HEALTH through biomedical and
behavioral research, research training and
communications.
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Small Companies Can Help NIH meet its mission

• Conduct innovative R/RD that results in product,
  process, or service that will...
• Improve patient health
• Speed process of discovery
• Reduce cost of medical care/cost of
• research
• Improve research communication tools

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SBIR/STTR Participating Agencies
TOTAL 2.0 B FY 2005

• DOD SBIR/STTR
• NASA SBIR/STTR
• DOE SBIR/STTR
• NSF SBIR/STTR
• DHS SBIR
• USDA SBIR
• DOC SBIR
• ED SBIR
• EPA SBIR
• DOT SBIR

NIH 571 M SBIR 69 M STTR 640
M Total CDC 8.0 M SBIR FDA 0.8 M
SBIR AHRQ 2.1 M SBIR

• HHS SBIR/STTR

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National Institutes of Health
http//www.nih.gov/icd/
Office of the Director
National Center on Minority Health and Health
Disparities

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NIH SBIR/STTR FUNDING RATESFISCAL YEAR 2004
631 M SBIR/STTR
32
44
49.2
49
15
302
215
37
39
37
Success Rate ()
973
59
20
18
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Awarded Funds Distribution
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NUANCES NIH SBIR STTR Programs

• SBIR and STTR Program
• Multiple Award Mechanisms
• Multiple Receipt Dates
• Budget Guidelines
• 100K/ 750K
• External Peer Review
• Critiques sent to all applicants
• Revise Resubmit

• Single Solicitation
• 95 Awards are grants
• April 1, Aug 1, Dec 1
• Realistic appropriate
• Academia and industry
• Original 2 amendments

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Peer Review of SBIR/STTR Grant Applications
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NIH SBIR/STTR PROGRAM Review Process for
Research Grant
Submits SBIR/STTR Grant Application to NIH
2-3 months after submission
2-3 months after review
IC Staff Prepare funding Plan for IC Director
Grantee Conducts Research
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APPLICATION, REVIEW, and AWARD TIMELINE
SBIR/STTR Scientific/Technical Adv
Council Awd Receipt Dates Peer
Review Board Review Date Apr 1
June/July Sept/Oct Nov Aug 1
Oct/Nov Jan/Feb Mar Dec 1
Feb/March May/June July
7 to 9 months
90-Day pre-award costs are allowable At your
own risk..
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Application Assignments
Center for Scientific ReviewReceipt Referral
Office

• Institutes/Centers

Match between proposed research and ICs mission
For funding
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Scientific Review Group or Study Section Actions

• Scored, Scientific Merit Rating (priority scores
  100 to 300, typically)
• Unscored (lower half priority scores 301-500)
• Deferral

STUDY SECTIONS DO NOT FUND! INSTITUTES FUND!
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Funding Opportunities

• SBIR/STTR Omnibus Grant Solicitation
• (NIH, CDC, and FDA) Release
  January April 1, Aug 1, Dec 1 receipt dates
• SBIR Contract Solicitation (NIH, CDC)
• Release August Early November receipt date
• NIH Guide for Grants and Contracts
• Release Weekly Various receipt dates

http//grants.nih.gov/grants/funding/sbir.htm
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PA04-127 SBIR Advanced Technology (SBIR at
NIAID)
Objective To support RD for products and
services that require FDA approval such as
development of vaccines, biologics, drugs and
prevention strategies for infectious and
immunologic diseases, allergy, and
transplantation.

• Unique Features
• Flexible budget and project durations
• Phase I 2 yrs, 300K total costs each year
• Phase II 3 yrs, up to 1Million total cost per
  year

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RFA-DK-05-010 SBIR/STTR to Develop New
Therapeutics and Monitoring Technologies for Type
1 Diabetes (TD1)
Objective To apply cutting edge technology to
investigate the development of new approaches to
predict, prevent, treat, and cure type 1 Diabetes
(T1D) and its complications .

• Unique Features
• Special receipt date (March 15, 2006)
• Letter of Intent Receipt Date (Feb. 15, 2006)
• Both SBIR/STTR Ph. I, Ph. II and Fast-track
• Flexible budget and project durations
• Phase I 500,000 total costs /yr up to two yrs.
• Phase II 1,000,000 total costs/yr up to 3 yrs
• Multiple Institute participation
  (NIDDK/NIAID/NEI/NHLBI/NINDS/NICHD)

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Tips/Suggestions
Key to the NIH Application, Review, and Award
Process
Communication
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Contact NIH Staff
Assess the fit Whats New PAs/RFAs Assist in
finding collaborators Review Issues Dos and
Donts Define product and focus application
Application
Review
Award
Identification Tools Solicitation Part II
CRISP Database
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Contact NIH Staff Review Staff

• Scientific Review Administrator.
• Point of contact during review process
• Recruitment/Assignment of Reviewers
• Concerns about I/C Assignment or Review

Review
Identification Tool Grant Receipt Notice
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Contact NIH Staff Program Staff Post Review

• Discuss outcome of peer review
• Review Summary Statement
• What the rating means (numeric vs. )
• Strengths and weaknesses
• Likelihood of funding
• Next steps

If at first you dont succeed.
Revise and resubmit
Application
Review
Award
Identification Tool Summary Statement
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Contact NIH Staff Grants Management Staff

• Pre-Award Steps
• Budget, Eligibility, Submission
• Post-Award Advice Guidance
• Prior approval requirements
• Changes in PI, organization, scope
• Final reporting requirements

Award
Identification Tools Solicitation Part I
Notice of Grant Award
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SBC Eligibility Requirement U.S. Company

• Organized for profit,
• Place of business located in the United States,
• Operates primarily within the United States
• or which makes a significant contribution to
• the United States economy through payment
• of taxes or use of American products,
• materials or labor

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SBC Eligibility Requirement Ownership

• Individual proprietorship,
• Partnership,
• Limited Liability Company (LLC)
• Corporation (Inc., Corp.),
• Joint Venture (JV),
• association, trust or cooperative, except that
• where the form is a joint venture, there can
• be no more than 49 percent participation by
• foreign business entities in the joint venture

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SBC Eligibility Requirement Ownership

• Small Business Administration, January 3, 2005
• gt 51 percent owned and controlled
• by one or more individuals who are citizens
• of, or permanent resident aliens in, the
• United States,
• or (SBIR only) is at least 51 owned controlled
  by another for-profit business concern that is at
  least 51 owned and controlled by one or more
  individuals who are citizens of, or permanent
  resident aliens in, the United States.
• SBA makes the final size determination

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Commercialization Valley
3 months? 2 years? 10 years?
Phase II

Phase I
Phase III
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Technical Assistance Programs
Business strategic planning Builds alliances
and investor partnerships

• Commercialization
• Assistance

(Phase II awardees)
Identify other uses of technology Determines
competitive advantages Develops market entry
strategy
Pilot Niche Assessment
(Phase I awardees)
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http//grants.nih.gov/grants/funding/sbir.htm
Alerts/News Flashes Solicitations Targeted
Research Opportunities Award Information
Collaborative Opportunities Success Stories
Resources
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New for FY2006

• SBIR and STTR electronic submission through
  Grants.gov for December 1
• New electronic application SF424RR
• New Public Access Policy

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New Public Access Policyto Publications
Resulting from NIH-funded Research

• NIH-funded investigators are requested to submit
  to the NIH National Library of Medicine's (NLM)
  PubMed Central (PMC) an electronic version of the
  author's final manuscript upon acceptance for
  publication, resulting from research supported,
  in whole or in part, with direct costs from NIH.

Effective May 2, 2005
NIH Guide, February 3, 2005 http//grants1.nih.gov
/grants/guide/notice-files/NOT-OD-05-022.html
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Kathleen Shino Acting NIH SBIR/STTR Program
Coordinator Phone [phone] Fax
301-480-0146 Email ks48e_at_nih.gov or
Kay Etzler NIH SBIR/STTR Program
Analyst Phone [phone] Email
etzlerk_at_od.nih.gov
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Transonic Systems, Inc.R44 DK50499

• Flow-QC Hemodialysis
• Improved Dialysis Efficiency
• FDA-cleared, compact, and inexpensive
• device and measurement protocol works
• with any manufacturers hemodialysis machine
• A three-phase study by researchers at
• Vanderbilt University, Dialysis Inc. and Renal
• Care Group link monthly vascular access
• blood flow monitoring with the
• Transonic HD01 Monitor to reduced
• access morbidity and costs by 48.
• May measurably improve the health of 210,000
  American kidney failure patients receiving
  hemodialysis, and may potentially save Medicare
  and other insurers an estimated 0.9 billion
  dollars/year.