NIH Mission

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NIH Mission
Improve human health through biomedical and
behavioral research, research training and
communications.
Jo Anne Goodnight NIH SBIR/STTR Program
Coordinator
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DHHS Budget and Award Amount
630.9
Propose a Realistic and Appropriate Budget
for the Research Take Home Message 1
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NIH Organization
Office of the Director
http//www.nih.gov/icd
National Institute on Alcohol Abuse and Alcoholism
National Institute of Arthritis
and Musculoskeletal and Skin Diseases
National Cancer Institute
National Institute on Aging
National Institute of Child Health and
Human Development
National Institute of Allergy and Infectious
Diseases
National Institute of Dental and Craniofacial Rese
arch
National Institute of Diabetes and Digestive
and Kidney Diseases
National Institute on Drug Abuse
National Institute of Environmental Health
Sciences
National Institute on Deafness and
Other Communication Disorders
National Eye Institute
National Human Genome Research Institute
National Heart, Lung, and Blood Institute
National Institute of Mental Health
National Institute of Neurological Disorders
and Stroke
National Institute of General Medical Sciences
National Institute of Nursing Research
National Center on Minority Health and Health
Disparities
National Institute of Biomedical Imaging and
Bioengineering
National Center for Complementary and
Alternative Medicine
National Library of Medicine
Fogarty International Center
National Center for Research Resources
Largest SBIR/STTR set-asides

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SOLICITATION RECEIPT DATES
SBIR/STTR Omnibus Grant Solicitation (NIH, CDC
and FDA)Release January Submission Apr 1, Aug
1, Dec 1
Contract Solicitation (NIH and CDC) Release
August 2, 2004 Receipt November 5, 2004 NIH
Guide (DHHS) Release Weekly Receipt Dates as
noted
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NIH SBIR/STTR RESEARCH AREAS
Biosilicon devices Biocompatible materials
Acousto-optics / opto-electronics Imaging
technologies Genetically engineered proteins
Proteomics / Genomics Complementary Alt. Med
(CAM)
Our Ideas. examples Biodefense Biosensors
Nanotechnologies Bioinformatics Behavioral
research Computational Biology Telehealth
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NIH SBIR/STTR RESEARCH GRANT TOPICS
Your ideas...
Angioscopes to Zebrafish

• Investigator-initiated RD
• Research topics related to the NIH mission
• Other areas of research within the
• mission of an awarding component

Take-home Message 2
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NIH Guide for Grants ContractsSpecial
SBIR/STTR Opportunities
http//grants.nih.gov/grants/guide/index.html
Go Beyond the SBIR/STTR Omnibus Solicitation.
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NIH GUIDE PAs and RFAs SBIR/STTR Opportunities
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SBIR/STTR Tip of the RD Iceberg
Never, ever, think outside the box.
--Joe Henebury DOT Prog. Mgr
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Grant Application Process
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NIH SBIR/STTR PROGRAM Application Process for
Research Grant
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Grant Application AssignmentWhat if I cannot
determine which IC is most appropriate?
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Application Assignments

• Scientific Review Groups
• NIH Center for Scientific Review RECEIPT and
  REFERRAL STAFF refer applications to an Initial
  Review Group and Study Section
• -- Match between research and scientific review
  group within IRG
• -- Scientific expertise/specialization
• -- Special Emphasis Panels
• Ad hoc Not Chartered

• Institutes/Centers
• NIH Center for Scientific Review RECEIPT and
  REFERRAL STAFF refer applications to Institute or
  Center as the potential funding component
• Match between research proposed and ICs mission
• Multiple IC assignments when technologies
  cross-cut more than one IC

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Applications Submitted to NIH Center for
Scientific Review REGARDLESS OF
INSTITUTE/CENTER TOPIC LINKAGE
Cover Letter A Valuable Tool

• Suggest potential awarding component(s)
• Discuss areas of expertise appropriate for the
  applications review
• Indicate individual(s) or organization(s) in
  conflict

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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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Review ConsiderationsSelection Criteria

• External peer reviewers (academia / industry)--
  scientists and engineers determine the merit of a
  proposal.
• All applicants receive debriefing
  automatically.
• Evaluation factors
• 1. Significance (Real Problem/Commercial
  Potential)
• 2. Approach (Research Design, Feasible)
• 3. Innovation (New or Improved?)
• 4. Investigators (PI and team)
• 5. Environment (Facilities/Resources)
• Protection of Human Subjects
• Animal Welfare
• Budget

Program staff do NOT participate in peer review
process
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HINT!
Research Plan should include answers to questions
described under Review Criteria! (See
Solicitation)
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NIH SBIR/STTR SELECTION STATISTICSFISCAL YEAR
2003
327
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563 M SBIR/STTR (set aside 556M)
44
43
5
95
981
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61
Success Rate ()
27
24
22
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NIH SBIR/STTR ProgramWhats New?

• PHS 398/2590 Undergoing revision
• Submission Dates CDC will use same 3 standard
  receipt dates as NIH and FDA
• Clarification of Instructions for Preparing Human
  Subjects Section of Research Plan
• Sample SBIR Applications
• FDA Resources and Useful Websites
• Type 2 Competing Continuation Ph II Awards

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NIH SBIR/STTR Program Distinguishing Features

• Investigator-initiated Research
• Award Amount and Project Period (REASONABLE,
  APPROPRIATE, JUSTIFIED!)
• Multiple Submission Dates
• (New/Amended Phase I/Phase II)
• Phase II Competing Continuation Awards
• Gap Funding options
• Communication Throughout Process

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Transitioning SBIR / STTR Projects to the
Marketplace
Phase I
Phase II
Phase III
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InNIHovative Solutions to Commercialization
Issues
Competing Continuation Phase II Award
From the Test Tube to the Medicine Cabinet
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Competing Continuation Phase II Award Purpose

• - To take existing, promising compounds developed
  under a Phase II through the next step of drug
  discovery and development.

• Provide additional Phase II research support to
  continue assessing and improving devices or
  conducting preclinical studies of drugs or
  devices that ultimately require
• clinical evaluation
• approval of a Federal regulatory agency
• refinements to durable medical equipment (DME)
  designs

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Competing Continuation Phase II Award Eligibility

• SBIR Phase II awardee
• Promising pharmacologic agents or devices have
  already been identified (or developed) and some
  preclinical pharmacology has been conducted.
• Response to an NIH Program Announcement
• Generally, 750k-1M/year for up to 3 years

Contact your Program Director to discuss!
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Competing Continuation Phase II
Award Participating ICs
NCI NIAID NHLBI NIMH NICHD
NIAAA NINDS NIDCD NIA
Also see PHS 2004-2 SBIR/STTR Grant Solicitation
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Competing Continuation Phase II
Award Participating ICs
NHLBI NIAID NINDS NIDCD NIA
http//grants.nih.gov/grants/guide/pa-files/PA-04-
028.html
http//grants1.nih.gov/grants/guide/rfa-files/RFA-
AI-04-005.html
http//grants.nih.gov/grants/funding/sbirsttr1/20
03-2_SBIR-STTR-topics.pdf
http//grants.nih.gov/grants/funding/sbirsttr1/20
03-2_SBIR-STTR-topics.pdf
http//grants.nih.gov/grants/funding/sbirsttr1/20
03-2_SBIR-STTR-topics.pdf
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For More Information
www.nih.gov
http//grants.nih.gov/grants/funding/sbir.htm
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NIH Success Stories