1. Jo Anne Goodnight NIH SBIR/STTR Program Coordinator NIH Mission Improve human health through biomedical and behavioral research, research training and communications.

2. SBIR STTR 2004 Budget NIH$563.3M$67.6M CDCFDAAHRQ~8.1M~0.8M~2.0MN/A Phase I $100K* 6 months* $100K* 1 year* Phase II $750K* 2 years* $750K* ****Propose a Realistic and Appropriate Budget for the Research**** Take Home Message #1 DHHS Budget and Award Amount $630.9

3. Office of the Director Largest SBIR/STTR set-asides National Center on Minority Health and Health Disparities NIH Organization 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 Diabetes and Digestive and Kidney Diseases National Institute of Dental and Craniofacial Research 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 Library of Medicine National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Institute of Biomedical Imaging and Bioengineering

4. SOLICITATION RECEIPT DATES SOLICITATION RECEIPT DATES SBIR/STTR Omnibus Grant Solicitation (NIH, CDC and FDA) Release: January Receipt: Apr 1, Aug 1, Dec 1 Contract Solicitation (NIH and CDC) Release: August Receipt: November (~2nd Friday) NIH Guide (DHHS) Release: Weekly Receipt : Dates as noted

5. NIH SBIR/STTR RESEARCH AREAS Our Ideas…. examples Biodefense Biosensors Nanotechnologies Bioinformatics Behavioral research Computational Biology Telehealth Biosilicon devices Biocompatible materials Acousto-optics / opto-electronics Imaging technologies Genetically engineered proteins Proteomics / Genomics Complementary & Alt. Med (CAM)…

6. Take-home Message #2 l Investigator-initiated R&D l Research topics related to the NIH mission l “Other” areas of research within the mission of an awarding component l … Your Your ideas... NIH SBIR/STTR RESEARCH GRANT TOPICS AngioscopestoZebrafish

7. Review Considerations Selection 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

8. NIH SBIR/STTR SELECTION STATISTICS FISCAL YEAR 2003 Success Rate (%) 24% 44% 27% 43% 28% 22% 981 32718 61 $563 M SBIR/STTR (set aside $556M) 95 5

9. NIH SBIR/STTR Program What’s 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

10. 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) (New/Amended; Phase I/Phase II)  Phase II Competing Continuation Awards  Gap Funding options  Communication Throughout Process

11. For More Information http://grants.nih.gov/grants/funding/sbir.htm Jo Anne Goodnight NIH SBIR/STTR Program Coordinator Phone: 301-435-2688 Email: jg128w@nih.gov Kay Etzler NIH SBIR/STTR Program Phone: 301-435-2713 Email: etzlerk@od.nih.gov

12. NIH Success Stories Illumina developed ultra high throughput specialized laboratory (Oligator Farm® facility) synthesizer of oligonucleotides. LigoCyte has developed a monoclonal antibody capable of inhibiting inflammatory disease in the lung. The SmartWheel examines the biomechanics of wheelchair propulsion by precisely measuring parameters including stroke frequency, propulsion angle, acceleration, forces applied to the handrim, velocity, and distance traveled. The SmartWheel is the only commercial product in the world that measures propulsion biomechanics in the natural environment of the wheelchair user.