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Assessment of the SBIR and STTR Programs at the National Institutes of Health

National Academies of Sciences, Engineering, and Medicine; Policy and Global Affairs; Board on Science, Technology, and Economic Policy; Committee on the Assessment of the SBIR and STTR Programs at NIH .

The National Institutes of Health (NIH) asked the National Academies of Sciences, Engineering, and Medicine to conduct a quadrennial review of its Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, in accordance with a legislative mandate. Using quantitative and qualitative analyses of data, this report reviews the operations and outcomes stemming from NIH's SBIR/STTR awards. Drawing on published research and conducting new analyses based on both publicly available data and applicant data provided by NIH, Assessment of the SBIR and STTR Programs at the National Institutes of Health analyzes (1) the effectiveness of NIH's processes and procedures for selecting SBIR and STTR awardees; (2) the effectiveness of NIH's outreach to increase SBIR and STTR applications from small businesses that are new to the programs, from underrepresented states, and from woman-owned and minority-owned businesses; (3) collaborations between small businesses and research institutions resulting from the programs; and (4) a range of direct economic and health care impacts attributable to the programs.

Contents

• The National Academies of SCIENCES • ENGINEERING • MEDICINE
• COMMITTEE ON THE ASSESSMENT OF THE SBIR AND STTR PROGRAMS AT NIH
• BOARD ON SCIENCE, TECHNOLOGY, AND ECONOMIC POLICY
• Preface
• Acknowledgment of Reviewers
• List of Acronyms
• Summary
  • STUDY SCOPE
  • STUDY METHODOLOGY AND LIMITATIONS
  • KEY FINDINGS
  • KEY RECOMMENDATIONS
  • FINAL THOUGHTS
  • ESTABLISHMENT OF THE SBIR AND STTR PROGRAMS: BACKGROUND AND CONTEXT
  • THEORETICAL SUPPORT FOR THE SBIR AND STTR PROGRAMS
  • CONFLICTING PROGRAMMATIC GOALS
  • THE NATIONAL ACADEMIES STUDY MANDATE
  • PROGRAM OPERATION
  • ORGANIZATION OF THIS REPORT
  • NIH ORGANIZATION
  • THE LIFE SCIENCES ECOSYSTEM
  • BROAD POLICY RATIONALE FOR THE SBIR/STTR PROGRAMS
  • BROAD CHALLENGES FACING SBIR/STTR ASSESSMENT
  • OVERVIEW OF THE SBIR AND STTR PROGRAMS AT NIH
  • DIFFERENCES ACROSS NIH INSTITUTES AND CENTERS
  • CONCLUDING THOUGHTS
  • FINDINGS AND RECOMMENDATIONS
  • ANNEX 3-1 PROGRAM MANAGER INTERVIEWS: QUESTIONS, AND DATES AND ATTENDEES
  • METHODOLOGY AND SAMPLING
  • DISTRIBUTION OVER TIME: APPLICATIONS, AWARDS, AND TOTAL NIH FUNDING
  • DEMOGRAPHIC DISTRIBUTION
  • PHASE I TO PHASE II CONVERSION
  • CHANGES IN PROGRAM SELECTIVITY OVER TIME
  • FIRST-TIME APPLICANTS AND MULTIPLE-AWARD RECIPIENTS
  • GEOGRAPHIC DISTRIBUTION
  • PATTERNS OF COLLABORATION
  • MISSING PATENT DATA
  • SUMMARY
  • FINDINGS AND RECOMMENDATIONS
  • INNOVATION AND COMMERCIALIZATION OUTCOMES
  • IMPACT ON HEALTH CARE
  • ADDITIONAL DATA NEEDED FOR FUTURE ANALYSES
  • FINDINGS AND RECOMMENDATIONS
  • ANNEX 5-1: DATA SOURCES FOR NAME-MATCHED OUTCOMES
  • ANNEX 5-2: ADDITIONAL TABLES

  This activity was supported by a contract between the National Academy of Sciences and the National Institutes of Health (HHSN263201800029I, Order No. 75N98019F00860). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

  Suggested citation:

  National Academies of Sciences, Engineering, and Medicine. 2022. Assessment of the SBIR and STTR Programs at the National Institutes of Health. Washington, DC: The National Academies Press. https://doi.org/10.17226/26376.

  Additional copies of this publication are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.

  Printed in the United States of America