U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS), THE NATIONAL INSTITUTES OF HEALTH (NIH) AND THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM PROGRAM SOLICITATION PHS 2020-1 Closing Date: October 23, 2019, 5:00 PM Eastern Daylight Time Participating HHS Components: • The National Institutes of Health (NIH) • The Centers for Disease Control and Prevention (CDC) IMPORTANT Deadline for Receipt: Proposals must be received by October 23, 2019, 5:00 PM Eastern Daylight Time. Please read the entire solicitation carefully prior to submitting your proposal. IMPORTANT: All proposals must be submitted using the electronic contract proposal submission (eCPS) website. Paper proposals will not be accepted. Please go to https://www.sbir.gov/sites/default/files/SBIR-STTR_Policy_Directive_2019.pdf to read the SBIR/STTR Policy Directive issued by the Small Business Administration for further information. Table of Contents 1 INTRODUCTION .............................................................................................................................................................. 1 2 PROGRAM DESCRIPTION ............................................................................................................................................ 4 2.1 Objectives ........................................................................................................................................................ 4 2.2 Three Phase Program ...................................................................................................................................... 4 2.3 Fast Track Proposals (NIH Only) .................................................................................................................... 5 2.4 Direct to Phase II Proposals ............................................................................................................................ 5 2.5 I-Corps™ at NIH ............................................................................................................................................. 5 2.6 Grant Opportunity - Phase IIB Competing Renewal Awards (INFORMATION ONLY) .............................. 7 2.7 Awarding Components .................................................................................................................................... 8 3 DEFINITIONS .................................................................................................................................................................... 9 3.1 General Definitions ......................................................................................................................................... 9 3.2 Definitions (Relating to R&D) ...................................................................................................................... 12 4 PROPOSAL FUNDAMENTALS .................................................................................................................................... 17 4.1 Introduction ................................................................................................................................................... 17 4.2 Offeror Eligibility and Performance Requirements....................................................................................... 17 4.3 SBIR/STTR Performance Benchmarks for Progress towards Commercialization........................................ 17 4.4 Multiple Principal Investigators .................................................................................................................... 18 4.5 Joint Ventures and Limited Partnerships ....................................................................................................... 18 4.6 Majority Ownership in Part by Multiple Venture Capital, Hedge Fund, and Private Equity Firms .............. 18 4.7 Conflicts of Interest ....................................................................................................................................... 18 4.8 Market Research............................................................................................................................................ 18 4.9 Debriefing ..................................................................................................................................................... 19 4.10 Phase I Award Information ........................................................................................................................... 19 4.11 Phase II Award Information .......................................................................................................................... 19 4.12 Registrations and Certifications .................................................................................................................... 19 4.13 Promotional Materials ................................................................................................................................... 20 4.14 Prior, Current, or Pending Support of Similar Proposals or Awards ............................................................. 20 4.15 Reporting Matters Involving Fraud, Waste, and Abuse ................................................................................ 21 4.16 State Assistance and Technical Assistance ................................................................................................... 21 4.17 Payment ......................................................................................................................................................... 22 4.18 Proprietary Information ................................................................................................................................. 22 4.19 Identification and Marking of SBIR Technical Data in Contract Reports and Deliverables ......................... 22 5 CONTRACT REQUIREMENTS .................................................................................................................................... 23 5.1 NIH Policy on Enhancing Reproducibility Through Rigor and Transparency.............................................. 23 5.2 CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (December 2015) ............................ 23 5.3 Animal Welfare ............................................................................................................................................. 24 5.4 PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (December 2015) .................................. 24 5.5 Required Education in the Protection of Human Research Participants ....................................................... 24 5.6 Inclusion of Women and Minorities in Research Involving Human Subjects .............................................. 25 5.7 Good Clinical Practice Training for NIH Awardees Involved in NIH-Funded Clinical Trials ..................... 25 5.8 Clinical Trial Registration and Results Information Submission .................................................................. 26 5.9 Single Institutional Review Board (sIRB) ..................................................................................................... 27 5.10 Research Involving Recombinant or Synthetic Nucleic Acid (Including Human Gene Transfer Research) 27 5.11 Copyrights ..................................................................................................................................................... 28 Page ii 5.12 Technical Data Rights ................................................................................................................................... 28 5.13 Patents and Invention Reporting ................................................................................................................... 29 5.14 Salary Rate Limitation .................................................................................................................................. 29 5.15 Other Contract Requirements ........................................................................................................................ 29 6 METHOD OF EVALUATION ....................................................................................................................................... 32 6.1 Evaluation Process ........................................................................................................................................ 32 6.2 Award Decisions ........................................................................................................................................... 33 6.3 Phase I Technical Evaluation Criteria ........................................................................................................... 33 6.4 Phase II Technical Evaluation Criteria .......................................................................................................... 34 7 PROPOSAL SUBMISSION ............................................................................................................................................ 35 7.1 Questions ....................................................................................................................................................... 35 7.2 Pre-Proposal Conference ............................................................................................................................... 35 7.3 Limitation on the Length of the Technical Proposal (Item 1) ....................................................................... 35 7.4 Submission,