Inactive Total Small Business Set-Aside (FAR 19.5)

AMENDMENT #4 TO THE SOLICIATION: to 1) Provide the .pdf files for Human Subject Attachments A.1 and A.2 and; 2) Revised Appendix E and the Phase I and II business proposal applications to include FAR ... AMENDMENT #4 TO THE SOLICIATION: to 1) Provide the .pdf files for Human Subject Attachments A.1 and A.2 and; 2) Revised Appendix E and the Phase I and II business proposal applications to include FAR Provision 52.204-24 and FAR Clause 52.204-26. See attachments: 75N91023R00041 AMENDMENT 4, APPENDIX A.1 — HUMAN SUBJECTS AND CLINICAL TRIALS INFORMATION FORM, APPENDIX B - Phase I Business Proposal, APPENDIX D - Phase II Business Proposal, APPENDIX E - PROPOSAL FUNDAMENTALS, and HumanSubjectStudy_3_0-V3.0 Form H 5-23. Offerors are required to acknowledge each Solicitation Amendment by including each Standard Form 30, attached, (SF-30) signed by your organization’s signature authority and submitted with your proposal. Proposal Due Date: July 3, 2023, 5:00PM EDT (Unchanged) AMENDMENT #3 TO THE SOLICIATION: The purpose of this amendment is to respond to additional questions received regarding solicitation 75N91023R00041. See attachments entitled, "SBIR SOLICITATION 75N91023R00041 QA AMENDMENT 3.pdf, APPENDIX A - Phase I Technical Proposal - Amend 3, APPENDIX B - Phase I Business Proposal - Amend 3 and APPENDIX C - Phase II Technical Proposal - Amend 3" for full amendment. Offerors are required to acknowledge each Solicitation Amendment by including each Standard Form 30, attached, (SF-30) signed by your organization’s signature authority and submitted with your proposal. Proposal Due Date: July 3, 2023, 5:00PM EDT (Unchanged) AMENDMENT #2 TO THE SOLICIATION: The purpose of this amendment is to respond to questions received regarding solicitation 75N91023R00041. See attachment entitled, "75N91023R00041 AMENDMENT 2.pdf" for full amendment. Offerors are required to acknowledge each Solicitation Amendment by including each Standard Form 30, attached, (SF-30) signed by your organization’s signature authority and submitted with your proposal. Proposal Due Date: July 3, 2023, 5:00PM EDT (Unchanged) AMENDMENT #1 TO THE SOLICITATION: The purpose of this amendment is change the due date for Solicitation Questions from June 12, 2023, 5:00PM EDT to June 14, 2023, 5:00PM EDT. Offerors are required to acknowledge each Solicitation Amendment by including each Standard Form 30, attached, (SF-30) signed by your organization’s signature authority and submitted with your proposal. Proposal Due Date: July 3, 2023, 5:00PM EDT (Unchanged). Please see attached for Solicitation 75N91023R00041 and all associated attachments. Attachments include: ARPA-H SBIR SOLITICATION APPENDIX A - Phase I Technical Proposal APPENDIX B - Phase I Business Proposal APPENDIX C - Phase II Technical Proposal APPENDIX D - Phase II Business Proposal APPENDIX E - PROPOSAL FUNDAMENTALS APPENDIX F - CONTRACT REQUIREMENTS APPENDIX G - DEFINITIONS

Inactive Total Small Business Set-Aside (FAR 19.5)

Synopsis: The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals from small business concerns that possess the research and development (R&D) expertise to conduct innovative... Synopsis: The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals from small business concerns that possess the research and development (R&D) expertise to conduct innovative research that will contribute toward ARPA-H mission needs and Small Business Innovation Research (SBIR) program objectives. SOLICITATION 75N91023R00041 is anticipated to be made available on or about June 2, 2023 through SAM.gov. This solicitation is anticipated to have a closing date of July 3, 2023 for receipt of proposals. The purposes of the SBIR program are to: (a) stimulate technological innovation; (b) strengthen the role of small business in meeting Federal research/research & development (R/R&D) needs; (c) foster and encourage participation by socially and economically disadvantaged small business concerns and women-owned business concerns; and (d) increase private sector commercialization of innovations derived from Federal R/R&D, thereby increasing competition, productivity and economic growth. For purposes of the SBIR program, a small business concern is any business concern that, on the date of award, (1) is organized for profit, with a place of business located in the United States, which 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; (2) is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture; (3) more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; OR more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern; AND, (4) has, including its affiliates, no more than 500 employees. Note: This size standard is established by law for the SBIR program, regardless of the NAICS Code assigned. See 13 C.F.R. § 121.702. THE FOLLOWING RESEARCH TOPICS ARE ANTICIPATED TO BE INCLUDED IN THIS SBIR CONTRACT SOLICITATION • ARPA-H 01 - Novel telehealth instruments for assessing pediatric well-being • ARPA-H 02 - Microneedle-Based Patches and Digital Patch Interfaces for Remote and Real-time Transdermal Drug Delivery and Chronic Disease Management • ARPA-H 03 – Robotics for Autonomous Soft Tissue Surgery • ARPA-H 04 – Intra-operative Contrast Agents • ARPA-H 05 – Scale-Up: Transition disruptive technologies from proof-of-concept prototypes to commercially scalable and deployable technologies