Inactive
Total Small Business Set-Aside (FAR 19.5)
Notice ID:47QFCA-24-R-0036
Amendment 3: Notification of upcoming Webinar The Webinar is a one time VIRTUAL event that is being held on July 2, 2024 from 1:00-2:30 ET. Attendees will hear briefings on ARPA-H FY24 SBIR/STTR topic...
Amendment 3: Notification of upcoming Webinar The Webinar is a one time VIRTUAL event that is being held on July 2, 2024 from 1:00-2:30 ET. Attendees will hear briefings on ARPA-H FY24 SBIR/STTR topics and proposal requirement information identified below and with DRAFT Solicitation 47QFCA-24-R-0036. This is an informational dissemination Webinar ONLY. There will be no vendor interaction with the Government. The Webinar will be recorded and a link will be provided following the webinar. Each attendee will be required to register individually for the event. The event is free of charge; however pre-registration is required. Register online at: https://investorcatalysthub.org/event/arpa-hs-small-business-program-information-session/ Please continue to monitor SAM.gov for additional information to include a special notice posting specific to the webinar as well as the final solicitation issuance. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Amendment 02: This is an administrative update only to correct in this synopsis two (2) occurrences where ARPA-H was referred to as APRA-H. First occurance found below as it refers to proposals and 2nd in the DRAFT solicitation attachment where the webinar is discussed. All other information remains unchanged. ~~~~~~~~~~~~~~~~~~~~~~~~~~~ Amendment 01: This update is being posted to provide a DRAFT solicitation document inclusive of Sections 1, 3 and 9 of the anticipated solicitation as well as the DRAFT appendix/attachments. Industry should continue to monitor SAM.gov for updates regarding the release of the final solicitation as well as potential webinar information. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ This synopsis is being issued by GSA AAS Innovation on behalf of ARPA-H, to notify industry of an upcoming requirement for Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) Phase I, Direct to Phase II, and/or Fast Track contracts in support of ARPA-H’s FY2024 SBIR/STTR topic areas. Firms with the capability to conduct innovative research and development and to commercialize the results, are encouraged to participate. AAS Innovation may award multiple procurement Definitive type Phase I, Phase II, and/or Fast Track contracts, from a single solicitation, in support of ARPA-H’s FY2024 SBIR/STTR topic area within the SBA approved SBIR/STTR thresholds for these project(s). (Procurement contracts will be awarded; no grants will be awarded resulting from this Solicitation) The purposes of the SBIR/STTR 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/STTR 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. Additional, SBIR/STTR program information can be found in the Small Business Administration’s policy directive found here: https://www.sbir.gov/sites/default/files/SBA%20SBIR_STTR_POLICY_DIRECTIVE_May2023.pdf THE FOLLOWING ARPA-H’S FY2024 SBIR/STTR TOPIC AREAS ARE ANTICIPATED TO BE INCLUDED IN THIS SBIR CONTRACT SOLICITATION: 1. Ambulatory Edema Monitor The purpose of this topic is filling a huge, and neglected gap in the field of lymphatic medicine – that of the inability to detect sub-clinical edema and importantly to do this in a scalable and equitable way. The goal is to develop a wearable tool that can be used at home or in an outpatient setting even in rural areas around the country to detect early subclinical edema. 2. Predictive Language Models for Cognitive Disability Adaptive Communication Tools The goal of this topic is to stimulate development of intelligent, learning and adaptive alternative and augmentative communication tools that will enable users with speech or language impairment to communicate expressively in education, social and workplace environments. These tools should be aimed to foster language acquisition in the zone of proximal development, with the ultimate goal of fostering inclusion and communication-driven autonomy for individuals with autism and neurocognitive disabilities. 3. Cell and Gene Therapy Process Analytical Technology and Quality Control Testing The purpose of this topic is to address high manufacturing costs, drug shortages, expired/unstable intermediates or products, and regional treatment silos that limit the ability to provide quality and economical healthcare for all. There are two main goals: 1) Advanced in-line or at-line process analytical technologies informing on critical process parameters and 2) Rapid, automated, walk-up-enabled product quality testing. These enabling technologies will integrate into a holistic solution for the decentralized manufacturing paradigms of the future. 4. Wearable Cell sorting and Gene Delivery Systems The purpose of this topic is to develop an entirely new format for cell and gene therapy delivery that maximizes the attributes of both ex vivo and in vivo cell therapy technologies by leveraging materials/device science and biology to target cells more efficiently. Solutions will thereby surpass the unmet needs of both ex vivo cell therapy (long wait time and complex manufacturing logistics) and in vivo cell therapy (inadequate tissue targeting leading to potential unwanted off-target effects). 5. Precision Brain Targeting: non-invasive delivery at the right place and time The purpose of this topic area is to spur the development of innovative non-invasive approaches (i.e., those that do not require injection into the peripheral or central nervous system) for precise and timely brain targeting for treatment of organ-specific diseases, such as glioblastoma, neurological, or psychiatric disorders. Solutions will be novel, non-invasive methods for targeting the brain with specificity of brain region, cell type, and timing, including the ability to modulate and turn off therapeutic delivery. 6. NutriTech: Revolutionizing Personalized Food as Medicine The purpose of this topic area is to develop digital health tools and diagnostics that use information such as dietary habits, health data and genetic information to inform on personalized food as medicine recommendations such as specific meal plans, groceries, suggested portion sizes and recommended nutrient intake to improve health outcomes. Solutions should evaluate specific nutritional needs of a patient, including the intersection of environmental and biological (genetics, epigenetics, gut microbiome, endocrinology, etc.) factors that impact metabolism, combined with social factors (social determinants of health, dietary habits, lifestyle habits, cultural connections to food) and other health data. 7. Clinic-ready Imaging Devices and Protocols for Visualizing the Inner Ear with High Accuracy To address the challenging clinical problem of visualizing the inner ear’s anatomy and function, this announcement requests the development of novel, non-destructive technologies to image the anatomy and function of the delicate system with high detail, in human patients. 8. Advanced Continuously Wearable Blood Pressure Monitoring Technologies The overall purpose of this topic to develop a new technology for home blood pressure monitoring that will better support all future applications of wearable physiological monitoring and close the capability gap between current wearable physiological monitoring systems and home/ambulatory blood pressure monitoring using traditional means. This may yield a technology that can be licensed and integrated into multi-capability wearable physiological monitoring systems or an easier to use stand-alone home/ambulatory blood pressure monitoring device ADDITIONAL NOTES FOR SBCs: All interested SBCs must be properly registered in the System for Award Management (SAM). Additional information on SAM registration and annual confirmation requirements can be received by calling 1-866-606-8220 or via the internet at https://www.sam.gov. All applicants to the SBIR and STTR programs are required to register at the SBA Company Registry https://www.sbir.gov/registration prior to proposal submission and attach proof of registration as part of the proposal submission. Completed registrations will receive a unique SBC Control ID and .pdf file. Proposals to ARPA-H topic areas may require industry to pay special attention to the requirements concerning Human Subjects and use of Vertebrate Animals if your project will encompass either item. Additional requirements may be applicable. https://grants.nih.gov/grants/policy/air/index.htm https://grants.nih.gov/policy/humansubjects.htm The SBIR/STTR solicitation will incorporate MANDATORY foreign disclosure requirements and other important programmatic changes as required by the SBIR and STTR Extension Act of 2022 (Pub. L. 117-183). The potential solicitation and subsequent contract awards will incorporate FAR 52.204-29 and FAR 52.204-30, Federal Acquisition Supply Chain Security Act (FASCSA) Orders. Small business concerns are highly encouraged to review the full text of these clauses and required representations. A solicitation will be available at SAM.gov on or about June 6, 2024 and only electronic proposal submissions will be received (no hard copies). It is the responsibility of interested vendors to monitor SAM.gov for the solicitation release. All changes that occur prior to the closing date will be posted to the SAM website.
