Autonomous Interventions and Robotics (AIR) Advanced Research Projects Agency for Health (ARPA-H)

This document outlines a sample Other Transaction Agreement (OTA) used by the Advanced Research Projects Agency for Health (ARPA-H) for research and development projects. It details the agreement's scope, term, management structure, and administration, including roles of the Agreements Officer (AO) and Agreements Officer’s Representative (AOR). Key articles cover financial obligations, payment milestones, dispute resolution, and comprehensive intellectual property rights, including patent and data rights, with provisions for foreign access and transfer restrictions. The agreement also addresses tangible property disposition, public release of information, civil rights, security, and applicable law. Attachments provide templates for the Research Description Document, Report Requirements, Schedule of Milestones and Payments, and the AOR Appointment Memo, emphasizing compliance with federal regulations and the structured management of research initiatives.

This document outlines a detailed financial proposal spreadsheet for government RFPs, federal grants, and state/local RFPs. It provides instructions for proposers to enter cost data across various categories over six time periods, distinguishing between green-filled cells for data entry (such as labor hours, indirect cost bases, and subcontractor totals) and yellow-filled cells for calculated values. The spreadsheet is structured into several tabs including Proposal Data, Cost Proposal Phases I and II, Labor Rates, Indirect Rates and Fee, Materials/Supplies, Equipment, Travel, Other Direct Costs (ODC), Consultants, and Cost Share. Key information required includes ISO and NAICS codes, points of contact, contractor business type, CAGE and UEI codes, performance periods, contract type, research title, and estimated costs for both prime and subcontractors. The document emphasizes the importance of accurate data entry to ensure proper calculation of total estimated costs, and includes provisions for cost share arrangements, explicitly stating that project teams are not permitted to receive fees or profits under ARPA-H awards.

ARPA-H-SOL-26-146 outlines the Autonomous Interventions and Robotics (AIR) program, seeking proposals for autonomous robotic surgery. The program has two technical areas: endovascular robotics (TA1) and microbots (TA2). TA1 focuses on developing fully autonomous robotic endovascular systems for procedures like thrombectomy and vascular embolization, with a sub-area (TA1-B) dedicated to creating a simulation environment and collecting imaging data. TA2 aims to develop untethered, autonomous surgical microbots (200 nm to 2 cm) for various interventional procedures, excluding purely biological/chemical solutions or ingestible imaging-only microbots. The program spans five years, with Phase 1 (two years) and Phase 2 (three years), and includes collaboration with the FDA for regulatory assessment. Eligibility criteria specify that a team cannot be a prime for both TA1-A and TA1-B, but can be a prime for one TA and a subcontractor for another.

The Advanced Research Projects Agency for Health (ARPA-H) has issued Innovative Solutions Opening (ISO) Solicitation Number ARPA-H-SOL-26-146 for its Autonomous Interventions and Robotics (AIR) program. This program seeks proposals for autonomous robotic surgery across two main technical areas: endovascular robotics (TA1) and microbots (TA2). TA1 focuses on developing fully autonomous robotic systems for endovascular procedures like thrombectomy and embolization, alongside an in silico simulation environment (TA1-B) for testing and validation. TA2 aims to develop untethered, autonomous surgical microbots (200 nm to 2 cm) for various interventional procedures, with a strong emphasis on practical clinical applications and commercial viability. The program is structured in two phases over five years, with specific milestones and metrics for each technical area, culminating in cadaver model experiments for TA1 and large animal demonstrations for TA2. Eligibility information specifies that FFRDCs and government entities cannot be prime or sub-performers, and non-U.S. entities may participate with a focus on U.S.-conducted work. The FDA will collaborate to develop regulatory assessment frameworks for these novel technologies.

ARPA-H-SOL-26-146, titled “Autonomous Interventions and Robotics (AIR),” is an Innovative Solutions Opening (ISO) from the Advanced Research Projects Agency for Health (ARPA-H). This solicitation seeks proposals for autonomous robotic surgery solutions, divided into two technical areas: Autonomous Endovascular Robotics (TA1) and Microbots (TA2). TA1 focuses on developing autonomous robotic systems for endovascular procedures like thrombectomy and embolization, alongside a simulation environment for testing and validation. TA2 aims to create untethered, autonomous surgical microbots for various interventional procedures. The program spans five years with a two-year Phase 1 and a three-year Phase 2. Eligibility is open to universities, non-profits, and businesses, with specific prohibitions for FFRDCs and government entities. The document outlines detailed objectives, metrics, timelines, and submission processes, emphasizing the need for robust failure mode management, regulatory engagement, and commercial viability.

ARPA-H-SOL-26-146, titled "Autonomous Interventions and Robotics (AIR)," is an Innovative Solutions Opening (ISO) soliciting proposals for autonomous robotic surgery. The program, sponsored by the Advanced Research Projects Agency for Health (ARPA-H), aims to revolutionize medical interventions through two technical areas: autonomous endovascular robotics (TA1) and microbots (TA2). TA1 focuses on developing systems for procedures like thrombectomy and embolization, including robotic control, navigation algorithms, and a simulation environment (TA1-B) for testing and validation. TA2 seeks to develop untethered microbots (200 nm to 2 cm) for various clinical indications, emphasizing motility, sensing, and action, with a focus on practical, cost-effective solutions. The program outlines a five-year timeline with Phase 1 (two years) and Phase 2 (three years), featuring specific milestones for platform development, imaging integration, autonomous navigation, therapy delivery, and performance metrics. Eligibility extends to universities, non-profits, and businesses, with strict guidelines on FFRDC and non-U.S. entity participation. Proposals undergo a comprehensive review based on scientific merit, proposer capabilities, and cost. Key dates include a Proposer's Day on December 16, 2025, a Solution Summary due date of January 26, 2026, and a Full Proposal due date of March 30, 2026.

The Administrative and National Policy Requirements document outlines critical submission guidelines for government proposals, including formatting, accepted file types, and English language requirement. Key sections cover team member identification, organizational conflict of interest (OCI) disclosures, and comprehensive research security disclosures as per NSPM-33, requiring detailed information on other affiliations, positions, and foreign government-sponsored talent recruitment program participation. The document also addresses novelty of proposed work, intellectual property (IP) assertions (including technical data, computer software, and patents), software component standards, and human/animal subject research. Finally, it mandates representations regarding unpaid delinquent tax liability, felony convictions, and cybersecurity program details, especially concerning Controlled Unclassified Information (CUI).

The document outlines the certifications required for individuals involved in projects funded by ARPA-H, focusing on compliance with regulations against Malign Foreign Talent Recruitment Programs (MFTRP). Institutions must certify that covered individuals, defined as Principal Investigators (PIs) or Senior/Key Personnel, are not participating in MFTRPs. Covered individuals must also personally certify their non-participation and agree to annual recertification for the award's duration. Additionally, institutions are responsible for reporting any new covered individuals or changes to existing conflict of commitment disclosures within 10 days of discovery. New personnel cannot commence work until a Research Security Assessment is completed by ARPA-H and a corresponding certification is submitted. These measures ensure research security and compliance with federal guidelines in ARPA-H funded projects.

The document outlines a project schedule, likely for a government Request for Proposal (RFP), federal grant, or state/local RFP, focusing on a Work Breakdown Structure (WBS) with a Go/No-Go indicator. The file provides a basic structure for tracking tasks and milestones across a 24-quarter timeline. While specific task details are minimal, the presence of a 'G/N' column suggests a critical decision point for each task, indicating whether it proceeds or not. This format is typical for initial project planning and evaluation within government procurement processes, allowing for clear progress tracking and strategic decision-making over an extended period.

The Task Description Document (TDD) provides a comprehensive template for detailing tasks within proposals for federal grants, RFPs, and state/local RFPs. It mandates a structured breakdown of tasks and subtasks, requiring a general objective, a detailed approach, identification of human/animal subject involvement, location of work (especially on university campuses), and the primary responsible organization. Each task must define measurable milestones and specific deliverables, including associated Intellectual Property assertions. This document ensures clear communication of project plans, accountability, and adherence to regulatory and reporting requirements, serving as a critical tool for government contracting and grant management.

The Biographical Sketch Common Form (November 1, 2023) provides guidelines for individuals identified as senior/key personnel on Federally funded research projects. Its primary purpose is to assess an individual's qualifications to conduct proposed activities. Key requirements include disclosing contracts and support from foreign government-sponsored talent recruitment programs, as well as other foreign government-sponsored activities, in accordance with NSPM-33 guidance. The form prohibits participation in malign foreign talent recruitment programs and warns against submitting personal information. Required sections include identifying information, persistent identifier, position title, organization and location, professional preparation, appointments and positions, and a list of products demonstrating qualifications. Each senior/key person must certify the accuracy and completeness of the provided information and confirm non-participation in malign foreign talent recruitment programs. Misrepresentation can lead to prosecution. The document also includes a Privacy Act and Burden Statement, outlining data usage and reporting burden, with an OMB control number of 3145-0279.

The "CURRENT AND PENDING (OTHER) SUPPORT COMMON FORM" is a standardized document issued by the National Science Foundation (NSF) on November 1, 2023. It provides instructions for senior/key personnel on federally funded research projects to disclose current and pending support, including proposals, active projects, and in-kind contributions. The form aims to assess capacity, identify conflicts of commitment, and prevent scientific and budgetary overlap or duplication. It mandates disclosure of consulting activities under specific conditions and requires reporting of support from foreign government-sponsored talent recruitment programs. The document outlines detailed submission requirements for identifying information, proposals, active projects, and in-kind contributions (valued at $5000 or more with time commitment). It emphasizes the exclusion of personal information and includes a certification section requiring individuals to attest to the accuracy and completeness of their disclosures and confirm non-participation in malign foreign talent recruitment programs. The form also contains a Privacy Act and Burden Statement, informing users about data use and estimated reporting time.

This government file outlines a comprehensive spreadsheet-based system for cost proposals, particularly for federal government RFPs, grants, and state/local RFPs. The system is designed with specific data entry instructions, distinguishing between proposer-entered (green-filled) and calculated (yellow-filled) cells. It supports a base period and two option periods, each allowing for up to six time periods to account for rate changes. Key data required includes ISO and NAICS codes, points of contact, contractor business type, CAGE code, UEI number, contract type (Other Transaction), research title, and estimated costs for both prime and subcontractors. The file details cost breakdowns for labor, fringe benefits, overhead, material handling, G&A/F&A, and includes sections for materials, equipment, and travel, with specific instructions for inputting hourly labor rates, indirect rates, and fee percentages across different phases.