This document outlines instructions for preparing and delivering a presentation related to a proposal, likely for government RFPs or grants. The presentation is intended to facilitate discussion rather than be formally evaluated. Key instructions include adapting the template, keeping content succinct and focused on innovation, and adhering to a 10-15 minute timing with 15 minutes for Q&A. Presenters should assume the audience is familiar with the problem and MOCS ISO details, focusing instead on their specific solution and technological innovations. The presentation should cover a brief team introduction, a concept summary detailing technical areas, current technology, and unique approaches, and a Basis of Estimate (BOE) supporting the project budget. The final slide is for questions the presenter has for the MOCS team. The audience will include program managers and contracting teams.

This document, "APPENDIX B: FULL PROPOSAL CONTENT AND INSTRUCTIONS," outlines the detailed requirements for proposals submitted to an ARPA-H ISO, likely for federal grants or contracts. It specifies formatting, page limits, and mandatory components like Appendix B and Attachments 1-3. Proposals must be concise, written in English, and adhere to strict guidelines for font, margins, and paper size. Key sections include an Executive Summary, Technical Plan, Human Research, End User Engagement, Regulatory, Product Development & Business Model, Risk Mitigation, and a Management Plan. The document details expectations for each section, emphasizing the need for credible plans, measurable milestones, established partnerships (especially for human research and end-user engagement), and a robust team with specific roles like a Project Manager and a clinical research coordinator. It also outlines required attachments such as a Target Product Profile, References, and Letters of Support, which are excluded from the page limits. The overall purpose is to guide proposers in submitting comprehensive and compliant applications for funding, ensuring all evaluation criteria are addressed.

The document outlines the required content and instructions for submitting proposals to the ARPA-H ISO, specifically for Volume I: Technical and Management. It details formatting requirements, page limits for various sections (excluding attachments, references, and letters of support), and the essential components of a complete proposal, including Appendix B and Attachments 1-3. Key sections include an Executive Summary, Technical Plan with milestones and a Gantt chart, Human Research, End User Engagement with required partnerships, Regulatory considerations, Product Development & Business Model, Risk Mitigation, and a comprehensive Management Plan. The Management Plan specifies team structure, key personnel requirements (e.g., PI, Project Manager, Clinical Research Coordinator, OBGYN, Clinical Bioethicist, and Malpractice Attorney for TA 2), facilities, and commercialization capabilities. Proposers must address technical challenges, regulatory pathways, market analysis, and risk mitigation, with a strong emphasis on human research and end-user engagement in rural and urban settings.

The document outlines requirements for a Price/Cost Proposal, supplementing a spreadsheet with justifications and additional information. Proposers must incorporate indirect costs within labor rates or describe them in other cost elements, providing substantiation for large price/cost drivers like equipment. The proposal requires an index for additional materials and adherence to specific formatting. Key sections include labor, materials & equipment (with support for items over $10,000), travel, other direct costs, human research, end user engagement, cost sharing, and a value analysis explaining the proposed effort's benefits to taxpayers and government. The document also details administrative information such as the team lead organization's SAM.gov UEI, TIN, CAGE code, and contact information for technical and administrative points of contact.

This document is a cost proposal spreadsheet template, Attachment 2, for federal government RFPs, grants, and state/local RFPs. It provides instructions for submitting cost proposals for multi-party teams and outlines requirements for fully burdened labor rates, profit exclusion, and detailed cost breakdowns across three phases. Proposers must complete all tabs, providing granular costs for Phases I and II, and a Rough Order of Magnitude (ROM) for Phase III. Key cost categories include direct labor, contractors and consultants, materials and equipment, travel, other direct costs (ODCs), human research, and end-user engagement. The template also addresses cost-sharing arrangements, requiring justification and adherence to specific spending guidelines. The assumed start date for pricing purposes is May 1, 2026.

The “ADMINISTRATIVE & NATIONAL POLICY REQUIREMENTS DOCUMENT” outlines crucial administrative and policy requirements for proposal submissions to ARPA-H. This document covers team member identification, FFRDC participation, and strict disclosure rules for Organizational Conflicts of Interest (OCI) and Research Security. Proposers must detail all team members, including senior/key personnel, and disclose any malign foreign talent recruitment program participation or foreign ownership. It also requires disclosures on the novelty of proposed work, intellectual property (IP) rights, and adherence to regulations for human and animal subjects research. Additional sections address unpaid tax liabilities, felony convictions, and cybersecurity and biosecurity protocols, including dangerous gain-of-function research and synthetic nucleic acid procurement. The document ensures transparency, integrity, and compliance with federal policies for ARPA-H funded projects.

The Advanced Research Projects Agency for Health (ARPA-H) has issued an Innovative Solutions Opening (ISO) (ARPA-H-SOL-26-143) for the Making Obstetric Care Smart (MOCS) program. This initiative seeks proposals to transform maternity care by developing data-driven solutions for labor and delivery. The program focuses on two technical areas (TAs): TA1 aims to create a point-of-care risk assessment tool for fetal hypoxia, while TA2 seeks to develop a novel intrapartum fetal monitoring system powered by multiplexed sensors and machine learning. The MOCS program, a 48-month, three-phase effort, emphasizes stakeholder engagement, clinical collaboration with diverse delivery sites, and commercialization pathways to ensure successful adoption of these innovations. Eligibility requires active SAM.gov registration, and non-U.S. entities may participate under specific conditions. Proposers must engage in a mandatory pre-proposal discussion before submitting full proposals, which will be evaluated based on scientific merit, proposer capabilities, mission relevance, and cost.

ARPA-H-SOL-26-143, Amendment 01, focuses on the "Making Obstetric Care Smart (MOCS)" initiative, an Innovative Solutions Opening (ISO) aimed at transforming labor and delivery care. The amendment updates key dates for proposers, including mandatory pre-proposal discussions, frequently asked questions submission, and the final proposal due date of January 21, 2026. The MOCS program seeks innovative solutions across two technical areas (TAs): TA1, developing a point-of-care test for fetal hypoxia risk stratification, and TA2, creating a novel intrapartum fetal monitoring system with predictive capabilities. The program spans 48 months over three phases (Prototyping, Refinement, Translation) and emphasizes robust stakeholder engagement, commercialization, and independent verification and validation. Eligibility is open to all responsible sources, with specific guidelines for multi-party teaming arrangements and prohibitions for certain government entities.

ARPA-H-SOL-26-143, Amendment 02, for the Making Obstetric Care Smart (MOCS) program clarifies page limits for full proposals. The Advanced Research Projects Agency for Health (ARPA-H) seeks innovative solutions for data-driven maternity care through two Technical Areas (TAs): TA1 focuses on a rapid risk assessment tool for difficult deliveries due to fetal hypoxia, while TA2 aims to develop a novel intrapartum fetal monitoring system powered by multiplexed sensors and machine learning. The program, a 48-month, three-phase initiative, emphasizes stakeholder engagement, with performers required to partner with diverse delivery sites. Proposals must detail technical approaches, commercialization strategies, and compliance with regulatory requirements. Eligibility requires mandatory pre-proposal discussions and active SAM.gov registration. Non-U.S. entities may participate under strict conditions. The program prioritizes multi-party teaming over prime/sub arrangements to foster collaboration and dynamic team structures.