Comment from Michael Liddell

Subject: Freeman's Contribution: Comprehensive Strategic Framework to Accelerate 'Fewer Animals, Better Data, Faster Cures' — 30 Innovations + Post-Quantum Blockchain Infrastructure Dear Secretary Kennedy, I am writing in direct response to the public invitation issued by HHS Press Secretary Emily Hilliard requesting ideas and solutions to optimize the Department's landmark 'Fewer Animals, Better Data, Faster Cures' initiative. I am honored to submit the attached strategic framework, which I have prepared specifically to support HHS's publicly stated objectives and to build upon the extraordinary work your team has already accomplished. On March 18, 2026, HHS and FDA achieved something historic: the release of the first comprehensive draft guidance on New Approach Methodologies (NAMs) in drug development, paired with NIH's $150 million Complement-ARIE investment. This memo is written to ensure that framework reaches its full potential — legally durable, scientifically airtight, and protected by infrastructure that no adversary, domestic or foreign, can compromise. The attached proposal — 'Fewer Animals. Better Data. Faster Cures. Unbreakable Data.' — is organized into six sections: SECTION I: Complete inventory of every HHS action already in motion (so the full architecture is visible in one place) SECTION II: Ten identified gaps that could stall implementation or invite legal challenge SECTION III: Twenty-four specific next-generation innovations, each with legal authority citations and no legislative changes required SECTION IV: Twenty-seven numbered supporting resources with direct URLs and specific 'USE' directives SECTION V: Priority action checklist organized by timeline (Immediate / Short-Term / Medium-Term / Durable) SECTION VI: Six new Post-Quantum Cryptographic (PQC) secured blockchain innovations (Innovations 25-30) that protect the entire NAMs data infrastructure against both current cyber threats and future quantum computing attacks The post-quantum blockchain section is the new element unique to this submission. It proposes integrating NIST-finalized FIPS 203/204/205 post-quantum cryptographic standards into every NAMs data system — the Data Hub, the Cross-Sponsor Evidence Pooling database, the FDA submission pipeline, and the Digital Twin infrastructure — creating an immutable, tamper-proof, litigation-resistant data trust layer. This is not speculative. These NIST standards were finalized in August 2024 and are federally approved for immediate deployment. Building the NAMs infrastructure on this foundation from Day 1 costs far less than retrofitting later — and transforms every NAM submission into a record whose integrity can be mathematically proven, not just asserted. Every proposal in this document: • Operates within existing HHS, FDA, and NIH statutory authority • Requires no legislative changes • Is specifically designed to withstand APA 'arbitrary and capricious' challenge • Is grounded in peer-reviewed science, federal regulatory precedent, and international comparator data • Builds directly on — and does not contradict — the March 18 draft guidance and Complement-ARIE framework I respectfully request that this submission be reviewed by the relevant team leads identified below, and that the proposed innovations be considered for incorporation into the final guidance (Docket FDA-2025-D-6131, comment period closing May 18, 2026) and into the broader HHS NAMs implementation strategy. The attached document is ready for immediate staff distribution and is formatted for formal submission to the public docket. Respectfully and in service of the mission, Freeman