Comment on FR Doc # 2026-14146

Althea PBC builds and operates the technology infrastructure for state-regulated psilocybin services in Oregon and Colorado: the system of record, participant screening workflows, scheduling, compliance documentation, and outcomes measurement used by state-licensed facilitators, licensed service centers and healing centers, and the participants they serve. Althea is not a clinical care provider; all services referenced here are delivered by independently licensed facilitators under state regulatory frameworks. Together with researchers in the University of Colorado School of Medicine Department of Psychiatry, Althea co-authored a retrospective observational study of real-world use, safety, and mental health outcomes of regulated psilocybin services, drawing on 2,363 participants served by 253 state-licensed facilitators between December 2024 and March 2026. We believe this is the largest real-world dataset on regulated psychedelic services delivery in the United States. The manuscript is in peer review with a top medical journal and is expected to publish in the coming months; findings shared here are preliminary, and we will provide HRSA the full citation and final results upon publication. Preliminary findings: two weeks after dosing, self-reported depression scores (PHQ-9) improved 49 percent (Cohen's d = -1.13) and anxiety scores (GAD-7) improved 51 percent (d = -1.23), consistent across sexes and baseline severity. Across 2,363 dosing sessions, 94 mild and transient adverse events and five more serious events (including two EMS calls) were reported, with no new incidents of psychosis-like behavior and no evidence of treatment-emergent suicidality. The safety profile was achieved by licensed, non-physician facilitators without on-site physician presence. For most stakeholders this RFI is prospective. For Oregon and Colorado it is operational history: multiple years running, at scale and under state regulation, substantially the delivery model HRSA is contemplating. Our attached comment answers the RFI's questions from that operational evidence. Key points: 1. Workforce. The state programs demonstrate that licensed, competency-trained facilitators without medical degrees can safely deliver these services. We recommend HRSA anchor workforce guidance on state facilitator licensure, competency-based training, and supervised practicum rather than degree requirements. 2. Screening. Structured, auditable, standardized screening workflows with human review of automated flags and defined medical escalation pathways should be treated as a core safety requirement. Telehealth is appropriate for screening, preparation, and follow-up; administration and observation should remain in person. 3. Access economics. The binding constraint on access in underserved communities is cost structure, not clinical complexity. Group administration models under state-defined facilitator-to-participant ratios deliver services at a per-participant cost several times lower than individual sessions. We recommend HRSA explicitly provide for group administration and adapt the tested state ratios. 4. Medical oversight. We support pre-administration contraindication review by a licensed medical provider, which can be remote or asynchronous. Neither state requires on-site physician presence during sessions, and the state safety record has not demonstrated a need for one where screening and escalation protocols are sound. 5. Facilities. Oregon and Colorado service center, secure storage, and product tracking rules are a tested template for health center requirements. 6. Technology and evidence. The highest-leverage technology for safe scaling is infrastructure that standardizes screening, documents safety-relevant decisions, and measures outcomes continuously. AI should support, not replace, human judgment. We recommend any certification framework require standardized outcome measurement embedded in the care workflow, so the federal program generates its own evidence base in underserved populations. Althea operates a public outcomes dashboard at be.withalthea.com/psilocybin-outcomes as a working example. Our full comment, attached, responds to each RFI question in detail and includes eight specific recommendations. We would welcome the opportunity to brief HRSA staff on the operational data underlying this comment. Respectfully submitted, Niko Skievaski, Co-founder and CEO, Althea PBC, Boulder, Colorado