Safe Psychedelic Care

Patient. I came home from the Marines with post-traumatic stress and a depression my clinicians called treatment-resistant, and the system could not hold me. For well over a decade since, I have sat with altered states in structured settings with competent guides, MDMA and psilocybin among them. What helped most was not any one substance. It was the care around the ceremonies: the preparation before and the integration after. The first time these medicines opened me all the way, no one present understood what was happening. I came through. Not everyone does. That is the seat this comment is most loyal to.

Operator. I am a former diplomat, and I spent fifteen years building systems and software in healthcare, including as an executive of a company whose FDA-cleared device supports nervous system regulation through biofeedback, AI and care delivered by telemedicine. Before that, my firm in Silicon Valley ran healthcare innovation initiatives for executives of major pharmaceutical companies. I know what it takes to carry a regulated product to patients, and I have watched good programs fail for want of an owner. That is why each recommendation here names a precedent, who would carry it, and the evidence that would retire it.

Guide. I work with adults twenty-one and older, within the harm reduction tradition, and I do not supply any controlled substance. Across nearly five hundred ceremonies I have sat with people through the session and stayed for the months after, through preparation and integration sessions. I serve as an integration partner to ketamine clinics, where the medicine is prescribed and the setting licensed, and I have mentored more than a hundred and fifty guides one on one. Hundreds of the people I serve have used seven published readiness, experience and outcome measures as self-assessments, to see where they stand and how they change.

Why it matters to me. The Department of Veterans Affairs' 2026 annual report counted 6,488 suicides among veterans in 2024, an average of 17.7 a day. Those are my brothers and sisters. I also know, as too many families now know, what it costs when the people deciding a family's future cannot tell a person trying to heal from a person who is a danger. A clear, public standard of safe practice gives everyone who has to judge this work something true to judge it by.

Disclosure of financial interests. The Agency asked everyone who requested to speak at the hearing to disclose financial relationships, and I hold myself to the same. I own Hyparxis LLC, through which I am paid for ceremony, retreats and psychedelic coaching support, with integration offered as a harm reduction service, including to ketamine clinics. I have consulted across the field and been privileged to help organizations build their work: training programs, clinical trials, retreat centers, clinics, technology platforms for psychedelic care (including one named as an example in Attachment 3), and lawmakers drafting policy. I am developing integration software of my own. My recommendations point toward the part of care I do. Weigh them accordingly.

Four areas, matching the notice's four topics. Each line names the Agency tool it would use, so staff can see where it would sit.

• Training and credentialing. Judge competence, not hours alone. Rate recorded sessions against a published bar, require sobriety and peer consultation, and keep more than one pathway open, so chaplains, nurses, peers and Indigenous practitioners are not turned away. Agency tools: labeling, REMS training and certification, guidance.

• Patient safety. Treat preparation, the session and integration as one offering. A sober facilitator present throughout, consent agreed before dosing, the dose taken in the room, and at least three integration sessions after, with circles and an ongoing provider relationship, that find out what happened and help it take root. Agency tools: REMS elements to assure safe use, labeling, guidance.

• Access. Certify a setting by what happens inside it, indoors or out, in hospice and at home, support group care, pay for the whole episode rather than the dose, make income-based pricing a norm, and leave room for state programs and ceremonial use. Agency tools: REMS settings written by capability, and coordination with CMS, SAMHSA and the states.

• Data. Adopt the consensus measures that already exist and add the few fields still missing. Keep records at the site under pseudonyms, and let boundary violations and imposed belief travel the same reporting path as other harms. Publish de-identified results as open data. Agency tools: common data elements, Sentinel's distributed design, real-world evidence, openFDA.

Section 4 sets out each of these in full, with the precedent behind it. Section 5 suggests an order of work.

The Agency held its hearing on 14 September 2026. Its roster lists eighty public commenters, each given two minutes, across the four topics. No transcript has been posted. At the last check, on 5 October, the docket showed 280 posted comments, the newest posted 30 September. I read all 280, with every attachment the site would serve as text, 96 of the 110 files. The rest are image-only scans or files the site did not serve.

Where the record converges. Care is a course, not a single dose. Filers drafted follow-up schedules running from a first contact within one to three days to contacts at twelve weeks, twelve months or longer (0042, 0050, 0086, 0216, 0279), and I found none opposing follow-up. Competence should be shown, not assumed from hours, a point made on both sides of the license question (0035, 0234). Data elements should be defined before registries are built (0279, 0092). Misconduct, including boundary violations, belongs in the safety record and needs a reporting path outside the provider (0017, 0152, 0170, 0209). Payment should cover preparation, the session and integration together, not the drug alone (0035, 0041, 0086, 0216, 0280).

Where it divides.

• License or competence. One view treats a license as accountability and cites a participant abused by an attendant who answered to no board (0017). Another asks that credentials rest "on competencies, not on discipline" (0035).

• One monitor or two. Some ask for two trained people in the room throughout (0176, 0022). One notes that the Spravato REMS requires one provider (0055), and one asks that a trained peer under clinical supervision fill the second seat (0203).

• Access or restriction. One asks for certified settings and no telehealth-only screening or follow-up (0274). Another warns that clinic-only care could exclude people in advanced illness and asks for home and hospice settings (0262).

• Technology. Some would let video or remote monitoring stand in for a second person (0036, 0136). Others would allow technology only beside a trained person and reject fully remote or AI-only monitoring (0086).

• Data custody. Some ask for a national or shared registry (0107, 0268, 0274). Others ask for pseudonymous or existing local records in place of a new central store (0006, 0028).

What the notice set aside. The notice placed religious, ceremonial and personal use outside its questions. As jurisdiction that is sound. As a description of the room it is not, because the meaning people meet in that state arrives whether or not a rule names it. One Oregon-licensed facilitator wrote that "psychedelic policy often cites centuries of entheogenic practice while excluding living religious and sacramental communities" (0012). I bring the sacred back only where the notice allows it, as patient safety.

What is thin. Many propose follow-up schedules, but few treat finding out what happened as its own safety element, separate from integration care (0120 comes closest), or say who makes the contact (0042 names a coordinator). I found no filer asking that the person keeping watch be sober, though Colorado already requires it. Chaplains are named as team members (0219), and the risk of a clinician becoming a spiritual authority is named (0096), but I found none joining the two into a role with a guardrail. Few pair care outside clinics with a written safety floor, few say how a complaint against an unlicensed facilitator would be heard, and few address moral injury. This comment is written into those gaps.

The evidence on the hours after. In the Oregon cohort led by Korthuis and colleagues, 346 adults were followed through twenty-four licensed service centers. Of four serious behavioral reactions, two showed nothing to the facilitator who sat the whole session, and three of the four came to light only through the study's follow-up. Reports of thoughts of dying or suicide were highest at the last point measured, three months. The authors note that state rules collect safety events only within three days of services, which underestimates them over time. Oregon's 2025 review counted 5,935 clients, nine severe reactions requiring hospital transport and thirteen calls to emergency services. Among 608 people who reported difficulties lasting beyond a day, Evans and colleagues found about a third reported difficulties lasting more than a year.

What follows from it. Harm is rare. When it comes, it is often invisible in the room and found only because someone asked. One filer put it plainly: "Missing follow-up is a limitation in knowledge, not evidence that no adverse event occurred" (0120). Finding out what happened is the least the care around a session owes, and it can be adopted now.

A second record: the PATH Caucus white paper. On 1 October, four days before this docket closed, the bipartisan Congressional PATH Caucus published a synthesis of the responses to its own request for information, prepared by Pinney Associates and finalized in July. Its respondents included clinicians, researchers, Indigenous leaders, community organizations, payers, state regulators and patients, and its authors note it may be especially useful to FDA staff. Where two separate records agree, the Agency can move with more confidence.

• Where the two agree. Someone trained should give continuous support from dosing until discharge, which may take six to twelve hours, and people without graduate or medical degrees can be trained to do it. Credentialing should be tiered, with pathways for licensed clinicians, trained facilitators, peer support practitioners and Indigenous experts. Preparation and integration are part of the care. Group sessions, telehealth for preparation and integration, and peer follow-up can widen access. Registries should not be overly burdensome and should record product source across settings. Indigenous and ceremonial practice should be protected from intrusion and commercialization.

• What this comment adds. The paper speaks mostly to Congress, HHS, SAMHSA, NIH and CMS. This comment answers the Agency's own questions, in the order asked, with a precedent for each. It follows the person past discharge into the first nights and weeks, and it offers an access practice any provider can adopt before coverage arrives.

Each answer follows the notice's own order. Each opens with the recommendation in bold, gives the reasons, and closes with the precedent already in use.

Topic 1 · Provider training and credentialing

Evidence base for curricula. Anchor curricula in competencies, and require the subjects the evidence says are missing.

• The states have already set curricula: Oregon 128 hours across nine subject areas, Colorado 150, and New Mexico's proposed rule a hundred supervised hours, eighty of them in the room during sessions.

• The evidence linking hours to outcomes is thin. A meta-analysis of sixteen psilocybin studies found no significant link between therapy hours and depression outcomes.

• A 2026 study of thirteen US training programs found most teach nothing on spiritual, religious or existential material, though about a third of people with extended difficulties after a psychedelic describe spiritual ones. Require that content, along with screening and referral, crisis response and follow-up contact.

• No single body yet covers the field. A consensus panel on the model of the OPEN e-Delphi, drawing state regulators, clinicians, facilitators, peer supporters, chaplains and Indigenous practitioners, could set the competencies, with state programs and professional bodies such as the Board of Psychedelic Medicine and Therapies reviewing them.

Precedent: Oregon OAR 333-333-3050, Colorado 4 CCR 755-1, New Mexico 7.35.3 NMAC (proposed), Hultgren et al. 2025, Palitsky et al. 2026, Evans et al. 2023.

Personnel by phase of care. One facilitator carries the person through every phase, with clinicians where the risk calls for them.

• Screening. A licensed clinician reviews medical and psychiatric history and every medication, with the facilitator present.

• Preparation. At least two sessions, one on one with the facilitator who will sit the session, the last at least a day before it.

• Treatment. One trained, sober facilitator present throughout, a clinician reachable quickly, and a named backup facilitator. Add a second person where the person, the substance or the setting calls for one: complex or sexual trauma, serious medical or psychiatric illness, a first high dose, a group, or the dying, whose families need tending too.

• Integration. At least three sessions with the facilitator after the session, group integration circles, and an ongoing relationship with an experienced integration provider for the months after, with safety checks made by the facilitator, a peer support specialist or a coordinator under clinical supervision.

• The workforce for a follow-up call exists. A peer support line evaluated with university researchers found that 65.9 percent of 848 callers surveyed said the call de-escalated their distress.

Precedent: Agency trial guidance (on-call physician), Oregon OAR 333-333-5200 (backup facilitator), Fireside Project (0203).

Training for care coordination and continuity. Treat psychedelic competence and a clinical license as different, complementary skills, and keep the person's own team in the loop.

• A license certifies the treatment of illness. Navigating altered states asks for something else: staying non-directive while a person is highly suggestible and the power imbalance the notice names is amplified (0096), telling a hard but useful experience from an emergency, and holding hours of non-verbal or mystical material without interpreting it. The ethics of non-ordinary states is its own subject (0080).

• The Board of Psychedelic Medicine and Therapies told this docket it is still developing its national certification exam (0058). Until competence can be shown, the facilitator and the person's existing clinicians should work as one team.

• With consent, the facilitator shares the plan before the session and makes a warm handoff after it, calling the person's own therapist or doctor rather than handing over a phone number. Where screening finds risk factors, a therapist or integration coach should be in place for the weeks after.

• Name spiritual care as a competency too. Board-certified chaplains are trained, and bound by their professional code, not to impose belief.

Precedent: Oregon OAR 333-333-5080 (safety and support plan), Palitsky et al. 2026, 0080, 0096.

Credentialing requirements. Credential competence shown, sobriety and accountability, through more than one pathway.

• The competencies that matter most are the capacity to listen, to care, to hold a steady presence for hours, and to understand altered states from the inside. I encourage that no facilitator sit for a client without significant personal experience with the particular medicine, gained where that is lawful.

• A skilled facilitator directs as little as possible, so the work builds the person's own agency, and leans in where safety is at stake, as with a contraindication. Knowing when to intervene is itself the competence.

• Rate a recorded session against a published bar before a facilitator sits alone, and again each year. MAPS-sponsored trials already rated recorded sessions against a written adherence and competence manual.

• State in writing that the person keeping watch must be sober, as Colorado already does (Rule 6.11).

• Require a background check, peer consultation as a condition of practice, and a complaint channel that reaches someone other than the facilitator. Communities of practice already offer this. I have been a member of the Psychedelic Guide Network for years, and I recommend every guide consider it or a peer community like it.

• Allow more than one pathway in, as the PATH Caucus white paper recommends: licensed clinicians, trained facilitators, peer support practitioners and Indigenous experts. Ministers, chaplains, nurses, emergency medical technicians and coaches already do this work well, and a mandate tied to a single clinical license would turn many of them away. Ask each facilitator to name and honor the traditions they draw from, and to leave peyote to the Indigenous peoples who steward it.

Precedent: MAPS adherence manual, Colorado Rule 6.11 (sobriety), PATH Caucus white paper, Oregon practicum guidance.

Topic 2 · Promotion of patient safety

Patient education and informed consent. Prepare before consenting, and make consent name what the notice names.

• The notice asks about "the potential for an amplified power imbalance between patient and provider" and "the risk of psychological distress or a challenging psychedelic experience." Consent should name both in plain words, along with what the facilitator is and is not trained to do, any recording or software used, any touch, that difficult effects can last months, that beliefs may change, and that the session may not help.

• Prepare every person for meaning that may arrive uninvited. Johns Hopkins researchers found a mystical-type experience in about two of three volunteers at the highest dose. It is a frequent event, and a person who meets it with no words for it has a safety problem.

• Every agreement is made before dosing, while the person is sober: any additional dose, any touch, any recording, and the plan for leaving. Touch is never sexual. Attachment 4 shows what this preparation looks like from the participant's side.

Precedent: Oregon OAR 333-333-5040 (informed consent).

Pre-session screening. Screen with a named tool, and record which tool was used.

• Washington's task force found no validated risk assessment tool for this setting. Until one exists, every program should name the tool it uses so outcomes can be compared.

• Screen for personal or family history of psychosis or bipolar I disorder, heart disease and blood pressure, pregnancy, and current thoughts of harming oneself or others. Review every medication and supplement. Lithium stops the plan, antidepressants bring the prescriber into the decision, and no facilitator should advise starting, stopping or tapering a prescription.

• Readiness measures such as the Psychedelic Preparedness Scale and the Self-Compassion Scale, with the PHQ-9, GAD-7 and PCL-5 as a baseline, inform the conversation and never replace clinical screening.

Precedent: Washington Psilocybin Task Force report (2023).

Monitoring during administration. Match the protocol to the substance, and keep a person in the room until the person in their care is steady.

• Psilocybin, MDMA, LSD, mescaline, ketamine, ibogaine and 5-MeO-DMT differ in duration, physiology and interactions. Classic psychedelics and MDMA raise blood pressure. Ibogaine can disturb cardiac rhythm for more than a day and belongs in a medical setting.

• Oregon ties the minimum length of the session to dose, requires visual and audio contact throughout, and bars video as a substitute. Colorado runs the session until the participant shows no obvious adverse effects.

• Record every session with consent, reviewable by someone outside the room, and give the person a copy. Touch is used only as agreed beforehand or to keep someone from harm.

• One filer asks to be left alone with the medicine (0102). A person who knowingly chooses that should be free to, so presence is a standard offered to everyone and refused only by informed choice.

• Require basic life support certification, a written emergency plan, a discharge and transport plan written before the session, and a stability check before anyone leaves. One filer describes muscle weakness setting in hours after ingestion at a licensed Oregon center (0142), one more reason to let no one leave unsteady.

Precedent: Oregon OAR 333-333-5200 and 5250, Colorado Rule 6, esketamine REMS.

Integration and its coordination. A committed practice after every session, with safety checks built into it.

• A minimum of three integration sessions after every ceremony, the first within seventy-two hours, then an invitation into group integration circles and an ongoing relationship with a provider experienced in this work through the months that follow, at least three. Each contact carries a free validated measure, a missed contact is recorded as data, and a referral path is ready for anything that lingers, including the 988 Suicide and Crisis Lifeline. Oregon requires only an attempted contact within seventy-two hours.

• Inside that practice sits ascertainment: the contact capable of finding out what happened. It is the floor of integration, never a substitute for it. Make it active, a call or a video visit, since one filer reports only 15 to 25 percent completed emailed questionnaires (0224). Treat three sessions as a floor, not a ceiling. Filers propose schedules to twelve weeks (0086), twelve months (0022, 0274) and twenty-four months (0042).

• The first weeks deserve extra attention. In mice, psilocybin, MDMA, LSD and ibogaine reopened a critical period for social learning lasting two to four weeks or more (Nardou and colleagues, 2023). Human evidence is still emerging, so this is a reason for closer care in that window, not a promise of change.

• A referral path is stronger when it names the safety infrastructure the field already has: peer support lines such as Fireside Project, on-site harm reduction such as the Zendo Project, drug checking through DanceSafe, safety education from SPAN, support for spiritual crises through the Spiritual Emergence Network, and research and training from MAPS.

Precedent: Oregon OAR 333-333-5250, Korthuis et al. 2026, Evans et al. 2023.

Diversion. The dose is taken in the room, under observation. Nothing goes home. This is already how the Agency handles esketamine, and it narrows the main path to diversion without new machinery.

Precedent: Esketamine REMS.

Detecting ethical violations. Make misconduct visible and reportable, including where no board licenses the facilitator.

• Put boundaries in writing: no romantic or sexual relationship with a client during services or for a year after. Let a recording, held with consent, be reviewed by someone outside the room, and give every person a complaint channel that reaches someone other than the facilitator.

• Report boundary violations, coercion and imposed beliefs through the same path a state uses for serious adverse events. I support Dr. Matthew Johnson's point that imposed belief belongs in safety surveillance, not only in licensing (0096).

• Where a person asks for spiritual care, make it available, given in keeping with the person's own beliefs and free to decline, as Medicare hospice rules already require. The Veterans Health Administration already pairs chaplains with clinicians in moral injury groups. Whoever gives spiritual care should be trained not to direct belief.

Precedent: Oregon OAR 333-333-5120, 42 CFR 418.56 and 418.64(d)(3).

Topic 3 · Considerations for access

Coverage and reimbursement. Pay for the episode, not the dose.

• CPT Category III codes 0820T to 0822T describe continuous in-person monitoring during administration, carry no relative value units, and no psychedelic-specific code covers the follow-up contact.

• Price and cover preparation, the session and integration as one episode of care, never sold apart. Colorado already bars a separate fee for the first integration session. Defining the episode this way gives payers a unit they can one day reimburse, including the preparation and integration sessions that help a person carry the experience into daily life.

• Payers will need evidence of the whole episode: outcomes at the integration sessions, emergency and hospital use, and the cost of preparation and integration (0268).

Precedent: CPT 0820T, 0821T, 0822T, Colorado 4 CCR 755-1.

Affordability. Make cost a design question from the start, with income-based pricing as a norm.

• Until coverage exists, most people pay out of pocket, and price decides who receives supported care and who turns to settings with none of the protections described here.

• Oregon asks every licensee for a social equity plan and names reduced rates, sliding scale pricing and subsidies as ways to meet it. That expectation should travel to every setting.

• In my own practice, fees are tiered by household income, scholarship applications are open to everyone, payment plans are available, and I work with foundation scholarship programs to subsidize care. I encourage the field to treat this as standard practice. Nonprofit partners such as Heroic Hearts Project already fund care for veterans, and guidance and payers should make room for them.

• Report how many people received reduced-cost care alongside outcomes, so access can be measured rather than assumed.

Precedent: Oregon Psilocybin Services social equity plan resources.

Provider and payer coordination. Let the follow-up contact count as care and as data at once. A contact made by trained staff under clinical supervision, with a validated measure, produces the outcome data payers ask for, and the warm handoff in Topic 1 keeps the person's primary clinician informed.

Precedent: peer support and care coordination models (0203, 0042).

Implementation logistics. Certify a setting by what happens inside it, and support group care with a stated ratio.

• Groups deserve more study, not less. Healing together is one of the oldest forms of this work: people who share an experience can support one another through it, integration deepens when participants learn from each other, and care costs less when one trained team serves several people.

• Research on groups is early. In Arizona, the Scottsdale Research Institute's FDA-authorized phase one trial, funded by the state, doses police officers, firefighters and veterans together in groups of eight from the same line of work, with four trained facilitators. Its results are not yet published. More trials like it should follow.

• For groups I propose twelve at most, one trained facilitator for every three, tighter as the dose climbs. State rules range from one per two to one per twenty-five by dose in Oregon, one per four in Colorado, and one per two in New Mexico's proposed rule. Treat any ratio as a starting point until studies compare them.

• Colorado permits the session in a hospice, a care facility or the participant's own home for people who are dying, disabled or homebound. A list of approved building types becomes an access rule by accident. Hospice and home care belong in any federal standard. The federal Right to Try Act already lets people with a terminal illness seek eligible investigational drugs, and the dying should not have to leave a hospice bed or their own home to be cared for well.

• Do not confine sessions to clinics. For many people, time outdoors, in contact with the living world, is part of the therapeutic process itself, and the felt connection to life is often what the experience is about. A standard can allow natural settings with the same safeguards: a sober facilitator present, privacy, a plan for weather, terrain and the way back indoors, and the drive to the nearest emergency room known before the first dose.

• Schedule the session as a full-day block with preparation and integration on the same calendar. Store, log and dispose of the drug as its schedule requires. Allow longer phase-in periods in HRSA workforce shortage areas.

• Medical approval is one path among several, alongside state-regulated services and protected religious and ceremonial use, and guidance should be written so it does not close the others.

Precedent: Colorado Rule 6.18, Oregon OAR 333-333-5230, Scottsdale Research Institute trial, HRSA shortage data.

Telehealth. Use it for screening, preparation and integration, never for the session itself. Medical screening should be in person where the history calls for it. Follow-up by phone or video reaches people who cannot travel, which is often the difference between a contact made and a contact missed.

Precedent: Oregon OAR 333-333-5200 (video may not satisfy monitoring).

Topic 4 · Best practices for data collection and standardization

Common data elements. Adopt the consensus measures that already exist, and add the few fields still missing.

• The OPEN consensus set, developed with experts from clinical trials, psilocybin services, and ceremonial and Indigenous practice, defines 39 core measures and recommends a brief safety checklist from the facilitator within a day and from the client at one week.

• Add what it lacks: facilitator sobriety attested, contact outcome at each follow-up (completed, declined, unreachable), referral sent and accepted, and product source and lot (0050, 0077, 0170).

• Before and after the session, use the free measures in wide use: PHQ-9, GAD-7, PCL-5 and WHO-5. Before it, add readiness: the Psychedelic Preparedness Scale and the Self-Compassion Scale. After it, add the thirty-item Mystical Experience Questionnaire (MEQ-30) and the Psychological Insight Questionnaire. For veterans, add the fourteen-item Moral Injury Outcome Scale.

• Record drug, product and dose, indication or purpose, setting type (clinical, state-regulated, ceremonial or other) and core patient characteristics, including comorbidities and medications, in the same fields across sources.

Precedent: OPEN consensus measures (Journal of Psychopharmacology, 2024).

Adverse event reporting. Leave reporting rules to the states, and encourage each to find harm by asking.

• Where serious events are reported, and how fast, is a decision each state is already making. Colorado asks for twenty-four hours, and New Mexico's proposed rule for two days.

• What I would encourage everywhere: find events by asking, through the follow-up contacts; let boundary violations, coercion and imposed beliefs travel the same path; and reach past three days, since a three-day window misses what arrives later.

• Define adverse events on two clocks: acute, during the session and the days after, and long-term, as difficulties lasting beyond a day and tracked through the integration sessions to at least three months, as Evans and colleagues did.

Precedent: Colorado (24 hours), New Mexico proposed rule (2 days).

Repositories and interoperability. Keep records at the site, under pseudonyms, and send back only summary answers.

• A coordinated registry network can be built on the distributed design the Agency already runs in Sentinel, linking sources rather than building one store: health records and claims, state program data from Oregon and Colorado, adverse event reports, peer support line data, and federal surveys such as the National Survey on Drug Use and Health. Use one common format, and add a Certificate of Confidentiality wherever follow-up runs as research.

• Then open it. Publish de-identified, aggregate results on a public portal, the way openFDA already serves adverse event data and Oregon publishes its program numbers. Much of this field has been pushed underground. What the Agency monitors should return to the public that lived it, where researchers, educators, clinicians and builders can see which training and care protocols work, design better trials, and perhaps learn something about consciousness itself.

• Privacy shapes who is willing to report. In 2016 the Ninth Circuit upheld federal guidance that treats a state medical marijuana card as reasonable cause to refuse a firearm sale (Wilson v. Lynch). In June 2026 the Supreme Court limited how the underlying ban applies to drug users not shown to be intoxicated or dangerous (United States v. Hemani). The law is still settling, and veterans weigh it before reporting anything.

• A voice is not a pseudonym, so recordings stay encrypted, belong to the person, and are deleted on request unless the law or an open complaint requires keeping them.

Precedent: FDA Sentinel, Wilson v. Lynch (9th Cir. 2016), United States v. Hemani (2026).

• Name integration as a committed practice in guidance: at least three integration sessions after every ceremony, the first within seventy-two hours, with group circles and an ongoing provider relationship for at least three months, the data fields in Topic 4 collected at each contact, and the preparation before that makes the session whole.

• Use the minimum standard in Attachment 3 as a working checklist. Test it against the settings already operating under state rules in Oregon and Colorado, and against New Mexico's program as it opens, before codifying any line of it.

• Widen the next stage of listening to practitioners who work outside clinics, peer supporters, chaplains and veterans' programs, so the guidance is written with the people who keep watch.

• Treat every requirement as provisional, with the evidence that would retire it named at the start, as the REMS statute already does with its scheduled assessments.

I am not asking for one template across compounds, a single brand of psychotherapy written into a label, a license requirement for the person who keeps watch, a registry that becomes a list of names, or a chaplain assigned to anyone who did not ask.

I would welcome a working conversation with staff about any of this, and I will keep the standard public and revise it as this record and the evidence grow.

• I know of no controlled trial showing that more integration prevents harm. The case rests on what Oregon found only by asking and on long clinical experience, and detection is not mitigation. A higher floor also raises cost and needs a workforce that does not yet exist at scale.

• Research on group care is still early. The Arizona trial named in Topic 3 is among the first to study it directly and has not yet published results, so the ratio proposed here is a starting point to be tested, not a finding.

• The estimate in my attachments that fewer than one ketamine clinic in six offers integration is my own count from clinic partners.

• My view comes from my own practice, a caseload that chose me, with no control group.

Every source cited in this comment, with a link to the original. Docket comments are listed together at the end.

1. Federal Register notice. Considerations for Potential Future Therapeutic Use of Psychedelic Drugs. 91 FR 43095, 14 July 2026. federalregister.gov/d/2026-14155

2. FDA. Psychedelic Drugs: Considerations for Clinical Investigations, guidance for industry. fda.gov/media/169694/download

3. Federal Food, Drug, and Cosmetic Act, section 505-1, Risk Evaluation and Mitigation Strategies, 21 U.S.C. 355-1. law.cornell.edu/uscode/text/21/355-1

4. FDA. Spravato (esketamine) prescribing information and REMS. accessdata.fda.gov label · spravatorems.com

5. FDA. Sentinel Initiative. fda.gov/safety/fdas-sentinel-initiative

6. FDA. Framework for FDA's Real-World Evidence Program, 2018. fda.gov/media/120060/download

7. Korthuis PT et al. Safety and Mental Health Outcomes of Oregon State-Regulated Psilocybin Services. JAMA Network Open 9(8): e2630608, 2026. doi.org/10.1001/jamanetworkopen.2026.30608

8. Korthuis PT et al. Open Psychedelic Evaluation Nexus consensus measures for supervised psilocybin services: an e-Delphi study. Journal of Psychopharmacology 38(8): 761-768, 2024. doi.org/10.1177/02698811241257839

9. Oregon Health Authority. Oregon Psilocybin Services, 2025 Year in Review. oregon.gov 2025-Year-in-Review.pdf

10. Oregon Administrative Rules, OAR 333-333-3050, 5040, 5080, 5120, 5200, 5230, 5250. law.cornell.edu, OAR chapter 333

11. Colorado 4 CCR 755-1, Natural Medicine rules, Rule 6, including 6.11, 6.17, 6.18, 6.19 and 6.23. law.cornell.edu, 4 CCR 755-1-6

12. New Mexico Department of Health. Proposed 7.35.3 NMAC, medical psilocybin program. nmhealth.org/publication/view/rules/9904

13. Washington Health Care Authority. Psilocybin Task Force legislative report, 2023. hca.wa.gov report

14. Coe M, Harris-Stephenson M, Henningfield J (Pinney Associates). Summary and Recommendations on the Safe, Ethical, and Equitable Integration of Psychedelic-Assisted Therapy in the United States. White paper for the bipartisan Congressional PATH Caucus, finalized July 2026, published 1 October 2026. bergman.house.gov white paper

15. Evans J et al. Extended difficulties following the use of psychedelic drugs. PLOS ONE 18(10): e0293349, 2023. doi.org/10.1371/journal.pone.0293349

16. Hultgren J, Hafsteinsson MH, Gruneau Brulin J. A dose of therapy with psilocybin: a meta-analysis of therapy hours and outcomes. General Hospital Psychiatry, 2025. sciencedirect.com

17. Palitsky R et al. A landscape analysis of psychedelic facilitation training in the US. PLOS ONE 21(5), 2026. doi.org/10.1371/journal.pone.0350037

18. MAPS. Adherence Ratings Manual for MDMA-assisted therapy, version 6, 2021. maps.org manual

19. Pleet MM, White J, Zamaria JA, Yehuda R. Reducing the Harms of Nonclinical Psychedelics Use Through a Peer-Support Telephone Helpline. Psychedelic Medicine 1(2): 69-73, 2023. doi.org/10.1089/psymed.2022.0017

20. Nardou R et al. Psychedelics reopen the social reward learning critical period. Nature 618: 790-798, 2023. doi.org/10.1038/s41586-023-06204-3

21. McAlpine RG, Blackburne G, Kamboj SK. Validation of a scale measuring psychedelic preparedness. Scientific Reports 14: 3280, 2024. doi.org/10.1038/s41598-024-53829-z

22. Neff KD. The development and validation of a scale to measure self-compassion. Self and Identity 2(3): 223-250, 2003. doi.org/10.1080/15298860309027

23. Barrett FS, Johnson MW, Griffiths RR. Validation of the revised Mystical Experience Questionnaire. Journal of Psychopharmacology 29(11): 1182-1190, 2015. doi.org/10.1177/0269881115609019

24. Davis AK et al. Development of the Psychological Insight Questionnaire. Journal of Psychopharmacology 35(4): 437-446, 2021. doi.org/10.1177/0269881120967878

25. BrainFutures. A Guide to CPT and HCPCS Codes for Psychedelic-Assisted Therapy, 2023. brainfutures.org guide

26. Code of Federal Regulations, 42 CFR 418.56 and 418.64(d)(3), hospice interdisciplinary group and spiritual counseling. ecfr.gov, 42 CFR part 418

27. Department of Veterans Affairs. National Veteran Suicide Prevention Annual Report, 2026. mentalhealth.va.gov

28. RAND. Magic Mushrooms Are Most-Used Psychedelic Drug, 27 June 2024. rand.org · Yockey A, Hoopsick R. Prevalence and Correlates of Past-Year Psilocybin Use in the U.S., 2024. AJPM Focus, 2026. doi.org/10.1016/j.focus.2026.100518

29. Scottsdale Research Institute whole-mushroom psilocybin trial: azfamily.com, 23 December 2025 · ABC15 Arizona, 19 December 2025

30. Oregon Psilocybin Services. Social equity plan resources. oregon.gov resources

31. Wilson v. Lynch, 835 F.3d 1083 (9th Cir. 2016). ca9.uscourts.gov · United States v. Hemani, No. 24-1234 (U.S. 18 June 2026). justia.com

32. Docket comments cited, FDA-2026-N-7542: 0006, 0012, 0017, 0022, 0028, 0035, 0036, 0041, 0042, 0050, 0055, 0058, 0077, 0080, 0086, 0092, 0096, 0102, 0107, 0120, 0136, 0142, 0152, 0170, 0176, 0203, 0209, 0216, 0219, 0224, 0234, 0262, 0268, 0274, 0279, 0280. regulations.gov/docket/FDA-2026-N-7542

Safety, support and practice organizations

Fireside Project, peer support line · Zendo Project, psychedelic harm reduction · DanceSafe, drug checking · Safer Psychedelics Association of New England (SPAN), safety education · Psychedelic Guide Network, peer consultation for guides · MAPS, research and training · Chacruna Institute, reciprocity with Indigenous and traditional communities · Spiritual Emergence Network, support for spiritual crises · Board of Psychedelic Medicine and Therapies, certification in development · Heroic Hearts Project, care for veterans · 988 Suicide and Crisis Lifeline · SAMHSA · Oregon Psilocybin Services · Colorado Natural Medicine Division