Federal Register #2026-14146

RFI: Training and Care Delivery Models for Safe Administration of Potential FDA-Approved Psychedelic Therapies

The Department of Health and Human Services (HHS), via the Health Resources and Services Administration (HRSA), is seeking stakeholder input on safe and effective models for administering potential future FDA-approved psychedelic therapies in ambulatory clinical settings. - Government Buyer: - Department of Health and Human Services (HHS) - Health Resources and Services Administration (HRSA) - No OEMs or vendors are specified, as this is a Request for Information (RFI) and not a product or service procurement - Products/Services Requested: - Stakeholder feedback and recommendations on: - Workforce training requirements for safe psychedelic therapy administration - Clinic operational and facility needs - Technology-enabled scalability, including use of artificial intelligence and digital health tools - Protocols for patient screening, administration, and follow-up care - Certification, telehealth, and technology integration - Unique/Notable Requirements: - Emphasis on improving access for medically underserved communities - Focus on ambulatory clinical settings, such as health centers and rural health clinics - Detailed feedback on training models, certification, and operational protocols to ensure safety and scalability - No procurement of products or services; this is an information-gathering effort

Description

This request for information (RFI) issued by the Health Resources and Services Administration (HRSA) under the Department of Health and Human Services seeks stakeholder feedback on training and care delivery models to ensure the safe and effective delivery of potential future FDA-approved psychedelic drugs. The focus is on ambulatory clinical settings such as health centers and rural health clinics, with an emphasis on access for medically underserved communities. The RFI solicits input on workforce training, clinic requirements, and the potential use of technology to scale access while maintaining safety. Comments are due by August 13, 2026.

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