Federal Register #HRSA-2026-0034

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

The Department of Health and Human Services, through the Health Resources and Services Administration (HRSA), is seeking stakeholder input on training and care delivery models for the safe administration of potential FDA-approved psychedelic therapies in ambulatory clinical settings. - Government Buyer: - Department of Health and Human Services - Health Resources and Services Administration (HRSA) - Purpose: - Request for Information (RFI) to gather feedback and recommendations from stakeholders - Focus on safe administration of future FDA-approved psychedelic therapies - Emphasis on ambulatory clinical settings, including health centers and rural health clinics - Special attention to improving access for medically underserved communities - Requested Information: - Workforce training requirements for providers (pre-administration screening, in-clinic drug administration, post-administration follow-up) - Clinic operational and facility needs for safe therapy delivery - Technology-enabled scalability, including use of artificial intelligence and digital health tools - Certification or licensing requirements for providers - Detailed protocols, publications, and supporting evidence to inform future policy - No specific OEMs, vendors, products, or purchase quantities are requested - The RFI is strictly for information gathering and does not involve procurement of goods or services

Description

This request for information (RFI) issued by the Health Resources and Services Administration (HRSA) under the Department of Health and Human Services solicits stakeholder feedback on training and care delivery models to ensure safe and effective delivery of potential future FDA-approved psychedelic drugs. The focus is on administration in ambulatory clinical settings such as health centers and rural health clinics, with an emphasis on access for medically underserved communities. The RFI seeks 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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