FDA Finalizes Psychedelic Drug Trial Guidance; Education Dept. Seeks Comments on eZ-Audit System

FDA Issues Final Guidance on Psychedelic Drug Clinical Investigations

The Food and Drug Administration announced the availability of a final guidance for industry titled "Psychedelic Drugs: Considerations for Clinical Investigations," published in the Federal Register on July 14, 2026. The guidance outlines general considerations for drug development programs exploring the therapeutic potential of psychedelic drugs for the treatment of medical conditions, including psychiatric disorders and substance use disorders.

The agency explains that it developed the guidance because interest in the therapeutic potential of psychedelic drugs has been increasing and designing clinical trials to evaluate these compounds presents unique challenges. The guidance addresses recommendations for study design, including considerations for data collection, data generation, and patient monitoring as they apply to clinical trials on investigational products.

The final guidance finalizes the draft guidance of the same title issued on June 26, 2023, which was published at 88 FR 41407. The agency states that it considered docket comments received in response to the draft guidance as part of the revision, and that a few revisions were made to enhance clarity. The guidance is being issued consistent with FDA's good guidance practices regulation at 21 CFR 10.115.

FDA notes that the guidance represents the agency's current thinking and does not establish any rights for any person, nor is it binding on FDA or the public. The agency states that an alternative approach may be used if it satisfies the requirements of the applicable statutes and regulations. FDA also considered the applicability of Executive Order 14192, per OMB guidance in M-25-20, and finds the action to be neither regulatory nor deregulatory.

The guidance references several existing, OMB-approved information collections relevant to sponsors. These include collections under 21 CFR parts 50 and 56 concerning protection of human subjects and institutional review boards (OMB control number 0910-0130); collections under 21 CFR parts 210 and 211 on current good manufacturing practice requirements (OMB control number 0910-0139); collections under 21 CFR part 312 relating to the investigational new drug applications pathway, including clinical trials and trial design, chemistry, manufacturing and controls information, study protocols, and pharmacological and toxicology information under 21 CFR 312.23, and IND safety reports under 21 CFR 312.32 (OMB control number 0910-0014); and collections under 21 CFR part 314 for new drug applications, including submission of clinical study data under 21 CFR 314.50(d)(5) and risk evaluation and mitigation strategies (OMB control number 0910-0001). The guidance additionally recommends the use of questionnaires to assess clinical trial subjects' expectations about potential drug effects and at the end of treatment to improve data interpretability.

Education Department Proposes Extension of eZ-Audit Information Collection

The Department of Education is proposing an extension without change of a currently approved information collection request for its eZ-Audit system, acting under the Paperwork Reduction Act of 1995. The collection carries OMB Control Number 1845-0072, and the Department is soliciting public comment through September 14, 2026.

According to the notice, eZ-Audit is a web-based process designed to facilitate the submission of compliance and financial statement audits, expedite the review of those audits by the Department, and provide more timely and useful information to public, non-profit, and proprietary institutions regarding the Department's review. The system establishes a uniform process under which all institutions submit directly to the Department any audit required under the Title IV, HEA program regulations.

The Department estimates 6,632 total annual responses and 6,603 total annual burden hours associated with the collection. Respondents and affected parties include State, Local, and Tribal Governments; Private Sector entities; and Individuals or Households. The notice states there has been no change to the form or method of submission and that eZ-Audit continues to have a minimal number of financial template line items and general information questions.

The Department states it is especially interested in public comment addressing whether the collection is necessary to the Department's proper functions, whether the information will be processed and used in a timely manner, whether the burden estimate is accurate, how the quality and utility of the collected information might be enhanced, and how the burden on respondents might be minimized, including through the use of information technology.

What to Watch

• September 14, 2026 — Deadline for public comments on the Education Department's proposed extension of the eZ-Audit information collection (OMB Control Number 1845-0072).

Related

• Civic AI hub
• Five Federal Agencies Seek Public Comment on Information Collection Renewals Across Agriculture, Environment, and Marine Science
• NCUA Bans Reputation Risk in Supervision; FDA Files Flour Irradiation Petition
• Education Dept. Extends Funding for 43 American Indian Vocational Rehabilitation Projects Through Sept. 2027