This rule finalizes the removal of the requirements issued in the Designated Placement Requirements Under Titles IV-E and IV-B for LGBTQI+ Children final rule that was published on April 30, 2024 (hereafter referred to as the 2024 final rule). The 2024 final rule required title IV-E/IV-B agencies to ensure that a Designated Placement is available for all children who self-identify with an alternative sexual orientation or self-identify as something other than their sex in foster care who request

Original title: “Designated Placement Requirements Under Titles IV-E and IV-B for LGBTQI+ Children; Rescission”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Psychedelic Drugs: Considerations for Clinical Investigations." Because interest in the therapeutic potential of psychedelic drugs has been increasing and designing clinical trials to evaluate these compounds presents unique challenges, FDA developed the draft guidance to present foundational aspects for sponsors to consider. This final guidance provides general considerations

Original title: “Psychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Availability”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs." This guidance provides recommendations to industry on formal meetings between FDA and sponsors or requestors of over-the- counter (OTC) monograph drugs or organizations nominated by sponsors or requestors to represent their interests in a proceeding and discusses the procedures and pri

Original title: “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs”

Read twice and referred to the Committee on the Judiciary.

Original title: “S 4972: Medical Bankruptcy Fairness Act of 2026”

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public hearing on the potential future therapeutic use of psychedelic drugs. In collaboration with federal partners, FDA is holding this public hearing to obtain feedback and perspectives on issues associated with the potential future therapeutic use of drug products containing a psychedelic drug substance in supervised and supportive settings.

Original title: “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs; Public Hearing; Request for Comments”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Topical Dermatologic Corticosteroids: In Vivo Bioequivalence." This guidance provides recommendations to applicants who submit abbreviated new drug applications (ANDAs) for topical dermatologic corticosteroids of all potency groups (referred to in this notice as topical corticosteroids). The guidance describes recommendations for an in vivo pharmacodynamic approach to demonstr

Original title: “Topical Dermatologic Corticosteroids: In Vivo Bioequivalence; Guidance for Industry; Availability”

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

Original title: “National Vaccine Injury Compensation Program; List of Petitions Received”

The National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is giving notice of the invention listed below, which is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies

Original title: “Government-Owned Inventions; Availability for Licensing”

The FDA last week confirmed that it would suspend the release of complete response letters pending the resolution of a citizen petition from an unnamed pharma company. Nevertheless, 14 new CRLs are now available on the agency’s portal.

Original title: “FDA posts new rejection letters days after confirming pause”

Information about the Blue Grass Chemical Agent-Destruction Pilot Plant

Original title: “Blue Grass Chemical Agent-Destruction Pilot Plant”

Information about the Pueblo Chemical Agent-Destruction Pilot Plant

Original title: “Pueblo Chemical Agent-Destruction Pilot Plant”

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the drug establishment registration and drug listing requirements with respect to establishments engaged in distributed manufacturing and foreign drug establishments. This action, if finalized, will provide a pathway for a distributed manufacturing establishment that manufactures drugs at multiple different physical locations to register as a single drug manufacturing establishment and align drug establishment regist

Original title: “Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments”

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Medical Monitoring Project (MMP). The purpose of this data collection is to describe

Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”

Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled World Trade Center Health Program Stakeholder Experience Feedback Collection. The data

Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”

The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a single establishment using a “hub-and-spoke” model.

Original title: “FDA Proposes Rule to Modernize Drug Manufacturing Registration”

Information on STRF diagnosis and testing, treatment, and disease reporting.

Original title: “Clinical Guidance for Soft Tick Relapsing Fever (STRF)”