Department of Health and Human Services June 26, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Removal of the Vaccine Requirements for Head Start Programs
This final rule removes the vaccine and testing requirements included in the Interim Final Rule with Comment Period (IFC) titled, ``Vaccine and Mask Requirements To Mitigate the Spread of COVID-19 in Head Start Programs,'' which the Administration for Children and Families published on November 30, 2021. Specifically, this rescission removes the requirement from the Head Start Program Performance Standards (HSPPS) that all Head Start staff, contractors whose activities involve contact with or providing direct services to children and families, and volunteers working in classrooms or directly with children are fully vaccinated for COVID-19. The associated HSPPS requirement that staff who are exempt from the vaccination requirement have ``at least weekly'' COVID-19 testing is also removed.
Psychedelic Drugs: Considerations for Clinical Investigations; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Psychedelic Drugs: Considerations for Clinical Investigations.''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increasing and designing clinical trials to evaluate these compounds presents unique challenges, FDA has developed this draft guidance to present foundational aspects for sponsors to consider. This draft guidance provides general considerations for sponsors developing psychedelic drugs for treatment of medical conditions (e.g., psychiatric disorders, substance use disorders) and discusses considerations for clinical investigations using psychedelic drugs.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding When Conventional Platelets Are Not Available or Their Use Is Not Practical; Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of an immediate in effect guidance entitled ``Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical.'' FDA is issuing this guidance to provide a notice of exceptions and alternatives to certain requirements in the biologics regulations regarding blood and blood components. This notice is being issued to respond to a public health need and address the urgent and immediate need for platelets for the treatment of active bleeding when conventional platelets are not available, or their use is not practical. In addition, the guidance document provides recommendations to blood establishments for the manufacture and labeling of cold-stored platelets (CSP).
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