Department of Health and Human Services October 15, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
Revocation of Emergency Use of a Biological Product During the COVID-19 Pandemic; Availability
The Food and Drug Administration (FDA or Agency) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Janssen Biotech, Inc. (Janssen), for the Janssen COVID-19 Vaccine. FDA revoked the Authorization on June 1, 2023, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.
Medicare Program: Appeal Rights for Certain Changes in Patient Status
This final rule implements an order from the Federal district court for the District of Connecticut in Alexander v. Azar that requires HHS to establish appeals processes for certain Medicare beneficiaries who are initially admitted as hospital inpatients but are subsequently reclassified as outpatients receiving observation services during their hospital stay and meet other eligibility criteria.
Using Relative Supersaturation To Support `Urinary Tract Health' Claims for Adult Maintenance Cat Food; Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry #284 entitled "Using Relative Supersaturation To Support `Urinary Tract Health' Claims for Adult Maintenance Cat Food." FDA's Center for Veterinary Medicine (CVM) has evaluated the use of relative supersaturation (RSS) methodology to support urinary tract health claims for certain adult maintenance cat food. RSS is a measurement that estimates the potential for crystal formation and bladder stone growth, which is a common affliction in cats. This guidance provides recommendations for how pet food manufacturers can use RSS methodology to substantiate general structure or function claims that an adult maintenance cat food supports urinary tract health by promoting a healthy mineral content in the urinary tract.
Medical Devices; Quality System Regulation Amendments; Correction
The Food and Drug Administration (FDA or Agency) is correcting a final rule that appeared in the Federal Register on February 2, 2024. In that final rule, FDA amended the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the device CGMP. FDA is correcting an editorial error that inadvertently omitted a definition in the codified of the final rule. This action is editorial in nature and is intended to ensure the accuracy and clarity of the Agency's regulations.
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; KISQALI (ribociclib)
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the supplemental application for KISQALI (ribociclib), approved September 17, 2024, meets the criteria for redeeming a priority review voucher.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; MIPLYFFA (Arimoclomol)
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that MIPLYFFA (arimoclomol), approved on September 20, 2024, manufactured by Zevra Denmark AS, meets the criteria for a priority review voucher.
Findings of Research Misconduct
Findings of research misconduct have been made against Bret Rutherford, M.D. (Respondent), who was formerly a Research Psychiatrist, New York State Psychiatric Institute (NYSPI). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute of Mental Health (NIMH), National Institutes of Health (NIH), grants R01 MH102293 and R61/R33 MH110029. The administrative actions, including debarment for a period of three (3) years followed by supervision for a period of three (3) years, were implemented beginning on September 27, 2024, and are detailed below.
Endosseous Dental Implants and Endosseous Dental Implant Abutments-Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Endosseous Dental Implants and Endosseous Dental Implant AbutmentsPerformance Criteria for Safety and Performance Based Pathway." The device-specific guidance identified in this notice was developed in accordance with the finalized guidance entitled "Safety and Performance Based Pathway." This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; AQNEURSA (Levacetylleucine)
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that AQNEURSA (levacetylleucine), approved on September 24, 2024, manufactured by IntraBio Inc., meets the criteria for a priority review voucher.
Agency Information Collection Activities: Submission for OMB Review; 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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
