🧪FDA Classifies Herpes Simplex Virus Assay as Class II Device
The Food and Drug Administration (FDA, the Agency, or we) is classifying the herpes simplex virus nucleic acid-based assay for central nervous system infections into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the herpes simplex virus nucleic acid-based assay for central nervous system infections. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More🧬FDA Classification of Muscular Dystrophy Newborn Screening Test
The Food and Drug Administration (FDA, the Agency, or we) is classifying the muscular dystrophy newborn screening test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the muscular dystrophy newborn screening test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More💊FDA Seeks Input on Generic Drug User Fees for 2028-2032
The Food and Drug Administration (FDA or Agency) is issuing this notice to request that interested parties, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for Fiscal Years (FYs) 2028-2032. At the end of September 2027, new legislation will be required for FDA to continue collecting generic drug user fees for subsequent fiscal years for the generic drug program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of interested parties in developing recommendations for the next GDUFA program. The FD&C Act also requires that FDA hold continued discussions with patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent representation by interested parties.
Learn More🏥OPM Seeks Comments on CAHPS Enrollee Survey Renewal
Healthcare and Insurance, Office of Personnel Management (OPM) offers the general public and other federal agencies the opportunity to comment on the administration of the Consumer Assessment of Healthcare Providers and Systems (CAHPS[supreg]) survey for the Federal Employees Health Benefits (FEHB) and the Postal Service Health Benefits (PSHB) Programs. CAHPS[supreg] surveys ask consumers and patients to report on and evaluate their experiences with health care. These surveys cover topics that are important to consumers and focus on aspects of quality that consumers are best qualified to assess, such as the communication skills of providers and ease of access to health care services.
Learn More🏦Federal Reserve Notice on Bank Holding Company Mergers and Acquisitions
This regulatory notice outlines the process for bank holding companies to apply for mergers or acquisitions under the Bank Holding Company Act. It includes provisions for public commentary and highlights the importance of maintaining transparency in the application process. The Federal Reserve encourages public input on the proposals, which remain subject to regulatory scrutiny.
Learn More🛢️DHS Approves Seahawk Services as Commercial Gauger
Notice is hereby given, pursuant to CBP regulations, that Seahawk Services (West Deptford, NJ), has been approved to gauge petroleum and certain petroleum products for customs purposes for the next three years as of March 8, 2023.
Learn More✈️FAA Notice of Intent to Designate Abandoned STC for Aviation
This notice announces the FAA's intent to designate Edward L. Soncrant Supplemental Type Certificate (STC) No. SA4289WE as abandoned and make the related engineering data available upon request. The FAA has received a request to provide engineering data concerning this STC. The FAA has been unsuccessful in contacting Edward L. Soncrant concerning the STC. This action is intended to enhance aviation safety.
Learn More✈️Proposed AD for Boeing 787-9 and 787-10
The FAA proposes to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 787-9 and 787-10 airplanes. This proposed AD was prompted by reports of multiple supplier notices of escapement (NOEs) indicating that multiple cargo barrier fitting links were possibly manufactured with an incorrect titanium alloy material. This proposed AD would require a high frequency eddy current (HFEC) or handheld X-ray fluorescence (XRF) spectrometer inspection of the cargo barrier fitting link to determine the titanium alloy material, and applicable on-condition actions. The FAA is proposing this AD to address the unsafe condition on these products.
Learn More🏥Notice on ACHC Hospice Accreditation Program and Public Comment
This proposed notice acknowledges the receipt of an application from the Accreditation Commission for Health Care, for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs.
Learn More⚡Electric Rate Filings and Tariff Amendments Overview
The Department of Energy's notice details several electric rate filings and tariff amendments submitted by various companies, including PJM Interconnection and Alabama Power Company. These filings aim to establish effective dates for new tariffs and invoke regulatory compliance standards, offering stakeholders insight into upcoming changes in electricity pricing structures.
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