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The Postal Service has announced that it is filing a request with the Postal Regulatory Commission. This request seeks to add a new domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List. The contract in question involves Priority Mail and USPS Ground Advantage® services. Interested parties can find more details about this submission on the Postal Regulatory Commission's website under specific docket numbers.

The Department of Health and Human Services and the Food and Drug Administration (FDA) are proposing to permanently waive certain premarket notification requirements for specific medical devices. This action follows temporary waivers provided during the COVID-19 pandemic to make medical devices more accessible. The proposal includes making seven class I devices and 84 class II devices permanently exempt from the 510(k) premarket notification requirement, which typically involves a costly and time-consuming process. The public is invited to comment on the proposed exemptions and suggest improvements to the regulatory system concerning medical devices.

The Postal Service has filed a request with the Postal Regulatory Commission to add a specific domestic shipping services contract to its list of service agreements. This request aims to include the Priority Mail Express, Priority Mail, and USPS Ground Advantage® Contract 823 in the Competitive Products List outlined in the Mail Classification Schedule. The documents related to this filing, available under Docket Nos. MC2025-531 and K2025-529, were submitted on November 27, 2024, and can be accessed on the Postal Regulatory Commission's website.

The Postal Service announced that it is seeking approval from the Postal Regulatory Commission to add a new domestic shipping services contract to the Negotiated Service Agreements list in the Mail Classification Schedule's Competitive Products List. This request includes services like Priority Mail Express, Priority Mail, and USPS Ground Advantage®. The details of this request were filed on November 27, 2024, and more information can be found on the Postal Regulatory Commission's website.

Central New York Railroad Corporation (CNY) is a small railroad company that continues to lease and operate a rail line from Norfolk Southern Railway Company, covering about 123.1 miles between New York and Pennsylvania. This notice states that CNY plans to amend their lease to extend the term and adjust renewal conditions, while keeping all other original terms in place. CNY assures that the transaction will not make it a larger railroad and estimates their earnings won't go beyond $5 million a year. The Surface Transportation Board will allow this change to be effective from April 12, 2025, unless any misleading information is found or if objections are filed in time.

The Food and Drug Administration (FDA) is proposing a rule to require testing of talc-containing cosmetic products to detect and identify asbestos, which is a known carcinogen. This rule would mandate the use of standardized testing methods involving both Polarized Light Microscopy and Transmission Electron Microscopy to ensure that cosmetics do not contain asbestos, which poses health risks to consumers. Manufacturers would need to test each batch or lot of their products or rely on certified analysis from suppliers, and they must maintain records of the testing. This rule aims to enhance consumer safety by reducing the risk of asbestos exposure from cosmetic products.

The Food and Drug Administration (FDA) is proposing to reject the new drug application from Vanda Pharmaceuticals for TRADIPITANT capsules, intended to treat nausea in gastroparesis. The application was found lacking as it did not provide substantial evidence of the drug’s effectiveness and safety based on submitted studies and data. Vanda has the option to request a hearing to contest this decision, though they must address all the identified deficiencies. If no hearing request is filed, or if it is not deemed substantial, the FDA will officially deny the application.

Louisiana Southern Railroad, L.L.C. (LAS), a small rail company, has filed a notice to continue leasing and operating about 165.8 miles of rail lines from the Kansas City Southern Railway Company (KCS). The lease agreements have been in place since 2005 and were recently amended to extend until November 2034. LAS must meet certain conditions, such as informing employees and unions about the transaction, because their annual revenues exceed $5 million. However, LAS has requested a waiver for the 60-day advance notice requirement, which will be decided separately. The document mentions the possibility of legal challenges but notes that LA's operations are exempt from environmental and historic preservation reporting.

Santa Maria Valley Railroad, LLC (SMVR), which is not currently a rail carrier, plans to acquire and operate two rail lines in Santa Barbara County, California. They intend to: (1) buy a line from Coast Belle Rail, LLC, and (2) take over the operation of another line leased from Union Pacific Railroad Company. This change means that SMVR will take over from Coast Belle as the common carrier, but their revenues are expected to remain under $5 million. The transaction is anticipated to start on or after April 12, 2025, and is exempt from certain environmental and historic preservation reviews.

The Food and Drug Administration (FDA) has sent a proposed information collection to the Office of Management and Budget (OMB) as part of the Paperwork Reduction Act of 1995. This proposal concerns the process of submitting petitions to reclassify medical devices, which involves determining the level of regulatory control necessary for a device to be safe and effective. The FDA has outlined specific rules and formats for these reclassification petitions. The proposal, which shows an increase in submissions and associated workload, is open for public comments until January 17, 2025.