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The Food and Drug Administration (FDA) has issued a final rule establishing new guidelines for nonprescription drugs that require an "Additional Condition for Nonprescription Use" (ACNU). This rule allows drugs that can't be safely used with labeling alone to be sold without a prescription if the manufacturer implements an approved ACNU to ensure proper use. It aims to expand consumer access to certain drugs that would otherwise need a prescription and outlines specific requirements for drug application, labeling, and reporting failures of the ACNU process. The rule will take effect on January 27, 2025, and is intended to improve public health by making more medications safely available as nonprescription options.

Land Rush Rail Corporation (LRRC), a non-carrier company, filed for an exemption to lease and operate a 37.26-mile rail line in Kansas and Oklahoma, previously under Blackwell Northern Gateway Railroad's control. This transition follows a Federal Railroad Administration emergency order that stopped BNGR's operations, granting a temporary license to Chicago, Rock Island & Pacific Railroad to manage the line. LRRC's annual revenue from this transaction is projected not to exceed $5 million, and the transaction may proceed on or after March 20, 2025, unless revoked. The exemption is categorized as environmentally and historically negligible, exempting it from broader regulatory reviews.

The Department of Health and Human Services has issued a notice clarifying that businesses that started producing hand sanitizers during the COVID-19 pandemic are not required to pay certain facility fees under the Food, Drug, and Cosmetic Act. These businesses, many of which normally produce alcoholic beverages, were allowed to make hand sanitizers due to a temporary policy by the FDA to address shortages. The Department emphasizes that imposing such fees would be inconsistent with the intent of the CARES Act and clarifies that these businesses are not considered drug manufacturing facilities under the law, unless they also engage in producing other over-the-counter drugs.

San Joaquin Valley Railroad Co. (SJVR) has filed for an exemption to continue leasing and operating 101.5 miles of rail lines from Union Pacific Railroad Company. This lease, initially established in 1994 and most recently renewed in 2020, has been extended by a Lease Amendment signed in January 2025, allowing operations to continue for another five years. SJVR's notice also requests a waiver for a 60-day advance notice to labor unions, which will be decided separately. Moreover, SJVR confirms that its projected revenues will not exceed the limit set for a Class III carrier, despite current revenues being over $5 million.

Arkansas Southern Railroad, L.L.C. (ARS) has filed for an exemption to extend and amend its lease agreements with The Kansas City Southern Railway Company (KCS) for two railroad lines. The amendments, agreed upon in July 2020, will extend the lease until November 30, 2034, and include a commitment related to train interchange. ARS confirms this transaction won't increase their annual revenues beyond $5 million or change their carrier classification. Petitions to challenge the exemption can be submitted, with the earliest transaction effective date being March 14, 2021.

Dover and Delaware River Railroad, LLC (DDRR), a small railway company, plans to amend its lease agreement with Norfolk Southern Railway Company. This change will not turn DDRR into a larger rail carrier and will involve an interchange commitment. The transaction is set to take effect on January 16, 2025, and people can contest it by filing petitions before that date. The project is exempt from environmental and historical reviews, according to federal regulations.

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.

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.

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.