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The Food and Drug Administration (FDA) has decided that the drug NYMALIZE (nimodipine), oral solution at a strength of 3 mg/mL, was not taken off the market for safety or effectiveness reasons. This decision enables the approval of generic versions of this drug, provided they meet other requirements. Although the 3 mg/mL version was discontinued, the FDA believes it would still be safe and effective if sold today, but suggests making some labeling changes to prevent confusion with another version that is 6 mg/mL.

Sonoma-Marin Area Rail Transit District (SMART), a Class III rail carrier, has filed for an exemption to acquire and operate an 87.65-mile rail line from North Coast Railroad Authority (NCRA) in California. The transaction allows SMART to be the freight operator using a noncarrier contract operator and is expected to be completed on or after March 4, 2021. SMART assures that its annual revenues from the deal will not exceed $5 million and that there are no agreements limiting future connections with other carriers. This transaction is mostly exempt from environmental and historic preservation reviews.

Mingus Mountain Railroad, LLC (MMRL) has filed a notice to acquire and operate a 38.74-mile rail line from Clarkdale Arizona Central Railroad, L.C. (CACR) in Arizona. MMRL is not a carrier yet but plans to run regular train services and acquire additional trackage rights after this transaction, becoming a Class III rail carrier. They assure that their annual earnings will not exceed $5 million, preventing them from becoming a larger Class I or II carrier. The transaction could be finalized by March 30, 2025, unless issues arise with the details provided in the notice.

The U.S. Department of Agriculture (USDA) has introduced an interim rule to help quantify, report, and verify greenhouse gas emissions linked with the production of biofuel feedstock crops grown using climate-smart agriculture (CSA) practices. This rule is part of an effort to provide standardized guidelines for farmers and other entities within the biofuel supply chain, aiming to boost participation in environmental service markets. By offering a more uniform approach, the USDA hopes to increase transparency and efficiency in tracking reduced-carbon intensity crops, potentially enhancing environmental benefits and market opportunities. Comments from the public will be considered by the USDA as they seek to finalize the rule, which remains open for feedback until March 18, 2025.

Farmrail System, Inc. has submitted a notice of exemption to continue controlling Land Rush Rail Corporation (LRRC) once LRRC becomes a Class III railroad. This relates to LRRC's plan to lease and operate a rail line owned by the Oklahoma Department of Transportation and Blackwell Industrial Authority. The line does not connect with Farmrail's other railroads, which exempts it from certain approval requirements. The transaction involves Class III carriers only, meaning employee labor protections typically required for larger transactions do not apply. If all information is accurate, the earliest the transaction may proceed is March 20, 2025.

The Postal Regulatory Commission has announced a recent filing by the Postal Service regarding a negotiated service agreement. The public is informed about this filing and can submit their comments until December 9, 2024. The document lists various requests by the USPS to add or amend contracts to the Competitive Product List, and details the public proceedings for each request, including docket numbers, filing titles, acceptance dates, and public representatives involved. This notice will be published in the Federal Register.

Kansas City West Bottoms Railroad, LLC (KCWB) is planning to lease and operate a section of railroad track from Union Pacific Railroad Company in the Kansas City area. The agreement will involve the State Line Yard Tracks and a portion of the KC Metro Big Mary Subdivision between two mileposts. This transaction is pending exemption approval and is part of a larger plan involving Jaguar companies, which intend to manage KCWB as a Class III rail carrier. The transaction is expected to be finalized after March 5, 2025, provided all legal requirements are met and any exemptions are not revoked.

BNSF Railway Company has filed a notice of exemption to obtain temporary, restricted trackage rights over two rail lines owned by Union Pacific Railroad Company in California. These trackage rights will allow BNSF to transport empty and loaded ballast trains to and from a ballast pit near the lines. The agreement for these rights is set to expire on December 31, 2025. The Surface Transportation Board is handling this case, and interested parties may file relevant petitions or documents related to this matter.

The Food and Drug Administration (FDA) has released a final guidance document on marketing submissions for devices with artificial intelligence-enabled software. This guidance provides recommendations for including a Predetermined Change Control Plan (PCCP) in submissions, which outlines planned AI software modifications, their development and validation, and their potential impact. The FDA aims to streamline the approval process for such modifications by avoiding repeated marketing submissions while ensuring device safety and effectiveness. The guidance reflects the FDA's efforts to regulate AI-enabled medical device software innovatively and effectively.

OPSEU Pension Plan Trust Fund, Jaguar Transport Holdings, LLC, and Jaguar Rail Holdings, LLC have applied for permission to continue overseeing Kansas City West Bottoms Railroad, LLC, once it starts operating as a Class III rail carrier. This exemption would allow Kansas City West Bottoms Railroad to take over a short stretch of rail line from its current operator, Union Pacific Railroad Company, without needing additional approvals. The transaction, which doesn’t involve connecting to other Jaguar-owned railroads or using a Class I carrier, is set to become effective on March 5, 2025. It's also noted that the action doesn't require an environmental or historic preservation review.