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The Food and Drug Administration (FDA) has released a final guidance document titled "Validation and Verification of Analytical Testing Methods Used for Tobacco Products." This guidance aims to help manufacturers of tobacco products ensure that their testing methods for ingredients, constituents, and additives are consistent, reliable, and suitable for regulatory submissions. The document outlines best practices in analytical testing, including validation and verification of methods, which are crucial for regulatory compliance concerning new and modified risk tobacco products. The guidance also incorporates feedback from a draft issued in December 2021 and emphasizes the use of standard analytical methods.

The Food and Drug Administration (FDA) has submitted a proposal to the Office of Management and Budget (OMB) for review, seeking to extend the collection of information related to drug, biological product, and device applications under the Paperwork Reduction Act. This involves certifications that accompany these submissions to ensure compliance with legal standards, including listing data for clinical trials in a registry. The FDA estimates that it will take approximately 15 to 45 minutes to complete the necessary certification forms, depending on the type of application, and aims to simplify compliance for sponsors and applicants. No public comments were received on this proposal when it was initially published.

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.

Carload Express, Inc., a holding company that manages several rail carriers, filed a petition seeking exemption from prior approval requirements to acquire control of The Maryland and Delaware Railroad Company (MDDE), a Class III rail carrier. The Surface Transportation Board has agreed to grant this exemption, concluding that detailed review is unnecessary and that the acquisition aligns with U.S. rail transportation policy by fostering effective management and reducing regulatory hurdles. The acquisition aims to maintain current service without affecting competition, as MDDE and Delmarva Central Railroad Company, both under Carload’s control, do not serve the same industries and MDDE's connection to the national rail network will remain unchanged. Carload is required to inform shippers along relevant lines about the Board's decision, with the exemption effective from January 31, 2025.

The Food and Drug Administration (FDA) has released a final guidance document titled "Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act." This guidance outlines how the FDA plans to assess the public health significance of food allergens not already classified as major allergens, like milk or peanuts. It focuses mostly on allergies caused by IgE antibodies known to trigger severe allergic reactions. The FDA also made updates in response to feedback, including changes related to non-IgE-mediated allergies and new data references.

RYAL, LLC, a noncarrier company owned by Paul Didelius, has filed for a modified certificate of public convenience and necessity to lease and operate a 26-mile rail line in Washington State. This line is owned by the Port of Royal Slope and was previously leased to WRL, LLC. The line was authorized for abandonment in 1980 but remained operational after being sold to the Port in 1982. There are no subsidies involved, and shippers will not face preconditions for service. RYAL has also provided proof of insurance coverage as part of its filing.

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.

Paul Didelius, a noncarrier individual, has filed a notice to maintain control over RYAL, LLC once it becomes a Class III rail carrier. This is linked to a separate notice for RYAL to lease and operate a 26-mile rail line in Washington. Didelius confirms that none of the rail systems he controls connect physically and that they are all Class III carriers, which exempts the transaction from certain regulatory approvals. The public can file disputes or petitions related to this exemption, but it won't automatically stop the exemption from taking effect.

Strasburg Rail Road Company (SRC), a Class III rail carrier, has filed a notice seeking an exemption to maintain control over a new entity, SRC Railway LLC, as it becomes a rail carrier. Railway LLC plans to lease and operate a 4.25-mile rail line in Lancaster County, Pennsylvania, owned by SRC. This transaction is exempt from certain approval requirements because it involves only Class III carriers, and there is no connection outside the corporate family. The exemption could take effect as soon as January 20, 2021, unless any petitions to revoke it are filed by January 12, 2021.

The Food and Drug Administration (FDA) has released a final guidance for the cosmetic industry titled “Registration and Listing of Cosmetic Product Facilities and Products.” This guidance aims to help companies with the registration and listing process required by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). It includes a draft section in Appendix B with new questions and answers, open for public comment. The guidance underscores that small businesses are exempt from these regulations and invites comments to be submitted by January 13, 2025.