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📊Court Decision Correction on Tapered Roller Bearing Tariffs

On December 31, 2024, the U.S. Department of Commerce (Commerce) published in the Federal Register the amended final results of the 2018-2019 administrative review of the antidumping duty (AD) order on tapered roller bearings and parts from the People's Republic of China (China). This notice incorrectly stated that for the non- selected companies that do not have a superseding cash deposit rate, Commerce will issue revised cash deposit instructions through U.S. Customs and Border Protection (CBP).

⚖️DEA Notice

Invizyne Technologies, Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

⚠️EPA Proposes TRI Regulations Affecting PFAS Compliance for Businesses

The National Defense Authorization Act for Fiscal Year 2020 (NDAA) adds certain per- and polyfluoroalkyl substances (PFAS) automatically to the Toxics Release Inventory (TRI) beginning January 1 of the year following specific triggering events. The Environmental Protection Agency (EPA or Agency) is proposing to make conforming edits to the TRI regulation to explicitly include PFAS that are added to the TRI chemical list automatically pursuant to the NDAA in the regulation's definition of "toxic chemical." This edit confirms that the TRI supplier notification provision requires covered suppliers to notify customers receiving a mixture or other trade name product containing a TRI-listed chemical with the first shipment of each calendar year, with such a requirement beginning on January 1 of the applicable year; thus, supplier notifications are required as of January 1 for any NDAA-added PFAS.

🔗RFI on Domestic Semiconductor Manufacturing & Procurement Strategies

This request for information (RFI) seeks input on ways the Federal Government can build the resilience of domestic semiconductor manufacturing and maintain this essential capability through the procurement of commercial IT end products that include semiconductors fabricated in the United States. Specific feedback is sought on potential procurement approaches to minimize supply chain disruption and increase fabrication of semiconductors in the United States.

🏭Subzone Status Approved for True Manufacturing in Missouri

⚖️EPA Proposes Regulation for C.I. Pigment

The Environmental Protection Agency (EPA or Agency) is proposing to address the unreasonable risk of injury to human health presented by C.I. Pigment Violet 29 (CASRN 81-33-4, also known as PV29), under its conditions of use as documented in EPA's January 2021 Risk Evaluation for PV29 and the September 2022 Revised Risk Determination for PV29 prepared under TSCA. TSCA requires that EPA address by rule any unreasonable risk of injury to health or the environment identified in a TSCA risk evaluation and apply requirements to the extent necessary so the chemical no longer presents unreasonable risk. To address the identified unreasonable risk, EPA is proposing requirements to protect workers from the unreasonable risk of PV29 during manufacturing and processing, certain industrial and commercial uses of the chemical, and disposal, while also allowing for a reasonable transition period prior to enforcement of said requirements.

📜FDA Guidance on Device Manufacturing Discontinuances and Notifications

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act." This guidance updates the previous version of the guidance, of the same title, issued on November 17, 2023, and finalizes the concurrently issued draft guidance entitled "Select Updates for the 506J Guidance: 506J Device List and Additional Notifications." This guidance finalizes a list of device product codes for which a manufacturer of such devices is required to notify FDA in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) (hereafter referred to as the "506J Device List") and clarifies that manufacturers may submit voluntary notifications regarding supply chain issues at any time, unrelated to the declaration or potential declaration of a public health emergency (PHE).

💊FDA Draft Guidance on Complying with 21 CFR 211.110 Available

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Considerations for Complying With 21 CFR 211.110." This guidance, when finalized, will describe considerations for complying with the requirements for ensuring batch uniformity and drug product integrity. In addition, this guidance discusses related quality considerations for drug products that are manufactured using advanced manufacturing. FDA is committed to supporting and enabling pharmaceutical innovation and modernization as part of the Agency's mission to protect and promote the public health. FDA encourages industry representatives and manufactures who are interested in using innovative control strategies to contact the Agency.

🏭GoPro's Proposed Production Activity in Foreign-Trade Zone 29

📊Antidumping Duty Order on Welded Pipe from Japan – Implications

The U.S. Department of Commerce (Commerce) finds that revocation of the antidumping duty (AD) order on welded large diameter line pipe (line pipe) from Japan would be likely to lead to continuation or recurrence of dumping at the levels indicated in the "Final Results of Sunset Review" section of this notice.