📦Proposed Rule to Revise Hazardous Materials Regulations for Carriers
This NPRM proposes to revise the Hazardous Materials Regulations (HMR) to provide domestic carriers the option to maintain electronic copies of emergency response information rather than requiring a hard copy printed on paper.
Learn More🚚Proposed Rulemaking for Hazardous Materials Transportation Regulations
This NPRM proposes to adopt the provisions of DOT special permit (SP) 21379 into the hazardous materials regulations to streamline the transportation of large refrigerating machines filled with flammable gases.
Learn More🚛Proposed Rule to Simplify Hazardous Materials Regulations
This NPRM proposes to revise the Hazardous Materials Regulations (HMR) to remove redundant pages contained in an Appendix that repeats references already listed in U.S. Environmental Protection Agency (EPA) regulations.
Learn More🌾Proposed Rule to Reduce Hazardous Materials Training Burdens for Farmers
This NPRM proposes to streamline the exceptions for in-depth security training requirements for farmers by raising the dollar amount of the exception threshold to account for inflation.
Learn More🧬FDA Classifies Fluorescence Devices for Hematologic Malignancies
The Food and Drug Administration (FDA, the Agency, or we) is classifying the fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More🚂Regulatory Changes on LNG Transportation - Business Implications
PHMSA, in coordination with the Federal Railroad Administration, is amending the Hazardous Materials Regulations in response to the recent decision of the United States Court of Appeals for the District of Columbia Circuit in Sierra Club, et al. v. DOT, et al., No. 20-1317 (Jan. 17, 2025).
Learn More🌱Overview of Amendments to Genetically Engineered Organism Regulations
On December 2, 2024, a Federal court vacated the Animal and Plant Health Inspection Service (APHIS) final rule issued on May 18, 2020 (the May 2020 final rule) that revised APHIS' regulations governing the movement of certain genetically modified organisms and was issued under the authority of the Plant Protection Act. APHIS is therefore amending the CFR to conform the CFR to the Federal Court's vacatur of that rule. The Court's vacatur was effective December 2, 2024, and had the legal effect of vacating the May 2020 final rule in its entirety and restoring the legal effect of the pre-May 2020 regulations. These technical conforming amendments revise the CFR to reflect the court's vacatur of the May 2020 final rule.
Learn More🧬FDA Proposes Reclassification of Hematology Devices Affecting ISH Systems
The Food and Drug Administration (FDA) is proposing to reclassify in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation, along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for this device type.
Learn More⚙️FDA Classifies Coagulation System for Blood Measurement Devices
The Food and Drug Administration (FDA, Agency, or we) is classifying the coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More🍷New TTB Proposal for Major Food Allergen Labeling in Alcohol Beverages
The Alcohol and Tobacco Tax and Trade Bureau (TTB) proposes to require a labeling disclosure of all major food allergens used in the production of alcohol beverages subject to TTB's regulatory authority under the Federal Alcohol Administration Act. Under the proposed regulations, unless an exception applies, labels must declare milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame, as well as ingredients that contain protein derived from these foods, if used in the production of the alcohol beverage. TTB proposes a compliance date of 5 years from the date that a final rule resulting from this proposal is published in the Federal Register.
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