Search Results for keywords:"Regulatory Requirements"

The Food and Drug Administration (FDA) has announced the availability of a draft guidance titled "Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease." This guidance focuses on policy for genomic alterations in animals like swine and rabbits, which are used as models for human or animal diseases in biomedical research. The FDA may not require developers of these altered animals to submit an application for approval if the risk factors have been reviewed and are determined to be manageable. The public can submit comments about this draft guidance electronically or in writing until March 10, 2025.

The Foreign-Trade Zones Board authorized a production activity for Renaissance Lakewood, LLC in Lakewood, New Jersey, located in Foreign-Trade Zone 235. This decision came after the Township of Lakewood submitted a proposal on September 30, 2024, which followed all regulatory requirements, including public comment solicitation. On January 28, 2025, it was confirmed that no further review was necessary, and the planned activities were approved under applicable laws and regulations.

The Federal Aviation Administration (FAA) has issued a new airworthiness directive (AD) for certain Daher Aerospace Model TBM 700 airplanes due to reports of wear in the inner flap actuator drive nut. This directive requires operators to clean and lubricate the internal actuator rods, and measure and replace the drive nuts if necessary, to maintain the airplane's safety and control. The AD is effective March 11, 2025, and aims to prevent potential loss of flap control, which could lead to reduced or loss of control of the airplane.

The Coast Guard has established a new anchorage ground near Rice Island on the Lower Columbia River to enhance navigation safety by creating more space for commercial vessels to anchor. This rule, set to be effective from January 15, 2025, comes in response to increased commercial traffic in the area. During the review process, 42 comments were received, addressing concerns like the depth of the anchorage ground and potential environmental impacts on species such as the Green Sturgeon. The Coast Guard assessed regulatory requirements and determined that this new anchorage ground would not have significant economic or environmental impacts.