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🚧PHMSA Extends Comment Period for Hazardous Materials Regulations

On October 28, 2024, PHMSA published a notice of proposed rulemaking (NPRM) titled "Hazardous Materials: Advancing Safety of Highway, Rail, and Vessel Transportation (HM-265)," proposing amendments to the Hazardous Materials Regulations (HMR) to adopt several modal-specific amendments that would enhance the safe transportation of hazardous materials in commerce by highway, rail, and vessel transportation. In response to a request for an extension of the comment period submitted by the Railway Supply Institute (RSI), PHMSA is extending the comment period for the HM-265 NPRM by an additional 90 days.

✈️New FAA Regulations on Instrument Approach Procedures Effective 2025

This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPS) and associated Takeoff Minimums and Obstacle Departure procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

🩺FDA Draft Guidance on Pulse Oximeters for Regulatory Compliance

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Pulse Oximeters for Medical Purposes--Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations." This draft guidance document, when finalized, will provide recommendations regarding non-clinical and clinical performance testing of certain pulse oximeters for medical purposes, including devices with a pulse oximeter function that estimates the amount of oxygen in arterial blood and pulse rate. These recommendations are being proposed based in part on concerns that the accuracy of pulse oximeters can be affected by, among other factors, a person's skin pigmentation. The recommendations are being proposed to inform the performance evaluation for these devices, to support premarket submissions, regardless of submission type, and to promote consistency and facilitate efficient review of these submissions. Among other topics, the draft guidance also proposes recommendations for labeling, which are intended to promote the safe and effective use of pulse oximeters and help users understand the benefits and risks associated with the use of the device. This draft guidance is not final nor is it for implementation at this time.

💼NIH Notice

📦USPS Notice on Priority Mail Express and Negotiated Service Agreement

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

⚡Combined Notice of Filings

💼NIH Closed Meetings for Grant Applications in 2025

💼NIH Closed Meeting on Drug Research Contract Proposals Notification

📦Postal Service Announces Priority Mail and Ground Advantage Changes

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

⚖️FDA Guidance on Evaluating Food Allergen Public Health Importance

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for FDA staff and interested parties entitled "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 document provides our current thinking on the approach we generally intend to take when we evaluate the public health importance of a food allergen other than one of the major food allergens (i.e., milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybean, and sesame) listed in the Federal Food, Drug, and Cosmetic Act (FD&C Act).