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⚠️FDA Guidance to Reduce Sepsis Risk in Human Cells and Tissues

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for immediate implementation entitled "Recommendations To Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." FDA is issuing this guidance to provide establishments making donor eligibility determinations with recommendations to reduce the risk of transmission of infections due to sepsis by HCT/Ps. This notice is being issued to respond to a public health safety concern and to address the urgent need for updated recommendations in making a donor eligibility determination when screening a donor for clinical evidence of sepsis and clinical signs to consider.

⚖️Compliance Requirements for Off-the-Record Communications Notice

📦Postal Service Notice on Priority Mail Express and USPS 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.

📦Postal Service Announces Change in Shipping Services 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.

🌊Environmental Assessment Notification for Hydro Generation Licensing

📦USPS Announces Priority Mail and Ground Advantage Contract 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 Unapproved Medical Product Communications

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers." This guidance describes FDA's enforcement policy regarding certain firm-initiated communications of scientific information on unapproved use(s) of the firm's approved/ cleared medical products to health care providers (HCPs) engaged in prescribing or administering medical products to individual patients. This guidance finalizes the revised draft guidance of the same title issued in October 2023. The October 2023 revised draft guidance revised and replaced the draft guidance entitled "Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices," issued in March 2014, which itself revised the final guidance entitled "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices," issued in January 2009. This guidance is not for current implementation, pending the Office of Management and Budget's (OMB's) decision on the collection of information.

📦USPS Product Change Notice for Priority Mail Services (2025)

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.

⚡Correction of Energy Conservation Standards for Walk-In Coolers

🌿Business Implications of Ute Ladies'-Tresses Delisting Proposal

We, the U.S. Fish and Wildlife Service (Service), propose to remove Ute ladies'-tresses (Spiranthes diluvialis) from the Federal List of Endangered and Threatened Plants. This determination also serves as our 12-month finding on a petition to delist Ute ladies'- tresses. After a review of the best available scientific and commercial information, we find that delisting the species is warranted. Our review indicates that the threats to Ute ladies'-tresses have been eliminated or reduced to the point that the species no longer meets the definition of an endangered or threatened species under the Endangered Species Act of 1973, as amended (Act). Accordingly, we propose to delist Ute ladies'-tresses. If we finalize this rule as proposed, the prohibitions and conservation measures provided by the Act, particularly through sections 7 and 9, would no longer apply to Ute ladies'-tresses. We request information and comments from the public regarding this proposed rule and the draft post-delisting monitoring (PDM) plan for Ute ladies'-tresses.