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⚡Correction of Energy Conservation Standards for Walk-In Coolers

📄FDA Draft Guidance on AI-Enabled Device Software Functions

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Artificial Intelligence Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations." This draft guidance, when finalized, will provide recommendations regarding the contents of marketing submissions for devices that include artificial intelligence (AI)-enabled device software functions including documentation and information that will support FDA's evaluation of safety and effectiveness. To support the development of appropriate documentation for FDA's assessment of the device, this draft guidance also proposes recommendations for the design, development, and implementation of AI- enabled devices that sponsors may wish to consider using throughout the total product lifecycle (TPLC). This draft guidance is not final nor is it for implementation at this time.

🌲Wilderness Area Assessments

Pursuant to the Wilderness Act of 1964, and in accordance with National Park Service (NPS) Management Policies 2006, the NPS intends to evaluate all previously unassessed lands within the following parks for their eligibility for inclusion in the national wilderness preservation system: Chattahoochee River National Recreation Area, Everglades National Park, Gulf Islands National Seashore, Jean Lafitte National Historical Park and Preserve, Little River Canyon National Preserve, and Virgin Islands National Park.

📜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previous version of the guidance, of the same title, issued on November 17, 2023, and finalizes the concurrently issued draft guidance entitled "Select Updates for the 506J Guidance: 506J Device List and Additional Notifications."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).

⚖️Notice of Water Quality Certification for Northern States Power Project

🏥FDA Issues Interim Guidance on Compounding Bulk Drug Substances

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act." This guidance describes FDA's interim regulatory policy concerning compounding by outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that outsourcing facilities can use in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.

🏥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.

🤖FDA Draft Guidance on AI Use in Drug Regulation Available for Comments

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products." In accordance with its mission of protecting, promoting, and advancing public health, FDA's Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Veterinary Medicine (CVM), the Oncology Center of Excellence (OCE), the Office of Combination Products (OCP), and the Office of Inspections and Investigations (OII), is issuing this draft guidance to provide recommendations to industry on the use of artificial intelligence (AI) to produce information or data intended to support regulatory decision-making regarding the safety, effectiveness, or quality for drug and biological products.

🌊Incidental Take Authorization for Hoonah Cargo Dock Project

NMFS has received a request from the City of Hoonah (Hoonah) for authorization to take marine mammals incidental to pile driving and removal activities associated with the Hoonah Cargo Dock project in Hoonah, Alaska. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-time, 1-year renewal that could be issued under certain circumstances and if all requirements are met. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorization and agency responses will be summarized in the final notice of our decision.

📄PCAOB Amendment Impacts on Registration Compliance for Firms