Notice 7 Jan 2025 compliance, information collection, atf, department of justice, firearms training

📄DOJ Notice on Firearm Training Request Information Collection

The Department of Justice (DOJ), The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

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Compliance, Regulatory, Defense 7 Jan 2025 compliance, china, business regulation, defense, national security, military

⚔️Notice of Chinese Military Companies and Its Business Implications

The Deputy Secretary of Defense has determined that the entities listed in the SUPPLEMENTARY INFORMATION section of this notice qualify as "Chinese military companies" in accordance with the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021.

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Compliance, Regulatory 7 Jan 2025 compliance, information collection, reporting requirements, federal energy regulatory commission, energy industry, electric reliability organization

⚡FERC-725 Notice

In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection, FERC 725, Certification of Electric Reliability Organization; Procedures for Electric Reliability Standards. There were no changes made to the reporting requirements for this information collection.

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Regulatory Compliance, Trade Policy 7 Jan 2025 compliance, international trade, antidumping, trade regulations, innerspring units, us commerce department

📈Antidumping Duty Orders on Innerspring Units

As a result of these expedited sunset reviews, the U.S. Department of Commerce (Commerce) finds that revocation of the antidumping duty (AD) orders on uncovered innerspring units (innersprings) from the People's Republic of China (China), the Socialist Republic of Vietnam (Vietnam), and South Africa would be likely to lead to the continuation or recurrence of dumping at the levels indicated in the "Final Results of Sunset Reviews" section of this notice.

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Compliance, Regulatory Requirements 7 Jan 2025 compliance, fda, guidance, human cells, tissue products, sepsis

⚠️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.

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Compliance, Economic Development 7 Jan 2025 compliance, energy, environmental assessment, virginia, hydroelectric project, ferc
Compliance, Regulatory Requirements 7 Jan 2025 compliance, department of energy, energy conservation, walk-in coolers, walk-in freezers, regulatory standards
Compliance, Regulatory 7 Jan 2025 compliance, fda, ai-enabled devices, marketing submission, lifecycle management

📄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.

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Compliance, Regulation, Environmental Policy 7 Jan 2025 compliance, environmental impact, land use, regulations, wilderness areas, national parks

🌲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.

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Compliance, Regulatory Requirements 7 Jan 2025 compliance, regulations, fda, supply chain, manufacturing, medical devices

📜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).

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