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🦠FDA Guidance on Reducing Mycobacterium Tuberculosis Transmission Risks

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for immediate implementation entitled "Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." FDA is issuing this guidance to assist establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations for screening donors for evidence of, and risk factors for, infection with Mycobacterium tuberculosis (Mtb), the organism that causes tuberculosis. The guidance also recommends additional steps that HCT/P establishments should take to reduce risk of transmission of Mtb until such time as appropriate FDA-licensed, approved, or cleared donor screening tests are available for use to test donors for Mtb infection. The guidance identifies Mtb as a relevant communicable disease agent or disease (RCDAD) and supplements the recommendations contained in other donor eligibility guidance documents for donors of HCT/Ps. This guidance is being issued to address the urgent public health need to reduce the risk of transmission of Mtb by HCT/Ps.

✈️FAA Proposes Airspace Modification for Battle Mountain Airport

This action proposes to modify the Class E airspace area designated as surface area, establish a Class E airspace area designated as an extension to a Class D or Class E surface area, modify Class E airspace extending upward from 700 feet above the surface of the earth, and remove Class E airspace extending upward from 1,200 feet above the surface at Battle Mountain Airport, Battle Mountain, NV. Additionally, this action proposes administrative amendments to update the airport's existing Class E airspace legal descriptions. These actions would support the safety and management of instrument flight rules (IFR) operations at the airport.

⚔️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.

⚡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.

📈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.

⚠️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.

🌊Environmental Assessment Notification for Hydro Generation Licensing

⚡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.