Regulatory Compliance, Business Operations 7 Jan 2025 regulatory compliance, postal service, shipping, priority mail, business agreements

📦Notice on Priority Mail Express and USPS 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.

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Regulatory Compliance, Business Operations 7 Jan 2025 regulatory compliance, postal service, shipping, negotiation, business

📦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.

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Compliance, Regulatory Requirements 7 Jan 2025 regulatory compliance, fda, medical devices, clinical studies, gender-specific data

⚖️FDA Guidance on Sex-Specific Data in Medical Device Studies

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Evaluation of Sex- Specific and Gender-Specific Data in Medical Device Clinical Studies." This document provides guidance on the study and evaluation of sex- and/or gender-specific data in clinical investigations or research involving one or more subjects to determine the safety or effectiveness of a device. The purpose of this guidance is to encourage science- driven consideration of sex and/or gender, as appropriate for both the scientific question being addressed and the intended use of the device, when designing medical device clinical studies and reporting data from such studies in accordance with legal requirements. This draft guidance is not final nor is it for implementation at this time.

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Compliance, Regulatory Requirements 7 Jan 2025 regulatory compliance, fda, human cells, health industry, tissues, draft guidances

🩺FDA Draft Guidance on Reducing Disease Transmission Risks in HCT/Ps

The Food and Drug Administration (FDA or Agency) is announcing the availability of three specific draft guidances for industry entitled "Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps);" "Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps);" and "Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." These draft guidances are intended to update existing guidances and to assist establishments making donor eligibility determinations in understanding the requirements for determining donor eligibility, including donor screening and testing, for donors of HCT/Ps. These draft guidances are also intended to provide establishments making donor eligibility determinations with recommendations to reduce the risk of transmission of specific communicable disease agents and diseases, specifically, hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV), by HCT/Ps.

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Compliance, Regulatory Requirements, Operational Efficiency 7 Jan 2025 regulatory compliance, spent fuel storage, nuclear regulatory commission, exemption, cask system, constellations energy generation

⚛️NRC Grants Exemption for Constellation

The U.S. Nuclear Regulatory Commission (NRC) issued an exemption to Constellation Energy Generation, LLC, permitting LaSalle County Station (LSCS) to maintain four loaded and to load four new 68M multi-purpose canister with continuous basket shims in HI-STORM 100 Cask System at its LSCS Units 1 and 2 independent spent fuel storage installation in a storage condition where the terms, conditions, and specifications in the Certificate of Compliance No. 1014, Amendment No. 8, Revision No. 1, are not met.

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Compliance, Financial Impact, Regulatory Change 7 Jan 2025 regulatory compliance, postal service, negotiated service agreements, shipping, business contracts

📦USPS Notice on New Priority Mail Express 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.

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Regulatory Compliance, Humanitarian Services 7 Jan 2025 regulatory compliance, immigration, department of health and human services, office of refugee resettlement, unaccompanied children
Regulatory Changes, Market Trends 7 Jan 2025 regulatory compliance, postal service, logistics, shipping, business agreements

📦USPS Notice

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.

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Regulatory Requirements, Business Operations 7 Jan 2025 regulatory compliance, postal service, shipping agreements, business logistics

📦New USPS Priority Mail Contract Notice for Businesses 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.

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Regulatory Requirement, Business Agreement 7 Jan 2025 regulatory compliance, postal service, shipping, usps, business agreements

📦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.

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