News & Analysis as of

Suppliers Reporting Requirements

Wiley Rein LLP

FCC Bans “Bad Labs” Connected to Foreign Adversaries, Seeks Comment on Additional Restrictions for Equipment Authorization Program

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Continuing its efforts under Chairman Brendan Carr’s leadership to safeguard United States communications infrastructure from foreign threats, the Federal Communications Commission (FCC or Commission) adopted an Order and...more

Axinn, Veltrop & Harkrider LLP

FTC Finalizes Long-Awaited HSR Overhaul

The long-awaited new HSR rules and Form have been released. They go into effect in approximately 90 days (mid-January), unless blocked by a federal judge. Companies engaging in M&A now face increased burdens compared to the...more

Nilan Johnson Lewis PA

PFAS Reporting Requirements at the Federal and State Level – How Will Manufacturers Respond? – Part 4 of 10

Part 4. PFAS Reporting Requirements at the Federal and State Level – How Will Manufacturers Respond? Per- and polyfluoroalkyl substances, known by the acronym PFAS and better known by the moniker “forever chemicals,” are...more

Fox Rothschild LLP

EPA Finalizes Rule Removing De Minimis Exemptions, Subjecting Companies to Enhanced PFAS Reporting and Notification Requirements

Fox Rothschild LLP on

We reported earlier this year that the Environmental Protection Agency’s (EPA) proposed rule would require stricter (1) reporting of perfluoroalkyl and polyfluoroalkyl substances (PFAS) to the Toxics Release Inventory (TRI)...more

Miller Canfield

Fighting Against Forced Labour and Child Labour in Supply Chains

Miller Canfield on

The Fighting Against Forced Labour and Child Labour in Supply Chains Act will take effect on January 1, 2024, requiring certain organizations in Canada that are involved in the production or distribution of goods to submit a...more

Farella Braun + Martel LLP

Life Is Too Short for Bad Wine Distribution Agreements: 10 Key Considerations

If you are like most wine brands, DTC through your tasting room, club, and website can only take you so far. Success usually means accessing the general on- and off-premise markets, and accessing those markets means working...more

Goodwin

Field Alert Reporting: Supplier Contracting Implications for Drug Developers

Goodwin on

For emerging companies establishing their first supply chains, ensuring notification requirements in supply agreements for when commercial-stage manufacturing issues arise may not be top of mind. However, it is important for...more

Morrison & Foerster LLP

German Federal Government Agrees On Act On Human Rights Due Diligence Obligations Of Companies

On March 3, 2021, the German Federal Cabinet adopted an act on corporate due diligence obligations in supply chains (“Due Diligence Act”; sometimes also referred to as “Supply Chain Act”) (“Government Draft”). The Government...more

Sheppard Mullin Richter & Hampton LLP

Made in America – President Biden’s Executive Order on Buying (Even More?) American

On January 25, 2021, President Joe Biden signed an Executive Order on “Ensuring the Future is Made in All of America by All of America’s Workers,” laying his administration’s foundation for further strengthening Buy American...more

Hogan Lovells

FDA explains how EUA medical devices can electronically comply with AE reporting requirements

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On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance...more

Society of Corporate Compliance and Ethics...

Chemical Watch releases report on regulatory developments in the electronics industry

Report on Supply Chain Compliance 3, no. 11 (May 28, 2020) - A free report details some of the developments within the electronics industry during the COVID-19 pandemic. According to the report...more

Foley & Lardner LLP

Managing the Commercial Impact of the Coronavirus: An Effective Supply Chain Response Plan

Foley & Lardner LLP on

...The coronavirus (provisionally named SARS-CoV-2, with its disease being named COVID-19) has now been documented in six of the world’s seven continents, with more than 80,000 cases, sparing only Antarctica. Closer to home,...more

Stinson LLP

The Impact of the Coronavirus on the Global Supply Chain

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At the end of December, China acknowledged the existence of the coronavirus, and this burgeoning heath crisis is becoming a supply chain problem. China, a major manufacturing hub for materials, products and components being...more

Holland & Knight LLP

Government Contractors Subject to New Counterfeit Parts Reporting Requirements

Holland & Knight LLP on

A new Federal Acquisition Regulation (FAR), "Reporting of Nonconforming Items to the Government Industry Data Exchange Program," will become effective on December 23, 2019. The new FAR provision (FAR 46.317) and clause (FAR...more

Stinson - Government Contracting Matters

Final FAR Rule Mandating GIDEP Reporting of Actual or Suspected Counterfeit Parts Issued: More Questions Than Answers

Supply chain risks are on the rise. Protecting the supply chain is a critical aspect of our national security, health and public safety. Whether parts are electronic or not, if they aren’t what they are represented to be,...more

Baker Donelson

Adverse Action Reporting – Avoid Medicare Enrollment Denial or Revocation

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CMS revised its policy guidance regarding adverse action reporting requirements once again in the Medicare Program Integrity Manual (MPIM) Transmittal 865. This guidance is arguably inconsistent with the regulations and with...more

Foley & Lardner LLP

HHS to Collect Data From the EMS System: Good Time to Examine Accounting, Cost, Billing, and Collection Systems

Foley & Lardner LLP on

While recent legislation impacting the Emergency Medical Services (EMS)/ambulance industry drew attention inside the industry for its reduction in Health and Human Services’ (HHS) spend on non-emergent dialysis transports and...more

Hogan Lovells

Corporate News - February 2017

Hogan Lovells on

A monthly newsletter covering topics of interest in the field of UK corporate law including mergers and acquisitions, listed companies, equity capital markets, corporate governance and general company law. ...more

Womble Bond Dickinson

Next Steps: Helping Your Organization Implement the New Medicare Overpayment Rule - Part II

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On February 12, 2016, the Centers for Medicare & Medicaid Services (“CMS”) published a final rule that explains the requirements for providers and suppliers reporting and returning overpayments under Medicare Parts A & B (the...more

Womble Bond Dickinson

Next Steps: Helping Your Organization Implement the New Medicare Overpayment Rule - Part I

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On February 12, 2016, the Centers for Medicare & Medicaid Services (“CMS”) published a final rule that explains the requirements for providers and suppliers reporting and returning overpayments under Medicare Parts A & B (the...more

Williams Mullen

CMS Clarifies 60-Day Reporting Requirements For Medicare Parts A & B

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The Centers for Medicare and Medicaid Services (“CMS”) has clarified the reporting requirements and lookback period for overpayments from Medicare Parts A and B in Final Rule 6037 (“Final Rule”), issued by CMS on February 12,...more

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