News & Analysis as of

Supply Chain Proposed Rules Manufacturers

Katten Muchin Rosenman LLP

FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more

Fox Rothschild LLP

Minnesota Will Continue to Receive Public Comments on Proposed New Rules on PFAS in Products Reporting

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Minnesota’s Pollution Control Agency (MPCA) held a public hearing on May 22, 2025 concerning its proposed rules that would implement PFAS-in-products reporting requirements and associated fees on entities covered by Amara’s...more

Bergeson & Campbell, P.C.

Chemical Product Law and Supply: A Guide to New TSCA

Hello, this is Lynn Bergeson. As many of our listeners may know, we here at Bergeson & Campbell, P.C. recently published a book through the American Bar Association’s Section of Environment, Energy, and Resources, titled...more

Bergeson & Campbell, P.C.

Minnesota Extends Public Comment Period on Proposed PFAS Reporting Rule as Entities Voice Concerns about Compliance with Deadlines...

On May 22, 2025, the Minnesota Pollution Control Agency (MPCA) held a public hearing on its “Proposed Permanent Rules Relating to PFAS in Products; Reporting and Fees” (proposed rule). Administrative Law Judge (ALJ) Jim...more

Morrison & Foerster LLP

So Long, CPSC?

The Trump administration may eliminate the Consumer Product Safety Commission (CPSC), according to a recently leaked draft fiscal year 2026 budget for the Department of Health and Human Services (HHS). This “pre-decisional”...more

Kelley Drye & Warren LLP

Minnesota Proposes Rules for Reporting PFAS-Containing Products by January 2026

On April 21, 2025, the Minnesota Pollution Control Agency (“MPCA” or ​“the Agency”) released proposed rules that if finalized would help effectuate the Gopher State’s ban on per- and polyfluoroalkyl substances (“PFAS”) in...more

Beveridge & Diamond PC

Minnesota Pollution Control Agency Releases Proposed Reporting Rule for PFAS in Products

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The Minnesota Pollution Control Agency (MPCA) is seeking comment on a first-of-its-kind proposed rule that will require manufacturers of products containing intentionally added per- and polyfluoroalkyl substances (PFAS) to...more

Bergeson & Campbell, P.C.

Comments on Minnesota’s Proposed Rule for Reporting Products Containing Intentionally Added PFAS Are Due May 21, 2025

With the January 1, 2026, reporting deadline fast approaching for reporting on products containing intentionally added per- and polyfluoroalkyl substances (PFAS), on April 21, 2025, the Minnesota Pollution Control Agency...more

ArentFox Schiff

As the (Customs and Trade) World Turns: October 2024

ArentFox Schiff on

Welcome to the October 2024 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and...more

Holland & Knight LLP

BIS Proposes Rule to Secure Connected Vehicle Supply Chains from Foreign Adversary Threats: Rule Will Create New Compliance...

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The U.S. Department of Commerce's Bureau of Industry and Security (BIS) issued a Notice of Proposed Rulemaking (Proposed Rule) on Sept. 26, 2024, to address certain undue or unacceptable risks identified in Executive Order...more

King & Spalding

CMS Issues IPPS and LTCH Proposed Rule for FY 2025

King & Spalding on

On April 10, 2024, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) Proposed Rule for Fiscal Year (FY) 2025 (the Proposed Rule). In...more

Sheppard Mullin Richter & Hampton LLP

Should You Be Concerned About Foreign Entities of Concern?

Grants and tax credits, who doesn’t love them? The Bipartisan Infrastructure Law (BIL) is full of them, and, recent Department of Energy (DOE) Notification of a Proposed Interpretive Rule provides guidance on who will get to...more

McCarter & English Blog: Government Contracts...

Back to School: Time to Study the OMB Final Rule Implementing BABA

Just in time for the season of new backpacks, lunch boxes, and school supplies, the Office of Management and Budget (OMB) has assigned some homework to contractors looking to participate in Federal financial assistance...more

Foley & Lardner LLP

Electrified Industrial Policy: IRS Proposed Regulations on Section 30D EV Tax Credits & EV Manufacturing Grants

Foley & Lardner LLP on

The Inflation Reduction Act of 2022 (the “IRA”) and the Infrastructure Investment and Jobs Act of 2021 (the “IIJA”) set in motion an ongoing series of changes that are aimed at transforming, among other things, the automotive...more

Venable LLP

CHIPS Act Rollout Continues as Commerce Department Proposes National Security "Guardrails" on Incentives Program and Flexes...

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In its continuing efforts to strengthen the United States' hand in its ongoing international economic bout with China, the Biden Administration's Department of Commerce last week issued a Notice of Proposed Rulemaking (NPRM)...more

Foley & Lardner LLP

Antitrust: Heightening Expansion, Review, and Enforcement

Foley & Lardner LLP on

Manufacturing companies should actively prepare for heightened antitrust scrutiny of their business practices in 2023, including practices that have not traditionally garnered the focus of the federal antitrust enforcers. ...more

Sheppard Mullin Richter & Hampton LLP

Another Piece to the Puzzle: OMB Issues Proposed Guidance on “Build America, Buy America” Requirements

Coinciding nicely with the discussion of “Buy America” priorities at the February 7, 2023 State of the Union address, on February 9, 2023 the White House’s Office of Management and Budget (“OMB”) issued a proposed rule to...more

Venable LLP

U.S.-China Relationship: Assessing the Risk of Marketing Electronics Made Outside the United States

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Just weeks after President Biden and Chinese leader Xi Jinping met face-to-face to restore dialogue between the two countries, the Federal Communications Commission adopted new rules that could limit national security threats...more

Foley & Lardner LLP

Foley Manufacturing Update - November 2022

Foley & Lardner LLP on

The most recent article in Foley & Lardner’s Supply Chain Disruption Series provides background on a number of key terms and conditions for buyers and sellers in the supply chain to consider in commercial forms. Click here to...more

ArentFox Schiff

CY 2023 Proposed HOPPS Rule– What Drug Manufacturers Need To Know

ArentFox Schiff on

The Centers for Medicare & Medicaid Services (CMS) issued its annual proposed rule related to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems for 2023 (the HOPPS Proposed Rule) on...more

Foley & Lardner LLP

Top Legal Issues Facing the Manufacturing Sector in 2022

Foley & Lardner LLP on

As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...more

Morgan Lewis - As Prescribed

One License to Unite Them All: FDA Proposes National Standards for Wholesale Distributors and Third-Party Logistic Providers

The US Food and Drug Administration (FDA) has issued a proposed rule—“National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers” (Proposed Rule)—pursuant to FDA’s obligations...more

Alston & Bird

FDA to Develop National Standards for Drug Distributors – Medical Products Supply Chain Week in Review

Alston & Bird on

Since our last update, the Senate confirmed Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration. The FDA resumed domestic and foreign inspections. The agency also published a proposed rule to update...more

Foley & Lardner LLP

Foley Weekly Automotive Report - August 2021 - 2

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This report helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - U.S. new light vehicle sales in July fell to an estimated SAAR of 14.5...more

Hogan Lovells

Proposed rule seeks to significantly strengthen U.S. Government “Buy American” requirements

Hogan Lovells on

On 30 July 2021, the FAR Council published a proposed rule to significantly strengthen “Buy American” requirements applicable to goods sold to the U.S. Government. The proposed rule promotes the procurement of goods,...more

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