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Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

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On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...more

Bergeson & Campbell, P.C.

Comments on Maine’s Proposed CUU Amendment Due September 2, 2025

The Maine Department of Environmental Protection (MDEP) began a public consultation on July 30, 2025, on a proposed amendment to Chapter 90: Products Containing Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS). The...more

Beveridge & Diamond PC

California Proposes Listing Microplastics Under Safer Consumer Products Program

The California Department of Toxic Substances Control (DTSC) has taken a step toward regulating microplastics. On June 20, 2025, DTSC proposed to add microplastics to its Candidate Chemical List (CCL) under the state’s Safer...more

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On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance.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

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

Faegre Drinker Biddle & Reath LLP

Comment Period Open for Massive New PFAS Reporting Requirements in Minnesota

On April 21, 2025, the Minnesota Pollution Control Agency (MPCA) issued the proposed PFAS in Products: Reporting and Fees Rule for public consultation. The proposed rule details how the MPCA will require manufacturers 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

Bergeson & Campbell, P.C.

Petitions Filed to Add Chemicals to List of Chemical Substances Subject to Superfund Excise Tax

On April 2 and April 3, 2025, the Internal Revenue Service (IRS) announced that petitions have been filed to add the following chemicals to the list of taxable substances...more

Burr & Forman

ADEM Proposes Revisions to its Recycling Rules – 15 Years in the Making

Burr & Forman on

After 15 years without significant revisions, the Alabama Department of Environmental Management (ADEM) is proposing an overhaul of its recycling rules.  The proposed regulations, which ADEM released for public notice and...more

DLA Piper

Maine DEP Proposes Currently Unavoidable Use Procedures for PFAS in Products Law

DLA Piper on

Maine’s Department of Environmental Protection (DEP) recently published a proposed rule prescribing procedures and criteria for determining Currently Unavoidable Uses (CUU) of intentionally added per- and polyfluoroalkyl...more

Holland & Knight LLP

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

Holland & Knight LLP on

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

Jones Day

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

Jones Day on

The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

Foley Hoag LLP

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed...

Foley Hoag LLP on

FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...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

Foley Hoag LLP

HRSA Proposes to Overhaul 340B Dispute Process

Foley Hoag LLP on

On November 29, 2022, the Health Resources and Services Administration (“HRSA”) published a notice of proposed rulemaking (“Proposed Rule”)[1] to implement an Administrative Dispute Resolution (“ADR”) process for resolving...more

Bergeson & Campbell, P.C.

EPA Seeks Comment on Initial Regulatory Flexibility Analysis on Proposed PFAS Reporting Rule

On November 25, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited comment on an Initial Regulatory Flexibility Analysis (IRFA) and Updated Economic Analysis following the...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

Beveridge & Diamond PC

EPA Hints at Critical Changes to TSCA PFAS Reporting Rule, Seeks Comment

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The U.S. Environmental Protection Agency's (EPA) June 2021 proposal of a Toxic Substances Control Act (TSCA) reporting rule targeting manufacturers of per- and polyfluoroalkyl substances (PFAS) sparked a major outcry from...more

Clark Hill PLC

EPA Proposes Updates to Air Toxics and Performance Standards For Lead Acid Battery Plants

Clark Hill PLC on

On Feb. 11, EPA proposed updates to both the National Emissions Standards for Hazardous Air Pollutants (NESHAP) that apply to Lead Acid Battery (LAB) Manufacturing Area Sources (Subpart PPPPPP) and the New Source Performance...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Proposes Amendments to Medical Device Quality System Regulation

On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good manufacturing practice...more

BCLP

PFAS Update: EPA Proposes Reporting on the Last 10 Years of Manufacture or Import of Products Containing PFAS

BCLP on

The Environmental Protection Agency (“EPA”) is proposing new reporting requirements for Per- and Polyfluoroalkyl Substances (“PFAS”) that would require manufacturers, including importers, to report on their manufacture or...more

Kilpatrick

TSCA’s Information Grab – Manufacturers and Importers Subject to Proposed Expansive Ten-Year “Look Back” PFAS Reporting...

Kilpatrick on

Did you manufacture or import a water repellant t-shirt or a nonstick cooking pan or high performance mountain wear in the past ten years? If so, you could be required to provide ten years of past data and details regarding...more

Woods Rogers

EPA Proposes Retroactive PFAS Reporting

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On June 28, 2021, the U.S. Environmental Protection Agency (“EPA”) published a proposed rule that would require a one-time report from companies that manufactured or imported per- and polyfluoroalkyl substances (PFAS) in any...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

OSHA Issues Proposed Rule to Update Its Hazard Communication Standard

Employers have been on the lookout for a temporary emergency standard for COVID-19 from the federal Occupational Safety and Health Administration (OSHA), but what they have thus far received is a proposed rule to update the...more

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