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Safe Harbors Manufacturers

Foley & Lardner LLP

BIOSECURE Act: Anticipated Movement, Key Provisions, and Likely Impact

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Last night, the House of Representatives passed the BIOSECURE Act (BIOSECURE or the Act) by a bipartisan vote of 306 to 81.  The BIOSECURE Act prohibits federal agencies from procuring or obtaining any biotechnology...more

K&L Gates LLP

California's Updated Proposition 65 Regulations New Short-Form Warnings and More

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Longtime efforts by the California Office of Environmental Health Hazard Assessment (OEHHA) to amend the so-called “short-form” safe harbor warnings for California’s Proposition 65 appear to be nearing completion. On 13 June...more

Alston & Bird

California Modifies Proposed Amendments to Proposition 65’s Warning Requirements

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Our Environment, Land Use & Natural Resources Group explains the updates the California Office of Environmental Health Hazard Assessment plans to make to the proposed changes to California’s Proposition 65 safe harbor warning...more

Latham & Watkins LLP

IRS Safe Harbor Eases Path for Domestic Content Bonus Tax Credits

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IRS Notice 2024-41 provides taxpayers with a clearer path toward qualifying for domestic content bonus tax credits through a new elective safe harbor....more

Troutman Pepper

Treasury and IRS Issue Additional Domestic Content Guidance Under IRA and New Elective Safe Harbor

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On May 16, the Treasury Department (Treasury) and the Internal Revenue Service (IRS) issued Notice 2024-41, which modifies Notice 2023-38 (Prior Guidance) by expanding the list of Applicable Projects (defined below) to...more

Troutman Pepper

California Considers Modifying Prop 65 Warning Requirements (Again)

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In 2021 we wrote about the California Office of Environmental Health Hazard Assessment’s (OEHHA) plans to amend regulations governing Proposition 65 (Prop 65) short-form warning labels. On May 20, 2022, however, OEHHA...more

Alston & Bird

New Changes to Proposition 65’s Warning Requirements Are on the Horizon

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Our Environment, Land Use & Natural Resources Group explains proposed changes to California’s Proposition 65 safe harbor warning language....more

BakerHostetler

Overview and Observations of Notice 2023-38 - Domestic Content Bonus Requirements

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On May 12, 2023, the Internal Revenue Service (IRS) issued initial guidance in the form of the Notice that provides taxpayers with preliminary guidance relating to the application of the domestic content bonus requirements...more

Holland & Knight LLP

Break Out Your Calculator: IRS Releases Domestic Content Bonus Credit Guidance

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Following the release of energy community bonus credit and low-income community bonus credit guidance, the U.S. Department of the Treasury and IRS recently provided taxpayers with the domestic content bonus credit guidance....more

Sheppard Mullin Richter & Hampton LLP

Pharmaceutical Manufacturers Ask EDVa to Allow Cost-Sharing Under the AKS

Pharmaceutical manufacturers are challenging the breadth of the Federal Anti-Kickback Statute (“AKS”) in federal court, arguing that the government is harming the very vulnerable patients it aims to serve by prohibiting...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA’s Final Rule on Intended Use: ‘Getting Right Back to Where We Started From’

On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more

Greenberg Glusker LLP

The Ever-Shifting Landscape of Prop 65 Acrylamide Regulation

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It has thus far been a noteworthy year for acrylamide, a Proposition 65-listed substance that naturally forms in the cooking and heating of many plant-based foods. Both the courts and the California Office of Environmental...more

Stoel Rives LLP

Prop 65 Changes Coming That Could Cause Headaches For Businesses

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If you sell goods in the State of California, you are probably familiar with Proposition 65 (“Prop 65”), which requires businesses to provide a warning before they “knowingly and intentionally expose any individual to a...more

Robinson+Cole Manufacturing Law Blog

California Regulators Propose New Regulations to Limit Use of “Short Form” Proposition 65 Warnings

Proposition 65 is the California law that requires warning labels on products sold to California customers that potentially expose users to certain chemicals which may cause a risk of cancer or reproductive harm. ...more

ArentFox Schiff

New Safe Harbors Offer Opportunities for Innovative Arrangements, Including Digital Health

ArentFox Schiff on

Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...more

Greenberg Glusker LLP

WARNING: Ability to Use Proposition 65 Short-Form Warnings May be Short Lived

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The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed significant changes to the Proposition 65 warning requirements that may impact businesses’ Proposition 65...more

Bergeson & Campbell, P.C.

Proposition 65: OEHHA Proposes Significant Changes to “Short-Form” Warnings

On January 8, 2021, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed significant revisions to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations for “short-form”...more

Morgan Lewis

California Proposes Changes to Proposition 65 Short-Form Safe Harbor Warnings

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Proposition 65 mandates that companies doing business in California provide warnings about exposures to chemicals listed as known to the state to cause cancer or reproductive toxicity. The California Office of Environmental...more

McGuireWoods LLP

The Long and Short of It: Changes Proposed to Prop 65 Safe Harbor Warning Requirements

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Businesses selling consumer products in California should be aware that California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed substantial changes to Proposition...more

Morgan Lewis

OIG Embraces Broader Anti-Kickback Statute Safe Harbor Protection for Warranties

Morgan Lewis on

The US Department of Health and Human Services’ Office of Inspector General updated the warranty safe harbor to account for bundled product and service warranties to reflect realities of healthcare product sales, but rejects...more

Patterson Belknap Webb & Tyler LLP

Does HHS’s Elimination of the Safe Harbor for Manufacturer Rebates Leave Manufacturers with Increased Antitrust Risk?

On November 20, 2020, the U.S. Department of Health & Human Services (HHS) finalized a rule to take effect in 2022, which eliminates the safe harbor under the federal anti-kickback statute for manufacturer rebates to Medicare...more

K&L Gates LLP

OIG Finalizes Rebate Rules: Removal of Safe Harbor Protections for Rebates and Creation of New Safe Harbors for Other Discounts...

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On 20 November 2020, the United States Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released its final rule on drug rebates entitled “Removal Of Safe Harbor Protection For Rebates...more

Baker Donelson

HHS/OIG Finalizes Rule Stripping PBM Rebates of Safe Harbor Protection

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On November 20, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued a Final Rule to finalize a February 6, 2019 proposal stripping rebates received from drug manufacturers by...more

Nilan Johnson Lewis PA

Anti-Kickback Statute and Stark Law Regulations: Final Rules Issued

Nilan Johnson Lewis PA on

On November 20, 2020, the Department of Health and Human Services (HHS) published two final rules that aim to reduce regulatory barriers to care coordination and accelerate the transformation of the healthcare system to...more

King & Spalding

HHS Finalizes Rule Challenging Drug Manufacturer Rebates to PBMs and Payors

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Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule - INTRODUCTION - On November 20, 2020, as part of a release of several drug pricing rules, the U.S. Department of Health and Human Services (“HHS”)...more

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