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Fees Manufacturers

Environmental General Counsel PC

EPR Packaging Laws: Oregon's Program Plan Provides Roadmap for Compliance and Producer Fees

On March 31, Circular Action Alliance (“CAA”), the Producer Responsibility Organization (“PRO”) for California, Colorado, and the only contender for PRO in Oregon, submitted the first draft of its Program Plan (“the Plan”)...more

Smith Gambrell Russell

EPA to Increase Chemical Manufacturer’s Fees

Smith Gambrell Russell on

On Tuesday, November 14, the EPA issued a proposed rule which would increase fees charged under the Toxic Substances Control Act (TSCA) to manufacturers and handlers of chemical substances. The proposed rule would more than...more

Beveridge & Diamond PC

TSCA Sticker Shock: EPA Proposes Large Fee Increases

Beveridge & Diamond PC on

Does your company manufacture domestically or import chemicals that the U.S. Environmental Protection Agency (EPA) is reviewing under section 6 of the Toxic Substances Control Act (TSCA)? Does your company submit applications...more

Wiley Rein LLP

EPA’s 18.9% TSCA Fee Inflation Adjustment

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Amid historic and massive increases in inflation[1] and unprecedented supply chain challenges, the Environmental Protection Agency (EPA or Agency) raised its Toxic Substances and Control Act (TSCA) fees by 18.9%. These fees...more

ArentFox Schiff

FDA Announces New Fees for Manufacturers of Over-the-Counter Drugs

ArentFox Schiff on

As we explained in a previous alert, one of the lesser-known provisions of the March 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act was a significant overhaul of the way that most OTC drugs are regulated in...more

Womble Bond Dickinson

FDA Reissues Notice Announcing Increased OTC Monograph Facility Fees

Womble Bond Dickinson on

On March 26, 2021, the FDA updated and reissued the fee rates for the newly created over-the-counter (OTC) monograph Drug User Fee program (OMFUA) for FY2021 in a Federal Register Notice (FRN) titled “Fee Rates under the...more

Sheppard Mullin Richter & Hampton LLP

FDA Announces Facility Fees for OTC Drug Manufacturers

On Friday, March 26, 2021, FDA published a Federal Register notice, “Fee rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021,” announcing 2021 fee rates under its over-the-counter (OTC)...more

Bergeson & Campbell, P.C.

Comments On Proposed Changes To TSCA Fees Rule Due February 25

On January 11, 2021, EPA published a proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule. 86 Fed. Reg. 1890. Under TSCA, EPA collects fees from chemical manufacturers and processors to help...more

Arnall Golden Gregory LLP

OTC Monograph Fees Announced… Not So Fast!

On December 29, 2020, the U.S. Food and Drug Administration published a Federal Register notice setting the fee rates under the Over-the-Counter Monograph User Fee Act (OMUFA) Program for Fiscal Year 2021. Reed Tech...more

Bergeson & Campbell, P.C.

EPA Proposes Updates To TSCA Fees Rule

On December 21, 2020, the U.S. Environmental Protection Agency (EPA) released a pre-publication notice of proposed updates to the Toxic Substances Control Act (TSCA) Fees Rule. Specifically, the proposed updates to the...more

Wiley Rein LLP

OTC Drug User Facility Fees – Don’t Miss the Changes!

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On January 4, 2021, FDA unexpectedly withdrew the notice entitled Fee Rates Under the Over the Counter Monograph User Fee Program for Fiscal Year 2021 stating that it had been ordered to cease further collection efforts...more

Wiley Rein LLP

TSCA Cost Sharing Consortias Are Broken Due to EPA Rule – Can They Be Fixed?

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Under the EPA fee rule for TSCA (40 C.F.R. § 700.45), manufacturers (including importers) of chemicals undergoing risk evaluation are subject to the TSCA fee of $1.35 million. Following publication of a preliminary list of...more

Downey Brand LLP

UPDATE: EPA May Exempt Certain Manufacturers and Importers from TSCA Fees Rule

Downey Brand LLP on

On March 25, 2020, the U.S. Environmental Protection Agency announced its plan to consider a proposed rule that may exempt many manufacturers and importers from its new Toxic Substances Control Act (TSCA) Fees Rule... The...more

Downey Brand LLP

Manufacturers and Importers May Be Surprised By The New TSCA Fees Rule

Downey Brand LLP on

The U.S. Environmental Protection Agency’s Toxic Substances Control Act (TSCA) Fees Rule will sweep in many companies that may be unaware that they must comply. The Fees Rule requires manufacturers or importers of one or more...more

Robins Kaplan LLP

Financial Daily Dose 12.03.2019 | Top Story: US Threatens Tariffs on French Goods Over New Digital Services Tax

Robins Kaplan LLP on

Because who wants a nice quiet December, right? Yesterday, the U.S. opened yet another trade war front by proposing retaliatory tariffs of up to 100% on a wide range of French imports after announcing that “it found France’s...more

Barnea Jaffa Lande & Co.

Software Companies No Longer Subject to Expansion Orders in the Field of Industry?

The question of categorizing high-tech companies as software industry companies arises in many due diligence inquiries. The operative meaning of this categorization suggests that the application of transaction terms set in...more

Buchalter

Points & Authorities - Summer 2013: The Entertainment Issue

Buchalter on

In This Issue: - It’s Always Something: The Repeated Assaults on Licensee Rights in Bankruptcy - Clearance: Start Early and Avoid the Clutter - New Faces - Points from the President - The...more

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