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Manufacturers Public Comment

Beveridge & Diamond PC

EPA Announces 8-Month Delay in Submission Window for TSCA PFAS Reporting Rule

The U.S. Environmental Protection Agency (EPA) is modifying the Toxic Substances Control Act (TSCA) regulation imposing reporting and recordkeeping requirements for perfluoroalkyl and polyfluoroalkyl substances (the Rule) to...more

McDermott+

CMS Releases Final Procedural Notice on Transitional Coverage for Emerging Technology (TCET)

McDermott+ on

The Centers for Medicare & Medicaid Services (CMS) issued the final procedural notice on Transitional Coverage for Emerging Technologies (TCET), effective as of August 12, 2024. TCET is a new pathway that uses existing...more

BCLP

More Changes Under Consideration For Prop. 65 Short-Form Warnings

BCLP on

The California agency that administers Proposition 65 is considering further revisions to the regulations governing the use and format of the short-form warning....more

Bergeson & Campbell, P.C.

EPA Releases Draft Risk Evaluation Documents for DIDP and DINP for Public Comment and Peer Review

The U.S. Environmental Protection Agency (EPA) announced on May 20, 2024, the availability of and solicited public comment on the draft manufacturer-requested risk evaluation (MRRE) for di-isodecyl phthalate (DIDP) and the...more

White & Case LLP

USTR Issues Details of the Proposed Section 301 China Tariff Increases, Seeking Public Input

White & Case LLP on

On May 22, 2024, the United States Trade Representative ("USTR") unveiled the details of the proposed increases in Section 301 tariffs on imports from China. If adopted, the action would raise tariffs on solar power products,...more

Davis Wright Tremaine LLP

EPA Seeks Comments on "Clean" Label for Construction Industry

Inflation Reduction Act pledged millions to label program intended to cut climate pollution linked to manufacturing of construction products and materials - The Environmental Protection Agency ("EPA") is seeking public...more

Troutman Pepper

TTB Seeking Public Input on Potential Alcoholic Beverage Labeling Changes

Troutman Pepper on

As we previously reported, the Treasury Department released a 2022 report on Competition in the Markets for Beer, Wine, and Spirits (the Competition Report) recommending, in part, that the Alcohol and Tobacco Tax and Trade...more

Akerman LLP

Updated Advanced Computing and Semiconductor Manufacturing Export Controls Take Effect

Akerman LLP on

On October 17, 2023, the Commerce Department’s Bureau of Industry and Security (“BIS”) released two interim final rules (“IFRs”) that amended the Export Administration Regulations (“EAR”) to significantly expand export...more

Kelley Drye & Warren LLP

CPSC Collecting Data on PFAS in Consumer Products

The Consumer Product Safety Commission (CPSC) is initiating a wide-ranging data collection effort on the use and presence of per- and polyfluoroalkyl substances (PFAS) in consumer products. As detailed in a September 30...more

Mintz - Energy & Sustainability Viewpoints

Last Call: Public Comments on Inflation Reduction Act Clean Energy Tax Incentives Are Requested By November 4

On October, 5, 2022, the U.S. Department of Treasury (Treasury) and Internal Revenue Service (IRS) published six Notices requesting public comments by November 4, 2022 on certain of the clean energy tax incentives included in...more

Beveridge & Diamond PC

FTC Proposes New Efficiency and Repair Instruction Requirements

Beveridge & Diamond PC on

Key Takeaways: • What Happened: The Federal Trade Commission (FTC) seeks public comment on a proposed expansion of EnergyGuide labeling requirements to new product categories, and a requirement to include repair...more

Barnea Jaffa Lande & Co.

Informing on Cyber Risks during Sale of IoT Products

IoT products are fraught with risks when it comes to privacy, personal data, and cyberattacks, and consumers must be informed of these risks before purchasing. A new draft directive published by the Israeli Consumer...more

Troutman Pepper

Industry Comments Loom Large in D.C. Court Finding FDA Regulation of Premium Cigars “Arbitrary and Capricious”

Troutman Pepper on

On July 5th, the U.S. District Court for the District of Columbia ruled that the decision of the Food and Drug Administration (FDA) to “deem” premium cigars subject to the same federal law as other tobacco products like...more

Faegre Drinker Biddle & Reath LLP

Updated EPA Analysis on Long-Term Health Effects of Formaldehyde Exposure Could Have Lasting Implications for Manufacturers

On April 14, 2022, the Environmental Protection Agency (EPA) released draft conclusions in a report updating its analysis regarding formaldehyde exposure, suggesting that long-term exposures to small amounts of formaldehyde...more

Goldberg Segalla

EPA Proposes Ban on Chrysotile Asbestos

Goldberg Segalla on

On April 5, 2022, the Environmental Protection Agency (“EPA”) announced proposed regulation that would prohibit the use, manufacture, and import of chrysotile asbestos, also known as ‘white asbestos.’ Chrysotile asbestos is...more

Holland & Knight LLP

Export-Import Bank Approves "Make More in America" Domestic Financing Program

Holland & Knight LLP on

In a move to strengthen U.S. supply chain resiliency, the board of directors of the Export-Import Bank of the United States (EXIM) unanimously approved a new domestic financing program, "Make More in America Initiative," on...more

Hogan Lovells

New Acrylamide Prop 65 lawsuits: preliminary injunction reinstated; proposed regulation disapproved

Hogan Lovells on

Two significant decisions were recently issued regarding California’s Proposition 65 (Prop 65). First, the U.S. Court of Appeals for the Ninth Circuit reinstated a district court’s preliminary injunction halting new...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

Hogan Lovells

FDA transition plan for COVID-19 medical devices requests new submissions to agency

Hogan Lovells on

On December 22, 2021, the U.S. Food and Drug Administration (FDA) published two draft guidance documents intended to help medical device manufacturers transition out of the temporary rules put in place for the duration of the...more

Holland & Knight LLP

U.S. Export-Import Bank Seeks Public Comments on Proposed Domestic Financing Program

Holland & Knight LLP on

The Export-Import Bank of the United States (EXIM) on Dec. 23, 2021, published a notice seeking public comment on a proposed expansion of its medium- and long-term buyer financing programs to include domestic transactions....more

BCLP

Federal PFAS Development: Preliminary Effluent Guidelines Program Plan 15

BCLP on

The United States Environmental Protection Agency (“EPA”) has outlined additional steps that it plans to take to investigate and in some cases regulate the discharge of per- or polyfluoroalkyl compounds (“PFAS”) in certain...more

Goodwin

Mitigation of Cybersecurity Risks in Medical Device Software: FDA Discussion & Insights for OEMs, Remanufacturers, and Servicers

Goodwin on

I. OVERVIEW - The U.S. Food & Drug Administration (“FDA”) has increased its focus on mitigating cybersecurity risks in medical device software. On June 24, 2021, the FDA issued two documents that are important not only...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

Hogan Lovells

FDA seeks comments on how to transition approved drug products to device status under Genus - Major regulatory changes for imaging...

Hogan Lovells on

On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more

WilmerHale

FTC’s Second Open Commission Meeting Continues to Highlight Competition Agenda

WilmerHale on

On July 21, 2021, the Federal Trade Commission (“FTC” or “Commission”) held its second Open Commission Meeting. There were three items on the agenda: (1) whether or not to rescind a 1995 policy statement on prior approval and...more

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