News & Analysis as of

Manufacturers Comment Period

Bergeson & Campbell, P.C.

ECHA Begins Public Consultation on Six Proposals to Identify New SVHCs

According to an item in the September 4, 2024, ECHA Weekly, the European Chemicals Agency (ECHA) has begun a public consultation on six proposals to identify new substances of very high concern (SVHC). The substances and...more

Bennett Jones LLP

In Case You Missed It… The Comment Period on The Federal Government Consultation on Plastic Waste and Pollution from Textile and...

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Environment and Climate Change Canada (ECCC) published a consultation document on July 4, 2024, seeking input from stakeholders on a proposed roadmap for addressing plastic waste and pollution from the textile and apparel...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

White & Case LLP

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

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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

Bergeson & Campbell, P.C.

EPA Publishes ANPRM Regarding Lead Wheel Weights

The U.S. Environmental Protection Agency (EPA) published on April 3, 2024, an advance notice of proposed rulemaking (ANPRM) regarding lead for wheel-balancing weights (lead wheel weights). 89 Fed. Reg. 22972. EPA requests...more

Epstein Becker & Green

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

Epstein Becker & Green on

Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

Skadden, Arps, Slate, Meagher & Flom LLP

Commerce Department Seeks Comment on Restrictions on ‘Connected Vehicle’ Components From ‘Foreign Adversaries’

The U.S. Department of Commerce is soliciting comment on possible restrictions on “connected vehicle” components obtained from “foreign adversaries.” On March 1, 2024, the department’s Bureau of Industry and Security (BIS)...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

Jones Day

FDA on Board With Continuing Remote Inspections

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The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more

Troutman Pepper

EPA Revises HFC Rule for Refrigeration and Air Conditioning Products

Troutman Pepper on

On December 26, 2023, the U.S. Environmental Protection Agency (EPA) published an Interim final rule updating its October final rule restricting the use of some hydrofluorocarbons (HFCs), a key substance used in refrigeration...more

Holland & Knight LLP

Treasury Department, IRS Release Foreign Entity of Concern Proposed Regulations

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The U.S. Department of the Treasury and IRS on Dec. 1, 2023, released proposed rules under Section 30D of the Internal Revenue Code, the Clean Vehicle Tax Credit, as they relate to the definition of "foreign entity of...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

Miller Nash LLP

Proposed Prop 65 Pose Increased Litigation Risks

Miller Nash LLP on

California’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed changes to the short form warnings currently permitted by Proposition 65. These changes have the potential to greatly raise the cost of doing...more

Jones Day

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

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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

Bergeson & Campbell, P.C.

FDA Seeks Comment on Cosmetics Direct and Forms Regarding Registration of Cosmetic Product Facility and Cosmetic Product Listing

On September 15, 2023, the U.S. Food and Drug Administration (FDA) announced that it is seeking comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067)....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

Holland & Knight LLP

FDA, PFAS and Food Packaging: More to Come?

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The U.S. Environmental Protection Agency (EPA) is not the only federal agency that regulates per- and polyfluoroalkyl substances (PFAS). And states aren't the only ones scrutinizing PFAS in food packaging products. PFAS,...more

Husch Blackwell LLP

MOCRA: FDA Draft Guidance on Facility Registration and Product Listing

Husch Blackwell LLP on

As we previously discussed, MoCRA requires cosmetic product manufacturer and processors to register their facilities with the U.S. Food and Drug Administration (FDA). On August 7, 2023, FDA announced that it had published a...more

Jones Day

Clarifying Cosmetics Reform: FDA Issues Draft Guidance on Registration and Product Listings

Jones Day on

Heralding the significant changes coming to the U.S. cosmetics industry starting in 2023, the U.S. Food and Drug Administration ("FDA") has issued draft guidance to companies regarding cosmetic facility registrations and...more

Perkins Coie

FDA Publishes Draft Guidance For Submitting Cosmetic Product Facility Registrations and Product Listings Under MoCRA

Perkins Coie on

The U.S. Food and Drug Administration (FDA) issued draft guidance on August 7, 2023, clarifying new requirements for cosmetic facility registrations and product listings under the Modernization of Cosmetics Regulation Act of...more

BakerHostetler

Transforming Cosmetics Regulation: FDA’s Mandatory Compliance Shift for Safer Beauty

BakerHostetler on

On August 7, 2023, the U.S. Food and Drug Administration (FDA, the Agency) published draft guidance aimed at assisting cosmetics companies with achieving and maintaining compliance with new cosmetic product facility...more

Eversheds Sutherland (US) LLP

Treasury and the IRS release much-anticipated guidance, including with respect to the monetization of energy tax credits

On June 14, 2023, the Department of the Treasury (Treasury) and the Internal Revenue Service (IRS) released a package of much-awaited guidance (the Guidance) consisting of (i) proposed regulations addressing the tax credit...more

ArentFox Schiff

IP Industry Comment Opportunity At USPTO: Strategies to Address Counterfeiting and Piracy

ArentFox Schiff on

On May 26, 2023, the US Patent and Trademark Office (USPTO) published a Federal Register notice seeking public comments on anti-counterfeiting and antipiracy strategies to better address this enormous US challenge....more

Jones Day

EPA Proposes TSCA Amendments to Improve Efficiency of New Chemical Review Process

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The proposal would also make per- and polyfluoroalkyl substances ("PFAS") and certain persistent, bioaccumulative, and toxic chemical substances ("PBTs") ineligible for exemptions available under the Toxic Substances Control...more

Wiley Rein LLP

Deadline Approaching for Submitting Comments on FHWA’s Review of Longstanding Buy America Waiver for “Manufactured Products”

Wiley Rein LLP on

WHAT: The period for submitting comments on the Federal Highway Administration’s (FHWA) review of its longstanding waiver of Buy America requirements for “manufactured products,” which was originally set to close on April 17,...more

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