News & Analysis as of

Manufacturers Comment Period Supply Chain

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

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

Holland & Knight LLP

Treasury Department, IRS Release Clean Vehicle Tax Guidance

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The U.S. Department of the Treasury and IRS have released several pieces of guidance regarding the tax incentives for clean vehicles provided under Sections 30D (new clean vehicle credit), 25E (previously owned vehicle...more

Morgan Lewis

US Department of Commerce Details Proposed National Security Guardrails for CHIPS Incentives Program

Morgan Lewis on

The comment period has opened for the US Department of Commerce’s recently issued CHIPS for America incentive program notice of proposed rulemaking, which lays out funding requirements, incentives, and restrictions for...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

Holland & Knight LLP

USTR Continues 4-Year Review of Actions Taken Against China Under Section 301

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The U.S. Trade Representative (USTR) is accepting public comments through Jan. 17, 2023, on its four-year review of actions taken in the Section 301 investigation against China. Responses can be submitted through the USTR...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

Proskauer - Minding Your Business

FTC Announces Inquiry into the Infant Formula Shortage

On May 24, 2022, the FTC announced a widespread inquiry into the ongoing infant formula shortage. The agency had been tasked by the White House with investigating any price gouging or unfair market practices in the industry....more

Holland & Knight LLP

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

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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

Benesch

Bottlenecks and Supply Constraints - U.S. DOT Comment Period Ends in One Week

Benesch on

Supply chain disruption is a global pandemic era challenge that will continue to grow in impact for the near-term future. The scope of supply chain challenges extends from low supply and lack of transportation capacity to the...more

Wiley Rein LLP

Commerce Department's Bureau of Industry and Security Request for Comments on Semiconductor Manufacturing and Advanced Packaging...

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On March 15, 2021, the Department of Commerce’s (Commerce) Bureau of Industry and Security (BIS), Office of Technology Evaluation, issued a notice of request for public comments (notice) seeking information to assist it in...more

Jones Day

2020 Regulatory Amendments Attempt to Simplify Proposition 65 Warning Obligations

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The Situation: New regulatory amendments to Proposition 65 went into effect on April 1, 2020. These amendments: (i) allow manufacturers, distributors, and suppliers of consumer products to satisfy Proposition 65's warning...more

Akin Gump Strauss Hauer & Feld LLP

Commerce Department Extends Export Controls over Foreign-Made Items in Huawei’s Contract Manufacturing Supply Chain

- The U.S. Department of Commerce has published a highly complex and novel interim final rule extending the controls of the Export Administration Regulations (EAR) over foreign-made items in Huawei’s contract manufacturing...more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

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In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

Arnall Golden Gregory LLP

Pharma Supply Chain Cornucopia: More FDA Guidance on DSCSA Product Identifier and Verification Requirements

So far this Fall, the Food and Drug Administration (FDA) has issued four guidance documents regarding the product identifier and verification systems requirements of the Drug Supply Chain Security Act (DSCSA). ...more

Holland & Knight LLP

FDA Guidance on DSCSA Product Identifier Requirements

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Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more

Hogan Lovells

USTR Requests Input on Impact of Trade Agreements on Government Procurement

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On August 21, 2017, the Department of Commerce (Commerce) and the Office of the United States Trade Representative (USTR) issued a request for public comment on the impact of government procurement provisions of U.S. trade...more

Mintz - Health Care Viewpoints

FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post,...more

Greenberg Glusker LLP

Required Action on the Horizon for California Consumer Products Companies

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Yesterday, the Department of Toxic Substances Control (“DTSC”) released its draft Stage 1 Alternatives Analysis Guide (“Guide”) under the California Safer Consumer Products program. Public comments are being accepted on the...more

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