News & Analysis as of

Manufacturers New Guidance

Barnea Jaffa Lande & Co.

The Consumer Protection and Fair-Trade Authority: businesses are required to disclose changes to product characteristics or...

Recently, the Consumer Protection and Fair-Trade Authority issued a position paper regarding the disclosure obligations businesses must meet when making changes to product characteristics or components. According to the...more

Hinch Newman LLP

FTC Made in USA Labeling Rule Compliance and Defense Lawyer on Refreshed Agency U.S. Origin Claim Guidance

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On July 2, 2024, the Federal Trade Commission announced a “refreshed version” of the agency’s Complying with the Made in USA Standard guidance document. The refreshed guidance document includes, without limitation, updated...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

New FDA Guidance on AI and Medical Products

Troutman Pepper on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

Robinson+Cole Environmental Law +

PFAS Reporting Rules to Ring in the New Year

As we have previously reported, PFAS (per- and polyfluoroalkyl substances) are a class of substances coming under increasing regulatory scrutiny.  As manufacturers ring in the new year they should be aware of two new PFAS...more

Bass, Berry & Sims PLC

Alaska Board of Pharmacy Issues Notice Altering the Notification of Facility Changes

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On September 13, the Alaska Board of Pharmacy (Board) issued a notice summarizing a regulatory update stating that pharmacies, wholesale drug distributors, outsourcing facilities, third-party logistics providers, and...more

King & Spalding

OMB Finalizes Regulatory Guidance On “Buy America Preferences For Infrastructure Projects”

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Revised guidance takes effect on October 22, 2023 and will be supplemented by forthcoming memorandum - On August 23, the Office of Management and Budget (“OMB”) published final Guidance for Grants and Agreements to...more

Quarles & Brady LLP

FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

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On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more

Akin Gump Strauss Hauer & Feld LLP

OMB Issues Final Buy America Rule and Guidance for Infrastructure Projects

On August 14, 2023, the Office of Management and Budget (OMB) released a pre-publication version of final guidance implementing the Build America, Buy America Act (BABAA).The guidance adds a new Part 184 in 2 C.F.R. and...more

Sheppard Mullin Richter & Hampton LLP

Treasury Issues New Proposed Guidance on Domestic Content Requirements of the Inflation Reduction Act – Updated Qualification...

A few months ago we wrote about Congress utilizing the Inflation Reduction Act of 2022 to offer bonus tax credits to certain energy facilities for meeting specified “domestic content” requirements. Relying heavily on the...more

Harris Beach PLLC

New Guidance on Inflation Reduction Act Credit for Advanced Energy Projects

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On May 31, 2023, the Internal Revenue Service (“IRS”) released Notice 2023-44 (the “Notice”), which provides additional information regarding the Qualifying Advanced Energy Project Credit Allocation Program under § 48C (e) of...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

Pillsbury Winthrop Shaw Pittman LLP

IRS, Department of Treasury Release Guidance on Domestic Content Rules for Energy Projects

The Guidance sets out the requirements for using domestic steel, iron and manufactured products in order for a project to be eligible for the domestic content bonus credit amount. Projects that meet the domestic content...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

Paul Hastings LLP

IRS Issues Initial Guidance on Domestic Content Bonus Credit for Energy Projects

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The Inflation Reduction Act of 2022 (the “IRA”) added and modified certain renewable energy tax credit provisions of the U.S. Internal Revenue Code of 1986, as amended (the “Code”). The IRA additions included a new domestic...more

BakerHostetler

Cybersecurity in Medical Devices

BakerHostetler on

The U.S. Food and Drug Administration (FDA) has issued new guidance to the medical device industry on the importance of cybersecurity measures in product development. ...more

Foley Hoag LLP

FDA Releases Guidance on Submissions for AI/ML-Enabled Devices

Foley Hoag LLP on

On April 3, 2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan...more

Holland & Knight LLP

Treasury Department Issues Section 48D Guidance on CHIPS Act Semiconductor Tax Incentive

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The Chips and Science Act of 2022 (CHIPS Act) added Section 48D to the Internal Revenue Code to incentivize the manufacture of semiconductors and semiconductor manufacturing equipment in the United States. The credit is equal...more

Venable LLP

FDA Medical Device Updates to Emergency Use Authorizations and Enforcement Discretion Issued During the COVID-19 Public Health...

Venable LLP on

On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

OSHA’s ‘Site-Specific Targeting Inspection’ Program for Nonconstruction Employers Continues Under New Directive

The new year began with the Occupational Safety and Health Administration (OSHA) clearly establishing that it is focusing on enforcement in 2023. After announcing that it is expanding its instance-by-instance citation policy...more

Latham & Watkins LLP

NHTSA Updates Cybersecurity Best Practices for the Safety of New Vehicles

Latham & Watkins LLP on

The National Highway Traffic Safety Administration’s updated guidance encourages auto industry suppliers and manufacturers to consider cybersecurity a top organizational priority. On September 9, 2022, the National...more

King & Spalding

FDA’s Draft Computer Software Assurance Guidance Changes the Game for Quality System and Production Software Validation

King & Spalding on

On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer Software Assurance for...more

Hogan Lovells

NHTSA issues updated cybersecurity best practices for the safety of modern vehicles

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The National Highway Traffic Safety Administration (“NHTSA”) recently issued updated guidance on cybersecurity best practices for motor vehicle safety. This non-binding guidance demonstrates NHTSA’s continued emphasis on...more

Robinson+Cole Manufacturing Law Blog

OFCCP Issues Summer Guidance on Affirmative Action Certification Requirement for Federal Contractors

As most federal contractors are likely aware, this year marked the first year when covered entities were required to certify compliance with their annual affirmative action plan requirement using the new Contractor Portal of...more

Eversheds Sutherland (US) LLP

The Superfund Tax is back: Recent IRS guidance and background

As this nation prepared to celebrate the Independence Day long weekend, many were preparing for the July 1, 2022, reinstatement of the Superfund chemicals tax (the Superfund Tax). The Superfund Tax is an excise tax imposed on...more

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