News & Analysis as of

Rulemaking Process

Epstein Becker & Green

A Final Rule Bites the Dust, Part II: FDA Gives up on Regulating LDTs as Medical Devices

As the song goes, the Food and Drug Administration’s (“FDA’s”) 2024 Final Rule regulating laboratory-developed tests (“LDTs”) as medical devices (“Final Rule”), is not merely dead—it’s really most sincerely dead....more

Akin Gump Strauss Hauer & Feld LLP

No Appeal of LDT Decision Means Ball Is Back in FDA’s Court for Policy Clarification

Over the weekend, the Department of Justice (DOJ) did not file an appeal of the U.S. District Court for the Eastern District of Texas’ decision to vacate and set aside the agency’s final rule on the regulation of laboratory...more

Womble Bond Dickinson

Proposed Rule 707 Targets AI-Crafted Evidence

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Artificial Intelligence is taking society by storm and has even made a name for itself in the courtroom. With the ease of utilizing AI to generate various forms of data, presenting evidence at trial can be a much less arduous...more

Cooley LLP

Cooley Advisory: FCC About to Have Only Two Commissioners (Less Than a Quorum)

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Federal Communications Commission (FCC) Commissioner Nathan Simington announced yesterday that he will resign his seat at the FCC on Friday, June 6, and Democratic Commissioner Geoffrey Starks announced that he also will...more

Miller Starr Regalia

Third District Holds County Could Require Supplemental Environmental Information From Grading Permit Applicant As Condition of...

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Like a gift to land use lawyers that never stops giving, the strange and wondrous interrelationship between CEQA and the Permit Streamlining Act (“PSA”; Gov. Code, § 65920 et seq) continues to inspire litigation and require...more

PilieroMazza PLLC

Protect Small Business Opportunities: The “Rule of Two” Faces Potential Elimination

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The federal government is actively trying to reduce its size and deregulate agencies across the Executive Branch. As noted in a previous Client Alert by Sam Finnerty, the Federal Acquisition Regulation (FAR) has not been...more

Troutman Pepper Locke

FERC Reaffirms MISO Interconnection Queue Cap on Rehearing

Troutman Pepper Locke on

On May 27, 2025, FERC addressed arguments raised on rehearing of a January 30, 2025 order, which accepted the Midcontinent Independent System Operator, Inc.’s (“MISO”) proposal to modify its generator interconnection study...more

Benesch

Regulatory Housekeeping: U.S. DOT Regulatory Easing Includes FMCSA Final Rules and Proposed Rules

Benesch on

On May 29, 2025, the U.S. Department of Transportation (“DOT”) announced a wide range of deregulatory actions seeking to lower the operational burden and cost of compliance. ...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Agricultural Nutrient Pollution/State of New York Supreme Court (County of Albany) Addresses Whether Department of Health Can...

The State of New York Supreme Court/County of Albany (“Court”) addressed in a May 6th Order whether the New York State Department of Health (“DOH”) has the authority to issue Watershed Rules and Regulations (“Rules”) to...more

Wilson Sonsini Goodrich & Rosati

SEC Solicits Public Input on Definition of Foreign Private Issuer

On June 4, 2025, the U.S. Securities and Exchange Commission announced that it published a concept release to solicit public comment on the definition of foreign private issuer (FPI). FPIs benefit from a number of...more

Jones Day

California Air Resources Board Offers Direction as to Application of California Climate Disclosure Laws

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On May 29, 2025, a virtual public workshop held by the California Air Resources Board ("CARB") offered direction on how it interprets certain elements of California's climate disclosure laws. While CARB has a July 1, 2025,...more

Troutman Pepper Locke

ESG Investing in 401(k) Plans – More Rule Changes on the Way

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In our recent client alert, “Texas Federal Court Allows an ERISA Fiduciary Challenge Against Alleged “ESG Investing” Without Any ESG Funds,” we reported that a Texas district court recently upheld Biden-administration...more

Farella Braun + Martel LLP

EPA Continues Reassessment of its 2024 Designation of PFOA and PFOS as CERCLA Hazardous Substances

The EPA is continuing to reevaluate whether to change its position regarding the Biden administration’s 2024 listing of PFOA and PFOS as hazardous substances under CERCLA....more

King & Spalding

FDA Issues Two Guidances For the Device Q-Sub Process

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CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more

Pillsbury Winthrop Shaw Pittman LLP

SCOTUS Limits Scope of NEPA Reviews, Reinstates Approval of Uinta Basin Railway

In a highly anticipated decision for project developers and permitting agencies, the U.S. Supreme Court reversed the D.C. Circuit’s 2023 decision that had invalidated federal approval of the Uinta Basin Railway. In Seven...more

White & Case LLP

Commerce Department Opens New Steel and Aluminum Section 232 Tariff Inclusions Process

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The US Department of Commerce Bureau of Industry and Security (BIS) has established a new “Inclusions Process” for US companies to request that BIS add new derivative products to the steel and aluminum Section 232 tariffs....more

Saul Ewing LLP

Resource Adequacy Challenges in Maryland - Major Legislative Advances in Energy Storage Policy Are Intended To Be Part of the...

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In 2025, the General Assembly of Maryland made its boldest move ever to advance energy storage, as part of a legislative package responding to the resource adequacy challenges that are now emerging for the Free State....more

Troutman Pepper Locke

CARB Workshop on Climate Disclosure Laws: More Questions Than Answers

Troutman Pepper Locke on

On May 29, 2025, the California Air Resources Board (CARB) held a virtual public workshop to review and discuss its rulemaking response to California Senate Bills (SBs) 253, 261, and 219, which require companies that “do...more

Baker Botts L.L.P.

Pruning NEPA’s Branches: The Supreme Court Reshapes Environmental Reviews for Major Actions

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Over the last half century, federal courts have interpreted the National Environmental Policy Act (NEPA) to require federal agencies to study an ever-growing range of indirect effects and impacts when approving large...more

Beveridge & Diamond PC

Department of Interior Requests Information on Regulatory Reform by June 20, 2025

The U.S. Department of Interior (DOI) issued a Request for Information (RFI) asking affected industries to identify existing Interior regulations that can be modified or repealed to support the Trump administration’s "energy...more

Cooley LLP

FCC Proposes Rules to Ferret Out Control of Regulated Entities by Foreign Adversaries

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The Federal Communications Commission (FCC) has released a notice of proposed rulemaking on control of FCC-regulated businesses by “foreign adversaries.” If the FCC adopts these rules, nearly every entity that is subject to...more

Woodruff Sawyer

Looking Into the SEC Future for Financial Services Companies

Woodruff Sawyer on

As new Chair Paul Atkins begins to make his mark on the Securities and Exchange Commission, the news cycle has been heavily focused on crypto regulation. The SEC, however, is more than just a crypto regulator....more

Katten Muchin Rosenman LLP

Can There be Only One? The CFTC Faces an Unprecedented Moment with Potentially One Commissioner

As commissioners continue to depart, the Commodity Futures Trading Commission (CFTC or Commission) may soon find itself in an unprecedented situation - operating with only one sitting commissioner. While the Commission has...more

Foley Hoag LLP - Environmental Law

Supreme Court Holds That Agencies Have “Substantial” Discretion to Omit Upstream and Downstream Projects from Environmental...

On May 29, 2025, a unanimous Supreme Court (voting 8-0, with Justice Gorsuch recused) held that federal agencies need not consider the environmental effects of “upstream” and “downstream” projects that are separate in time or...more

Fenwick & West LLP

Takeaways from CARB’s Virtual Workshop Regarding California’s Corporate Climate Disclosure Rules

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On May 29, 2025, The California Air Resources Board (CARB) held a virtual workshop to “support the development of California’s Corporate Greenhouse Gas Reporting Program” reflected in the Climate Corporate Data Accountability...more

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