The End of COVID Waivers and Exceptions: What Now?
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
NGE On Demand: COVID-19 and IP Waiver for Patent Protection with Kevin O'Connor and Olivia Luk Bedi
Prohibitions on Use of Chinese Telecommunications Equipment and Services, Complying with the NDAA
COVID-19: Where are we now?
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Value-based health care: fraud & abuse laws
What patients misunderstand about their right of informed consent
Bill on Bankruptcy: ResCap Report, a Bargain at $83 Million
The Congressional Review Act (“CRA”), enacted in 1996, allows Congress to disapprove federal regulations promulgated by government agencies within 60 legislative working days after the rule is submitted to Congress. In order...more
When it comes to regulating motor vehicle emissions, California has long been different. California was the first state in the nation to enact tailpipe emission standards and as result of its "pioneering" efforts in the...more
Under Clean Air Act (CAA) Section 209(a) (42 U.S.C. § 7543), states are preempted from adopting or enforcing emissions standards for new motor vehicles or new motor vehicle engines. However, because California had adopted its...more
Good morning! This is Akin’s newsletter on climate change policy and regulatory developments, providing information on major climate policy headlines from the past week and forthcoming climate-related events and hearings...more
In a significant development for environmental law and state autonomy, the Supreme Court of the United States (SCOTUS) recently declined to review whether the U.S. Environmental Protection Agency (EPA) has the authority to...more
In November 2019, President-elect Donald Trump’s first administration’s withdrawal of California’s emissions waiver went into effect. ...more
On the day of his inauguration, President Joe Biden issued a historic number of executive orders, several of which focused on overturning actions taken by the Trump Administration’s Environmental Protection Agency (EPA). We...more
Republicans have swept the 2024 elections, returning Donald Trump to the White House as the 47th President and flipping the Senate to a Republican majority. Having narrowly maintained control of the House of Representatives,...more
California’s ambitious zero-emission, heavy-duty truck regulations face new legal challenges. Our Environment, Land Use & Natural Resources Group outlines the status of California’s Advanced Clean Fleet (ACF) Regulation,...more
The U.S. Environmental Protection Agency (EPA) announced on April 19, 2024, that it issued an emergency fuel waiver for E15 sales. EPA states that the waiver will help consumers protect themselves against fuel supply shocks...more
March and April have been busy months for vehicle emission regulation in the U.S. On March 20 and March 29 respectively, the U.S. Environmental Protection Agency (U.S. EPA) issued a set of final emission rules setting...more
Case Studies for Build America, Buy America Infrastructure Projects – Review of recent changes to government procurement and Buy America laws relating to infrastructure projects. Includes case studies covering construction...more
California continues to push toward its statewide carbon-neutrality goals. On August 25, 2022, the California Air Resources Board (CARB) unanimously approved regulations that require all new 2035 and later passenger...more
On June 1, 2022, the U.S. Environmental Protection Agency (EPA) issued a proposed rule that would modify its requirements for water quality certification under Clean Water Act (CWA) Section 401 (the “Proposed Rule”). The...more
On March 9, 2022, the US Environmental Protection Agency (EPA) rescinded a rule promulgated by the Trump Administration and revived California’s Clean Air Act waiver, allowing the state to set its own greenhouse gas emissions...more
In a move that was telegraphed at the outset of the Biden-Harris administration, the US Environmental Protection Agency announced March 9 that it is reversing a Trump-era decision to revoke California’s authority to set...more
A group of 16 Republican AGs, led by Ohio AG Dave Yost, sent a comment letter to the U.S. Environmental Protection Agency (“EPA”) urging it to not reinstate California’s waiver under the Clean Air Act, which the letter argues...more
I noted in yesterday’s post about the NHTSA proposal to withdraw the SAFE I Rule that EPA was expected to follow the NHTSA action by restoring the Clean Air Act Section 209 waiver for California’s Advanced Clean Car program....more
Last week, the National Highway Traffic Safety Administration proposed to withdraw Part I of the Trump Administration’s SAFE Rule, in which EPA had concluded that California’s regulation of motor vehicle GHG emissions was...more
Ninth Circuit Upholds U.S. EPA Waiver to CARB Regarding “Non-Road” Diesel Engine Regulations - On February 10, 2021, the U.S. Court of Appeals for the Ninth Circuit denied a challenge to the U.S. Environmental Protection...more
On September 23rd, Governor Gavin Newsom issued a precedent-setting executive order cementing California’s continued effort to take the lead on clean vehicle policy. Executive Order N-79-20 establishes as a goal that, where...more
The United States Environmental Protection Agency (EPA) has created a webpage devoted to providing answers to frequent questions related to Coronavirus (COVID-19). The information provided was last updated by EPA on April...more
Last week, the Alaska Department of Environmental Conservation (“ADEC”) issued two No Action Assurance Memorandums, one from the Division of Water (“Water Memo”) and one from the Division of Air Quality (“Air Memo”), to...more