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
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
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
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
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
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
The Environmental Protection Agency (EPA) has issued a memorandum describing how and when the Agency will implement temporary enforcement discretion for certain federal environmental noncompliance during the COVID-19...more
On March 26, 2020, the U.S. Environmental Protection Agency announced it may ease enforcement of environmental legal obligations during the COVID-19 national emergency. Though some have incorrectly interpreted this...more
H.B. 197, passed by the Ohio Senate and the Ohio House and now awaiting Governor DeWine’s signature, includes several provisions that may impact entities or communities regulated by Ohio EPA. First, Section 27 of H.B. 197...more
Multi-state coalition’s lawsuit challenges Trump EPA withdrawal of California Clean Air Act waiver. EPA formally announced its decision to withdraw California’s 2013 Clean Air Act waiver, which allowed the state to set its...more
Since the mid-1990s, Maine has had an EPA-approved waiver from the ozone nonattainment new source review (NNSR) requirements for NOx covering, at a minimum, areas of the state that attain the ozone standard. The NOx waiver...more