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 U.S. Department of Transportation Federal Highway Administration (FHWA) on March 7, 2024, announced a proposed rule that would discontinue its longstanding Buy America waiver for manufactured products used in FHWA-funded...more
The Build America, Buy America Act generally requires that non-federal government infrastructure projects that benefit from federal government funding impose requirements for the use of domestic iron and steel and...more
The landmark Bipartisan Infrastructure Law (“BIL”) is a once-in-a-generation initiative to address aging U.S. infrastructure needs and equalize greater access to public resources. While the Administration continues to move...more
“Now, the next part is very important…” As scrutiny of domestic preference requirements increases in the wake of the Biden Administration’s Executive Order on Ensuring the Future Is Made in All of America by All of...more
Calls for Significant Changes To Federal Domestic Preference Policy, Waivers, and Buy American Eligibility - President Biden signed an executive order (order or EO) on January 25, 2021, to direct more spending of the...more
The waiver is in effect through September 30. Here is the announcement from the Federal Motor Carrier Safety Administration. You can download a copy of the Guidance at the link...more
The U.S. Department of Transportation’s Federal Motor Carrier Safety Administration issued a “Waiver in Response to COVID-19 Emergency” on March 24, 2020 concerning renewals of licenses and medical certifications for holders...more
The Office of the Inspector General (OIG) of the U.S. Department of Transportation (DOT) has announced an audit of the Federal Aviation Administration’s (FAA) “approval and oversight processes” for Part 107 waivers for...more
The FDA Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food is now final and on April 5, 2017, the FDA published three waivers for certain qualifying businesses. The Sanitary...more
Welcome to the winter 2016 edition of our Under Construction newsletter. We hope your year has been good to your family, your company and you as we wrap up these remaining few weeks of 2016. A recent hot topic with...more
This Week - While the Senate was predominantly focused on the budget this week, the House moved forward with a number of high-profile issues. By a vote of 60-49, the House approved House Bill 1080, sponsored by Rep....more
Two Week Highway Trust Fund Extension While Conference Takes Place - Congress agreed to extend the Highway Trust Fund by two weeks until Dec. 4 so that House and Senate conferees could meet to craft a final version of...more
Unmanned Aircraft Systems (UAS), or drones as they are more commonly known, are under intense scrutiny by the Federal Aviation Administration (FAA). In fact, the FAA itself is under scrutiny, by big and small businesses...more
As we have previously reported, the Federal Highway Administration (FHWA) and Federal Transit Administration (FTA) recently adopted policies requiring Buy America compliance for utility relocations for federally funded...more