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Focus on Regulation

Federal Circuit Acetris Decision Changes Procurement Country of Origin Landscape

On Monday, in the much-anticipated decision in Acetris Health, LLC v. U.S. 18-2399, the Court of Appeals for the Federal Circuit (the “Federal Circuit”) ruled that U.S. manufacture of a drug is sufficient to confer U.S. origin under the Trade Agreements Act (“TAA”) – regardless of the origin of its main component, the Active Pharmaceutical Ingredient (“API”).

The decision affirmed a lower court ruling by the U.S. Court of Federal Claims (“CoFC”) that had found that Acetris product manufactured in the U.S. with API from India was considered a “U.S.-made end product.”  While this case addresses the country of origin (“COO”) analysis for drug products, it has the potential to be applied more broadly to other manufactured items procured by the Federal government.

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Kari’s Law Compliance Obligations Begin February 16, 2020

Kari’s Law, signed into law on February 16, 2018, requires organizations that use multi-line telephone systems (MLTS) to provide callers with the ability to dial 911 directly from any telephone in the system. MLTS are often used in hotels, office buildings, corporate and educational campuses, and other enterprises. As a result, a wide variety of organizations will be impacted by Kari’s Law and must comply with its requirements.

The Federal Communications Commission (FCC) recently published its implementing regulations. The regulations went into effect on January 6, 2020, with a compliance date of February 16, 2020. Continue Reading

Other Transaction Agreements: Where Does An Unsuccessful Bidder Go?

Recent Federal District Court Decision Highlights the Complexity of Jurisdictional Issues in Challenging Government Awards of Other Transaction Agreements

Growth of OT Agreements

A recent decision by the U.S. District Court for the District of Arizona highlights the complexity of jurisdictional issues faced by unsuccessful offerors that challenge government awards of “other transaction” (OT) agreements.  Over the past few years, OT agreements have grown significantly in popularity due to their immunity from the regulatory provisions that typically govern government procurement contracts, including those that address intellectual property rights, cost accounting, and other key terms.  Indeed, by some reports, Department of Defense (DoD) spending on OT agreements has grown from $2.3 billion in Fiscal Year (FY) 2017 to, by some accounts, more than $7 billion in FY 2019.  It is no wonder that companies that are not selected for an OT agreement have at times attempted to challenge their exclusion in various judicial fora. Continue Reading

Eleventh Cir. Rejects Broad Reading of “Autodialer”

On January 27, 2020, an Eleventh Circuit panel released a landmark ruling in Glasser v. Hilton Grand Vacations Company, LLC. The key issue in the case was how to interpret ambiguous language in the Telephone Consumer Protection Act’s (TCPA) definition of “automatic telephone dialing system” (ATDS or autodialer). In recent years, imprecise statutory phrasing and the Federal Communication Commission’s (FCC) liberal reading of the legislative history empowered plaintiffs to assert TCPA claims based on a wide array of calling systems. The Eleventh Circuit panel’s decision in Glasser rejects that trend, joins the D.C. Circuit in adopting a much narrower view of the TCPA’s scope, and establishes a clear circuit split with the Ninth Circuit. Continue Reading

National Security Commission on AI issues interim report

The National Security Commission on Artificial Intelligence (the “Commission”), established by the John S. McCain National Defense Authorization Act for Fiscal Year 2019, issued an interim report providing the Commission’s preliminary assessment of

  • foreign threats to U.S. national security in the current AI era;
  • how AI can improve the government’s ability to defend the U.S., cooperate with U.S. allies, and preserve a favorable balance of military power in the world;
  • the relationship between AI and economic competitiveness as a component of U.S. national security, including the strength of the U.S. scientific research community and workforce; and
  • ethical considerations in deploying AI systems for national security purposes.

The Commission is to submit its final report to Congress and terminate in October 2020, although the deadline may be extended.

CFIUS Regulations Released for Public Inspection

The long-anticipated foreign investment review regulations were released for public inspection on 13 January, 2020. The regulations, scheduled to appear in the Federal Register on 17 January, 2020, are in two Federal Register notices:

In connection with 31 CFR Parts 800 and 801, the Office of Investment Security at the Department of the Treasury issued a final rule and an interim rule with a request for comments on the interim rule. The final rule revises regulations that implement certain provisions of section 721 of the Defense Production Act of 1950, as amended by the Foreign Investment Risk Review Modernization Act of 2018 (FIRRMA). The interim rule adds to Part 800 a new definition for the term “principal place of business.” The final rule and interim rule are effective on 13 February, 2020. Comments concerning the definition of “principal place of business” are due 30 days from publication.

The Office of Investment Security also released a final rule, designated 31 CFR Part 802, that addresses the CFIUS review of certain transactions involving the purchase or lease by, or concession to, a foreign person of certain real estate in the United States. An interim rule adds to Part 802 a new definition for the term “principal place of business.” The final rule and interim rule are effective on 13 February, 2020. Comments concerning “principal place of business” are due 30 days from publication.

We are preparing an alert. In the meantime, if you have questions, please contact  Brian Curran, Anne Salladin, Ajay Kuntamukkala or Anthony Capobianco.

DDTC Publishes FAQs on U.S. Persons Working Abroad & ITAR Defense Services

On 6 January, 2020 DDTC announced guidance regarding U.S. persons providing defense services while abroad. The guidance is based on the ITAR and not the 2015 proposed rule, and is provided in a 14-part question-and-answer format.

Dutch competition authority imposes fine on company for deleted chat messages during a dawn raid

The Dutch competition authority (“ACM“) recently confirmed that the obligation to cooperate fully with an inspection/during a dawn raid is of utmost importance and of great relevance to companies under investigation.  On 10 December 2019, the ACM issued an infringement decision fining an unidentified company EUR 1.85 million for obstructing an ACM inspection.  This was on the basis that company employees deleted/destroyed potential evidence by deleting electronic chat and messaging services during the inspection.

The ACM’s decision is available here. Continue Reading

Webinar | New TRACED Act and Robocall Year in Review: What you need to know

It was a very busy year on the robocall front, and on 30 December 2019, President Trump signed into law the Pallone-Thune Telephone Robocall Abuse Criminal Enforcement and Deterrence (TRACED) Act (S. 151), which the House and Senate passed by wide, bipartisan margins earlier this year.

The TRACED Act is the most significant robocall legislation in years. It requires the Federal Communications Commission (FCC) to take steps to improve call verification, reduce the number of illegal robocalls, and enhance the federal government’s Telephone Consumer Protection Act (TCPA) enforcement efforts. Among other things, for example, the TRACED Act increases penalties for intentional violations by US$10,000 per call.

We’ll also discuss other key robocall developments from 2019, including the Nuisance Call Act, a New York law that requires live telemarketers to give consumers the option to be added to the seller’s do-not-call list, as well as an important FCC ruling that clarifies the requirements for sending online faxes.

Please join us on this webinar on Thursday, 9 January 2020 at 2:00pm ET as we explore what these and other developments from 2019 mean for your business and your TCPA compliance programs more broadly.

Date:
Thursday, January 9, 2020

Time:
02:00 PM EST

To register, please click here.

Congress Passes Bipartisan Robocall Legislation

On December 19, 2019, the U.S. Senate unanimously passed the Pallone-Thune Telephone Robocall Abuse Criminal Enforcement and Deterrence (TRACED) Act (S. 151), which the House of Representatives passed in a 417-3 vote earlier this month.  With the Senate’s passage of the reconciled bill, the bipartisan legislation now heads to President Trump’s desk for his review.

The Pallone-Thune TRACED Act requires the Federal Communications Commission (FCC) to take steps to improve call verification, reduce the number of illegal robocalls, and enhance the federal government’s Telephone Consumer Protection Act (TCPA) enforcement efforts.  More specifically, the Pallone-Thune TRACED Act, among other provisions: Continue Reading