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FDA Denies AbbVie’s Citizen Petition on Interchangeability

FDA has denied AbbVie’s Citizen Petition on interchangeability. Back in December 2015, AbbVie submitted a Citizen Petition to FDA requesting that the agency take certain actions regarding interchangeability standards for…more

Mind the (Pay) Gap: Retailers May Want to Prep for Pay Equity Inquiries From Investors

In 2016, several technology companies received or responded to proposals from investors that requested shareholder votes regarding whether the companies should be required to prepare reports addressing their policies and goals to…more

EPA Issues Proposed Rule for Prioritizing Existing Chemicals for Risk Review - Proposed Four-Step Process Aims to Incentivize Early Information Submission

The United States Environmental Protection Agency (EPA) has published its proposed rule for the prioritization of existing chemicals for the risk evaluation mandated under the Frank R. Lautenberg Chemical Safety for the 21st Century…more

‘Ancient’ Data (and Documents): Prepare for Federal Changes to a Long-standing Hearsay Exception

Unbeknownst to many, changes to the Federal Rules of Evidence governing the hearsay exception for ancient documents (FRE 803(16)), and additional rules governing self-authentication of evidence generated by electronic processes or…more

The Impact of Brexit on UK Staff Working for the EU Institutions

Among the many thorny issues that have arisen in the wake of the UK referendum vote to leave the European Union on 23 June 2016, the question of the potential consequences of a withdrawal from the Union for UK staff working at the EU…more

House Acts to Place Additional Limitations on SEC Rulemaking

With its passage of the SEC Regulatory Accountability Act last week, the U.S. House of Representatives has taken action to place additional constraints on future rulemaking by the Securities and Exchange Commission; however, many of…more

Sustainable Development Update - January 2017 #2

Sustainable Development Focus - Exponential growth in net zero energy buildings predicted for the next two decades - Building Design + Construction - Jan 5 - The global market for products and services related to…more

Second Circuit Rules on TIA Section 316(b); Overturns Marblegate (and Caesars)

Yesterday, in the latest chapter in the ongoing debate over Section 316(b) of the Trust Indenture Act, the Second Circuit reversed the district court’s decision in Marblegate, concluding that the TIA does not prohibit out-of-court…more

Germany’s Financial Regulator Implements New Electronic System Guaranteeing Whistleblowers Absolute Anonymity and Non-traceability

As we reported last summer, Germany’s Financial Supervisory Authority (BaFin) set up a centralized platform for receiving whistleblower complaints of alleged violations of supervisory provisions within the financial…more

What Can the Business Community Expect from a Trump Administration

As Donald Trump’s administration takes shape, the business community stands watch expecting a business-friendly White House. Trump’s promises of fewer regulations and lower taxes have small and large businesses alike feeling a bit like…more

Labor Law 2016: A Year In Review

Introduction - In the final year of his two term tenure, President Barack Obama’s National Labor Relations Board and Department of Labor continued their double barrelled efforts to remake labor law to benefit labor unions…more

Supreme Court to Decide Legality of Class Action and Collective Action Waivers

On January 13, 2017, the Supreme Court agreed to consider whether employee arbitration agreements containing class/collective action waivers are unlawful and unenforceable. The Court’s decision to consider this issue portends one of…more

Lifting Jurisdictional Immunity of Foreign States Sponsoring Terrorism in the U.S.

On 28 September 2016, the U.S. Congress adopted the ‘Justice Against Sponsors of Terrorism Act’ (JASTA). Even prior to its adoption, the bill was controversial as it lifts the immunity from jurisdiction of foreign States involved in…more

Accessibility Rules Continue to Take Shape Even As FCC Leadership Transitions

With FCC leadership soon shifting as the current administration winds down, there have been several interesting accessibility-related developments. In addition, several important FCC accessibility rule compliance deadlines have…more

FAR’s Signature Requirements Strictly Enforced

Though we live in the electronic age, the pen’s power endures in the government contracts world—at least when it comes to signatures for certified claims. The Armed Services Board of Contract Appeals (“ASBCA”) recently held that it…more

Controlling L. mono in RTE Foods: FDA Publishes Draft Guidance

Quick Bite: The FDA is seeking comment until July 17, 2017, on draft guidance about recommended practices to control Listeria monocytogenes in food facilities. The Details: The Food and Drug Administration (“FDA”) recently…more

Medical Marijuana Comes to Pennsylvania: What to Expect As the Keystone State Rolls Out its New Medical Marijuana Program

A lack of consensus regarding both medical and recreational marijuana has sparked intense debate across the country. Combined with federal law prohibitions, the state-by-state mosaic creates a dynamic legal landscape. Marijuana remains…more

Make Congress Great Again?

During its first week in session, the 115th Congress passed two bills aimed at reining in the executive branch’s powers. If signed into law, these bills could significantly impact employers who have faced myriad rulemakings and…more

Early January Environmental Odds And Ends

“The old order changeth, yielding place to new.” January 2017 has been a very active month, with several important environmental and federal administrative court rulings being issued, and many significant rules being proposed and…more

FDA Advances LDT Dialogue with New Discussion Paper Containing Updated CMS/FDA Oversight Proposal

On January 13, 2017, the Food and Drug Administration (FDA) released a discussion paper concerning an updated proposed framework for oversight of laboratory developed tests (LDTs). According to FDA, the updated proposal is the result…more

Federal Agencies Given New Breach Response and Preparation Guidelines

The White House has made a step toward implementing in federal agencies some breach response best practices currently used in the private sector. On Jan. 3, the White House issued a memorandum (Memo) updating for the first time in…more

Wireless Telecommunications Bureau Releases Draft Framework for Analyzing Zero-Rated and Sponsored Data Programs

On January 11, 2017, the Wireless Telecommunications Bureau (WTB or Bureau) of the Federal Communications Commission (FCC or Commission) issued an informal report—“Policy Review of Mobile Broadband Operators’ Sponsored Data Offerings…more

Supreme Court Will Review NLRB’s Anti-Arbitration D.R. Horton Rule

As we’ve noted in this space before, one of the most persistent efforts to undermine the Supreme Court’s decision in AT&T Mobility LLC v. Concepcion—which held that the Federal Arbitration Act (FAA) generally requires enforcing…more

Multi-Jurisdictional Prosecutions and the SFO Show Teeth in Rolls Royce Settlement

Rolls Royce’s $800 million global settlement further solidifies what the future of anti-bribery and corruption enforcement looks like: multi-jurisdictional prosecutions based on egregious conduct supported by strong evidence…more

The Bottom Line is the Bottom Line: Three Ways for Cutting Costs Across the Stages of E-Discovery

E-Discovery is often viewed as being a niche in the larger legal world. It’s often an ancillary topic in law schools, and according to one respondent in a recent Exterro survey, “Most lawyers view e-discovery as akin to janitorial…more

FLSA Civil Penalties to Increase Again

For the second time in less than a year, the U.S. Department of Labor will soon publish increases in the civil money penalties it can impose for certain violations of the federal Fair Labor Standards Act and/or related regulations…more

Justices to Consider Arbitration Agreements With Class Waivers – The End of the Beginning?

Apologies to Winston Churchill, but the conflict over the enforcement of arbitration agreements with class waivers has become an ongoing legal and ideological struggle. Some view individual arbitration as a quicker and less costly…more

How Much is That Facebook Page Worth to Your Business?

At first glance, this question may seem relatively unimportant in the context of an M&A transaction. It rings true that social media accounts usually receive little attention during the negotiation of a deal, which fact may be…more

Class Action Roundup: Fall 2016

In this edition of Class Action Roundup, we feature decisions from the third quarter of 2016, covering everything from pizza delivery and Uber drivers to payday lenders, canned tuna manufacturers, and even flushable…more

Expansive New Rule for Certain Employment-Based Immigrant and Nonimmigrant Visa Programs

Effective yesterday, January 17, 2017, a new USCIS rule seeks to improve multiple employment-based temporary nonimmigrant and immigrant visa (“green card”) programs. The new regulations are designed to help U.S. employers hire and…more

Antennas up, Employers: Are ALJs History?

The Supreme Court of the United States is, of course, known for landmark decisions affecting the lives of Americans. When we hear "SCOTUS" we think of famous civil rights cases such as Marbury v. Madison, (1803) which established the…more

The Forgotten Face of Student Lending

Mention student loans and the face that comes immediately to mind is probably someone in their early twenties. A recent report from the CFPB sheds light on an overlooked segment of the student loan population – consumers 60 years old…more

OSHA’s “Perp Walks” for the Week of January 9th.

OSHA has long bemoaned that the Occupational Safety and Health Act (“OSH Act”) does not allow OSHA to issue penalties sufficiently high enough to deter noncompliance. While reasonable minds can disagree about the sufficiency of the…more

DHS Finalizes Entrepreneur Parole Rule, Expanding Options for Foreign National Entrepreneurs

On January 17, 2017, the U.S. Department of Homeland Security (DHS) published its final rule entitled “International Entrepreneur Rule.” This rule follows President Obama’s November 14, 2014 promise to use existing statutory authority…more

TSCA: EPA Proposes Regulation of TCE Use in Vapor Degreasing under TSCA Section 6(a)

In an expected action, on January 11, 2017, the Administrator of the U.S. Environmental Protection Agency (EPA) signed a proposed rule under Section 6(a) of the Toxic Substances Control Act (TSCA) to regulate the use of…more

Federal Circuit Provides Guidance on Divided Infringement, Inducement of Infringement, and Indefiniteness

Patent owners will applaud the Federal Circuit’s latest pronouncement on divided infringement, inducement of infringement, and claim definiteness under 35 U.S.C. § 112. Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., Appeal No…more

Pop-up Shops: Breath of Fresh Air?

If you are involved in commercial real estate, especially if working with landlord clients, you’ve likely had a chance to work with retailers in creating a unique lease for a pop-up shop. These novel concepts are popping up all over…more

Blog: OIG Issues Final Rule Re: Exclusion Authority

The Final Rule related to the Health and Human Services Office of Inspector General’s (OIG) exclusion authority pursuant to the Social Security Act (the Act), as amended by the Affordable Care Act (ACA) and the Medicare Prescription…more

Privacy Perils: Beware Browser Autofill

The ingenuity of determined fraudsters should never be underestimated. Gizmodo, a technology website, reports on a simple scheme where hackers capture your sensitive information merely by hijacking the autofill features found in the…more

Sustainability Reporting Trends in the New Year – ’16 going on ‘17

If you’re feeling uncertain or confused about the future of sustainability reporting in the United States, you’re not alone. With the business world’s adoption of sustainability reports moving full steam ahead—and increasing hunger for…more

Environmental Enforcement Under Trump – Be Careful What You Wish For

Regardless of whether you are a Trump supporter or Trump hater, and there certainly seems to be very few people who are indifferent to the guy, trying to prognosticate what he will do is very difficult. He is a political outsider with…more

Transfer On Death Accounts And Deeds vs. Living Trust

A question I am often asked is, “If I have designated my various financial accounts as transfer on death (TOD), or payable on death (POD), and I have a transfer on death deed on my house, why do I need a Living Trust?” While it is…more

EEOC Issues Quality Practices Plan on Federal Sector Hearings, Appeals and Oversight Functions

WASHINGTON - The U.S. Equal Employment Opportunity Commission (EEOC) today published Federal Sector Quality Practices (FSQP) to address the quality of the agency's hearings and appeals in federal employee employment discrimination…more

No medical report means no accommodation

Although the Army Ammunition Depot is located in McAlester, it was a Muskogee federal court that upheld an employer’s right to require adequate medical support before granting an employee’s request their job be modified on account of…more

Ole Miss Substantially Prevails in Tax Court Case over Taxability of Coach Appearances

Tax exempt organizations must report and pay tax on their “unrelated business income.” Butler Snow recently represented The University of Mississippi (“UM”) in a federal income tax dispute in the United States Tax Court involving the…more

Federal Minimum Salary Drama? New York Says Fuhgettaboutit!

As if the start-again, stop-again saga with the U.S. Department of Labor’s rules increasing the minimum salary threshold for exempt workers wasn’t confusing enough, at least one state has jumped into the fray and changed its own…more

How Employment Agreements Can Protect An Employer's Intellectual Property And Defend Against Claims of Misappropriation

At approximately 4.6%, the current national unemployment rate is lower than it has been since before the 2008 recession. Generally speaking, this means that companies are hiring new employees. While hiring new employees is both a…more

Potential Repeal of Medical Device Tax

With the upcoming Republican-dominated Presidency and Congress in 2017, the Affordable Care Act, or at least parts of it, look to be on the chopping block. One of the changes that may be forthcoming is a repeal of the 2.3% medical…more

SCOTUS To Decide Class Action Waivers

The Supreme Court has agreed to resolve the simmering dispute between the NLRB and (essentially all) employers over class action waivers. The NLRB has maintained in a number of cases that employers may not enforce arbitration…more

2017 – The Year to Try Something New?

2017 has arrived, and already the year is looking like one of change outside the narrow bounds of the legal profession: The Cubs are national champions and University of Alabama is not, Brexit negotiations will be getting started, and…more

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Founded in February 2008, Zapproved is a software-as-a-service provider based in Portland, Ore. Our flagship product, Legal Hold Pro, was the first cloud-based litigation hold management software…

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