Administrative Agency Updates

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Characterization as “Essential Element” Amounts to a Disavowal of Scope

X2Y Attenuators, LLC v. International Trade Commission - Addressing the impact of an alleged disclaimer made in a patent on which asserted patents relied for priority, the U.S. Court of Appeals for the Federal Circuit...more

Federal Grant and Contract News for Nonprofits - August 2014

As is an annual tradition in Washington, the month of August is relatively quiet. However, the Court of Federal Claims (COFC) did issue a recent decision that provided guidance on how to distinguish a grant or cooperative...more

OSHA Initiative Directs Untimely Whistleblowers To NLRB

The Occupational Safety & Health Administration recently has entered into a referral agreement with the National Labor Relations Board (NLRB) under which it will direct workers wanting to pursue time-barred retaliation claims...more

EPA's Concern Over TCE Vapor Intrusion Is Misguided

On July 9, 2014, the Director of the U.S. Environmental Protection Agency's Superfund Division in Region 9 issued a memo to staff setting an “operational framework” to address “inhalation exposures [to trichloroethylene] in...more

D.C. Circuit Ruling Upholds New Ground Rules in Development of Electric Transmission Infrastructure

The Federal Energy Regulatory Commission's (FERC or "Commission") landmark regional electric transmission planning rulemaking, a multi-year effort by the Commission that has been met with vigorous opposition from some...more

DEA Issues Final Rule Up-Scheduling Hydrocodone Combination Products from Schedule III to Schedule II

On August 22, 2014, the Drug Enforcement Administration (DEA) published a final rule upscheduling hydrocodone combination products (HCPs) under the Controlled Substances Act (CSA) from Schedule III to Schedule II. The...more

This Week In Securities Litigation

In the roll-up to the Labor Day weekend, the SEC issued new rules regarding asset backed securities and credit rating agencies. The Commission also announced a new pilot program on tick size....more

Executive Labor Summary - July/August 2014

NLRB extends Weingarten right of union representation to drug and alcohol test situations - On July 31, a three-member panel of the National Labor Relations Board in Ralph's Grocery Co. ruled that a union-represented...more

Arizona Enacts Limited Privilege For Insurance Self-Audits

Arizona has enacted a privilege applicable to voluntary compliance audits conducted by insurance companies. This “self-evaluative” privilege protects audit documents and testimony in civil and some administrative proceedings....more

Supreme Court of PA Reaffirms the Broad Scope of the Commonwealth Court’s Declaratory Judgment Jurisdiction in Challenges to...

Many Pennsylvania Lawyers only encounter the Commonwealth Court of Pennsylvania in its appellate guise, but the court enjoys an unusual hybrid nature, having both appellate and original jurisdiction. The court’s original...more

Court Reluctantly Upholds Designation of Critial Habitat for Frog

Last week, the United States District Court for the Eastern District of Louisiana upheld the designation of approximately 1,544 acres of privately-owned timber land located in Louisiana as critical habitat for the dusky...more

“Don’t worry about me, I carry weapons”: employee’s violent statements warranted serious discipline but not dismissal

An electrician’s comment, “Don’t worry about me, I carry weapons” and “it would really feel good to kill something today” constituted workplace violence but did not warrant dismissal, the Ontario Labour Relations Board has...more

Tips for Reacting to an "In-Person" Public Records Request under Florida's Public Records Act

Under Florida's broad Public Records Act ("the PRA"), chapter 119, Florida Statutes, any person - whether an individual or a legal entity - can request access to or copies of public records in the custody of state agencies,...more

Food and Beverage News and Trends

Vermont AG defends the state’s GMO statute. On August 8, the Vermont attorney general filed a motion to dismiss a case brought by food trade groups against the state’s newly enacted statute requiring GMO foods be...more

AHA Renews Complaints about OIG Hospital Compliance Reviews

The American Hospital Association (AHA) has renewed its complaints about OIG “hospital compliance reviews.” Last Thursday AHA Executive Vice President Rick Pollack sent a letter to Health & Human Services Secretary Burwell...more

Managing the announcement of a Department of Education Program Review

Following the initial release of the well-known and controversial 2010 GAO report concerning alleged abuses in the for-profit sector, Secretary of Education Arne Duncan issued a public letter to Senators Tom Harkin and Mike...more

Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process

On August 14, the Food and Drug Administration (FDA) issued a draft guidance titled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The draft provides guidance on a streamlined process for...more

FDA Notifies Congress of Framework for Long-Awaited Guidance on Laboratory Developed Tests and Issues Final Guidance on Companion...

Laboratory Developed Tests - After many years of promising that it would be providing guidance on the regulation of laboratory developed tests (LDTs), the Food and Drug Administration (FDA) provided notice to Congress...more

City of San Diego's Settlement Over Alleged MS4 Permit Violations Results in Crackdown on Out-Of-Compliance Projects

On August 13, 2014, the San Diego Regional Water Quality Control Board approved a two-part settlement with the City of San Diego for violations of the City's Municipal Separate Storm Sewer System ("MS4") permits. Most of the...more

Ready, Set, Charge!

Professional discipline allegations are more art than science. Regulatory statutes usually provide little or no guidance for writing them. But whether you call them allegations, charges, citations, complaints or something...more

Back to School OMA/FOIA Update: Public Access Counselor (PAC) Decisions this Summer

The summer is nearly behind us, and it has been a busy summer for the Public Access Counselor (PAC) office of the Illinois Attorney General, which issued five binding decisions since May on Open Meetings Act (OMA) and Freedom...more

Pennsylvania Public Utilities Commission Appeals Act 13 Ruling to State Supreme Court

The Pennsylvania Public Utilities Commission (PPUC) is asking the state Supreme Court to review a July ruling by the Pennsylvania Commonwealth Court that strips PPUC of its authority to review and approve local drilling...more

California Coastal Commission Further Solidifies Enforcement Powers

An informal Attorney General advice letter and recent legislation attempt to clarify the Coastal Commission’s powers in carrying out its enforcement authority. The extent of the California Coastal Commission’s legal...more

Physicians Write Letter to FDA Regarding Biosimilar Naming Concerns

On Thursday, August 14, 2014, several physicians wrote a letter to Commissioner Hamburg of the U.S. Food and Drug Administration (FDA) expressing their concerns regarding the naming of biosimilar products in light of the...more

SEC Settles with Dually Registered Adviser Over Best Execution, Disclosure and Principal Transactions

The SEC settled administrative proceedings against an investment adviser, Dominick & Dominick LLC, a firm registered with the SEC both as an investment adviser and a broker-dealer (the “Adviser” or “D&D”), and Robert X....more

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