Administrative Agency Updates

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.
News & Analysis as of

Half a Loaf May Not Be Too Bad: The 9th Circuit Affirms Most of EPA’s Approval of the San Joaquin Valley SIP

Earlier this week, the 9th Circuit Court of Appeals granted part of a petition challenging EPA’s approval of California’s SIP for ozone and PM 2.5 in the San Joaquin Valley.  While the trade press has been focusing on the...more

Massachusetts Moves to Block Regulation A+

The Secretary of the Commonwealth of Massachusetts has filed a petition for review of Regulation A+. The Secretary is asking that the rule be vacated because it is arbitrary, capricious and not in accordance with the...more

FDA Makes More Electronic Submissions Mandatory

In recent months, the FDA has been pushing forward in its efforts to require that more information from regulated industry be submitted electronically. The move to electronic submissions should create a more efficient and...more

SEC Updates EDGAR for Regulation A+

The SEC has updated its EDGAR Filer Manual to document changes being made to accommodate Regulation A+ under the JOBS Act. EDGAR will be updated to add Regulation A submission form types DOS, DOS/A, DOSLTR, 1-A, 1-A/A,...more

New GAO Report on Contingent Workforce Shows 85% of Independent Contractors Are “Content with Their Employment Type”

A comprehensive government report on the contingent workforce made public two days ago revealed surprising data about independent contractors, finding that 85% of independent contractors “appeared content with their...more

Floods in Texas, Flood Mapping, Flood Dollars

Floods on the Rio Blanco these past few days demonstrate the link to climate change, but not in the way you think. It was a horrible Memorial Day weekend in Hays County, Texas. At least three people died from the worst...more

FDA releases additional draft guidance regarding implementation of BPCIA

On April 28, 2015, FDA released three final versions of guidance documents relating to biosimilars that were initially released in February 2012. One of the guidances provided Questions and Answers regarding implementation of...more

Corporate & Financial Weekly Digest - Volume X, Issue 20

In this issue: - Section 16(b) Decision Provides Important Guidance - FINRA Requests Comment on Proposed Amendments to Rules Governing Communications With the Public - Form BE-10 Filing Deadline...more

FDA Proposes New Expansive Animal Drug Antimicrobial Reporting Regulations

On May 20, 2015, the Food and Drug Administration (“FDA”) proposed new regulations implementing the annual reporting requirements that were originally enacted by Congress in section 105 of the Animal Drug User Fee Amendments...more

China FDA Releases Guideline for Medical Device Registration Studies

On May 19, 2015, the China Food and Drug Administration (“CFDA”) unveiled the Technical Guideline Governing Medical Device Clinical Evaluation (“Guideline”). The long-awaited Guideline explains the methodology for clinical...more

Another multi-million dollar TCPA settlement

TCPA settlements are becoming ho-hum because they are so frequent. They are plaintiffs’ attorneys’ dream cases because of strict liability damages. All the more reason to keep your eye on the TCPA compliance ball as it...more

Gambling and the Bank Secrecy Act

The Bank Secrecy Act (“BSA”) is a complex set of federal laws and regulations that require “financial institutions” to keep records, make reports, and conduct due diligence as a means of helping the federal government detect...more

JB Burke’s Legal Updates: Skilled Nursing Facilities – Q1 2015

The following summary highlights key federal and state court cases and federal administrative decisions involving skilled nursing facilities issued during the first quarter of 2015. Federal and State Court Cases...more

White House Opposes Bill Giving Small Businesses Greater Voice in CFPB Rulemaking

Last month, the White House informed Congress that it opposes a bill passed by the House of Representatives designed to give small businesses a larger role in developing Consumer Financial Protection Bureau (CFPB) rules and...more

EEOC Launches First Phase of Digital Charge System

On May 6th, the U.S. Equal Employment Opportunity Commission (“EEOC”) announced the launch of a pilot program called ACT Digital in 11 of its 53 offices, which allows for the digital transmission of documents between the EEOC...more

EEOC Conciliation Efforts Subject To Limited Judicial Review

In Mach Mining, LLC v. EEOC, the United States Supreme Court held that the conciliation efforts of the Equal Employment Opportunity Commission (EEOC) are subject to judicial review, although such review is limited to ensure...more

Progress Toward Renewable Fuel Standard Blending Mandates

The White House is reviewing EPA's proposed rules to set the 2014, 2015, and 2016 Renewable Fuel Standard (RFS) requirements. The proposals are not currently publicly available, but EPA has committed to propose them by June...more

Wildlife Agencies Propose Regulatory Changes to Species-Listing Process Under Endangered Species Act

On May 18, 2015, the federal agencies that oversee the enforcement of the Endangered Species Act, the US Fish and Wildlife Service and National Marine Fisheries Service proposed significant changes to the process by which...more

Texas Supreme Court: Companies Shielded from Defamation Claims for Statements in Internal Investigation Reports

Last week, the Texas Supreme Court joined the majority of jurisdictions in holding that a company enjoys an absolute privilege when providing the Department of Justice (DOJ) with an internal investigation report containing...more

California Supreme Court Agrees to Consider Whether California Health Care Workers Can Lawfully Waive a Second Lunch Period.

This week, the California Supreme Court agreed to review the decision in Gerard v. Orange Coast Memorial Center, No. G048039 (February 10, 2015), where the California Court of Appeal partially invalidated the Industrial...more

EPA Issues SNURs For Several Biobased Chemicals

On May 8, 2015, the U.S. Environmental Protection Agency (EPA) issued a direct final rule for 25 chemical substances that were the subject of premanufacture notices (PMN), including several biobased chemical substances. The...more

Canada and Mexico to Seek Retaliatory Measures Following WTO’s Final Ruling Against U.S. Meat Labeling Law

On May 18, the World Trade Organization’s (“WTO”) Appellate Body upheld a ruling that U.S. country-of-origin labeling (“COOL”) requirements for meat continue to discriminate against imported livestock from Canada and Mexico...more

What a PA Should Know When Searching for a Supervising Physician

Although supervising physicians are required to follow regulatory guidelines, it is also important that physician assistants (“PAs”) understand their role in the authority delegated to them and the specifics of regulatory...more

CFPB Enforcement Action Appeals: Quick Resolution with Unchecked Discretion

On March 9, 2015, Consumer Financial Protection Bureau (CFPB) Director Richard Cordray presided over oral argument in the first appeal hearing of an administrative enforcement action. The appeal involves two companies that...more

And Now Bad Actor Waivers for Forward-Looking Statements

The Securities Act (Section 27A(b)) and the Exchange Act (Section 21E(b)) exclude reliance on the safe harbor for forward-looking statements if, among other things, the statement is made with respect to an issuer that has,...more

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