Code of Federal Regulations

  • Diverse Issues in Higher Education

    Issue number #36-19 (October 2019) of publication Diverse Issues in Higher Education is now available

    Nov 21, 2019 12:02 PM

  • Business North Carolina

    Issue number #39-11 (November 2019) of publication Business North Carolina is now available

    Nov 21, 2019 12:02 PM

  • California CPA

    Issue number #88-5 (November 2019) of publication California CPA is now available

    Nov 21, 2019 12:02 PM

  • October 2019 Patent Eligibility Guidance Update

    Earlier this year, the United States Patent and Trademark Office (USPTO or “the Office”) published the 2019 Revised Subject Matter Eligibility Guidance (2019 PEG), which set forth newly revised procedures to be used by USPTO personnel in evaluating subject matter eligibility under 35 U.S.C. § 101. The 2019 PEG was developed in response to concerns that the Office was inconsistently applying the eligibility criteria set forth in Mayo, Alice, and other court decisions. While patent holders generally welcomed the 2019 PEG, the Office also received many comments that indicated the need for further clarification of the updated subject matter eligibility examination guidelines. (See Article)

    Nov 21, 2019 11:32 AM

  • FSMA Update: FDA Announces Continuation of Enforcement Discretion for Co-Manufacturer Supplier Verification

    On November 6, 2019, the Food and Drug Administration (FDA) announced in a Constituent Update that it will continue to exercise enforcement discretion with respect to certain supply-chain program requirements applicable to contract manufacturers (“co-manufacturers). The agency is taking this action to address situations where brand owners perform certain supply-chain program requirements on behalf of their co-manufacturers. This action extends the enforcement discretion FDA announced in November 2017, which was due to expire on November 6, 2019. Notably, FDA has not yet announced the length of time for this extension of the enforcement discretion but plans to do so in a forthcoming Federal Register notice. This memorandum provides a background on this issue and explains the FDA’s recent announcement. Please see full Publication below for more information. (See Article)

    Nov 21, 2019 11:32 AM

  • FDA Accepts Samsung Bioepis’s Bevacizumab Biosimilar (SB8)

    Samsung Bioepis Co., Ltd announced today that the FDA has accepted for review an aBLA for SB8, a bevacizumab biosimilar to Roche’s Avastin® product. If approved, SB8 will be commercialized in the US by Merck & Co. (See Article)

    Nov 21, 2019 11:32 AM

  • EEOC and Lifewell Living Center, LLC Conciliate Disability Charge

    ALBUQUERQUE - The U.S. Equal Employment Opportunity Commission (EEOC) and LifeWell Living Center, LLC have reached a voluntary conciliation agreement to resolve allegations of disability discrim­ination raised by a former employee, the federal agency said today. (See Article)

    Nov 21, 2019 11:32 AM

  • [Event] West Coast Tax Forum: California & Beyond: The Impact Of State, Federal And International Tax Developments On Golden State Taxpayers - December 10th, San Francisco, CA

    Tax professionals are on the frontlines, responding to state, federal and international tax developments that significantly impact business objectives. California taxpayers face particularly unique challenges. Join members of McDermott Will & Emery’s Tax practice for a half-day forum in our San Francisco office. This forward-looking program is designed to drive conversations around the most critical tax issues facing California-based entities and other US and foreign entities doing business in California. (See Article)

    Nov 21, 2019 11:32 AM

  • CCPA Privacy FAQs: How many companies have included a “Do Not Sell My Personal Information” link on their homepage?

    See Article)

    Nov 21, 2019 11:32 AM

  • Texas Magistrate Denies Motion for Attorneys’ Fees Incurred in Seeking Confirmation of Arbitration Award

    The plaintiff successfully confirmed an arbitration award concerning certain franchise agreements and then sought attorneys’ fees and costs incurred in connection with its confirmation action based on the attorneys’ fees provision in the franchise agreements. The defendants opposed because the arbitrator had already issued a final award awarding attorneys’ fees and costs in the arbitration. (See Article)

    Nov 21, 2019 11:32 AM

  • Google Partners With Ascension To Store And Analyze Millions Of Patient Health Records

    Google has confirmed that it is working with Ascension, one of the nation’s largest health systems in a project that will involve the health data of millions of Americans. Google and Ascension have partnered in a project to store and analyze patient data with the intended goal of using Google’s artificial intelligence tools to enhance patient care and medical decision making. (See Article)

    Nov 21, 2019 11:32 AM

  • Increased False Claims Act Scrutiny for Private Equity Firms Investing in Healthcare Providers

    Private equity firms investing in healthcare should take note of increasing False Claims Act (FCA) scrutiny by the government and whistleblowers. In two recent cases, the government has demonstrated a willingness to pursue private equity (PE) firms that invest in healthcare providers and take an active role in operations. (See Article)

    Nov 21, 2019 11:32 AM

  • OTCQX Proposed Rule Changes

    The OTC Markets Group published this week proposed amendments to the OTCQX Rules for U.S. Companies, U.S. Banks and International Companies. The rules will become effective on December 12, 2019; comments will be accepted until December 11, 2019. To qualify for the OTCQX, International Companies must, among other qualifications, have a class of securities traded on a Qualified Foreign Exchange (includes the Toronto Stock Exchange, the TSX Venture Exchange and the Canadian Securities Exchange), be an SEC Reporting Company or be a Regulation A Reporting Company. (See Article)

    Nov 21, 2019 11:32 AM

  • [Webinar] Surf's Up or Low Tide? California's Water Sector: 2019 in Review & 2020 Predictions - December 10th, 1:00 pm PT

    Join Lori Anne Dolqueist and Jennifer Capitolo on December 10, 2019 for “Surf's Up or Low Tide? California's Water Sector: 2019 in Review & 2020 Predictions”! This complimentary 60-minute webinar will give an overview of key events in 2019 that affected water utilities in California, including: • Governor Gavin Newsom's first year in office • 2019 legislative developments • State agency planning and regulatory actions • And a few predictions for 2020 (See Article)

    Nov 21, 2019 11:32 AM

  • School Case Clarifies Scope, Limits Of Right-To-Know Law

    In a recent Right-to-Know Law case, the Pennsylvania Office of Open Records (OOR) issued a final determination that sheds light on the extent to which a school district may decline producing requested records. The requester sought all emails sent from or received by school board members and the superintendent during a 21-day period in May 2019. (See Article)

    Nov 21, 2019 11:32 AM

  • U.S. Supreme Court Hears Arguments Over Scope of Title VII’s Protection of LGBT Individuals

    Title VII of the Civil Rights Act of 1964 prohibits employment discrimination on the basis of race, color, religion, sex, or national origin. (See Article)

    Nov 21, 2019 11:32 AM

  • Privacy and Data Security Alert | November 2019

    EU Court Allows Class Action to Proceed, Sets Precedent for Future Data Breach Class Actions - A class action brought against Google will be allowed to move forward after the plaintiff’s appeal was permitted, allowing him to continue his claim under section 13 of the Data Protection Act of 1998. The case stems from a workaround that enabled Google to place certain cookies on a user’s device without the user’s knowledge, allowing the company to secretly track users and collect “browser generated information.” (See Article)

    Nov 21, 2019 11:32 AM

  • [Webinar] Government Contracting Fundamentals Series: An Introduction to the FAR - December 11th, 12:00 pm ET

    Obermayer is excited to introduce its new “GovCon Examiner Live” webinar series, your resource for the fundamentals in government contracting and small business procurement. Over the course of 12 months, our experienced government contracting attorneys Maria Panichelli and Michael Richard will bring their popular GovCon Examiner blog to life with legal updates and practical tips for your business. (See Article)

    Nov 21, 2019 11:32 AM

  • Recent Legislation Changes Illinois Non-Resident Employee Withholding Rules

    Seyfarth Synopisis: Illinois recently enacted legislation that changes the rules for withholding income tax from non-resident employees. The new rules replace the current, somewhat more complicated rules with a more straight-forward method that is based on, among other things, the number of working days that an employee spends in Illinois. (See Article)

    Nov 21, 2019 11:32 AM

  • 2019 Moss Adams Health Care Conference – Vision 2020: The Future of Health Care

    Attendees of the annual Moss Adams Health Care Conference held in Las Vegas on November 7th and 8th, were treated to a heated exchange between political all-stars Karl Rove and James Carville over a variety of topics including the likely impeachment proceedings against President Trump, US policy in Syria and the upcoming elections (and the recently announced entry of yet another Democratic presidential candidate—Michael Bloomberg). But at the top of everyone’s minds in the audience were questions over healthcare policy and specifically Elizabeth Warren’s Medicare-for-All plan, with an estimated price tag of $34 trillion... (See Article)

    Nov 21, 2019 11:32 AM

  • CMS Proposes Enhanced Scrutiny over Medicaid Supplemental Payments

    On November 18, 2019, the Centers for Medicare & Medicaid Services (CMS) proposed changes to federal Medicaid rules that, if implemented, would affect billions of dollars of Medicaid payments nationwide, creating new uncertainty for state budgets and for Medicaid providers. The proposed rulemaking, entitled the Medicaid Financing and Accountability Regulation or MFAR, would broadly expand federal oversight over Medicaid supplemental payments and rewrite key rules governing how those payments are structured, financed, and distributed... (See Article)

    Nov 21, 2019 11:32 AM

  • FTC Releases Advertising Disclosures Guidance for Online Influencers

    The Federal Trade Commission (FTC) recently published a new guide, “Disclosures 101 for Social Media Influencers,” detailing the FTC rules for disclosing sponsorships to social media followers. (See Article)

    Nov 21, 2019 11:32 AM

  • Year-End Reminder: New Jersey’s Salary History Ban Takes Effect January 1, 2020

    In just a few short weeks, New Jersey employers will no longer be allowed to ask prospective employees about their salary history during the application or interview process or rely upon salary history in setting compensation. The rationale for the new statewide law is that setting compensation based on prior salary may perpetuate an unlawful pay disparity. By excluding salary history from the mix, employers will only be able to set compensation based on lawful considerations, including the specific job duties of the position and the applicant’s skill, education, training, and experience. (See Article)

    Nov 21, 2019 11:32 AM

  • Digital Health Report: Fall 2019

    Beware of “Most Favored Nations” Clauses in Commercial Contracts - Imagine that your digital health company has developed a groundbreaking product. You are eager to monetize the product, so you sign non-disclosure agreements with several of the most well-known hospitals in the United States. You successfully demonstrate the product and some of the hospitals are interested in pursuing a commercial deployment. You receive a draft contract from each hospital setting out the terms of your potential deals... (See Article)

    Nov 21, 2019 11:32 AM

  • U.S. Environmental Protection Agency Office of Criminal Enforcement, Forensics and Training: Environmental Crimes Case Bulletin/August – September 2019

    The United States Environmental Protection Agency (“EPA”) Office of Criminal Enforcement, Forensics and Training publishes an environmental Case Crimes Bulletin (“Bulletin”) that summarizes publicized investigative activity and adjudicated cases supported by EPA Criminal Investigation Division special agents, forensic specialists, and legal support staff. A copy of the August – September edition has been published. (See Article)

    Nov 21, 2019 11:32 AM

  • Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Labs., Inc.

    PLAINTIFF’S DISCLAIMER OF CLAIMS FOUND INVALID BY THE PTAB MOOTED ANY CONTROVERSY BEFORE THE APPELLATE COURT ASSOCIATED WITH THAT PATENT, AND A SECOND PATENT-IN-SUIT WAS NOT INVALID BECAUSE THE DISTRICT COURT DID NOT ERR IN REJECTING THE DEFENDANTS’ OBVIOUSNESS CHALLENGE. Case Name: Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Labs., Inc., No. 2018-1804, 2019 U.S. App. LEXIS 24141 (Fed. Cir. Aug. 14, 2019) (Circuit Judges Lourie, Moore, and Taranto presiding; Opinion by Lourie, J.) (Appeal from D.N.J., Shipp, J.). (See Article)

    Nov 21, 2019 11:32 AM

  • Annual EEO Public File Report Deadline for Stations in Alabama, Colorado, Connecticut, Georgia, Maine, Massachusetts, Minnesota, Montana, New Hampshire, North Dakota, Rhode Island, South Dakota, and Vermont

    December 1 is the deadline for broadcast stations licensed to communities in Alabama, Colorado, Connecticut, Georgia, Maine, Massachusetts, Minnesota, Montana, New Hampshire, North Dakota, Rhode Island, South Dakota, and Vermont to place their Annual EEO Public File Report in their Public Inspection File and post the report on their station website. In addition, certain of these stations, as detailed below, must submit their two most recent EEO Public File Reports along with FCC Form 2100, Schedule 396 as part of their license renewal application submissions due on December 1. (See Article)

    Nov 21, 2019 11:32 AM

  • States Set to Regulate the Internet of Things (IoT)

    Beginning in January 2020, two states will begin regulating the Internet of Things (IoT). California enacted its law last year, which applies to “any device, or other physical object that is capable of connecting to the Internet, directly or indirectly, and that is assigned an IP or Bluetooth address.” (See Article)

    Nov 21, 2019 11:32 AM

  • Pennsylvania Liquor Control Board Delays Brewery Renewals for Malt or Brewed Beverage Reporting Errors

    Multiple brewers have reached out in connection with receiving Correction Sheets to their annual renewals from the Pennsylvania Liquor Control Board (Pa.L.C.B.) regarding failure to submit monthly Malt or Brewed Beverage reports. The requirement to submit Malt or Brewed Beverage reports was addressed in Act 166 of 2016, and the Pa.L.C.B. has begun to strictly enforce that requirement through the renewal process. These reports are to be submitted monthly, by “any person selling malt or brewed beverages at wholesale, and any person selling at retail malt or brewed beverages that were not sold at wholesale.” Essentially, every brewer licensed in the State of Pennsylvania must report on the sales of their own manufactured malt or brewed beverages, whether sold at retail or wholesale... (See Article)

    Nov 21, 2019 11:32 AM

  • USCIS Steps Up VISA Enforcement Activity

    Employers who file I-129 petitions to sponsor foreign nationals for work visas make a number of representations to the U.S. Citizenship and Immigration Services (USCIS) about the terms of the foreign national’s employment, the nature of his duties and responsibilities, and the circumstances of the employer’s business. (See Article)

    Nov 21, 2019 11:32 AM