Public Comment

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Higher US Patent Fees On The Horizon

The USPTO has published a proposed fee schedule for patent fees likely to take effect October 1, 2017–the start of the USPTO’s next fiscal year. The proposed fee schedule makes “slight” changes to many fees, and more...more

Feds Propose Enhanced Cyber Standards for Nation’s Largest Banks and Their Boards

Bank regulators are continuing to demand more accountability from corporate leaders when it comes to compliance with cybersecurity safeguards. In an advance notice of proposed rulemaking issued yesterday, federal...more

Update To The Coordinated Framework For The Regulation Of Biotechnology Published In The Federal Reg

On September 22, 2016, Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology (Update to the Coordinated Framework) was published in the Federal Register ....more

FDA Announces Initiative to Redefine “Healthy” Claim for Food Labeling

The U.S. Food and Drug Administration (“FDA”) announced in September that it is considering how to redefine the term “healthy” as a nutrient content claim for the labeling of human food products. The FDA issued a guidance...more

Miscellaneous Tariff Bill Petition Process Goes Live - Potential for up to $500,000 in duty relief per product

The U.S. International Trade Commission (“ITC”) has begun accepting petitions seeking temporary duty suspensions and reductions pursuant to the American Manufacturing Competitiveness Act of 2016 (“the Act”). The Act...more

California Prop 65: More Unintended Consequences

Last month, the California Office of Environmental Health Hazard Assessment (“OEHHA”) adopted new Proposition 65 warning regulations. Much of the discussions regarding these new regulations have centered on the warning...more

TTAB Rules Changes Confirmed – Effective January 14, 2017

The public comments have been considered and the Trademark Trial and Appeal Board rule changes proposed in April 2016 and summarized in this blog post have been confirmed with only minor exceptions. The new rules will be...more

Proposed Rule Would Encourage Hyperlinking In Documents Electronically Filed In The New York Commercial Division

A rule proposed last week would encourage the use of hyperlinking in documents that are electronically filed with the Commercial Division of New York State Supreme Court as a means of increasing the efficiency with which the...more

New Proposed Immigration Rule Would Grant Temporary Status To International Entrepreneurs Looking To Start Companies In The United...

In August 2016, the U.S. Department of Homeland Security (DHS) announced a new proposed rule called the “International Entrepreneur Rule,” which, if passed, would benefit thousands of immigrant entrepreneurs looking to start...more

Pipeline Safety: PHMSA Releases New Rule on Emergency Authority

On Monday, October 3, 2016, the Pipeline and Hazardous Materials Safety Administration (PHMSA) released an interim final rule (IFR) establishing procedures to implement new imminent hazard authority created by the PIPES Act...more

Public Comments on New Regulations for International Entrepreneurs Due by October 17, 2016

Public comment to the U.S. Department of Homeland Security's (USDHS) Notice of Proposed Rulemaking creating a new "parole" immigration benefit for certain International Entrepreneurs is due to the agency by October 17, 2016. ...more

Medical Marijuana in Massachusetts – DPH Proposes Amendments to Regulations

The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Medical Marijuana Regulations (105 CMR 725) (the “regulations”). DPH believes that believes the proposed...more

CMS Issues Preliminary 2017 Medicare Clinical Lab Payment Determinations, Final 2016 Gap Fill Amounts

CMS has released the preliminary 2017 Medicare clinical laboratory fee schedule (CLFS) payment determinations for new and reconsidered test codes, including determinations regarding whether CMS will use crosswalking or...more

FERC Seeks Comment On Potential Modifications To Its Market Power Analyses

On September 22, 2016, the Federal Energy Regulatory Commission (FERC) issued a Notice of Inquiry (NOI) seeking comment on whether and, if so, how FERC might modify or enhance its methods for identifying and assessing market...more

CMS Finalizes Major Changes to Medicare/Medicaid Requirements for Long-Term Care Facilities

On September 28, 2016, the Centers for Medicare & Medicaid Services (CMS) released a highly-anticipated final rule to strengthen requirements that long-term care (LTC) facilities must meet to participate in the Medicare and...more

FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategy (REMS) Determinations

On September 21, 2016, the US Food and Drug Administration (FDA) issued Draft Guidance for Industry: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary, which is intended to clarify how the FDA...more

Financial Services Weekly News - September 2016 #3

Editor's Note - Investment Company Institute Publishes FAQ on SEC No-Action Letter Regarding Auditor Independence. On September 23, the Investment Company Institute (ICI) published a memorandum (ICI Memo) responding to...more

Massachusetts Determination of Need Proposal Would Implement State Health Policy Initiatives in Updating DoN Regulations

On September 21, the Massachusetts Department of Public Health conducted the first of two public hearings on proposed changes to the Determination of Need (DoN) regulations. The Proposal would implement significant changes...more

Proposed Regulation Issued Under New York State’s “Zombie Properties” Law: Law Firm, Attorneys, New York

The New York State Department of Financial Services (“DFS”) has proposed a new regulation (the “Proposed Regulation”) that will require mortgage lenders and servicers to report vacant and abandoned properties in accordance...more

FDA to Redefine “Healthy;” Requests Public Comment and Issues New Guidance

FDA hinted in May that it was planning to reconsider its longstanding and controversial criteria for using the term “healthy.” Today, it announced the beginning of the formal process to make changes to the definition of the...more

Massachusetts Hospital Licensing Regulations Proposed Amendments – Key Take-Aways

The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Hospital Licensure Regulations (105 CMR 130.00) (the “regulations”). The proposed amendments are designed to...more

Comments Due November 1, 2016 on Proposed Update to Framework for Biotechnology Regulation

On September 18, 2016, the Obama Administration issued two major documents in connection with its ongoing efforts to modernize the federal Coordinated Framework for the Regulation of Biotechnology. The first document, a...more

Estate Planning Valuation Discounts Under Section 2704: An Update

For about a generation, families have taken minority discounts when valuing interest in closely-held businesses for estate, gift and generation-skipping transfer tax purposes. This popular estate planning technique is often...more

NHTSA Releases Highly Anticipated Federal Automated Vehicles Policy

60-Day Comment Period Provides Important Chance to Have Local Voices Heard - With the goal of creating a path for the safe testing and deployment of autonomous vehicles on public roads nationwide, the U.S. Department of...more

“Full Employment for CISOs in New York”: New York Proposes the Nation’s First Cybersecurity Regulation

If you’re a CISO living in New York get ready for the phone calls!!! On September 13, 2016, Governor Andrew M. Cuomo proposed the nation’s first cybersecurity regulation. Starting on September 28, 2016 there is a limited 45...more

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