News & Analysis as of

Public Comment

CMS Proposes Reimbursement Reduction for 340B Drugs

by Baker Ober Health Law on

When CMS issued its proposed rule for OPPS and ASC Payment System on July 13, the agency included a proposal to substantially scale back reimbursement for Part B drugs to hospitals participating in the federal 340B Drug...more

CETA Draft Regulations Published on Patent Linkage and Term Restoration – 15 Day Public Comment Period

by Smart & Biggar on

The government has published the long anticipated draft regulations regarding: - changes to the Patented Medicines (Notice of Compliance) Regulations [“PMNOC Regulations”], and - proposed Regulations to implement...more

NASDAQ Proposes Revisions to Shareholder Approval Rules

by Dechert LLP on

Nasdaq, Inc. recently requested comments regarding possible updates to its “20% voting rule.” That rule, adopted in 1990, requires Nasdaq listed companies to obtain shareholder approval when issuing 20% or more of its stock...more

OSHA issues press release regarding Portal for Electronic Recordkeeping Reporting to be available beginning August 1

by Fisher Phillips on

OSHA issued a press release on July 14, 2017 (see link at https://www.osha.gov/injuryreporting/index.html ) regarding the availability of the portal for electronic recordkeeping reporting. The portal will become available on...more

Opportunity Foreclosed: The International Entrepreneur Parole Rule May Die Before it Gets Out of the Gate

The U.S. and worldwide entrepreneur community had been looking forward to July 17th with great anticipation. This was supposed to be the effective date of the new International Entrepreneur Parole immigration regulation....more

CFPB and Stakeholders Weigh In on the Credit Card Market

As required by law, the Consumer Financial Protection Bureau (CFPB) has once again asked for public comment on a variety of topics related to the credit card market. The comment period has ended for the most recent request...more

FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post,...more

Trump Administration Delays Implementation of “International Entrepreneur Rule”

This week, the Trump Administration stated it would postpone the implementation of the “International Entrepreneur Rule,” an Obama policy designed to facilitate immigrant entrepreneurs coming to the United States to help fund...more

Treasury, IRS Deem 2704 Proposed Regulations Put Undue Burden on Taxpayers

by Williams Mullen on

The U.S. Department of the Treasury and the IRS, in Notice 2017-38, have identified the proposed regulations (the “Proposed Regulations”) under § 2704 of the Internal Revenue Code as potentially imposing an undue burden on...more

Treasury Dept. Identifies 8 "Significant Tax Regulations" for Review to Reduce Burden

by Holland & Knight LLP on

The U.S. Department of the Treasury announced on July 7, 2017, in Notice 2017-38 (the Notice) that it has identified as "significant tax regulations" eight sets of U.S. federal tax regulations that were issued between Jan. 1,...more

Update on Challenge to Overtime Rule

by Miller Canfield on

As previously reported, the Fifth Circuit Court of Appeals is currently reviewing a challenge to the recent Fair Labor Standards Act ("FLSA") overtime changes. Previously, a Texas district court entered an injunction...more

Department of the Treasury Issues another Invitation to Taxpayers to Comment on Department Regulations

by K&L Gates LLP on

On June 30, 2017, we alerted stakeholders to the request by the Department of the Treasury (the “Department”) for public comments to assist the Department in its broad review of Department guidance that should be modified,...more

Canada Proposes New Regulations to Strengthen Rail Security for the Transportation of Dangerous Goods

On June 24, 2017, the federal government proposed new regulations under the Transportation of Dangerous Goods Act, entitled the Transportation of Dangerous Goods by Rail Security Regulations (Rail Security Regulations). The...more

Chipping Away - Does the DOL's Fiduciary Rule Continue to Be on the Chopping Block?

by Dechert LLP on

The U.S. Department of Labor (the “DOL”) published in the Federal Register on July 6, 2017 a Request for Information (the “RFI”) regarding the final regulation defining who is a “fiduciary” of an employee benefit plan as a...more

New Developments at OSHA - July 2017

by Stoel Rives LLP on

OSHA Seeks to Reverse Beryllium Rule For Certain Industries Beryllium, a lightweight metal, presents hazards in the workplace. It is has been linked to lung cancer and Chronic Beryllium Disease, a debilitating lung disease...more

EPA and U.S. Army Corps of Engineers Propose Rescission of WOTUS Rule

by Snell & Wilmer on

On June 27, EPA administrator Scott Pruitt along with the assistant secretary of the Army for civil works signed a proposed rule to rescind the Obama administration “waters of the United States” or “WOTUS” rule. The proposed...more

DOL Again Seeks Comments on New Fiduciary Rules and Exemptions

On June 29, 2017, the Department of Labor (“DOL”) requested another round of public comment on its fiduciary rule—this time in the form of a Request (“RFI”) for Information. The RFI seeks input on (a) whether to extend the...more

Financial Conduct Authority’s Asset Management Review – Authorised Funds Shake Up

On 28 June 2017, the Financial Conduct Authority (FCA) published the Asset Management Market Study Final Report (the “Asset Management Review”) as well as a Consultation Paper setting out some proposed changes to the FCA’s...more

The Final Rule: The Fifth Request for Public Comments

On June 29, 2017, the Department of Labor (DOL) released a request for information (RFI), seeking public comments yet again on its new “investment advice” fiduciary definition and related exemptions (Final Rule) which became...more

Department of the Treasury Invites Taxpayers to Comment on Department Regulations to Reduce Compliance Burdens

by K&L Gates LLP on

On June 14, 2017, the Department of the Treasury (the “Department”) issued a request for public comments to identify Department guidance that should be modified, eliminated, or streamlined in order to reduce compliance...more

USDOT Proposals May Help Reduce the Shortage of Drivers by Making it Easier to Obtain a Commercial Driver's License

by Holland & Knight LLP on

It is common knowledge that a shortage of qualified drivers is a chronic problem in the trucking industry. For instance, the American Trucking Associations (ATA) has estimated that there are 48,000 open jobs in the...more

Los Procesos de Consulta Para la Modernización del TLCAN

by Holland & Knight LLP on

El día de June 27th, 2017 la oficina del Representante Comercial de los Estados Unidos (USTR por sus siglas en inglés) inició las audiencias públicas sobre los más de 12,000 comentarios recibidos en torno a la modernización y...more

Schwabe In The Field: Certainty on the “Waters of the United States” Remains Elusive

On June 27, 2017, the Environmental Protection Agency (EPA) and U.S. Army Corps of Engineers (USACE) released a proposed rule (Proposed Rule) that will rescind the 2015 Clean Water Rule, often referred to as the Waters of the...more

Consultation Processes for the Modernization of NAFTA

by Holland & Knight LLP on

The Office of the U.S. Trade Representative was to begin public hearings on June 27, 2017, on more than 12,000 comments received regarding the modernization and renegotiation of the North American Free Trade Agreement...more

OSHA Proposes Delay Until December 1 for Electronic Recordkeeping Rule

by Fisher Phillips on

OSHA has proposed to delay the compliance date of the electronic recordkeeping portion of the new recordkeeping regulation, known as “Improve Tracking of Workplace Injuries and Illnesses,” from July 1, 2017 to December 1,...more

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Cybersecurity

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