Regulatory Transactions

From: MarketWatch

WASHINGTON, June 28, 2016 /PRNewswire-USNewswire/ — The Center for Regulatory Effectiveness states that environmental organizations have been successful in terminating offshore drilling in the Arctic and the Atlantic.

Now their strategy to terminate drilling in the Gulf of Mexico has been exposed and called to the attention of Administration officials, http://www.thecre.com/emerging/enforcement.html.

In that the Gulf of Mexico supplies some seventeen percent of the total US crude production it behooves interested stakeholders to participate in the resolution of this issue; in particular those residents in the Gulf states whose livelihood is dependent upon the continuance of an industry which has been in operation for decades.

From: Regulatory Affairs Professional Society

FDA Withdraws Document Calling on Biosimilar Developers to Submit 10 Random Suffixes

By Zachary Brennan

The US Food and Drug Administration (FDA) on Tuesday withdrew a document submitted to the Office of Management and Budget (OMB) that offered new details on how biosimilar developers would submit an ordered list of 10 random suffixes as part of the naming process for biologics and biosimilars.

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Other comments on the draft guidance, according to the document submitted to OMB, suggested a higher burden related to coming up with the proposed non-proprietary names so FDA revised its “estimate upward to account for burden associated with creating and submitting up to 10 proposed suffixes for designation.”

From: Reuters

By Georgina Prodhan

Europe’s growing army of robot workers could be classed as “electronic persons” and their owners liable to paying social security for them if the European Union adopts a draft plan to address the realities of a new industrial revolution.

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Their growing intelligence, pervasiveness and autonomy requires rethinking everything from taxation to legal liability, a draft European Parliament motion, dated May 31, suggests.

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Editor’s Note: Cross-posted from Regulatory Cyber Security/FISMA Focus.

From: hybridCARS

by Jon LeSage

As the federal government finalizes its guidelines for autonomous vehicles, it is receiving conflicting public comments from automakers and other interested parties.

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The National Highway Traffic Safety Administration (NHTSA) has received more than 60 public comments and documents. The commentary phase has included two public sessions in Washington, D.C. and San Francisco in April. The public comment period finished at the end of May.

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Editor’s Note: Regulatory restrictions on e-cigarettes are already triggering a black market, see here.

From: Reuters

BY TONI CLARKE

A White House office deleted language in a recently introduced tobacco regulation that would have removed flavored e-cigarettes from the market until they had been authorized by the Food and Drug Administration, an edited version of the document shows.

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In its originally submitted rule, the FDA said it recognized that numerous flavored products would come off the market within 180 days of the rule’s publication “and that this will significantly impact the availability of flavored tobacco products at least in the short term.”