Regulatory Transactions

From: Mondaq

Definition Of “Waters Of The U.S.” Remains Uncertain

Troutman Sanders LLP

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In July, the current Administration promulgated a new proposed rule that would rescind the 2015 final rule, pending issuance of a more substantive rulemaking that reevaluates the definition of waters of the U.S.  Congress is simultaneously considering making a statutory amendment to the definition of “waters of the U.S.” Federal Regulatory Certainty for Water Act, H.R. 1261, 115th Cong. (2017).  In response to the recent Supreme Court decision, the Trump Administration now intends to finalize a rule to revise the “applicability date” of the rule (to 2020, to allow time for the Administration to replace the rule) before the Sixth Circuit Court of Appeals can withdraw its stay of the 2015 final rule.  EPA and the Army Corps of Engineers reportedly sent a final rule late last week to the Office of Information and Regulatory Affairs for review.

From: Modern Healthcare

By Virgil Dickson

The CMS has called off plans to create a new regulatory pathway that would have accelerated granting Medicare coverage for medical devices.

The agency withdrew a proposed rulemaking that would have launched the expedited coverage of innovative technology, or EXCITE, from review at the White House’s Office of Management and Budget this month. The proposal had languished at the executive branch for nine months.

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From: Healthcare DIVE

Editor’s Note: A successful petition is often premised on:

(1) Stakeholders posting comments on the petition in the space provided below

      Here is the result of informed comments.

(2) The credibility of the organization sponsoring the petition

All stakeholders are encouraged to submit comments in the space provided below; we accept anonymous comments.

Cross-posted from CRE’s EB-5 Regulation IPD.

CRE Petition for Rulemaking

From: The Hill

By Lydia Wheeler

The Trump administration’s expected plan to transfer the licensing of gun exports from the State Department to the Commerce Department has Democratic lawmakers and foreign policy advocates readying for a fight.

The proposal under review by the White House Office of Information and Regulatory Affairs (OIRA) has yet to be made public, but experts fear it will lead to less oversight of commercial sales of assault weapons like submachine guns and flame throwers to foreign buyers.

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Editor’s Note: OIRA posting of this HHS/OASH Final Rule, “Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects,” triggered the delay discussed in the article below.

From: Outsourcing-Pharma.com

By Melissa Fassbender

A proposed Final Rule, which would delay the implementation of the revised Common Rule, comes as a surprise to many in the institutional review board (IRB) community, says WCG compliance VP.

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From: Broadcasting & Cable

By John Eggerton

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That starts the timetable for the new net neutrality regulation framework to go into effect. An FCC spokesman said: “The Order is effective following approval by the OMB under the Paperwork Reduction Act. Once OMB approves it, the FCC will publish a notice in the Federal Register with the effective date, which will be shortly after the FR publication of that notice.

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From: San Francisco Chronicle

Many H-1B holders could be denied extensions under draft White House plan

By Trisha Thadani

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How can the administration accomplish this? The administration is looking at reinterpreting a law passed in 2000, the American Competitiveness in the 21st Century Act, which overhauled the H-1B visa program. That law says that the government “may” grant extensions to foreigners while their green card is pending.

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Jonathan Withington, a spokesman for U.S. Citizenship and Immigration Services, an agency within the Department of Homeland Security that oversees visas, said it is considering a “number of policy and regulatory changes to carry out the president’s Buy American, Hire American executive order, including a thorough review of employment-based visa programs.”