July 20, 2018

In a blow to PBMs, Trump administration mulling overhaul to drug rebate safe harbor protections

From: FierceHealthcare

by Paige Minemyer

The Trump administration is considering a proposal to overhaul safe harbor protections for pharmaceutical company rebates, a plan that could lead to a significant shift in how drug prices are determined.

The Office of Management and Budget is reviewing a proposed rule from the Department of Health and Human Services on the matter. Details on how exactly HHS wants to rethink safe harbors are scant, as the rule will not be released publicly until OMB signs off on it.

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July 19, 2018

Passenger vessel operators seek regulatory relief

From: WorkBoat


The Staten Island Ferry Guy V. Molinari. The Passenger Vessel Association recommends the Coast Guard exempt large passenger terminals from the TWIC reader requirement. Staten Island Ferry photo.

The passenger vessel industry has weighed in with a list of suggestions to the federal government on federal regulations that should be dropped or revised.

In a letter to the Office of Information and Regulatory Affairs (OIRA) dated July 16, the Passenger Vessel Association outlined federal policies and rules that are hampering operations of U.S.-flagged passenger vessels, including dinner cruise vessels, sightseeing excursion boats, and car and passenger ferries.

July 9, 2018

Flawed opinion on lands withdrawn: Alaska sovereignty bolstered by new administration

From: Fairbanks Daily News-Miner


It was in the final week of the Obama administration that the Interior Department’s then-solicitor general, Hilary C. Tompkins, announced that a 1936 action by Congress to extend a provision of the Indian Reorganization Act to Alaska “provides specific authority for the secretary (of Interior) to take Alaska lands into trust.” Ms. Tompkins also determined that the authority was not limited by a U.S. Supreme Court decision on the subject and that neither the Alaska Native Claims Settlement Act of 1971 nor the Federal Land Policy and Management Act “expressly or impliedly repeal that authority.”

July 5, 2018

White House Kicks Off NEPA Reform

From: JD Supra

Karen BennettChristopher ClareAmanda TharpeKenneth von Schaumburg

The White House Council on Environmental Quality (“CEQ”) has issued an Advanced Notice of Proposed Rulemaking (“ANPRM”) providing an exceptional opportunity for stakeholders to participate in improving the federal National Environmental Policy Act (“NEPA”) review process.  The ANPRM, entitled “Update to the Regulations for Implementing the Procedural Provisions of the National Environmental Policy Act” (“NEPA”), was issued on June 20, 2018 pursuant to Executive Order 13807, “Establishing Discipline and Accountability in the Environmental Review and Permitting Process for Infrastructure Projects” (“E.O. 13807”).  E.O. 13807 directs CEQ to suggest actions to modernize the federal environmental review process and was one of several steps taken by the Trump Administration aimed at streamlining an often burdensome and lengthy regulatory review process.  Comments are due by July 20, 2018.

June 20, 2018

Sound off on federal maritime regs

From: WorkBoat


A sign notified port workers, longshoremen and truckers at Conley Terminal in Massachusetts of the Oct. 15, 2008 deadline for obtaining a Transportation Worker Identification Credential (TWIC). USCG photo.


The Office of Management and Budget (OMB) is seeking public comments on “how the federal government may prudently manage regulatory costs imposed on the maritime sector.” The initiative is part of President Trump’s February executive order instructing federal agencies to review regulations they enforce and make recommendations on which rules should be repealed, replaced or modified.

June 18, 2018

Commercial Drone Alliance Meets With White House Office on Drones Over People, Security

From: Drone Life

Posted By: Miriam McNabb

The Commercial Drone Alliance (CDA) met yesterday with the Office of Information and  Regulatory Affairs (OIRA) at the White House.  CDA representatives discussed the Alliance positions on two regulatory issues: drone flight over people and general drone security.


In their discussions with OIRA, CDA representatives emphasized the economic potential of commercial drones, but told authorities that drone regulation had to keep up in order for that potential to be realized.   “To get there, however, our nation’s regulatory framework must keep pace,” says a CDA statement. “… to promote American competitiveness and enable innovation to succeed, we must continue to move UAS rulemaking forward rapidly.

EPA, Corps will send WOTUS proposal to OMB

From: Agri-Pulse

By Steve Davies


OMB’s Office of Information and Regulatory Affairs coordinates review of proposed rules with other government agencies. OIRA has 90 days to review proposals, but the rulemaking agency or agencies can extend that review indefinitely. The latest regulatory agenda published by the administration anticipates the publication of a proposed WOTUS rule in the Federal Register by August and a final rule by November 2019.

June 11, 2018

DHS Still Awaiting Final Clearance on Rule to Rescind H-4 Work Authorization

From: India-West

The Department of Homeland Security filed a status update May 22 with the DC Court of Appeals noting that it is awaiting final clearance on a rule to rescind work authorization for certain H-4 visa holders. A final rule is not expected to be issued until 2019. Last month, 130 members of Congress, led by Indian American Rep. Pramila Jayapal, urged DHS to continue the work authorization. (Jay Sharma/SaveH4EAD photo)


In its status report, DHS noted that once the proposed draft has received final clearance from its agency, it will be sent to the Office of Management and Budget for review.

June 7, 2018

EPA’s openness plan sets off alarm

Editor’s Note: See also, CRE on the EPA Science Initiative and CRE Position on EPA Science Plan Takes Its Toll.

From: Bloomberg News



Two pesticide trade groups also filed comments: CropLife America, whose members include Monsanto Co., DuPont Crop Protection and Growmark Inc., and Responsible Industry for a Sound Environment.

Janet Collins, an executive vice president of CropLife, wrote that the proposed rule “likely will have far-reaching implications for the organization’s members whose products are closely regulated as part of the EPA Office of Pesticide Programs.”

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June 6, 2018

California and Carmakers ‘in Agreement’ on Emissions Standards

From: Bloomberg


  • Trump administration seeks to curb state’s power to set rules
  •  ‘Standards on the books actually should be on the books’


“We are now, I think it is fair to say, in a confusing situation,” Mary Nichols said Tuesday at the Edison Electric Institute convention in San Diego. “Maybe in the first time in recorded history, California and the auto industry are mostly in agreement that standards on the books actually should be on the books, and California should have a place in implementing those standards.”