Regulatory Transactions

From: FierceWirelessTech

 By Tammy Parker

The final section of new rules opening up the 5.15-5.25 GHz band for broader Wi-Fi use has now been enacted after being vetted by the Office of Management and Budget (OMB).

In March 2014, the FCC lifted the prohibition on outdoor Wi-Fi operations in the U-NII-1 band and also increased allowable power levels in the band. The commission’s order allows the use, under certain conditions, of existing Wi-Fi equipment designed to operate in the commonly used U-NII-3 band (5.725-5.825 MHz) in the newly opened U-NII-1 band (5150-5250 MHz).

Editor’s Note: It’s not only for-profit colleges that can leave students in debt and unemployed.

From: The Hill

By Benjamin Goad

The Education Department has submitted to the White House highly anticipated regulations meant to crack down on colleges that saddle students with debt without preparing them for the job market.

The agency’s final “gainful employment” rule, aimed squarely at for-profit college programs seen as predatory, must undergo review within the Office of Information and Regulatory Affairs before it is formally issued. Records posted by the office Friday indicate that would happen by next month.

From: LifeHealthPro

 By Allison Bell

New regulations could soon reshape the lives of the producers who sell all types of non-major-medical health benefits products.

The Employee Benefits Security Administration (EBSA) — an arm of the U.S. Labor Department — has submitted a package of proposed changes to the federal “excepted benefits” regulations to the Office and Management Budget for a regulatory impact review analysis. 

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From: GenomeWeb/Pharmacogenomics Reporter

Legislators Question FDA, Stakeholders on How LDT Oversight Impacts Industry, Patients, Innovation

By Turna Ray

NEW YORK (GenomeWeb) – Members of the US Congress today grilled a US Food and Drug Administration official regarding the agency’s legal authority to regulate lab-developed tests (LDTs), asking whether new requirements would trigger additional costs and taxes upon laboratories, and whether the FDA itself had the necessary resources to take on this enormous task.

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Need for economic analysis

From: Safety + Health

Washington – A proposed OSHA rule that would update the permissible exposure limit for beryllium is under review by the Office of Management and Budget.

OMB’s Office of Information and Regulatory Affairs received the rule Sept. 4. Reviews – which are required in many cases before OSHA can publish a rule – are limited to 90 days but can be extended.

Details of the proposal, which has been in the works for more than a decade, have not yet been made public.

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From: Health Industry Washington Watch

by Debra A. McCurdy

The Office of Management and Budget (OMB) has cleared an HHS Office of Inspector General (OIG) proposed rule that would expand the OIG’s Medicare and state health care program fraud and abuse authorities. Specifically, on September 4, 2014, the OMB gave final regulatory clearance to an OIG proposed rule that would add new anti-kickback safe harbors to reflect statutory changes, codify the ACA’s definition of “remuneration,” and add a gainsharing civil monetary penalty (CMP) regulation. The proposed rule should be published in the Federal Register in the near future.

From: OMB

Posted by Howard Shelanski

As part of President Obama’s effort to achieve smarter and more effective approaches to international regulation, today I am pleased to announce the release of the U.S.-Canada Regulatory Cooperation Council (RCC) Joint Forward Plan. The Forward Plan represents a significant pivot point for our regulatory cooperation relationships with Canada, and outlines new federal agency-level partnership arrangements to help institutionalize the way our regulators work together. 

From: The Hill

By Timothy Cama

The White House Office of Management and Budget (OMB) has started to review new regulations for hydraulic fracturing on federal land, the last step before the rules can be made final.

The rules for the oil and gas drilling process, also known as fracking, were proposed last year after a mid-2012 proposal was pulled back.

The Obama administration said it plans to unveil the final rules in September. The Interior Department submitted the rules to the OMB earlier this week, but the office did not publicize its review until Friday.