September 18, 2014

‘Non-PPACA’ benefits regs head for impact review

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. 

Read Complete Article

September 11, 2014

FDA Avoiding OMB-Mandated Economic Review of Lab-Developed Test Regulation?

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.

***

Need for economic analysis

September 10, 2014

Review underway on OSHA beryllium rule

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.

Read Complete Article

September 9, 2014

OMB Clears OIG Proposed Rule on Anti-Kickback Safe Harbors, CMPs for Beneficiary Inducements & Gainsharing

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.

September 2, 2014

Moving Forward on International Regulatory Cooperation

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. 

White House reviews federal-land fracking rules

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.

August 25, 2014

Interior’s Draft Arctic Drilling Rules Begin Interagency Review

From:  Natural Gas Intelligence

Carolyn Davis

The Interior Department on Friday officially launched an interagency review process that may impose the first minimum standards for oil and natural gas activity in U.S. Arctic waters.

A draft of the Arctic regulations was sent to the Office of Management and Budget (OMB) on Friday. Currently there are no specific mandates governing Arctic energy development. Federal agencies regulate drilling in the Arctic as they would for other offshore areas, but the 2010 Macondo well blowout in the Gulf of Mexico led to more stringent reviews of offshore drilling.

***

August 21, 2014

Next Steps in the Tobacco Deeming Regulation Process

From: CSPnet.com

Proposed regulations won’t go into effect for at least a year

By  Thomas A. Briant, Executive Director

MINNEAPOLIS — The U.S. Food and Drug Administration allowed the public to submit comments in response to the agency’s proposed tobacco deeming regulations until August 8th. The FDA issued the deeming regulations on April 24, 2014.  When the comment period closed earlier this month, almost 82,000 individual comments had been submitted on-line in response to the deeming regulations.  So, what happens next?

***

August 19, 2014

OMB OK’s Special Access Data Collection

From: Multichannel News

Cable Ops had Argued FCC Low-balled Estimated Additional Time and Money

By: John Eggerton

The Office of Management and Budget has given the FCC the green light to collect data from ISPs and others on the state of the special access (business broadband services) market. 

OMB had to sign off on the additional paperwork per the Paperwork Reduction Act. 

With that go-ahead, the FCC said Monday (Aug. 18) it was ready to proceed with the data collection. 

The National Cable & Telecommunications Association argued that the FCC had majorly lowballed the amount of work and money it will take by thousands of hours and millions of dollars.

August 15, 2014

Phthalates Panel Recommends Additional CPSC Restrictions

Editor’s Note: Regulatory agencies are legally bound to adhere to OMB’s peer review requirements. See here for more information.

From: The National Law Review

Alexandra M. (‘Andie’) Wyatt Paul E. Hagen Mark N. Duvall/Beveridge & Diamond PC

Over the next several months, the U.S. Consumer Product Safety Commission (CPSC) will be reviewing the report and recommendations of an agency advisory panel regarding risks of phthalates in children’s products. If implemented by CPSC through rulemaking, the recommendations of the long-delayed report would restrict phthalates more stringently.