November 21, 2014

FDA Decides to Delay UDI Labeling Rule for Some Orthopedic Implants

From: Regulatory Affairs Professional Society

By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) is granting labelers of certain types of implantable medical devices a temporary reprieve from its upcoming requirements that all medical device products be marked with a unique device identifier (UDI) meant to make the devices safer.


The rule was originally mandated by the Food and Drug Administration Amendments Act (FDAAA) of 2007, but was subject to lengthy delays, both due to extensive rewrites resulting from industry criticism and months of review by the Office of Management and Budget (OMB).

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November 19, 2014

DOJ Continues Enforcement of Accessibility Requirements for Websites and Mobile Apps – But Its Rulemaking Still Awaits

From: The National Law Review

On Nov. 17, the U.S. Department of Justice (DOJ) announced that it had entered into a settlement agreement with Ahold U.S.A., Inc., and Peapod, LLC, regarding the accessibility of and its associated mobile application. This follows on the DOJ having earlier this year entered into a consent decree with H&R Block (which culminated from a lawsuit originally initiated by the National Federation of the Blind) regarding the
accessibility of its website, online tax preparation product and mobile application.


November 18, 2014

OSHA’s confined spaces in construction rule under review by OMB

From: Safety + Health

Washington – OSHA’s final rule on confined spaces in construction currently is being reviewed by the Office of Information and Regulatory Affairs. The review is one of the final steps required before OSHA can formally publish the rule.

OIRA, which is a branch of the White House’s Office of Management and Budget, received the rule for review on Nov. 14. The office is limited to a 90-day review, but can request an extension. The rule has been in the works since at least 2003; the proposed rule was published in 2007.

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November 14, 2014

GAO Comptroller General Gene Dodaro: “If the data quality is not good, you’re limited in your abilities to use it”

Editor’s Note: For information on the Data Quality Act which controls the quality of virtually all data disseminated by the federal government, see here.

From: 1500AM

GAO: Not too early to track DATA Act progress

By Emily Kopp

At an event on the power of data analytics, speakers talked about its potential to solve some of government’s toughest challenges: stopping $150 billion in improper payments a year, collecting lost tax revenue, getting the Defense Department ready for its first full audit in 2017 and improving federal IT procurement by identifying bottlenecks in programs. The opportunities seem limitless.

November 5, 2014

US Telecom Association Tells FCC it Needs Additional Special Access Data to Conduct a Lawful Market Analysis

From: CCMI

Posted by Andrew Regitsky

The industry response to the FCC’s trimmed down special access request is due on December 15th and ILECs are not happy. With special access responders now required to file data for 2013 only, ILECs are concerned that a single data peoint will provide a misleading picture of the special access market to the Commission. Moreover, they believe that the Commission would unlawfully use the misleading data to restrict their special access pricing flexibility and possibly even their earnings.


October 31, 2014

UAS: The Small UAS [unmanned aircraft systems] NPRM Takes Another Step Forward

From: Plane-ly Spoken

By Mark McKinnon and Lisa Ellman

Yesterday, we wrote about the endgame for the small UAS rule and recent comments that the process might take until 2018 to complete.  Today we would like to talk about the opening move, which occurred with little fanfare in the last few days.

Before the Notice of Proposed Rulemaking (NPRM) can be released for comment, it first must go through a review process at the Office of Information and Regulatory Affairs (OIRA), which is part of the Office of Management and Budget (OMB) at the White House.  Plane-ly Spoken has learned that the FAA has, in fact, sent the small UAS NRPM to OIRA for their review.  This provides a golden opportunity for stakeholders to influence the process before the regulation is publicly released.

October 28, 2014

Labor Department Completes LGBT Anti-Discrimination Rule

Editor’s Note: For information on the Executive Branch’s unfinished business in ensuruing all marriages are treated equally in federal programs, see here.

From: BuzzFeed News

The Labor Department was tasked by the president this summer with devising regulations barring federal contractors from discriminating against LGBT workers.

WASHINGTON — The Labor Department has finalized a rule barring federal contractors from discriminating against LGBT workers, sending it to the Office of Management and Budget on Monday for review, BuzzFeed News has learned.

October 23, 2014

EPA sets energy booby traps for the US economy

From: Oil & Gas Journal

The US Environmental Protection Agency is setting booby traps for the economy as the last half term of the Obama presidency lumbers into view.

Three regulations in various stages of development will make energy costs explode.


Related to Tier 3 is an imminent proposal by EPA to lower the allowed concentration of ground-level ozone to 60-70 ppb from 75 ppb, the standard in place since 2008. When the agency proposed a 70-ppb standard 3 years ago, the White House Office of Management and Budget quashed it in response to opposition from business groups.

October 20, 2014

Nearly All New Nanoengineered Chemicals Are Regulated by EPA Due to Potential Risks

From:Chemical Regulation Reporter

By Pat Rizzuto

The Environmental Protection Agency has regulated nearly all nanoengineered chemicals that it has reviewed under its new chemicals program, an EPA program manager who reviews such chemicals said Oct. 16.

By contrast, the EPA’s new chemicals program typically regulates only 10 percent to 15 percent of the traditional compounds it reviews, said Jim Alwood, a program manager in the EPA’s Chemical Control Division who coordinates nanotechnology issues under the Toxic Substances Control Act.


The agency recently submitted a proposed data collection rule to the Office of Management and Budget.

October 14, 2014

DOL Makes It Official: New FLSA Regulations Delayed Until 2015

From: JDSupra Business Advisor

Doug Hass | Franczek Radelet P.C.

Back in late May, we told you that the Department of Labor had released its required Semiannual Regulatory Agenda. The Agenda, which is not binding on the DOL, included several FLSA-related items. Most importantly, the DOL listed its plans to address the “white collar” overtime exemption regulations with proposed rules next month, in November 2014. The section, “Defining and Delimiting the Exemptions for Executive, Administrative, Professional, Outside Sales, and Computer Employees,” appears on page 56 and 57 of the Agenda. At the time, we predicted that “even with a short 30-day comment period and a quick turnaround on a final rule, the DOL is unlikely to have any new regulation in place before spring 2015.”