FDA Outlines Future Medical Device Coordinating Center

FDALogoThe federal Food and Drug Administration’s planning board (Planning Board) for a medical device evaluation system (NMDES) recently recommended the creation of a centralized Coordinating Center to develop a national system to evaluate medical devices. Convened in 2014 by the U.S. Food and Drug Administration and the Brookings Center for Health Policy, the Planning Board emerged out of an FDA action plan in 2012 seeking to strengthen the medical device post-market surveillance system by building a more coordinated and efficient system that would track medical devices and share evidence regarding safety and efficacy.

In the report, issued on April 5, 2016, NMDES is described as a voluntary, coordinated network of partnerships that include government agencies, device manufacturers, provider organizations, health plans, and patient communities that share the common goal of “generating higher quality data and evidence at lower costs to inform and improve patient care.” The Coordinating Center proposed by the Planning Board would be responsible for governing, coordinating, and standardizing efforts among these participants. The Coordinating Center would not have explicit regulatory authority, but FDA’s authorities could authorize and initiate activities through the Coordinating Center.

NMDES as a Coordinated Network of Partners

ll post

This proposed network would build on the currently-existing limitations in obtaining evidence regarding medical devices, such as the absence of a broad adoption of unique device identifiers (UDIs) for tracking purposes, the expense of manual data entry and delays in data extraction, and limited participation in medical device tracking experts by health care providers and patients.

Although the Coordinating Center should be able to meet its objectives of optimizing data sharing, promoting best practices for device evaluation, and developing a process for disseminating safety and efficacy information, the proposed plan still has several hurdles to overcome. Under the timeline proposed in the report, it is “unlikely that a de novo entity can be organized.” Therefore, the Coordinating Center would have to be incubated at an “established hosting entity” with the plan to spin off the Coordinating Center and Governing Board into a “financially stable and independent entity.” Additionally, there is little concrete discussion of the source of early seed funding. Until such organizational and funding details are determined, NMDES and the Coordinating Center will remain aproposed system; however, as the report is the first in a series of papers to be released by the Planning Board, we expect more information to be forthcoming.

Article By M. Leeann Habte & Lindsey E. Gabrielsen of Foley & Lardner LLP

© 2016 Foley & Lardner LLP

Night Moves: FAA Makes Front Page News With Drone Exemption

On April 18, 2016, the FAA approved, for the first time ever, nighttime operation of a small unmanned aircraft system (UAS or “drone”) when used for commercial activity.  The FAA permitted Industrial Skyworks, Inc. to use drones to inspect buildings at night.

In order to get the exemption, the FAA required the following of Industrial Skyworks:

  • The pilot in command had to possess a commercial or private pilot certification that allowed night operations;

  • The pilot needed a medical certificate per 14 C.F.R. part 67; and

  • The drone had to remain in the pilot’s and visual observer’s line of sight at all times.

Industrial Skyworks bolstered its case by taking these steps to ensure the drone’s safe operation at night.

  • It would be launched from an illuminated landing and take-off area and equipped to continually alert the pilot of its location and altitude.

  • It possessed anti-collision lights visible from 5,000 feet.

  • The site of the preprogrammed flight was limited in size, and the area was restricted to authorized personnel.

  • The pilots completed a training program that included nighttime operating skills and experience.

  • The company created a comprehensive security plan, including a provision that the pilot in command and visual observer would arrive at the work site 30 minutes prior to flight to ensure their eyes adjusted to the darkness.

Article By Jeffrey K. Phillips of Steptoe & Johnson PLLC

© Steptoe & Johnson PLLC. All Rights Reserved.

U.S. Solar Installations Reach 1 Million

Last week the Solar Energy Industries Association (SEIA) and George Washington University (GWU) issued a report estimating that the United States has reached 1 million solar installations and will surpass 2 million installations by 2018.  This is a 1,000-fold increase over 15 years as only 1,000 systems were installed in 2001, and these numbers highlight the tremendous growth experienced by the solar industry.  Of the 1 million PV systems, there are currently over 942,000 residential installations, nearly 57,000 PV installations at businesses, non-profits and government agencies, and over 1,500 utility-scale PV installations.  SEIA and GWU anticipate 4 million installations by 2020 and for the U.S. to be installing one million PV systems annually by 2025. To learn more about this solar milestone and the factors contributing to the solar industry’s growth, read on!

While currently only supplying 1 percent of U.S. electricity generation, solar energy accounted for 30 percent of new capacity last year and is expected to continue developing.  This growth has profoundly affected the job sector, where solar jobs grew 123 percent in the past five years and created 1 in 83 new U.S. jobs in 2015.  Overall, the solar industry now employs over 200,000 Americans, three times more jobs than U.S. coal mining.

Multiple factors were credited for playing a role in the U.S. reaching 1 million solar installations, including lower installation costs and predictable, stable federal and state policies.  In the last ten years, installation costs have dropped more than 70 percent, driven by declining solar module prices.  Enacted in 2008, the solar Investment Tax Credit (ITC), a 30 percent tax credit for solar systems on residential and commercial properties, was extended in December through 2021.  Meanwhile, state policies such as net-metering and renewable portfolio standards (RPS) have allowed solar to enter markets.  Currently, 44 states have net metering policies and 29 have RPS policies.

One challenge for the future of solar is the inability of lower-income households to benefit from solar due to a multitude of barriers, including a high rate of renters, multi-tenant buildings, and a lack of access to financing.

Article By Thomas R. Burton, III of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
©1994-2016 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

June 2016 Visa Bulletin Update

The Department of State (DOS) has released the June 2016 Visa Bulletin that includes the “Application Final Action Dates” and “Dates for Filing Applications.”

For both family-sponsored and employment-based filings, the United States Citizenship and Immigration Service (USCIS) website indicates that the Application Final Action Dates chart must be used for May 2016.

Please see below for the Application Final Action Dates for both family-sponsored and employment-based preference filings:

Application Final Action Dates for Family-Sponsored Visa Applications

June Visa Bulletin

Movement from the May 2016 Visa Bulletin shows gradual but insignificant jumps in processing dates for this category, with the exception of China, F4 dates retrogressing from July 22, 2003 to January 1, 2003.

Application Final Action Dates for Employment-Based Preference Cases

IBI blog june 2016

Of particular note is that China EB-2 and EB-3 preference categories saw a retrogression from September 1, 2012 to January 1, 2010; and August 15, 2013 to January 1, 2010, respectively; and India EB-2 preference category also experienced a four-year retrogression from November 22, 2008 to October 1, 2004.

©2016 Greenberg Traurig, LLP. All rights reserved.
  • See more at: http://www.natlawreview.com/article/june-2016-visa-bulletin-update#sthash.svy3O7QO.dpuf

To Brexit or to Bremain? That is the Question on 23 June 2016

A View from BrusselsUK and Europe flag

As the 23 June date for the British referendum about its future in the European Union (EU) comes closer, the EU political leadership in Brussels remains uncertain how best to support the ‘Bremain’ forces in order to avoid the embarrassing and damaging departure of one of its largest and strongest members.

None of the political leaders in Brussels or in other EU capitals want to see the UK leave, but they have learned to be cautious and show restraint when it comes to engaging in EU related discussions in Britain. Often enough they were told to stay neutral (or silent) in order not to make things worse for the pro-EU forces. But they now ask themselves whether their passive stance is a sufficiently supportive strategy for a decision of this magnitude for all partners involved – also because many traditionally pro-EU industry stakeholders in the UK have remained reserved so far, leaving a lot of momentum to the “Leave” side.

Supporting the (B)Remain Camp while Preparing for the Eventuality

The top EU leadership has clearly spoken out in favour of the UK to remain a part of the European family. Already in 2014 European Commission President Juncker has given the financial services dossier to the British EU Commissioner Jonathan Hill, and has recently asked Jonathan Faull, a top level UK EU official in Brussels, to lead the Commission’s high level Brexit task force.

Influential national political leaders, including German Chancellor Angela Merkel, have clearly spelled out that they want the UK to remain, and have grudgingly accepted UK specific political concessions in an EU summit in February 2016 in order to support David Cameron. They are wary of potential Brexit copycats across Europe.

Behind closed doors, EU institutions such as the European Central Bank and the European Commission are preparing itself for the eventuality of the British voting to “leave” on 23 June. They cannot afford not to, given the enormous impact it would have on Europe – akin to the “Grexit” situation in recent years.

A View from the United States

On 22 April 2016, President Obama visited London and argued that he had a right to respond to the claims of Brexit campaigners that Britain would easily be able to negotiate a fresh trade deal with the US. He said,

“They are voicing an opinion about what the United States is going to do, I figured you might want to hear from the president of the United States what I think the United States is going to do. And on that matter, for example, I think it’s fair to say that maybe some point down the line there might be a UK-US trade agreement, but it’s not going to happen any time soon because our focus is in negotiating with a big bloc, the European Union, to get a trade agreement done. The UK is going to be in the back of the queue.”

The Only Certain Thing is Uncertainty

The overall uncertainty related to a potential Brexit is large and little is known about how the separation process between the UK and the European Union would look like in practice. Many questions remain unanswered, including the political dynamics a Leave decision would trigger within and outside the UK.

What seems certain is that if Britain does leave the EU, a multi-year separation and negotiation process will commence.

When Greenland left the European Economic Community in 1985 it took a full three years to complete – and this even though they only had a few really important political issues to solve. The UK has been part of the European Union since 1973 – thus the social, legal and economic entanglement is much higher.

Article By Wolfgang A. Maschek & Helen Kavanagh of Squire Patton Boggs (US) LLP

© Copyright 2016 Squire Patton Boggs (US) LLP

In Wake of Panama Papers Scandal Obama Calls for Stricter Bank Regulations, Tax Rules

In a news conference today President Obama addressed rules and proposed regulations announced Thursday intended to help the U.S. fight tax evasion and other crimes connected to anonymous offshore companies and accounts.  The announcements come after a month of intense review by the administration following the first release of the so-called Panama Papers, millions of documents stolen or leaked from Panamanian law firm Mossack, Fonseca.  The papers have revealed a who’s who of international politicians, business leaders, sports figures and celebrities involved with financial transactions accomplished through anonymous shell corporations.

The new regulations include a “customer due diligence” rule requiring banks, mutual funds, securities brokers and other financial institutions to determine, verify and keep records about the actual ownership of the companies with whom they do business.  The administration has also proposed regulations requiring owners of foreign-owned “single-member limited liability companies” to obtain employer identification numbers from the IRS.  In an effort to increase transparency and address “the problem of global tax avoidance,” both rules are intended to make more easily discoverable the actual ownership of offshore companies and accounts, allowing for easier investigation of suspected fraud, tax evasion and money laundering.  Currently, companies can do business in the U.S. anonymously by registering in states that do not require full disclosure of actual ownership.

The new rules create regulatory obligations for a broad array of financial institutions, and potential new obligations for off-shore investors.  A further release of Panama Papers is expected on Monday, with the identities of many U.S. companies and individuals involved in such “anonymous” shell corporations likely to be revealed, and greater scrutiny of such transactions and the financial institutions involved with them likely to follow.

Article By Raymond C. Marshall & David S. Cannon of Sheppard, Mullin, Richter & Hampton LLP

Copyright © 2016, Sheppard Mullin Richter & Hampton LLP.

Tokyo District Court Rules that “US-Style” Dismissal is Invalid

badge_button_japan_flag_800_2185Article 16 of the Japanese Labour Contracts Act provides that “If a termination lacks objectively reasonable grounds and is not considered to be appropriate in general social terms, it is treated as an abuse of rights and is invalid”.  Obviously the terms “objectively reasonable grounds” and “appropriate in general social terms” are ambiguous but here is a case which sheds a little light on those two phrases.

On March 29, 2016 the Tokyo District Court ruled that the termination of the five plaintiff employees by Japan IBM was invalid.   Chief Judge Toru Yoshida ordered Japan IBM to reinstate them and to pay their salary retroactive to the date of termination.  The plaintiffs were all dismissed without notice based on what IBM said was their poor performance.  The employees alleged that the real reason was a desired reduction of the workforce and that IBM picked on them because they were members of a labour union which was against any restructuring, and not because their performance actually justified their dismissals.

The Court did indeed find that the plaintiffs’ performance was lower than average. However, it ruled that continuous lower evaluation based on a relative evaluation system is not enough to justify the termination.  Merely because their performance was poorer than their colleagues’ did not mean that they were objectively unable to perform the duties of the role to an adequate standard.  As a result, said the Court, Japan IBM had abused the right to terminate.

The plaintiffs’ lawyer said proudly during media interview at the Court, “This judgement is a landmark case because the judgement proved that the Japanese legal theory of “abuse of right” can serve as a brake on US-style terminations”.  In fact it was already very clear that Japanese law would block dismissals without very good reason (i.e. not including performance unless supported by very strong evidence of very serious shortcomings), but we can probably forgive him in his moment of triumph.  Even if it is not strictly a landmark, the decision does make it clear that relatively (as opposed to absolutely) poor performance will not count as “objectively reasonable grounds” for a dismissal, and that a termination without prior warning (or which is stated to be for an untrue reason) will not be found to be “appropriate in general social terms”.

Therefore, unilateral terminations in Japan are often litigated. Since the sanction of default is usually reinstatement rather than a cash payment, getting it wrong for the sake of expediency is often not a sensible option.  This IBM case is a good lesson for employers in Japan accustomed to US or similar employment systems that poor performance is not always a justifiable reason to dismiss.  Establishing objectively reasonable grounds is a very high hurdle in Japan and may strain the patience of employers not used to that burden.  It is therefore much preferable to try to agree a severance with the employee.  While this may be expensive it will at least be effective to terminate his employment and draw a conclusive line under the matter.  The employee in turn gains a cash cushion and an opportunity to leave his employment with little loss of face and a clear record and reference.

Article By Kenichiro Kawada of Squire Patton Boggs (US) LLP
© Copyright 2016 Squire Patton Boggs (US) LLP

Oxford, Alabama, City Council Repeals Bathroom Ordinance Targeting Transgender Individuals

The Oxford, Alabama, City Council has repealed on May 4, 2016, an ordinance it passed a week previously that barred transgender people from using a bathroom that corresponds with their gender identity. (See our article, Oxford, Alabama, City Council Adopts Ordinance Restricting Access to Bathroom Facilities Based on Biological Sex.)

The ordinance made it unlawful for a person to use a bathroom or changing facility within the jurisdiction of the City that did not correspond to the sex indicated on the individual’s birth certificate. Persons deemed to have violated the ordinance could have faced a misdemeanor charge, punishable by a fine of up to $500 or up to six months’ incarceration.

 The ordinance quickly garnered national attention and civil rights groups, including the Human Rights Campaign and the Southern Poverty Law Center, publicly condemned the ordinance. In a letter issued to the Oxford City Council prior to the repeal, the Southern Poverty Law Center, the American Civil Liberties Union, and the ACLU of Alabama stated that the ordinance violated the Equal Protection Clause by singling out transgender people for different and unequal treatment. The groups also argued that the ordinance violated the due process clause, “because of its broad reach and lack of enforcement mechanisms,” which, according to the groups, left it unclear “whether people risk arrest simply for failing to carry their birth certificates to the restroom at all times.”

The letter also stated that the ordinance violated Title IX of the Education Amendments of 1972, which prohibits sex discrimination in public schools. The letter noted a recent Fourth Circuit Court of Appeals decision, G.G. v. Gloucester Cty. Sch. Bd., No. 15-2056, 2016 LEXIS 7026 (4th Cir. Apr. 19, 2016), in which the U.S. Court of Appeals for the Fourth Circuit, in Richmond, accorded deference to the Department of Education’s interpretation of regulations governing toilets, locker rooms and shower facilities. The Department of Education opined that a school must treat transgender students consistent with their gender identity.

In a special meeting, the Council voted 3-2 to repeal the ordinance. Because the mayor was ill and had not yet signed it, the Council could vote to recall the ordinance. In repealing the ordinance, some Council members expressed concerns regarding whether the ordinance violated Title IX of the Education Amendments of 1972.

In addition to the repeal of the Oxford ordinance, the U.S. Department of Justice took a similar position in a letter dated May 4, 2016, to North Carolina Governor McCrory. The DOJ stated that North Carolina’s law restricting bathroom access to restrooms based on an individual’s biological sex and not based on an individual’s consistent gender identity violates both Title VII of the Civil Rights Act and Title IX of the Education Amendments of 1972. (See our article, Department of Justice Warns Governor that North Carolina LGBT Law is Unlawful.)

Article By Thomas A. Davis, Michelle E. Phillips & Kimberley R. Ward of Jackson Lewis P.C.

Jackson Lewis P.C. © 2016

U.S. Designations Targeting a Major Panamanian Money Laundering Organization Not Aided by the Panama Papers Leak

Yesterday, the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) announced designations against the Panama-based Waked Money Laundering Organization, including its leaders, network of supporters and associates, and companies. According to press reports, Colombian law enforcement arrested the organization’s leader, Nidal Ahmed Waked Hatum, at a Bogota airport the day prior to the designations.

In total, OFAC added 8 individuals and 68 business entities to the List of Specially Designated Nationals (SDN List) pursuant to the Foreign Narcotics Kingpin Designation Act (Kingpin Act). Narcotics traffickers have used these businesses to obscure the source of drug money through a variety of means, including trade-based money laundering, bulk cash smuggling, real estate development, and illicit financial services.  The designation of Balboa Bank & Trust is particularly noteworthy, as it reflects Treasury’s continued willingness to use the Kingpin Act against financial institutions.  As noted in a previous entry, OFAC had not designated a bank pursuant to the Kingpin Act prior to November 2015.

OFAC clearly anticipates that these designations will cause significant disruptions, as it concurrently issued three General Licenses authorizing certain wind down transactions involving a hotel, newspapers, and a shopping mall.  U.S. persons should carefully consider the scope and expiration dates of these licenses prior to engaging in any dealings with these designated companies.

The designations do not signal the beginning of United States government actions in response to the Panama Papers leak.  Any potential use of those documents will be limited by the legal ethical issues surrounding the use of intentionally disclosed materials likely protected by the attorney-client privilege.  In addition to the legal ethical limitations, the evidentiary which serves as the administrative record for the designations would have required several months for investigation, drafting and interagency approval.  OFAC could not have finalized such an extensive package of designations within one month of the leak.

Article By Jeremy P. Paner of Holland & Hart LLP
Copyright Holland & Hart LLP 1995-2016.

FDA Issues Menu Labeling Final Guidance

Tomato labelThe enforcement date will likely begin in May 2017.

The US Food and Drug Administration (FDA) issued its final guidance on April 29 on Menu Labeling (Final Guidance).[1],[2] Importantly, the FDA intends to begin enforcing the Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Final Rule (Menu Labeling Final Rule)[3] one year from the date that the Final Guidance’s Notice of Availability (NOA) is published in the Federal Register. The NOA for the Final Guidance is expected to be published in early May 2016. Thus, enforcement of the Menu Labeling Final Rule will likely begin in May 2017.

The 58-page Final Guidance is largely a reprint of the previous draft guidance of the same name. The Final Guidance contains many nonsubstantive changes from the draft guidance and provides additional examples (as well as several new, revised, and/or reformatted questions and answers on topics such as covered establishments, alcoholic beverages, catered events, mobile vendors, grab-and-go items, and record-keeping requirements).
The more notable changes in the Final Guidance include the following:

  • The inclusion of examples for temporary menu items (e.g., jack o’lantern cookies or holiday gift tins of popcorn).

  • Exemptions for private off-site catering events from menu labeling, even where the catered items are standard menu items.

  • Mobile vendors who walk through entertainment venues (such as baseball parks) and sell food and beverages are not considered covered establishments, and thus are not required to comply with the Menu Labeling Final Rule.

  • Additional information provided to explain a menu board, where a “menu board” can include multiple forms of written material. The crucial factor of what constitutes a menu board is whether the written material is or is a part of the primary writing from which a customer makes an order selection.

  • Standalone coupons that can be used to place an order (i.e., the coupon contains the name of the standard menu item, the price, and the phone number/website) must provide calorie declaration. However, if a coupon does not include a web address or phone number for placing orders, then it is not considered a menu, and a calorie declaration is not required.

  • An additional description for the inclusion of sauce(s) nutrition information served in multiserving standard menu items.

  • Confirmation that the calorie declaration requirements for electronic menus and menus on the Internet are the same as the requirements for printed menus.

  • Clarification that standard menu items in different sizes are not considered variable menu items unless they come in different flavors, varieties, or combinations and are listed as a single menu item.

  • Additional examples of declarations of calories in combination meal products when a meal comes in multiple sizes with multiple choices of sides.

  • Clarification that, if a covered establishment has multiple digital menu boards with rotating displays, then the disclosure statements should appear on each rotating display of each digital menu board to help ensure that the statements are clear and conspicuous to the consumer and posted prominently.

  • Calorie declarations directly on the package of grab-and-go items should declare the calories for the entire package as they are usually prepared and offered for sale (rather than based on reference amounts customarily consumed (RACCs)).

  • Any substantiation records for nutrient values should be maintained either at the covered establishment or the corporate headquarters for the duration of the time that the standard menu items are offered for sale at the covered establishment. FDA also recognizes that it is not necessary to maintain information on nutrient values for foods that are no longer standard menu items and are no longer offered for sale at a covered establishment, because this information is no longer beneficial for consumers if they cannot purchase those items.

  • Further explanation of when FDA-required statements from responsible individuals employed at covered establishments for nutrient determinations are required, along with sample statement language.

  • Additional guidelines for alcohol—

    • For caloric declaration of multiple beers that have the same calorie amounts, a single calorie declaration can be used, provided that the declaration specifies that the calorie amount listed represents the calorie amounts for each individual beer variety.

    • Clarification that, to the extent that beers on tap are not self-serve, they are exempt from the requirements for calorie declarations of standard menu items.

    • Further explanation regarding the acceptability of covered establishments’ reliance on calorie information and nutrition information on alcohol beverage labels consistent with Alcohol and Tobacco Tax and Trade determinations.

    • Discussion about the inclusion of calorie information for “suggested” alcohol pairings.

    • The applicability of the Menu Labeling Final Rule to covered establishments that sell only one type of standard menu item (e.g., beer).

As previously stated, the Menu Labeling Final Rule and Final Guidance provide that the categories of covered establishments include not only restaurants and similar retail food establishments, but also movie theaters, amusement parks, bowling alleys, sports arenas, other entertainment venues, food service vendors, food takeout and delivery establishments, quick service restaurants, table service restaurants, convenience stores, coffee shops, bakeries, delis, grocery stores, supercenters, and fitness clubs.
However, the Common Sense Nutrition Disclosure Act of 2015, which passed in the US House of Representatives and is pending in the US Senate, would

  • direct the secretary of the US Department of Health and Human Services to issue new rules that allow a food establishment to post nutritional information exclusively on its website if the majority of its orders are placed online,

  • clarify that advertisements are not necessarily considered menus, and

  • aim to protect establishments from being sued for human error.[4]

We will continue to monitor congressional and FDA menu labeling activities.

Article By Robert G. Hibbert, Kathleen M. Sanzo, Christine Forgues Schlenker & Hilary L. Lewis of Morgan, Lewis & Bockius LLP
Copyright © 2016 by Morgan, Lewis & Bockius LLP. All Rights Reserved.

[1] FDA CFSAN Constituent Update, FDA Issues Final Guidance on Menu Labeling (Apr. 29, 2016), available here.

[2] A Labeling Guide for Restaurants and Retail Establishments Selling Away From-Home Foods – Part II (Menu Labeling Requirements in Accordance with 21 C.F.R. 101.11): Guidance for Industry (Apr. 2016), available here.

[3] Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Calorie Labeling of Articles of Food in Vending Machines; Final Rule. 79 Fed. Reg. 71156 (Dec. 1, 2014), available here.

[4] See Text of the Common Sense Nutrition Disclosure Act of 2015, H.R. 2017 (Referred to Senate Committee Feb. 22, 2016), available here.