compliance news
FCC Limits Use of Confidentiality Requests

The U.S. Federal Communications Commission (FCC) has issued a reminder that it does not and will not grant unnecessarily broad requests regarding the confidentiality of information submitted in response to FCC letters of inquiry (LOI).

According to a Public Notice issued by the FCC’s Enforcement Bureau, the agency is receiving an increasing number of requests from LOI respondents and their legal counsels to treat their entire response as confidential. In many cases, these requests fail to provide what the Bureau calls a “substantive explanation” for the request.

In its Notice, the Enforcement Bureau says that such overboard requests for confidentiality are “unacceptable” under the Commission’s rules “and will be dismissed if not appropriately narrowed in a timely manner.” Instead, the Bureau continues, “parties requesting confidential treatment of materials they submit to the Commission are required to identify the specific parts of the submission to which the confidentiality request applies.”

The Notice cites Sections 0.459(a)(1) and (b)(1) of the Commission’s rules as the basis for this policy.

EU Commission Amends Annex II of REACH
The Commission of the European Union (EU) has implemented modified safety data sheet requirements under its regulation addressing the registration, evaluation, authorization, and restriction of chemicals, or REACH Regulation (EC) N 1907/2006.

Published in the Official Journal of the European Union, Commission Regulation (EU) 2020/878 replaces the text of Annex II of the REACH regulation, “Requirements for the Compilation of Safety Data Sheets.”

The revised safety data sheet requirements apply as of January 1, 2021. However, safety data sheets that comply with the requirements presented in the current version of Annex II can continue to be provided until the end of 2022.

FCC Report on Robocall Blocking Tools Released
The U.S. Federal Communications Commission (FCC) says that tools available to block unwanted robocalls are “now substantially available” to consumers at no or low cost.

In a staff report prepared by the Commission’s Consumer and Governmental Affairs Bureau, the Commission found that billions of unwanted calls are now being blocked each year. The report also says that the available no or low-cost tools have few reported instances of “false positive” blocking (that is, when a potentially wanted call is blocked) and that there are no reported instances that the tools have blocked an emergency call or a call-back from a public safety official responding to a 911 emergency call.

Appendix B of the report provides details on the call blocking and call labeling options currently available from 12 major voice service providers operating in the U.S., as well as the estimated number of calls blocked or labeled by the provider.

“Tools are available today to help consumers block robocalls, spoofed calls, scam calls, telemarketers, and other unwanted calls,” said FCC Chair Ajit Pai upon the release of the staff report. “We will continue to prioritize the protection of consumers from scams and unwanted robocalls.”

FDA Issues Guidance on Enforcement of Non-Invasive Remote Monitoring Devices
As the impact of the COVID-19 pandemic continues to challenge the nation’s healthcare system, the U.S. Food and Drug Administration (FDA) has taken steps to ease its enforcement of certain types of remoting patient monitoring devices.
It is important to note that the easing of the FDA’s enforcement policy remains in effect only for the duration of the COVID-19 health emergency.
The Guidance, “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency,” is intended to support efforts to expand the availability and capability of suitable monitoring devices that can remotely monitor patients. Remote monitoring is essential in limiting the need for patient-provider contact and can also help provide monitoring support for patients in remote locations.

Specifically, the Guidance states that:

“… FDA does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of certain non-invasive remote monitoring devices that are used to support patient monitoring (hereinafter referred to as “subject devices”), during the declared public health emergency…without prior submission of a premarket notification…”

It is important to note that the easing of the FDA’s enforcement policy regarding non-invasive remote monitoring devices as detailed in this Guidance remains in effect only for the duration of the COVID-19 public health emergency. Further, Guidance documents issued by the FDA and other federal agencies are intended solely to provide interested parties with information on the current views of the agency with regard to a specific issue and do not have the force of law.

Health Canada, U.S. CPSC Issued Guidance on Human Factors
The U.S. Consumer Product Safety Commission (CPSC) and Health Canada have published a joint guidance on the application and use of human factors principles in the product development process.

Issued earlier this year by the CPSC’s Division of Human Factors and Health Canada’s Risk Assessment Division of its Consumer and Hazardous Products Safety Directorate, the “Guidance on the Application of Human Factors to Consumer Products” is intended to help developers and manufacturers of consumer products take into account four separate human factors considerations, as follows: 1) the intended product use environment; 2) the intended product user; 3) the product design or user interface; and 4) the tasks to be accomplished by the user.

The Guidance also proposes the adoption of human factors considerations in each of the six separate stages of product design, including product planning, idea and concept generation, design and development, testing and validation, production, and post-production evaluation.

According to the Guidance, developers, and manufacturers who adopt the four human factor principles throughout the six stages of product design, developers and manufacturers are more likely to produce consumer products that are safer and easier for consumers to use, while also reducing product lifecycle cost and risks.

FCC Denies Huawei’s Request for Extended Reply Time
The U.S. Federal Communications Commission (FCC) has denied a request from Huawei Technologies to extend the reply period in connection with the company’s final designation as a national security threat under the U.S. National Supply Chain Proceeding.

As we previously reported, the FCC issued a Report and Order that bans the use of monies from the federal Universal Service Fund (USF) to purchase telecommunications equipment and services from companies that pose a national security threat. The Commission initially designated Huawei and ZTE as “covered companies” under the scope of the ban.

According to the FCC, Huawei submitted more than 5000 pages of documentation during the public comment period following the issuance of the Report and Order. Now the FCC denied a Motion for Extension of Time filed by Huawei that would have given the company an additional week to review and comment on information submitted to the Commission by the National Telecommunications and Information Administration (NTIA) in support of that final designation. The Commission originally granted Huawei 10 days to respond.

In its Order, the FCC noted that the documentation submitted by the NTIA “reflects facts about Chinese law or Huawei’s operations that ought to be within the knowledge of officers of the company and readily available, and have been echoed in other submissions throughout this proceeding.” Under the circumstances, the Commission argued, “an extension of time is not warranted given the programmatic and national security interests at stake.”

FCC Grants Speech Recognition IP Captioned Telephone
The U.S. Federal Communications Commission (FCC) has granted conditional certification to a second telephone captioning service using automatic speech recognition (ASR) technology.

In a Memorandum Opinion and Order issued in early June, the FCC’s Consumer and Government Affairs Bureau granted conditional certification to CaptionMate, an internet protocol captioned telephone service (IP CTS) application developed by Clarity Products, LLC. CaptionMate functionality is based entirely on the use of ASR technology and does not require human communications assistance to support IP CTS services.

The CaptionMate application can be downloaded for use on iOS and Android smartphones and is also accessible through the company’s website.

The conditional approval of Clarity Products CaptionMate application is based on the FCC’s 2018 determination that automatic speech recognition is a permissible means of delivering captioned telephone services and follows the Commission’s conditional approval in early May of an IP CTS application by MachineGenius.

The Commission’s conditional certification serves to verify that the CaptionMate application meets or exceeds the standards required for compensation under the FCC’s Telecommunications Relay Service (TRS) Fund, subject to further verification against TRS standards.

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