January 6, 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Safer Technologies Program for Medical Devices.'' This final guidance describes a new, voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program. Devices and device-led combination products are eligible for this program if they are subject to review under a premarket approval application (PMA), De Novo classification request (``De Novo request''), or premarket notification (510(k)), taking into account the specific eligibility factors described in this guidance. Consistent with the Agency's statutory mission to protect and promote public health, FDA believes that this ``Safer Technologies Program'' or ``STeP'' will help patients have more timely access to these medical devices and device-led combination products by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, De Novo marketing authorization, and 510(k) clearance.

In accordance with the Privacy Act of 1974, the DoD is modifying and reissuing a current system of records titled, ``Defense Repository for Common Enterprise Data (DRCED),'' DUSDC 01. This system of records was originally established by the Office of the Under Secretary of Defense (Comptroller) to collect and maintain records on various individuals, including active and retired Military Service personnel, their dependents, DoD civilian personnel, and other DoD- affiliated individuals, to support the DoD's defense business enterprise by using technology to synchronize and normalize data to improve affordability, performance, reporting, and mission readiness. This system of records notice (SORN) is being updated to support additional information systems being established within the DoD using the same categories of data for the same purposes. The system number is changing from DUSDC 01 to DoD 0004, to reflect its status as a DoD-wide system of records. The DoD is also modifying the system location, system managers, authority for maintenance of the system, purpose of the system, individuals covered by the system, record source categories, and notification procedures. Additionally, the DoD is issuing a Notice of Proposed Rulemaking proposing to exempt this system of records from certain provisions of the Privacy Act, in today's issue of the Federal Register.

On January 6, 2020, the Bureau of Industry and Security (BIS) amended the Export Administration Regulations (EAR) to add Software Specially Designed to Automate the Analysis of Geospatial Imagery to the 0Y521 Temporary Export Control Classification Numbers (ECCN) Series as 0D521. In this action BIS extends that status for a year pursuant to the 0Y521 series extension procedures.

The Environmental Protection Agency (EPA) is finalizing a rule under the Toxic Substances Control Act (TSCA) to address its obligations under TSCA for hexachlorobutadiene (HCBD) (CASRN 87-68-3), which EPA has determined meets the requirements for expedited action under TSCA. This final rule prohibits all manufacturing (including import), processing, and distribution in commerce of HCBD and HCBD- containing products or articles, recognizing that there is unintentional production of HCBD as a byproduct during the production of chlorinated solvents, and that results in distribution in commerce of a very limited subset of that byproduct for burning as a waste fuel. These requirements will impact the amount of HCBD that will be manufactured, processed, distributed in commerce, used or disposed, thus reducing the exposures to humans and the environment from those activities prohibited under this final rule.

The Environmental Protection Agency (EPA) is finalizing a rule under the Toxic Substances Control Act (TSCA) to address its obligations under TSCA for 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP) (CASRN 732-26-3), which EPA has determined meets the requirements for expedited action under TSCA. This final rule prohibits the distribution in commerce of 2,4,6-TTBP and products containing 2,4,6-TTBP at concentrations above 0.3% in any container with a volume of less than 35 gallons for any use, in order to effectively prevent the use of 2,4,6-TTBP as an antioxidant in fuel additives or fuel injector cleaners by consumers and small commercial operations (e.g., automotive repair shops, marinas). This final rule also prohibits the processing and distribution in commerce of 2,4,6-TTBP, and products containing 2,4,6-TTBP at concentrations above 0.3 percent by weight, for use as an oil or lubricant additive, regardless of container size. These requirements will reduce the exposure to humans and the environment, by reducing the potential for consumer exposures to 2,4,6-TTBP and potential occupational exposure in certain industries where workers are unprotected, as well as potential releases to the environment from consumer and small commercial operations use.

The Environmental Protection Agency (EPA) is finalizing a rule under the Toxic Substances Control Act (TSCA) to address its obligations under TSCA for decabromodiphenyl ether (decaBDE) (CASRN 1163-19-5), which EPA has determined meets the requirements for expedited action under of TSCA. This final rule prohibits all manufacture (including import), processing, and distribution in commerce of decaBDE, or decaBDE-containing products or articles, with some exclusions. These requirements will result in lower amounts of decaBDE being manufactured, processed, distributed in commerce, used and disposed, thus reducing the exposures to humans and the environment.

The IRS published a document in the Federal Register on September 8, 2020, concerning requests for comments on Form 15227. This form does not require an Office of Management and Budget (OMB) control number, further public comments are not being solicited.

The U.S. Department of Energy (DOE) publishes this final rule to establish procedures for the issuance of DOE guidance documents in accordance with Executive Order 13891. In this final rule, DOE establishes internal agency requirements for the contents of guidance documents, and procedures for providing notice of, and soliciting public comment on, certain guidance documents. This final rule also establishes procedures for the public to petition DOE to modify or withdraw guidance documents.

This document sets forth final regulations relating to amendments made to section 402(c) of the Internal Revenue Code (Code) by section 13613 of the Tax Cuts and Jobs Act (TCJA). Section 13613 of TCJA provides an extended rollover period for a qualified plan loan offset, which is a type of plan loan offset. These regulations affect participants, beneficiaries, sponsors, and administrators of qualified employer plans.

The Securities and Exchange Commission (``Commission'') is adopting a new rule under the Investment Company Act of 1940 (``Investment Company Act'' or the ``Act'') that will address valuation practices and the role of the board of directors with respect to the fair value of the investments of a registered investment company or business development company (``fund''). The rule will provide requirements for determining fair value in good faith for purposes of the Act. This determination will involve assessing and managing material risks associated with fair value determinations; selecting, applying, and testing fair value methodologies; and overseeing and evaluating any pricing services used. The rule will permit a fund's board of directors to designate certain parties to perform the fair value determinations, who will then carry out these functions for some or all of the fund's investments. This designation will be subject to board oversight and certain reporting and other requirements designed to facilitate the board's ability effectively to oversee this party's fair value determinations. The rule will include a specific provision related to the determination of the fair value of investments held by unit investment trusts, which do not have boards of directors. The rule will also define when market quotations are readily available under the Act. The Commission is also adopting a separate rule providing the recordkeeping requirements that will be associated with fair value determinations and is rescinding previously issued guidance on the role of the board of directors in determining fair value and the accounting and auditing of fund investments.