November 2017 – Federal Register Recent Federal Regulation Documents

NMFS has received a request from the U.S. Department of the Navy (Navy) for authorization to take marine mammals incidental to continued construction activities as part of waterfront improvement projects at several Portsmouth Naval Shipyard (the Shipyard) berths in Kittery, Maine. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorization and agency responses will be summarized in the final notice of our decision.

The Food and Drug Administration (FDA or Agency) is announcing its intention to exempt certain subtypes of surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA intends to limit the proposed exemption to single-use, disposable respiratory protective devices (RPD) used in a healthcare setting and worn by healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These devices, commonly referred to as N95 filtering facepiece respirators (FFRs) and surgical N95 respirators (herein collectively referred to as N95s) are currently regulated by FDA under product code MSH. All other class II devices classified under FDA's surgical apparel classification regulation would continue to be subject to premarket notification requirements. FDA is publishing this document to obtain comments regarding this proposed exemption, in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Consumer Product Safety Commission is contemplating developing a rule to address the risk of injury and death associated with clothing storage unit furniture tipping over. This advance notice of proposed rulemaking initiates a rulemaking proceeding under the Consumer Product Safety Act. We invite comments concerning the risk of injury associated with clothing storage units tipping over, the alternatives discussed in this notice, and other possible alternatives for addressing the risk. We also invite interested parties to submit existing voluntary standards or a statement of intent to modify or develop a voluntary standard that addresses the risk of injury described in this notice.

We propose to adopt a new airworthiness directive (AD) for certain Airbus Model A318, A319, A320, and A321 series airplanes; all Model A330-200 Freighter, -200, and -300 series airplanes; and all Model A340-200, -300, -500, and -600 series airplanes. This proposed AD was prompted by reports of false traffic collision avoidance system (TCAS) resolution advisories. This proposed AD would require modifying the software in the TCAS computer processor or replacing the TCAS computer with a new TCAS computer. We are proposing this AD to address the unsafe condition on these products.

This document contains proposed regulations implementing section 1101 of the Bipartisan Budget Act of 2015 (BBA), which was enacted into law on November 2, 2015. Section 1101 of the BBA repeals the current rules governing partnership audits and replaces them with a new centralized partnership audit regime that, in general, assesses and collects tax at the partnership level. These proposed regulations provide rules addressing how certain international rules operate in the context of the centralized partnership audit regime, including rules relating to the withholding of tax on foreign persons, withholding of tax to enforce reporting on certain foreign accounts, and the treatment of creditable foreign tax expenditures of a partnership.

The Federal Maritime Commission (FMC or Commission) proposes to amend its rules governing Non-Vessel-Operating Common Carrier (NVOCC) Negotiated Rate Arrangements and NVOCC Service Arrangements. The proposed rule is intended to modernize, update, and reduce regulatory burdens.

The Federal Emergency Management Agency (FEMA) is withdrawing its proposed rule concerning proposed flood elevation determinations for Snohomish County, Washington and Incorporated Areas.

In compliance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collections and their expected burden. The Federal Register Notice soliciting public comment on the ICR, with a 60-day comment period was published on August 25, 2017.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.'' FDA has developed this draft guidance to implement a section of the 21st Century Cures Act (Cures Act) that requires FDA to revise ``V. Demonstrating Insignificant Risk of an Erroneous Result Accuracy'' of the guidance ``Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices'' (``2008 CLIA Waiver Guidance'') that was issued on January 30, 2008. This draft guidance updates FDA's thinking regarding the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SOLX SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) 020932 for ROXICODONE (oxycodone hydrochloride (HCl)) Sustained-Release Tablets, 10 milligrams (mg) and 30 mg, held by Roxane Laboratories, Inc. (Roxane). Roxane requested withdrawal of this application and waived its opportunity for a hearing.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Pacific Fishery Management Council's (Pacific Council) Ad hoc Ecosystem Workgroup (EWG) will hold a meeting via webinar to discuss the work associated with the Climate Change and Communities Initiative. The meeting is open to the public.

This rulemaking rescinds certain transportation planning regulations pertaining to the establishment of the metropolitan planning area (MPA) boundaries, the designation of metropolitan planning organizations (MPO), and the coordination among MPOs. The amendments contained in this rule carry out the statutory mandate to rescind the final rule published on December 20, 2016, on this topic.

This document extends the special transition period under sections II and IX of the Best Interest Contract Exemption and section VII of the Class Exemption for Principal Transactions in Certain Assets between Investment Advice Fiduciaries and Employee Benefit Plans and IRAs for 18 months. This document also delays the applicability of certain amendments to Prohibited Transaction Exemption 84-24 for the same period. The primary purpose of the amendments is to give the Department of Labor the time necessary to consider public comments under the criteria set forth in the Presidential Memorandum of February 3, 2017, including whether possible changes and alternatives to these exemptions would be appropriate in light of the current comment record and potential input from, and action by, the Securities and Exchange Commission and state insurance commissioners. The Department is granting the delay because of its concern that, without a delay in the applicability dates, consumers may face significant confusion, and regulated parties may incur undue expense to comply with conditions or requirements that the Department ultimately determines to revise or repeal. The former transition period was from June 9, 2017, to January 1, 2018. The new transition period ends on July 1, 2019, rather than on January 1, 2018. The amendments to these exemptions affect participants and beneficiaries of plans, IRA owners and fiduciaries with respect to such plans and IRAs.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Arizona Advisory Committee (Committee) to the Commission will be held at 12:00 p.m. (Mountain Time) Friday, December 1, 2017. The purpose of the meeting is for the Committee to discuss logistics for March briefing on voting rights.

The Coast Guard is establishing a temporary safety zone for navigable waters around the M/V SWAN during its transit from the Savannah River entry point to Garden City Terminal in Savannah, GA and during cargo operations. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by the transport and offloading of oversized cranes. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Savannah or a designated representative.