May 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to classify blood establishment computer software (BECS) and BECS accessories (regulated under product code MMH) into class II (special controls). FDA has identified special controls for BECS and BECS accessories that are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also giving notice that the Agency does not intend to exempt BECS and BECS accessories from premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The North Pacific Fishery Management Council submitted Amendment 116 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (BSAI FMP) to the Secretary of Commerce (Secretary) for review. If approved, Amendment 116 would limit access to the Bering Sea and Aleutian Islands (BSAI) Trawl Limited Access Sector (TLAS) yellowfin sole directed fishery by vessels delivering to motherships. Amendment 116 would establish eligibility criteria based on historical participation in the fishery, issue endorsements to groundfish License Limitation Program (LLP) licenses that meet eligibility criteria, and authorize delivery of BSAI TLAS yellowfin sole to motherships by only those vessels with an assigned groundfish LLP license with a BSAI catcher vessel TLAS yellowfin sole directed fishery endorsement. This action is necessary to provide benefits to historic participants, mitigate the risk that a ``race for fish'' could develop, and help to maintain the consistently low rates of halibut bycatch in the BSAI TLAS yellowfin sole directed fishery. Amendment 116 is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the BSAI FMP, and other applicable law.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the US2 Bridge across Lake Champlain, mile 91.8, between South Hero Island and North Hero Island, Vermont. This deviation is necessary to extend the operating life of the drawbridge until a replacement bridge is constructed. The deviation is necessary to allow the bridge to open only on the hour during the day for the 2018 boating season.

These special conditions are issued for The Boeing Company (Boeing) Model 777-8 and 777-9 airplanes. These airplanes will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport- category airplanes. This design feature is folding wingtips. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

We are superseding Airworthiness Directive (AD) 2018-09-10 for all CFM International S.A. (CFM) Model CFM56-7B engines. AD 2018-09-10 required initial and repetitive inspections of the concave and convex sides of the fan blade dovetail to detect cracking and replacement of any blades found cracked. This AD requires the same initial and repetitive inspections but revises the compliance time for the initial inspections of certain higher-risk fan blades. This AD was prompted by a recent engine failure due to a fractured fan blade that resulted in the engine inlet cowl disintegrating and debris penetrating the fuselage, causing a loss of pressurization, and prompting an emergency descent. We are issuing this AD to address the unsafe condition on these products.

This final rule removes DoD's regulation requiring naval personnel to provide support to dependents. It has been determined that the content of this part is internal DoD policy, and while that policy is publicly available, the part should be removed.

The Environmental Protection Agency (EPA) is proposing to approve revisions to the San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD or ``District'') portion of the California State Implementation Plan (SIP), which applies to the San Joaquin Valley of California (``Valley''). These revisions concern the District's demonstration regarding Reasonably Available Control Technology (RACT) requirements for the 2008 8-hour ozone National Ambient Air Quality Standard (NAAQS). We are also proposing to approve a public draft version of SJVUAPCD's supplement to its 2014 RACT SIP demonstration, which contains relevant permit conditions for J.R. Simplot's Nitric Acid plant in Helm, California (CA) and negative declarations where the District concludes it has no sources subject to certain Control Techniques Guidelines (CTG) documents. We are proposing action on local SIP revisions under the Clean Air Act (CAA or ``the Act''). We are taking comments on this proposal and plan to follow with a final action.

The Food and Drug Administration (FDA or Agency) is publishing this final order to exempt certain surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA is limiting the 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. This exemption will decrease regulatory burden on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. All other class II devices classified under FDA's surgical apparel classification regulation continue to be subject to premarket notification requirements. FDA is also amending the codified language for the surgical apparel devices classification regulation to reflect this final determination.

The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) by adding thirty-three (33) persons to the Unverified List (``UVL'') and adding an additional address for one (1) person currently listed on the UVL. The thirty- three persons are being added to the UVL on the basis that BIS could not verify their bona fides because an end-use check could not be completed satisfactorily for reasons outside the U.S. Government's control. A new address is added for one person as BIS has determined that this person is receiving exports from the United States at an additional address.

The Copyright Royalty Judges (Judges) publish for comment proposed regulations that set rates and terms for the making of an ephemeral recording of a sound recording by a business establishment service for the period January 1, 2019, through December 31, 2023.

We propose to adopt a new airworthiness directive (AD) for Airbus Helicopters Model AS355E, AS355F, AS355F1, AS355F2, and AS355N helicopters. This proposed AD would require measuring a vibration level in the tail rotor (T/R) drive. This proposed AD is prompted by reports of bearing degradation. The actions of this proposed AD are intended to prevent an unsafe condition on these helicopters.

The Coast Guard is proposing to establish a temporary safety zone on the waters of the Delaware River in Philadelphia, Pennsylvania. The regulation will restrict vessel traffic on a portion of the Delaware River from operating during a fireworks display on June 30, 2018 from 9:30 p.m. to 11:30 p.m. This regulation is necessary to protect the surrounding public and vessels from the hazards associated with a fireworks display. During the enforcement periods, no vessel may enter in or transit this regulated area without approval from the Captain of the Port or a designated representative.

The Comprehensive Environmental Response, Compensation, and Liability Act (``CERCLA'' or ``the Act''), as amended, requires that the National Oil and Hazardous Substances Pollution Contingency Plan (``NCP'') include a list of national priorities among the known releases or threatened releases of hazardous substances, pollutants or contaminants throughout the United States. The National Priorities List (``NPL'') constitutes this list. The NPL is intended primarily to guide the Environmental Protection Agency (``EPA'' or ``the agency'') in determining which sites warrant further investigation. These further investigations will allow the EPA to assess the nature and extent of public health and environmental risks associated with the site and to determine what CERCLA-financed remedial action(s), if any, may be appropriate. This rule proposes to add three sites to the General Superfund section of the NPL.

The Environmental Protection Agency (EPA) is proposing to approve elements of a state implementation plan (SIP) submission from Minnesota regarding the infrastructure requirements of section 110 of the Clean Air Act (CAA) relating to Prevention of Significant Deterioration (PSD) for the 1997 ozone, 1997 fine particulate (PM2.5), 2006 PM2.5, 2008 lead (Pb), 2008 ozone, 2010 nitrogen dioxide (NO2), 2010 sulfur dioxide (SO2), and 2012 PM2.5 National Ambient Air Quality Standards (NAAQS). The Minnesota Pollution Control Agency (MPCA) submitted the SIP revision to EPA on October 4, 2016.

FMCSA amends its regulations by making technical corrections throughout the Federal Motor Carrier Safety Regulations. The Agency makes minor changes to correct inadvertent errors and omissions, remove or update obsolete references, ensure conformity with Office of the Federal Register style guidelines, and improve the clarity and consistency of certain regulatory provisions.

The U.S. Copyright Office is proposing to update its regulation governing the group registration option for newsletters, which are defined in part as a class of serials that are published at least two days each week. The proposed rule would make a number of changes to reflect current Office practices, promote efficiency of the registration process, and encourage broader participation in the registration system by reducing the burden on applicants. Specifically, the proposed rule would require applicants to file an online application, rather than a paper application, and upload a complete digital copy of each issue through the electronic registration system instead of submitting them in physical form. The proposed rule would amend the definition of ``newsletter,'' and eliminate the requirement that each issue must be a work made for hire and the requirement that the applicants submit their claims within a certain period of time. In addition, the proposed rule would remove the requirement that the claimant provide the Library with complimentary subscriptions to or microfilm of the newsletter as a condition for using the group registration option. Under the proposed rule, however, newsletter publishers would remain subject to the mandatory deposit requirement. Specifically, if the newsletter is published in the United States in a physical format, the publisher must provide the Library with two complimentary subscriptions to the newsletter, unless it is informed that the newsletter is not needed for the Library's collections. Newsletters published only in electronic form would continue to be subject to the general, existing on-demand mandatory deposit regime for electronic serials. The Office invites public comment on these proposed changes.

This action proposes to establish Class E airspace extending upward from 700 feet above the surface at Freeport, PA, to accommodate new area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures serving McVille Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at this airport.

This action amends Class E airspace extending upward from 700 feet or more above the surface at Hamilton Municipal Airport (formerly Elisha Payne Airport), Hamilton, NY, to accommodate airspace reconfiguration due to the decommissioning of the Georgetown VHF omni- directional radio range tactical air navigation aid (VORTAC), and cancellation of the VORTAC approach. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the airport. This action also updates the geographic coordinates of the airport, and updates the airport name.

The Food Safety and Inspection Service (FSIS) is proposing to amend the Federal meat inspection regulations by removing the provision requiring the cleaning of hog carcasses before any incision is made preceding evisceration. This provision, although focusing on the presentation of carcass dressing defects, impedes the adoption of more efficient, effective procedures under other regulations to ensure that carcasses and parts are free of contamination. Also, the provision is no longer necessary because other regulations require carcass cleaning, the maintenance of sanitary conditions, and the prevention of hazards reasonably likely to occur in the slaughter process.

We, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are announcing receipt of a proposed amendment to the Pennsylvania Abandoned Mine Land Reclamation (AMLR) Plan (hereinafter, the Plan) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Through this proposed amendment, Pennsylvania would modify its AMLR Plan by adding Reclamation Plan Amendment No. 3, to allow the Pennsylvania Department of Environmental Protection (PADEP) to administer a State Emergency Program under Title IV of the Surface Mining Control and Reclamation Act of 1977. The plan covers coordination of emergency reclamation work between the Commonwealth and the OSMRE as well as procedures for implementing the National Environmental Policy Act and other Commonwealth procedures. This document gives the locations and times where the Pennsylvania AMLR Plan documents and this proposed amendment to that Plan are available for your inspection, establishes the comment period during which you may submit written comments on the amendment, and describes the procedures we will follow for the public hearing, if one is requested.

The Coast Guard will enforce various safety zones within the Captain of the Port New York Zone on the specified dates and times. This action is necessary to ensure the safety of vessels, spectators and participants from hazards associated with fireworks. During the enforcement period, no person or vessel may enter the safety zones without permission of the Captain of the Port (COTP).

NMFS implements an accountability measure (AM) for commercial king mackerel in the northern zone of the Gulf of Mexico (Gulf) exclusive economic zone (EEZ) through this temporary rule. NMFS has determined that the commercial quota for king mackerel in the northern zone of the Gulf EEZ will be reached by May 15, 2018. Therefore, NMFS closes the northern zone of the Gulf EEZ to commercial king mackerel fishing on May 15, 2018. This closure is necessary to protect the Gulf king mackerel resource.

The U.S. Copyright Office is further extending the deadline for the submission of written comments in response to its April 16, 2018 notice of proposed rulemaking, regarding revisions to its regulations to finalize a 2010 interim rule regarding mandatory deposit of electronic-only works, and to make electronic-only books published in the United States subject to the mandatory deposit requirements if they are affirmatively demanded by the Office.

This regulation establishes tolerances for residues of tebuconazole in or on ginseng, fresh at 0.15 parts per million (ppm) and ginseng, dried at 0.40 ppm. Bayer CropScience LP, requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

We are adopting a new airworthiness directive (AD) for certain Airbus Model A318 series airplanes and Model A319 series airplanes; all Model A320-211, -212, -214, -216, -231, -232, and -233 airplanes; and all Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. This AD was prompted by an evaluation by the design approval holder (DAH) indicating that the holes of the upper cleat to upper stringer attachments at certain areas of the left- and right-hand wings are subject to widespread fatigue damage (WFD). This AD requires modifying the holes of the upper cleat to upper stringer attachments at certain areas of the left- and right-hand wings. We are issuing this AD to address the unsafe condition on these products.