2017 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is classifying the nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

This document provides notice that PHMSA and the Federal Railroad Administration (FRA) are publishing a revised Regulatory Impact Analysis (RIA) updating the original RIA associated with the electronically controlled pneumatic (ECP) brake provision of PHMSA's May 8, 2015, Final Rule titled ``Enhanced Tank Car Standards and Operational Controls for High-Hazard Flammable Trains'' (Final Rule). The agencies are publishing the updated RIA in response to the mandate of the Fixing America's Surface Transportation (FAST) Act. The updated RIA incorporates new testing and analysis the National Academy of Sciences (NAS) reviewed, recommendations from two U.S. General Accountability Office (GAO) audits, and updates to the costs and benefits of the provision of the Final Rule based on current economic conditions. PHMSA invites comments on all aspects of the updated RIA and the agency will respond to all relevant comments received.

The Environmental Protection Agency (EPA) proposes to approve the state implementation plan (SIP) revision submitted by the State of West Virginia for the purpose of updating the effective date by which the State regulations incorporate by reference the national ambient air quality standards (NAAQS), additional monitoring methods, and additional equivalent monitoring methods. This update will effectively add the following to the West Virginia SIP: The 2015 ozone NAAQS, monitoring reference and equivalent methods pertaining to fine particulate matter (PM2.5), carbon monoxide (CO), and course particulate matter (PM10), and it will revise the ozone monitoring season to March 1st through October 31st, the Federal Reference Method (FRM), the Federal Equivalent Method (FEM), and the Photochemical Assessment Monitoring Stations (PAMS) network. The SIP revision will also change a reference from the ``West Virginia Department of Environmental Protection,'' to the ``Division of Air Quality.'' In the Final Rules section of this Federal Register, EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time.

Due to the receipt of an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the August 15, 2017, direct final rule that approves changes to Georgia's state implementation plan (SIP) related to new source review (NSR) permitting for prevention of significant deterioration (PSD). EPA will address the comment in a separate final action based upon the proposed rulemaking action, also published on August 15, 2017. EPA will not institute a second comment period on this action.

The Environmental Protection Agency (EPA) is taking direct final action to approve a revision to the Commonwealth of Virginia state implementation plan (SIP). This revision consists of an amendment to Virginia's SIP to incorporate by reference, the most recent federal ambient air quality standard for ozone. EPA is approving this revision in accordance with the requirements of the Clean Air Act (CAA).

The Environmental Protection Agency (EPA) is taking direct final action to approve a revision to the Commonwealth of Pennsylvania's state implementation plan (SIP). The revision includes amendments to the Pennsylvania Department of Environmental Protection's (PADEP) regulations and addresses the requirement to adopt reasonably available control technology (RACT) for sources covered by EPA's control techniques guidelines (CTG) standards for the following categories: Miscellaneous metal parts surface coating, miscellaneous plastic parts surface coating, and pleasure craft surface coatings, as well as related cleaning activities. The SIP revision also amends regulations for graphic arts systems and mobile equipment repair and refinishing as well as making general administrative changes. This action is being taken under the Clean Air Act (CAA).

This action establishes Class E airspace at Onida, SD. Controlled airspace is necessary to accommodate new special instrument approach procedures developed at Onida Municipal Airport, for the safety and management of instrument flight rules (IFR) operations at the airport.

This action proposes to modify VHF Omnidirectional Range (VOR) Federal airways V-20, V-31, V-33, V-308, and V-433; and remove V-379; in the vicinity of Nottingham, MD. This action is necessary due to the planned decommissioning of the Nottingham, MD, VORTAC navigation aid, which provides navigation guidance for portions of the above routes. The Nottingham VORTAC is being decommissioned as part of the VOR Minimum Operational Network (MON) program.

This action proposes to modify Class E airspace extending upward from 700 feet above the surface at Northeast Iowa Regional Airport, Charles City, IA. The FAA is proposing this action due to the cancellation of the instrument approach procedures associated with the decommissioned Charles City non-directional radio beacon (NDB). Additionally, the name of the airport would be updated to coincide with the FAA's aeronautical database. This action would enhance the safety and management of instrument flight rules (IFR) operations at this airport.

The Environmental Protection Agency (EPA) is proposing approval of a revision to the Ohio State Implementation Plan (SIP) submitted by the State of Ohio (Ohio) through the Ohio Environmental Protection Agency (OEPA). Ohio's SIP revision addresses the requirements of the Clean Air Act (CAA) and EPA's rules that require states to submit periodic reports describing progress towards reasonable progress goals (RPGs) established for regional haze, and a determination of the adequacy of the state's existing implementation plan addressing regional haze (regional haze SIP). EPA is proposing approval of the Ohio SIP revision on the basis that it addresses the progress report and adequacy determination requirements for the first implementation period for regional haze.

The Federal Energy Regulatory Commission (Commission) is inviting comments on the proposed rule published on October 10, 2017 in the Federal Register by the Commission at the direction of the Department of Energy.

This action finalizes the residual risk and technology review (RTR) conducted for the Manufacturing of Nutritional Yeast source category regulated under national emission standards for hazardous air pollutants (NESHAP). In addition, we are finalizing other amendments, including revisions to the form of the volatile organic compounds (VOC) standards for fermenters, removal of the option to monitor brew ethanol, inclusion of ongoing relative accuracy test audit (RATA), and revisions to other monitoring, reporting, and recordkeeping requirements.

The Coast Guard will enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal, Chicago River, Calumet-Saganashkee Channel on all waters of the Chicago Sanitary and Ship Canal and South Branch of the Chicago River between mile marker 318.9 and mile marker 321.9 from 7 a.m. until 2 p.m. on October 29, 2017. This action is necessary to protect the waterway and vessels from the potential hazards associated with a rowing competition.

The U.S. Army Corps of Engineers (Corps) is issuing this final rule to adjust its civil monetary penalties under the Clean Water Act (CWA) and the National Fishing Enhancement Act to account for inflation. This action is mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Inflation Adjustment Act), which requires agencies to adjust the levels of civil monetary penalties with an initial ``catch-up'' adjustment followed by annual adjustments for inflation. The Inflation Adjustment Act prescribes a formula for adjusting statutory civil penalties to reflect inflation, maintain the deterrent effect of statutory civil penalties, and promote compliance with the law. Using the adjustment criteria provided in the Inflation Adjustment Act for the initial ``catch-up'' adjustment and the December 16, 2016, Office of Management and Budget Memorandum regarding the ``Implementation of the 2017 annual adjustment pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015'', the 2016 catch-up adjustment and 2017 annual adjustment for inflation will increase the Class I civil penalty under Section 309 of the Clean Water Act to $20,966 per violation, and the maximum civil penalty increases to $52,414. The judicial civil penalty under Section 404(s) of the Clean Water Act increases to $52,414 per day for each violation. Under the National Fishing Enhancement Act, the Class I civil penalty increases to $22,957 per violation.

NMFS implements an accountability measure (AM) for the commercial sector for vermilion snapper in the South Atlantic exclusive economic zone (EEZ). NMFS projects that commercial landings of vermilion snapper will reach the commercial annual catch limit (ACL) for the July through December 2017 fishing period by October 17, 2017. Therefore, NMFS closes the commercial sector for vermilion snapper in the South Atlantic EEZ on October 17, 2017, and it will remain closed until January 1, 2018, the start of the January through June commercial fishing season. This closure is necessary to protect the South Atlantic vermilion snapper resource.

The Coast Guard will enforce a Special Local Regulation for the Fautasi Ocean Challenge Canoe Race on the dates of November 10, 17, and 24, 2017, to safeguard the participants and spectators, including all crews, vessels, and persons on the water in Pago Pago Harbor during the event. This regulation will functionally close the port to vessel traffic during the race, but will not require the evacuation of any vessels from the harbor. Entry into, transiting, or anchoring in the harbor will be prohibited to all vessels not registered with the sponsor as participants or not part of the race patrol, unless specifically authorized by the Captain of the Port (COTP) Honolulu or a designated representative. Vessels that are already moored or anchored in the harbor seeking permission to remain there shall request permission from the COTP unless deemed a spectator vessel that is moored to a waterfront facility within the regulated area.

In this document, a Notice of Proposed Rulemaking (NPRM) seeks comment on allowing the Commission to assign numbers by auction, on a first-come, first-served basis, by an alternative assignment methodology, or by a combination of methodologies. The NPRM seeks comment on allowing a secondary market for toll free numbers and on setting aside toll free numbers necessary to promote health and safety for use, without cost, by government agencies and non-profit health and safety organizations. The NPRM also seeks comment on whether to consider changes to overall toll free number administration. The intended effect of this NPRM is to make toll free numbers available on a more equitable and efficient basis by assigning mutually exclusive toll free numbers to the parties that value them most.

In this document, the Federal Communications Commission (Commission) proposes to eliminate rules that require certain broadcast and cable entities to maintain paper copies of Commission regulations.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the upper deck of the Steel Bridge across the Willamette River, mile 12.1, in Portland, OR. The deviation is necessary to support the Annual Run Like Hell Half Marathon event. This deviation allows the upper lift span of the bridge to remain in the closed-to-navigation position to ensure the safety of construction crew members.

In this final rule, NMFS specifies a 2017 limit of 2,000 mt of longline-caught bigeye tuna for each U.S. participating territory (American Samoa, Guam, and the Northern Mariana Islands). NMFS will allow each territory to allocate up to 1,000 mt each year to U.S. longline fishing vessels in a valid specified fishing agreement. As an accountability measure, NMFS will monitor, attribute, and restrict (if necessary), catches of longline-caught bigeye tuna, including catches made under a specified fishing agreement. These catch limits and accountability measures support the long-term sustainability of fishery resources of the U.S. Pacific Islands and fisheries development in the U.S. territories.

The Environmental Protection Agency (EPA) is taking final action to approve portions of a revision to the South Carolina State Implementation Plan (SIP) concerning the Cross-State Air Pollution Rule (CSAPR). South Carolina submitted a draft version of this SIP revision for parallel processing on May 26, 2017, and a final version on September 5, 2017. Under CSAPR, large electricity generating units (EGUs) in South Carolina are subject to Federal Implementation Plans (FIPs) requiring the units to participate in CSAPR's federal trading program for annual emissions of nitrogen oxides (NOX) and one of CSAPR's two federal trading programs for annual emissions of sulfur dioxide (SO2). This action approves the State's regulations requiring large South Carolina EGUs to participate in new CSAPR state trading programs for annual NOX and SO2 emissions integrated with the CSAPR federal trading programs and incorporates them into South Carolina's SIP, replacing the corresponding FIP requirements. These CSAPR state trading programs are substantively identical to the CSAPR federal trading programs, with the State retaining EPA's default allowance allocation methodology and EPA remaining the implementing authority for administration of the trading program. Under the CSAPR regulations, approval of these portions of the SIP revision automatically eliminates South Carolina units' obligations to participate in CSAPR's federal trading programs for annual NOX and SO2 emissions under the corresponding CSAPR FIPs addressing interstate transport requirements for the 1997 Annual Fine Particulate Matter (PM2.5) national ambient air quality standards (NAAQS). Approval of these portions of the SIP revision satisfies South Carolina's good neighbor obligation for the 1997 Annual PM2.5 NAAQS. EPA is not acting on any other portion of the September 5, 2017 submittal.

Due to the receipt of an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the August 14, 2017, direct final rule approving a State Implementation Plan (SIP) revision submitted by the State of Connecticut. The revision addresses the nonattainment new source review (NNSR) requirements for the 2008 8-hour ozone National Ambient Air Quality Standards (NAAQS). This action is being taken in accordance with the Clean Air Act.

Due to the receipt of an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the August 16, 2017, direct final rule approving a State Implementation Plan (SIP) revision submitted by the State of Vermont. Vermont's SIP revision addresses requirements of the Clean Air Act (CAA) and EPA's rules that require states to submit periodic reports describing the progress toward reasonable progress goals (RPGs) established for regional haze and a determination of adequacy of the State's existing regional haze SIP. This action is being taken in accordance with the Clean Air Act.

Due to the receipt of an adverse comment, the Environmental Protection Agency (EPA) is withdrawing portions of the August 21, 2017, direct final rule that approves changes to South Carolina's state implementation plan (SIP) related to definitions and open burning. EPA will address the comment in a separate final action based upon the proposed rulemaking action, also published on August 21, 2017. EPA will not institute a second comment period on this action.

This action removes the Notice to Airmen (NOTAM) part-time status from the legal description of the Class E airspace area designated as an extension at Elizabeth City CGAS/Regional Airport, Elizabeth City, NC, and adds NOTAM part-time language information to Class E surface area airspace. This action brings the airspace descriptions in line with the airspace hours listed in the applicable Chart Supplement. This action also updates the geographic coordinates of the airport and the Woodville non-directional radio beacon (NDB) in the associated Class D and E airspace. Also, an editorial change is made to the Class D and E surface area airspace legal descriptions, replacing Airport/Facility Directory with the term Chart Supplement.