2018 – Federal Register Recent Federal Regulation Documents

The Coast Guard will enforce a special local regulation for certain navigable waters of the Ohio River during the Wheeling Vintage Regatta on September 1, 2018 and September 2, 2018, to provide for the safety of persons, vessels, and the marine environment on the navigable waterways during this event. Our special local regulations for annual marine events in the Eighth Coast Guard District identify the regulated area for this event in Wheeling, WV. During the enforcement period, entry into this zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh or a designated representative.

The Coast Guard is establishing a temporary safety zone for all navigable waters of the Ohio River, extending the entire width of the river, from mile marker (MM) 0.0 to MM 0.5. This safety zone is necessary to protect persons, vessels, and the marine environment from potential hazards associated with a fireworks display. Entry of persons or vessels into this zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh or a designated representative.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Supplemental Questions and Answers Regarding Food Facility Registration.'' This draft guidance is intended to supplement the guidance document entitled ``Questions and Answers Regarding Food Facility Registration.''

This document corrects a proposed regulation in a notice of proposed rulemaking published in the Federal Register of August 2, 2018, regarding Modernized Drawback. Specifically, CBP inadvertently proposed in 19 CFR 190.32(d)(2) an exemption for drawback claims for wine which included an imprecise reference to the entirety of paragraph (b). The reference should have been only to paragraphs (b)(1) and (b)(2), the specific paragraphs regarding the ``lesser of'' rule. As is evident from the entirety of the proposed rule, paragraph (b)(3), which implements the statutory prohibition on double drawback, applies to all drawback claims for wine. This technical correction remedies a clerical error that occurred when the language of paragraph (b)(3) was moved from a different part of the proposed regulations.

The Environmental Protection Agency (EPA) is proposing to approve three state implementation plan (SIP) revisions submitted by the State of California addressing the nonattainment new source review (NNSR) requirements for the 2008 8-hour ozone National Ambient Air Quality Standards (NAAQS). These SIP revisions address the South Coast Air Quality Management District (SCAQMD or District), San Joaquin Valley Air Pollution Control District (SJVAPCD or District) and Yolo- Solano Air Quality Management District (YSAQMD or District) portions of the California SIP. This action is being taken pursuant to the Clean Air Act (CAA or ``Act'') and its implementing regulations.

The Clean Air Act requires each State Implementation Plan (SIP) to contain adequate provisions prohibiting emissions that will have certain adverse air quality effects in other states. On February 7, 2018, the State of Washington made a submission to the Environmental Protection Agency (EPA) to address these requirements. The EPA is approving the submission as meeting the requirement that each SIP contain adequate provisions to prohibit emissions that will contribute significantly to nonattainment or interfere with maintenance of the 2012 annual fine particulate matter (PM2.5) national ambient air quality standard (NAAQS) in any other state.

In this document, a Fourth Notice of Proposed Rulemaking (4th FNPRM) invites members of the public to comment on how best to transition existing spectrum holdings in the 39 GHz band to the new flexible-use band plan, and on using an incentive auction mechanism. The Federal Communications Commission (Commission or FCC) proposes to modify the 39 GHz, Upper 37 GHz, and 47 GHz band plans from 200 megahertz to 100 megahertz channels to facilitate the auctioning of all three bands at the same time. The Commission also proposes an incentive auction to reduce encumbrances and create contiguous blocks of spectrum through the 39 GHz and Upper 37 GHz bands. These proposals will promote the efficient use of this spectrum by incumbents and new licensees.

This document announces revisions to the Provider Enrollment Moratoria Access Waiver Demonstration (PEWD) for Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies. The demonstration was implemented in accordance with section 402(a)(1)(J) of the Social Security Amendments of 1967 and, as revised, gives CMS the authority to grant waivers to the statewide enrollment moratoria on a case-by-case basis in response to access to care issues and previously denied enrollment applications because of statewide moratoria implementation, and to subject providers and suppliers enrolling via such waivers to heightened screening, oversight, and investigations.

In this document, the Wireline Competition Bureau (WCB), the Wireless Telecommunications Bureau (WTB) (jointly referred to herein as the Bureaus), and the Office of Engineering and Technology (OET) adopt requirements promoting greater accountability for certain recipients of Connect America Fund (CAF) high-cost universal service support, including price cap carriers, rate-of-return carriers, rural broadband experiment (RBE) support recipients, Alaska Plan carriers, and CAF Phase II auction winners. Specifically, the Bureaus and OET establish a uniform framework for measuring the speed and latency performance for recipients of high-cost universal service support to serve fixed locations.

The Environmental Protection Agency (EPA) is proposing approval of two State Implementation Plan (SIP) revisions submitted by the State of Colorado. The revisions involve amendments to Colorado's Regulation Number 11, ``Motor Vehicle Emissions Inspection Program.'' The revisions enhance the use of Regulation Number 11's Clean Screen Program, allow self-inspecting vehicle fleets to use the On-Board Diagnostics (OBD) testing procedure, provide corrections to the Low Emitter Index (LEI) component of the Clean Screen Program, clarify existing provisions, correct administrative errors, delete obsolete language, establish inspection procedures for when emission control equipment tampering is detected, and make several other minor associated revisions. These actions are being taken under section 110 of the Clean Air Act (CAA).

The Coast Guard has modified a temporary deviation from the operating schedule that governs the Hawthorne Bridge crosses the Willamette River, mile 13.1, at Portland, OR. The deviation is necessary to accommodate a filming event for a movie. This modified deviation changes the period the bridge is authorized to remain in the closed-to-navigation position.

NMFS is prohibiting directed fishing for Pacific ocean perch in the West Yakutat District of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2018 total allowable catch of Pacific ocean perch in the West Yakutat District of the GOA.

The Food and Drug Administration's (FDA, Agency, or we) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research are announcing that the Agency is granting an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. We refer to this alternative as the ``Voluntary Malfunction Summary Reporting Program.'' This voluntary program reflects goals for streamlining malfunction reporting outlined in the commitment letter agreed to by FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments of 2017 (MDUFA IV Commitment Letter).

This action makes minor adjustments to the boundary descriptions of restricted areas R-2905A and R-2905B, Tyndall AFB, FL; R-2914B, and R-2919B, Valparaiso, FL; R-2915A and R-2915C, Eglin AFB, FL. The changes are needed because the FAA has adopted updated digital data that more precisely define maritime limits and other geophysical features used in the boundary descriptions. This requires minor changes to certain latitude/longitude points in the boundary descriptions of the above restricted areas in order to match the updated data and ensure accurate boundary depiction on aeronautical charts.

The Coast Guard proposes to establish special local regulations for certain navigable waters of the Choptank River. This action is necessary to provide for the safety of life on these waters near Oxford, MD, from October 7, 2018, through October 15, 2018, during a sailboat regatta. This proposed rule would prohibit persons and vessels from being in the regulated area unless authorized by the Captain of the Port Maryland-National Capital Region or the Coast Guard Patrol Commander. We invite your comments on this proposed rulemaking.

The Agricultural Marketing Service (AMS) is amending the Cotton Board Rules and Regulations, increasing the value assigned to imported cotton for the purposes of calculating supplemental assessments collected for use by the Cotton Research and Promotion Program. This amendment is required each year to ensure that assessments collected on imported cotton and the cotton content of imported products will be the same as those paid on domestically produced cotton. In addition, AMS is updating the Harmonized Tariff Schedule (HTS) statistical reporting numbers that were amended since the last assessment adjustment in 2017.

The Environmental Protection Agency (EPA) is taking final action to approve revisions to the San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD or ``District'') portion of the California State Implementation Plan (SIP). These revisions concern the District's 2014 demonstration regarding Reasonably Available Control Technology (RACT) requirements for the 2008 8-hour ozone National Ambient Air Quality Standard (NAAQS). We are also taking final action to approve into the California SIP the following documents that help support the District's RACT demonstration: SJVUAPCD's supplement to its 2014 RACT SIP demonstration, which contains SJVUAPCD's negative declarations where the District concludes it has no sources subject to certain Control Techniques Guidelines (CTG) documents and relevant permit conditions to implement RACT level requirements for J.R. Simplot's Nitric Acid plant in Helm, California (CA); and SJVUAPCD's 2016 Ozone Plan for the 2008 8-Hour Ozone StandardChapter 3.4 and Appendix C only. We are approving local SIP revisions to demonstrate that RACT is implemented as required under the Clean Air Act (CAA or the ``the Act'').

We are adopting a new airworthiness directive (AD) for certain Rolls-Royce Corporation (RRC) AE 2100D2A and AE 2100D3 model turboprop engines and AE 3007A2 model turbofan engines. This AD was prompted by the possibility of a low-cycle fatigue failure on certain turbine wheels. This AD requires removing the affected turbine wheels at the next engine shop visit or before reaching the new reduced life limit, whichever occurs first, and replacing them with parts eligible for installation. We are issuing this AD to address the unsafe condition on these products.

We are adopting a new airworthiness directive (AD) for certain Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes. This AD was prompted by a report that the retraction actuator eye-end of a Goodrich main landing gear (MLG) failed. This AD requires a one-time general visual inspection of the left-hand (LH) and right-hand (RH) MLG retraction actuators and replacement if necessary. We are issuing this AD to address the unsafe condition on these products.

This rule amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide for the safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

The Bureau of Consumer Financial Protection (Bureau) is amending Regulation P, which requires, among other things, that financial institutions provide an annual notice describing their privacy policies and practices to their customers. The amendment implements a December 2015 statutory amendment to the Gramm-Leach- Bliley Act providing an exception to this annual notice requirement for financial institutions that meet certain conditions.

EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 27 chemical substances which were the subject of premanufacture notices (PMNs). The chemical substances are subject to Orders issued by EPA pursuant to section 5(e) of TSCA. This action would require persons who intend to manufacture (defined by statute to include import) or process any of these 27 chemical substances for an activity that is designated as a significant new use by these rules to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notification, and has taken such actions as are required with that determination. In addition to this notice of proposed rulemaking, EPA is issuing the action as a direct final rule elsewhere in this issue of the Federal Register.

The Civilian Board of Contract Appeals (Board) amends its rules of procedure for cases arising under the Contract Disputes Act, and for disputes between insurance companies and the Department of Agriculture's Risk Management Agency in which decisions of the Federal Crop Insurance Corporation are brought before the Board under the Federal Crop Insurance Act. The Board's current rules were issued in 2008 and were last amended in 2011. After considering the one responsive comment received, the Board now promulgates its final rules of procedure.

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2019. Some of these changes implement certain statutory provisions contained in the 21st Century Cures Act and the Bipartisan Budget Act of 2018, and other legislation. We also are making changes relating to Medicare graduate medical education (GME) affiliation agreements for new urban teaching hospitals. In addition, we are providing the market basket update that will apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis, subject to these limits for FY 2019. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long- term care hospitals (LTCHs) for FY 2019. In addition, we are establishing new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs). We also are establishing new requirements or revising existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (now referred to as the Promoting Interoperability Programs). In addition, we are finalizing modifications to the requirements that apply to States operating Medicaid Promoting Interoperability Programs. We are updating policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital- Acquired Condition (HAC) Reduction Program. We also are making changes relating to the required supporting documentation for an acceptable Medicare cost report submission and the supporting information for physician certification and recertification of claims.