June 2019 – Federal Register Recent Federal Regulation Documents

This document summarizes actions taken to date, requests public comment on additional subjects, and announces that CMS is releasing additional material, including study data, related to the Risk Adjustment Data Validation (RADV) provisions of the proposed rule titled ``Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021'' that was published in the November 1, 2018 Federal Register, 83 FR 55037. The comment period for the RADV provisions of this proposed rule ends on August 28, 2019.

The Coast Guard is establishing a temporary safety zone for navigable waters within a 420-foot radius of the launch site located at position 41[deg]29'50'' N, 081[deg]47'52'' W at Lakewood Park, Lakewood, OH. This safety zone is needed to restrict vessels from a portion of Lake Erie during the Lakewood Independence Day fireworks display. The temporary safety zone is necessary to protect mariners and vessels from the navigational hazards associated with a fireworks display. Entry of vessel or person into this zone is prohibited unless specifically authorized by the Captain of the Port Buffalo.

The Coast Guard is establishing a temporary safety zone in the navigable waters of the Carquinez Strait near Benicia, CA in support of the Benicia Fourth of July Fireworks Display on July 4, 2019. This safety zone is necessary to protect personnel, vessels, and the marine environment from the dangers associated with pyrotechnics. Unauthorized persons and vessels are prohibited from entering into, transiting through, or remaining in the safety zone without permission of the Captain of the Port San Francisco or a designated representative.

The Coast Guard is establishing temporary safety zones in the navigable waters of the San Francisco Bay near Aquatic Park in support of the San Francisco Waterfront Celebration on July 4, 2019. These safety zones are necessary to protect personnel, vessels, and the marine environment from the dangers associated with pyrotechnics. Unauthorized persons or vessels are prohibited from entering into, transiting through, or remaining in the safety zones without permission of the Captain of the Port or a designated representative.

The Coast Guard will enforce the safety zone for Port Aransas 4th of July Fireworks Display on July 4, 2019, to provide for the safety of persons, vessels, and the marine environment on navigable waterways during this event. Our regulation for marine events within the Eighth Coast Guard District identifies the safety zone for this event in Port Aransas, TX. During the enforcement periods, entry into this zone is prohibited unless authorized by the Captain of the Port Sector Corpus Christi (COTP) or a designated representative.

The Coast Guard is establishing a temporary safety zone in the navigable waters of Mare Island Strait near the Vallejo Ferry Terminal in support of the Vallejo Independence Day Fireworks Display on July 4, 2019. This safety zone is necessary to protect personnel, vessels, and the marine environment from the dangers associated with pyrotechnics. Unauthorized persons or vessels are prohibited from entering into, transiting through, or remaining in the safety zone without permission of the Captain of the Port or a designated representative.

This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.

The Coast Guard is establishing a temporary safety zone for certain navigable waters of the Cooper River in North Charleston, SC. This action is necessary to provide for the safety of the general public, spectators, vessels, and the marine environment from potential hazards during a fireworks display. This rulemaking will prohibit persons and vessels from entering, transiting through, anchoring in, or remaining within the safety zone unless authorized by the Captain of the Port Charleston or a designated representative.

The Coast Guard is establishing a temporary safety zone for certain navigable waters of the Cooper River at Patriot's Point in Charleston, SC. This action is necessary to provide for the safety of the general public, spectators, vessels, and the marine environment from potential hazards during a fireworks display. This rulemaking will prohibit persons and vessels from entering, transiting through, anchoring in, or remaining within the safety zone unless authorized by the Captain of the Port Charleston or a designated representative.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations concerning the use of master files for biological products. This action, if finalized, will allow certain biological products approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to continue to incorporate by reference information about drug substances, drug substance intermediates, or drug products contained in master files after those products are deemed to be licensed under the Public Health Service Act (PHS Act) on March 23, 2020. The proposed rule also codifies FDA's practice of permitting applications for biological products submitted under the PHS Act to incorporate by reference information other than drug substance, drug substance intermediate, or drug product information contained in a master file. In addition, the proposed rule codifies FDA's practice of permitting investigational new drug applications to incorporate by reference any information contained in a master file for products subject to licensure under the PHS Act.

DoD is making a technical amendment to the Defense Federal Acquisition Regulation Supplement (DFARS) to provide a needed editorial change.

DOD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2018 that requires the use of reliability and maintainability sustainment factors in weapon system design.

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to modify the text of an existing clause prescription to require, instead of permit, the clause be included in applicable solicitations and contracts, pursuant to action taken by the Regulatory Reform Task Force.

DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to partially implement a section of the National Defense Authorization Act for Fiscal Year 2017 that addresses the requirement for additional cost or pricing data when only one offer is received in response to a competitive solicitation.

The Environmental Protection Agency (EPA) is approving State Implementation Plan (SIP) revisions, submitted under a cover letter dated June 23, 2017, by the Commonwealth of Kentucky, through the Kentucky Division for Air Quality on behalf of the Louisville Metro Air Pollution Control District (LMAPCD or District or Jefferson County) to EPA, for attaining the 1-hour sulfur dioxide (SO2) primary national ambient air quality standard (NAAQS or standard) for the Jefferson County SO2 nonattainment area (hereafter referred to as the ``Jefferson County nonattainment area,'' ``nonattainment area'' or ``Area''). The Jefferson County nonattainment area is comprised of a portion of Jefferson County in Kentucky surrounding the Louisville Gas and Electric Mill Creek Electric Generating Station (hereafter referred to as ``Mill Creek'' or ``LG&E''). This plan (hereafter called a ``nonattainment plan'' or ``SIP'' or ``attainment SIP'') includes Kentucky's attainment demonstration and other elements required under the Clean Air Act (CAA or Act). In addition to an attainment demonstration, the plan addresses the requirement for meeting reasonable further progress (RFP) toward attainment of the NAAQS, reasonably available control measures and reasonably available control technology (RACM/RACT), base-year and projection-year emissions inventories, enforceable emissions limitations and control measures, nonattainment new source review (NNSR) and contingency measures. EPA concludes that Kentucky has appropriately demonstrated that the nonattainment plan provisions provide for attainment of the 2010 1-hour primary SO2 NAAQS in the Jefferson County nonattainment area and that the nonattainment plan meets the other applicable requirements under the CAA.

The FAA proposes to adopt a new airworthiness directive (AD) for all The Boeing Company Model 757 airplanes. This proposed AD was prompted by a report that during a maintenance check an operator discovered cracking in the station 1460 frame web and inner chord between certain stringers. This proposed AD would require an inspection of the fuselage frames for any existing repair, repetitive surface high frequency eddy current (HFEC) inspections of the fuselage frames with a cargo liner support channel for any cracking, and applicable on- condition actions. The FAA is proposing this AD to address the unsafe condition on these products.

The Coast Guard is adding, deleting, and modifying the special local regulations for annual recurring marine events, safety zones for firework displays, and swim events in the Coast Guard Sector Northern New England Captain of the Port Zone. When enforced, these special local regulations and safety zones will restrict vessels from transiting regulated areas during certain annually recurring events. The special local regulations and safety zones are intended to expedite public notification and ensure the protection of the maritime public and event participants from the hazards associated with certain marine events.

We are adopting a new airworthiness directive (AD) for Airbus Helicopters Deutschland GmbH (Airbus Helicopters) Model MBB-BK 117 C-2 helicopters. This AD requires establishing or reducing the life limit of various parts. This AD was prompted by recalculations. The actions of this AD are intended to address an unsafe condition on these products.

This regulation establishes tolerances for residues of mefentrifluconazole in or on multiple commodities which are identified and discussed later in this document. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Current regulations prohibit overland supersonic civil flights in the United States, but include a procedure to request authorization for these flights for the purposes of test and development of new aircraft. The criteria for such authorizations were developed in the 1970s and placed in an appendix to the operating regulations. With renewed interest in supersonic aircraft development, the FAA is proposing to modernize the procedure for requesting these special flight authorizations.

This final rule makes non-substantive technical, organizational, and conforming amendments to existing Coast Guard regulations. This rule will have no substantive effect on the regulated public.

The Department of Homeland Security (DHS) is giving concurrent notice of a reissued system of records pursuant to the Privacy Act of 1974 for the ``Department of Homeland Security/U.S. Customs and Border Protection (CBP)-009 Electronic System for Travel Authorization (ESTA) System of Records and this proposed rulemaking. DHS/CBP previously issued a Final Rule to exempt this system of records from certain provisions of the Privacy Act on August 31, 2009, and codified in the Code of Federal Regulations. This Final Rule remains in effect until a new Final Rule becomes effective. DHS/CBP is reissuing a Notice of Proposed Rulemaking to expand the applicability of the previously issued exemptions from the Privacy Act to account for the expanded categories of individuals and record source categories described in the concurrently issued SORN.

This action corrects a final rule published in the Federal Register of May 17, 2019, that modifies Class E airspace at Sibley Municipal Airport, Sibley, IA. The geographic coordinates of the airport will be amended to be in concert with the FAA's aeronautical database.

The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) by removing eight (8) persons from the Unverified List (``UVL'') and correcting the name for one (1) person currently listed on the UVL. The eight persons are removed from the UVL on the basis that BIS was able to verify their bona fides because of an end-use check.

Under the Johnson O'Malley (JOM) Act, the Bureau of Indian Education (BIE) provides assistance, through contracts, for Indian students attending public schools and non-sectarian private schools. Congress recently updated the JOM Act with the JOM Supplemental Indian Education Program Modernization Act (JOM Modernization Act). This proposed rule would implement the JOM Act, as amended, to clarify the eligibility requirements for Indian students to receive the benefits of a JOM contract, to clarify the funding formula and process to ensure full participation of contracting parties, and to otherwise reconcile and modernize the rules to comport with the activities of the contracting parties under the Act, as amended.