May 3, 2019 – Federal Register Recent Federal Regulation Documents

This action proposes an amendment to special conditions for the Airbus A380 airplane. This airplane will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. This design feature is associated with the complex systems and the configuration of the airplane, including its full-length double deck. For these design features, the applicable airworthiness regulations do not contain adequate or appropriate safety standards regarding stairways between decks. 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. By issuance of this amendment to the special condition, the FAA is correcting an error that appeared in the Federal Register on August 28, 2006, for Special Conditions No. 25-326-SC, Docket No. NM314. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed 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.

This document contains a correction to a partial withdrawal of notice proposed rulemaking and notice of proposed rulemaking (REG- 113943-17) that was published in the Federal Register on March 26, 2019. If adopted, the withdrawn portion of the notice proposed rulemaking would have provided guidance for transactions in which property of a C corporation becomes the property of a REIT following certain corporate distributions of controlled corporation stock. The notice of proposed rulemaking provided revised guidance on the same subject.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of the Agency's annual compilation of notices of updates to the Agency's Susceptibility Test Interpretive Criteria web page. The Agency established the Susceptibility Test Interpretive Criteria web page on December 13, 2017, and since establishment has provided updates to both the format of the web pages and to the susceptibility test interpretive criteria identified and recognized by FDA on the web pages. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).

The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of vouchers as well as the approval of products redeeming a voucher. FDA has determined that ULTOMIRIS (ravulizumab-cwvz) approved December 21, 2018, meets the redemption criteria.

Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Criminal Justice Information Services (CJIS) Division will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the Federal Register Volume xx, Number xxx, pages xx-xx, on Month xx, 2019, allowing for a 60 day comment period.

We, the U.S. Fish and Wildlife Service, invite the public to comment on applications to conduct certain activities with foreign species that are listed as endangered under the Endangered Species Act (ESA). With some exceptions, the ESA prohibits activities with listed species unless Federal authorization is issued that allows such activities. The ESA also requires that we invite public comment before issuing permits for any activity otherwise prohibited by the ESA with respect to any endangered species.

The Environmental Protection Agency (EPA) is proposing to approve revisions to the Imperial County Air Pollution Control District (ICAPCD) portion of the California State Implementation Plan (SIP). These revisions concern emissions of particulate matter (PM) from open areas and wood burning appliances and update certain definitions relevant to stationary source permitting. We are proposing to approve local rules to regulate these emission sources under the Clean Air Act (CAA or the Act). We are taking comments on this proposal and plan to follow with a final action.

This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) 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 safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) Bakersfield Field Office, Bakersfield, California, intends to prepare an Environmental Impact Statement (EIS), analyzing the impacts of a proposal by Plains Pipeline, L.P. to replace its roughly 127-mile pipeline, which includes approximately 14 miles of Federal public lands, in Santa Barbara, San Luis Obispo and Kern counties. This notice announces the beginning of the scoping process to solicit public comments and identify issues.

The Environmental Protection Agency (EPA) is taking final action to approve a revision to the Antelope Valley Air Quality Management District (AVAQMD) portion of the California State Implementation Plan (SIP). This revision concerns emissions of volatile organic compounds (VOCs) from organic liquid loading. We are approving a local rule that regulates these emission sources under the Clean Air Act (CAA or the Act).

We are proposing to revise 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 2020 and to implement certain recent legislation. We also are proposing to make changes relating to Medicare graduate medical education (GME) for teaching hospitals and payments to critical access hospital (CAHs). In addition, we are proposing to provide the market basket update that would 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 2020. We are proposing to update 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 2020. In this proposed rule, we are including proposals to address wage index disparities between high and low wage index hospitals; to provide for an alternative IPPS new technology add-on payment pathway for certain transformative new devices; and to revise the calculation of the IPPS new technology add-on payment. In addition, we are requesting public comments on the substantial clinical improvement criterion used for evaluating applications for both the IPPS new technology add-on payment and the OPPS transitional pass- through payment for devices, and we discuss potential revisions that we are considering adopting as final policies related to the substantial clinical improvement criterion for applications received beginning in FY 2020 for IPPS (that is, for FY 2021 and later new technology add-on payments) and beginning in CY 2020 for the OPPS. We are proposing to establish new requirements or revise existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs). We also are proposing to establish new requirements and revise existing requirements for eligible hospitals and critical access hospitals (CAHs) participating in the Medicare and Medicaid Promoting Interoperability Programs. We are proposing to update policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program.