February 2019 – Federal Register Recent Federal Regulation Documents

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Agricultural Marketing Service's (AMS) intention to request for renewal a recordkeeping burden for the information collection for the Export Fruit Acts covering exports of apples and grapes.

This action proposes to amend Class E airspace extending upward from 700 feet above the surface at Butler County Regional Airport-Hogan Field, Hamilton, OH. The FAA is proposing this action as the result of an airspace review caused by the decommissioning of the Richmond VHF omnidirectional range (VOR) navigation aid, which provided navigation information for the instrument procedures at this airport, as part of the VOR Minimum Operational Network (MON) Program. Airspace redesign is necessary for the safety and management of instrument flight rules (IFR) operations at this airport.

This action amends Class D airspace, Class E airspace designated as an extension to a Class D surface area, and Class E airspace extending upward from 700 feet or more above the surface at Schenectady County Airport, Schenectady, NY, and Albany, NY by updating the geographic coordinates of this airport, Saratoga County Airport, Hunter NDB, and Cambridge VOR/DME. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at this airport. This action also replaces the outdated term Airport/ Facility Directory with the term Chart Supplement in the legal descriptions of associated Class D and E airspace of Schenectady County Airport, Schenectady, NY, and Ithaca Tompkins Regional Airport, Ithaca, NY. In addition, subsequent to publication, it was noted that the Cambridge VOR/DME was identified as VORTAC. This action corrects the error.

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.

This action proposes to modify Class E airspace extending upward from 700 feet above the surface at Alpine-Casparis Municipal Airport, Alpine, TX. This action is necessary due to the decommissioning of the Brewster County non-directional radio beacon (NDB), and cancellation of the NDB approach, and would enhance the safety and management of standard instrument approach procedures for instrument flight rules (IFR) operations at this airport. Additionally, the geographic coordinates are being updated to coincide with the FAA's aeronautical database.

The Office of the Comptroller of the Currency (OCC), the Board of Governors of the Federal Reserve System (Board), the Federal Deposit Insurance Corporation (FDIC), the Farm Credit Administration (FCA), and the National Credit Union Administration (NCUA) are amending their regulations regarding loans in areas having special flood hazards to implement the private flood insurance provisions of the Biggert-Waters Flood Insurance Reform Act of 2012 (Biggert-Waters Act). Specifically, the final rule requires regulated lending institutions to accept policies that meet the statutory definition of ``private flood insurance'' in the Biggert-Waters Act; and permits regulated lending institutions to exercise their discretion to accept flood insurance policies issued by private insurers and plans providing flood coverage issued by mutual aid societies that do not meet the statutory definition of ``private flood insurance,'' subject to certain restrictions.

The U.S. Department of the Treasury's Office of Financial Research (the ``Office'' or the ``OFR'') is adopting final rules (the ``Final Rules'') establishing a data collection covering centrally cleared transactions in the U.S. repurchase agreement (``repo'') market. This collection requires daily reporting to the Office by covered central counterparties (``CCPs''). The collected data will be used to support the work of the Financial Stability Oversight Council (the ``Council''), its member agencies, and the Office to identify and monitor risks to financial stability, and to support the calculation of certain reference rates.

The Environmental Protection Agency (EPA) is approving and incorporating by reference into the Oregon State Implementation Plan (SIP) the Lane Regional Air Protection Agency's (LRAPA) revised outdoor burning rule submitted by the Oregon Department of Environmental Quality (ODEQ) on July 19, 2018. The revised rule, as it applies in Lane County, Oregon, clarifies terminology and provides additional controls of outdoor burning activities, reducing particulate emissions and strengthening the Oregon SIP. In addition, the EPA is approving but not incorporating by reference the enforcement procedures and civil penalties rule for LRAPA submitted by the ODEQ on September 25, 2018. The revised rule brings the enforcement procedures and civil penalties rule, as it applies in Lane County, into alignment with recent changes in Oregon State regulations.

The Securities and Exchange Commission (``Commission'' or ``SEC'') is adopting a new rule of Regulation National Market System (``Regulation NMS'') under the Securities and Exchange Act of 1934 (``Exchange Act'') to conduct a Transaction Fee Pilot (``Pilot'') for National Market System (``NMS'') stocks to study the effects that exchange transaction fee-and-rebate pricing models may have on order routing behavior, execution quality, and market quality. We expect the data generated by the pilot, combined with data from existing sources, will facilitate an empirical evaluation of whether the existing exchange transaction-based fee and rebate structure is operating effectively to further statutory goals.

Based on affirmative final determinations by the Department of Commerce (Commerce) and the International Trade Commission (ITC), Commerce is issuing antidumping duty (AD) and countervailing duty (CVD) orders on rubber bands from the People's Republic of China (China).

EPA is making available for review and comment the data received from respondents of a voluntary survey, ``2018 Clean Water Act Hazardous Substances Survey'' (OMB Control No. 2050-0220). This data is being made available consistent with the preamble to the proposed action ``Clean Water Act Hazardous Substances Spill Prevention'' published on June 25, 2018. The data collected through the voluntary survey is available in Regulations.gov at Docket ID: EPA-HQ-OLEM-2017- 0444.

The U.S. Nuclear Regulatory Commission will convene a meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on April 3-4, 2019. A sample of agenda items to be discussed during the public session includes: A discussion on medical-related events; a discussion on the ACMUI's recommendations and comments on revision 10 of the draft Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere[supreg] and SIR_Spheres[supreg] Licensing Guidance; a discussion on the summary of changes to the NRC's requirements regarding medical use of byproduct material; a discussion of the ACMUI's recommendations related to the appropriateness of the required reporting and notification of a medical event; a presentation from Lucerno Dynamics on the detection of nuclear medicine injection infiltrations; and a discussion on the ACMUI's recommendations and comments on the draft Germanium-68/Gallium-68 Pharmacy Grade Generator Licensing Guidance. The agenda is subject to change. The current agenda and any updates will be available at https://www.nrc.gov/reading-rm/doc- collections/acmui/meetings/2019.html or by emailing Ms. Kellee Jamerson at the contact information below.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Guidance for Industry.'' The guidance document provides manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with our current thinking regarding evaluation of devices used in the recovery, isolation or delivery of regenerative advanced therapies, which FDA generally refers to as ``regenerative medicine advanced therapies'' or ``RMATs.'' Specifically, the guidance addresses how FDA intends to simplify and streamline its application of regulatory requirements for combination device and cell or tissue products; what, if any, intended uses or specific attributes would result in a device used with a regenerative therapy product to be classified as a class III device; the factors to consider in determining whether a device may be labeled for use with a specific RMAT or class of RMATs; when a device may be limited to a specific intended use with only one particular type of cell; and application of the least burdensome approach to demonstrate how a device may be used with more than one cell type. The issuance of this guidance fulfills the statutory requirement set forth in a certain section of the 21st Century Cures Act (Cures Act). The guidance announced in this notice finalizes the draft guidance of the same title dated November 2017.