February 21, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulation that defines ``biological product'' to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020 (FCA Act), and to provide its interpretation of the statutory term ``protein.'' Under this final rule, the term protein means any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. This final rule is intended to clarify the statutory framework under which such products are regulated.

The Federal Trade Commission (``FTC'' or ``Commission'') requests public comments on its Guides Concerning the Use of Endorsements and Testimonials in Advertising (``Endorsement Guides'' or ``Guides''). The Commission is soliciting the comments as part of its systematic review of all current Commission regulations and guides.

The Department of Veterans Affairs (VA) proposes to amend its regulations concerning its claims and appeals process governing various programs administrated by the Veterans Health Administration (VHA). The Veterans Appeals Improvement and Modernization Act of 2017 (AMA) amended the procedures applicable to administrative review and appeal of VA decisions on claims for benefits, creating a new, modernized review system. This rulemaking proposes amendments to sunset certain VHA regulations which are inconsistent with AMA.

The FAA is adopting a new airworthiness directive (AD) for The Boeing Company Model 737 series airplanes, except for Model 737-100, - 200, -200C, -300, -400, and -500 series airplanes. This AD was prompted by reports of separation of the lower aft wing-to-body fairing panel 194E (``fairing panel 194E'') during flight, due to worn or damaged nutplates on the support structure. This AD requires repetitive inspections for discrepancies of fairing panel 194E, wheel well panel 193D, and support structure, and related investigative and corrective actions if necessary. This AD also requires rework of the panels and support structure, which terminates the repetitive inspections. The FAA is issuing this AD to address the unsafe condition on these products.

This rulemaking proposes amendments to Marketing Order No. 966, which regulates the handling of tomatoes grown in Florida. The proposed amendments would change the Florida Tomato Committee's (Committee) size, length of the terms of office, and quorum requirements.

This action proposes to amend the Class E airspace extending upward from 700 feet above the surface at Burnett County Airport, Siren, WI. The FAA is proposing these actions as the result of an airspace review caused by the decommissioning of the Siren 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. The geographic coordinates of the airport would also be updated to coincide with the FAA's aeronautical database. Airspace redesign is necessary for the safety and management of instrument flight rules (IFR) operations at this airport.

This action amends VHF Omnidirectional Range (VOR) Federal airway V-7 in the vicinity of Sheboygan, WI. The modifications are necessary due to the planned decommissioning of the VOR portion of the Falls, WI, VOR/Distance Measuring Equipment (VOR/DME) navigation aid (NAVAID), which provides navigation guidance for portions of the affected air traffic service (ATS) route. The Falls VOR is being decommissioned as part of the FAA's VOR Minimum Operational Network (MON) program.

This action amends VHF Omnidirectional Range (VOR) Federal airway V-71 and area navigation (RNAV) route T-285. The FAA is taking this action due to the planned decommissioning of the Winner, SD (ISD), VOR navigation aid (NAVAID). The Winner VOR is being decommissioned in support of the FAA's VOR Minimum Operational Network (MON) program.

The Federal Energy Regulatory Commission has received a petition from the Energy Trading Institute requesting that the Commission hold a technical conference and conduct a rulemaking to update the requirements adopted in Order No. 741 and Commission's regulations addressing credit and risk management in the markets operated by Independent System Operators and Regional Transmission Organizations.

The Environmental Protection Agency (EPA) is proposing to update a regulation, Appendix P to 40 CFR part 51 (Appendix P), that specifies what State Implementation Plans (SIPs) must require of sources among four categories with respect to continuous emission monitoring, recording, and reporting. Those four Appendix P source categories are: Fossil fuel-fired steam generators; fluid bed catalytic cracking unit catalyst regenerators at petroleum refineries; sulfuric acid plants; and nitric acid plants. In particular, proposed amendments to Appendix P would revise the minimum frequency for submitting reports of excess emissions from ``each calendar quarter'' to ``twice per year at 6-month intervals.'' As a result, states may, in their SIPs, establish a semiannual reporting frequency for excess emissions at affected sources that aligns with what the EPA has generally established as the reporting frequency applicable to the Appendix P source categories under more recently updated regulations, such as New Source Performance Standards (NSPS) under 40 CFR part 60. Proposed amendments also include correction of an erroneous cross-reference in Appendix P.

The Environmental Protection Agency (EPA) is approving under the Clean Air Act (CAA) a request from the Indiana Department of Environmental Management (IDEM) to revise the Indiana State Implementation Plan (SIP) to incorporate the following: A new rule concerning nitrogen oxide (NOX) emissions for the ozone season from Electric Generating Units (EGUs) and large non-EGUs; revisions concerning NOX emission rate limits for specific source categories; the repeal of the NOX Budget Trading Program; and the repeal of the Clean Air Interstate Rule (CAIR) NOX ozone season trading program. This SIP revision will ensure continued compliance by EGUs and large non-EGUs with the requirements of the NOX SIP Call.

This Directive delegates authority to the Postmaster General to settle administrative tort claims presented pursuant to the Federal Tort Claims Act where the amount of the settlement does not exceed $500,000. This Directive implements the Administrative Dispute Resolution Act. This Directive will alert the general public to the new authority and is being published in the Code of Federal Regulations to provide a permanent record of this Delegation.

The Department of the Treasury (``Department'' or ``Treasury'') publishes this final rule to adjust its civil monetary penalties (``CMPs'') for inflation as 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 (collectively referred to herein as ``the Act''). This rule adjusts CMPs within the jurisdiction of two components of the Department to the maximum amount required by the Act.

The enabling statute of the Chemical Safety and Hazard Investigation Board (CSB) provides that the CSB shall establish by regulation requirements binding on persons for reporting accidental releases into the ambient air subject to the Board's investigative jurisdiction. The final rule is intended to satisfy this statutory requirement. The rule describes when an owner or operator is required to file a report of an accidental release, and the required content of such a report. The purpose of the rule is to ensure that the CSB receives rapid, accurate reports of any accidental release that meets established statutory criteria.