December 18, 2018 – Federal Register Recent Federal Regulation Documents

The Environmental Protection Agency (EPA) is proposing 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 proposing to approve revisions to a local rule 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.

The Food and Drug Administration (FDA or the Agency) is announcing a new date for the public hearing to discuss its efforts to eliminate youth electronic cigarette (e-cigarette) use as well as other tobacco product use, with a focus on the potential role of drug therapies to support youth e-cigarette cessation and the issues impacting the development of such therapies. FDA is also extending the comment period.

The Coast Guard is extending, for 30 days, the period for submitting public comments on the notice of availability of the Draft Merchant Mariner Medical Manual. The extension responds to requests made by the public.

The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its spent fuel storage regulations by revising the NAC International Multi-Purpose Canister (NAC-MPC) Storage System listing within the ``List of approved spent fuel storage casks'' to include Amendment Nos. 7 and 8 to Certificate of Compliance No. 1025. Amendment No. 7 would revise the technical specifications to eliminate the requirements for the heat removal system to be operable for La Crosse Boiling Water Reactor spent fuel stored in the NAC-MPC because convective cooling is not required, and to eliminate duplicative requirements. In addition, Amendment No. 8 removes duplicative surveillance requirements in the technical specifications because these requirements are already required by the revised Technical Specification A 3.1.6, ``CONCRETE CASK Heat Removal System.''

The U.S. Nuclear Regulatory Commission (NRC) is amending its spent fuel storage regulations by revising the NAC International Multi- Purpose Canister (NAC-MPC) Storage System listing within the ``List of approved spent fuel storage casks'' to include Amendment Nos. 7 and 8 to Certificate of Compliance No. 1025. Amendment No. 7 revises the technical specifications to eliminate the requirements for the heat removal system to be operable for La Crosse Boiling Water Reactor spent fuel stored in the NAC-MPC because convective cooling is not required, and to eliminate duplicative requirements. In addition, Amendment No. 8 removes duplicative surveillance requirements in the technical specifications because these requirements are already required by the revised Technical Specification A 3.1.6, ``CONCRETE CASK Heat Removal System.''

The Environmental Protection Agency (EPA) is approving portions of the State Implementation Plan (SIP) submission, submitted by the State of Mississippi, through the Mississippi Department of Environmental Quality (MDEQ), on December 11, 2015, to demonstrate that the State meets the infrastructure requirements of the Clean Air Act (CAA or Act) for the 2012 annual fine particulate matter (PM2.5) national ambient air quality standard (NAAQS). The CAA requires that each state adopt and submit a SIP for the implementation, maintenance and enforcement of each NAAQS promulgated by EPA, which is commonly referred to as an ``infrastructure'' SIP. Specifically, EPA is approving the portions of the submission that relate to the prevention of significant deterioration (PSD) requirements. All other applicable infrastructure requirements for the 2012 Annual PM2.5 NAAQS have been addressed in separate rulemakings.

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2018. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy and readability of the regulations.

This rule exercises the Department of Defense's (DoD's) authority to update current regulations to compute reasonable charges for inpatient and ambulatory (outpatient) institutional resources and also for pharmaceuticals, durable medical equipment (DME), supplies, immunizations, injections or other medications administered or furnished by DoD military treatment facilities (MTFs) under their three existing healthcare cost recovery programsThird Party Collections, Medical Services Account, and Medical Affirmative Claims. Specifically, the rule updates the reasonable charges methodologies for inpatient and ambulatory institutional billing to allow for the use of Itemized Resource Utilization (IRU) based ratesdeveloped from the cost to provide inpatient and ambulatory institutional healthcare resourcesin addition to current bundled prospective reimbursement approaches of diagnostic related group (DRG), ambulatory payment classification (APC), ambulatory surgery center (ASC) and ambulatory procedure visit (APV) based rates. It also revises the reasonable charges methodology for pharmaceuticals, DME, supplies, immunizations, injections or medication administered to allow for their calculation using either Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) prevailing rates or IRU based ratesdeveloped from the cost to provide these healthcare items and resources- regardless of whether CHAMPUS prevailing rates are available. The additional IRU methodology implements an itemized rate and reasonable charges structure that improves collections and operation of DoD's healthcare cost recovery programs by ensuring MTFs receive appropriate reimbursement for institutional healthcare resources as well as for pharmaceuticals, DME, supplies, immunizations, injections or medication provided or administered and is more consistent with civilian health insurance industry practice. The proposed rule also replaces ``hospital'' with ``institutional'' throughout most of the regulation to align it with civilian health insurance industry terminology and better promote identification and separate billing of institutional and professional services.

This document adopts as final, with changes, proposed amendments to the U.S. Customs and Border Protection (CBP) regulations implementing changes to the drawback regulations, as directed by the Trade Facilitation and Trade Enforcement Act of 2015 (TFTEA). These regulations establish new processes for drawback pursuant to TFTEA, which liberalize the merchandise substitution standard, simplify recordkeeping requirements, extend and standardize timelines for filing drawback claims, and require the electronic filing of drawback claims. This document also provides details with respect to the process required to perfect TFTEA-based claims filed under CBP's Interim Guidance procedures. Further, this document also finalizes regulations clarifying the prohibition on the filing of a substitution drawback claim for internal revenue excise tax in situations where no excise tax was paid upon the substituted merchandise or where the substituted merchandise is the subject of a different claim for refund or drawback of tax.