June 15, 2018 – Federal Register Recent Federal Regulation Documents

The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

DoD, GSA, and NASA are issuing an interim rule amending the Federal Acquisition Regulation (FAR) to implement a section of the National Defense Authorization Act for Fiscal Year 2017 that addresses measures against persons involved in activities that violate arms control treaties or agreements with the United States.

The Commission is noticing a recently filed Postal Service notice of intention to change prices not of general applicability to be effective July 1, 2018. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The U.S. Nuclear Regulatory Commission (NRC) is considering the renewal of Special Nuclear Materials (SNM) License No. SNM-1107 to allow Westinghouse Electric Company, LLC (WEC) to continue to operate its Columbia Fuel Fabrication Facility (CFFF) for an additional 40 years. The NRC has prepared a final environmental assessment (EA) and finding of no significant impact (FONSI) for this licensing action.

This document commences a hearing to determine whether the application filed by Family Voice Communications, LLC to renew its license for radio station KLSX(FM), Rozet, Wyoming, should be granted. The application has been designated for hearing based on the station's extended periods of silence since its first day of claimed operation on November 8, 2010.

This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, August 22, 2018. This meeting will focus on the state of evidence on Chimeric Antigen Receptor (CAR) T-cell therapies that are approved by the Food and Drug Administration (FDA). We are seeking the MEDCAC's recommendations regarding collection of patient reported outcomes (PRO) in cancer clinical studies. The MEDCAC will specifically focus on appraisal of evidence-based PRO assessments to provide information that impacts patients, their providers, and caregivers after a CAR T-cell therapy intervention for the patient's cancer. This meeting is open to the public in accordance with the Federal Advisory Committee Act.

The Food and Drug Administration (FDA or we) is classifying the fluid jet system for prostate tissue removal into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fluid jet system for prostate tissue removal's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

We are proposing to amend the fruits and vegetables regulations to allow the importation into the continental United States of fresh avocado fruit from continental Ecuador. As a condition of entry, fresh avocado fruit from continental Ecuador would have to be produced in accordance with a systems approach that would include production site registration, field sanitation, packinghouse procedures designed to exclude the quarantine pests, and procedures for packing, storing, and shipping the avocado fruit. The fruit would also have to be imported in commercial consignments, with each consignment identified throughout its movement from place of production to port of entry in the continental United States. The systems approach for all fresh avocado fruit from continental Ecuador, except Hass avocados, would also have to include production site pest control measures. Consignments would have to be accompanied by a phytosanitary certificate issued by the national plant protection organization of Ecuador certifying that the fruit was produced in accordance with the systems approach. This proposed rule would allow for the importation of fresh avocados from continental Ecuador into the continental United States while continuing to provide protection against the introduction of quarantine pests.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Coronary, Peripheral, and Neurovascular GuidewiresPerformance Tests and Recommended Labeling.'' This draft guidance provides recommendations for the information and testing that should be included in premarket submissions for guidewires intended for use in the coronary, peripheral, and neurovasculature. This draft guidance is not final nor is it in effect at this time.

NIOSH announces the availability of the final National Occupational Research Agenda for Agriculture, Forestry, and Fishing.

The Environmental Protection Agency (EPA) proposes to approve a state implementation plan (SIP) revision submitted by the Commonwealth of Pennsylvania on May 2, 2018. The purpose of this SIP revision is to remove from the Pennsylvania SIP, the Commonwealth's existing requirements limiting summertime gasoline volatility to 7.8 pounds per square inch (psi) Reid Vapor Pressure (RVP) in seven counties in the Pittsburgh-Beaver Valley Area. In the Final Rules section of this Federal Register, EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action, no further activity is contemplated. If EPA receives adverse comments relevant to this action, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time.

This final rule amends the Pension Benefit Guaranty Corporation's regulations on Benefits Payable in Terminated Single- Employer Plans and Allocation of Assets in Single-Employer Plans to prescribe interest assumptions under the benefit payments regulation for valuation dates in July 2018 and interest assumptions under the asset allocation regulation for valuation dates in the third quarter of 2018. The interest assumptions are used for valuing and paying benefits under terminating single-employer plans covered by the pension insurance system administered by PBGC.