July 2018 – Federal Register Recent Federal Regulation Documents

The Coast Guard has issued a temporary deviation from the operating schedule that governs two Multnomah County bridges: Morrison Bridge, mile 12.8, and Hawthorne Bridge, mile 13.1 crossing the Willamette River at Portland, OR. This deviation is necessary to accommodate the annual Providence Bridge Pedal event. The deviation allows the bridges to remain in the closed-to-navigation position.

The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive commercialization patent license to Sinotau Pharmaceutical Group, headquartered in Beijing, China, to practice the inventions embodied in the patent application(s) listed in the Supplementary Information section of this notice.

The Coast Guard is establishing a temporary safety zone for all navigable waters of the Kanawha River from mile marker 43.1 to mile marker 44.2. This temporary safety zone is necessary to protect persons, vessels, and the marine environment from potential hazards associated with the Riverfest fireworks display. Entry into this safety zone is prohibited unless specifically authorized by the Captain of the Port Sector Ohio Valley or a designated representative.

Notice is hereby given that John Calambokidis, Cascadia Research Collective, Waterstreet Building Suite 201, 218\1/2\ West Fourth Ave., Olympia, WA 98501, has applied in due form for a permit to conduct research on marine mammals.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

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.

In this document, the Federal Communications Commission's (FCC or Commission) Consumer and Governmental Affairs Bureau (Bureau) hereby grants renewals of certifications to the state and U.S. territory TRS programs listed below.

NMFS closes the northern area Angling category fishery for large medium and giant (``trophy'' (i.e., measuring 73 inches curved fork length or greater)) Atlantic bluefin tuna (BFT). This action is being taken to prevent further overharvest of the Angling category northern area trophy BFT subquota.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies.'' This document is intended to provide guidance to sponsors on the evidence necessary to demonstrate the effectiveness of new drugs, including biological drugs, or new drug uses intended for slowly progressive, low-prevalence rare diseases that are associated with substrate deposition and are caused by single enzyme defects. This guidance applies only to those low-prevalence rare diseases with a well-characterized pathophysiology and in which changes in substrate deposition can be readily measured in relevant tissue(s).

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.

The Food and Drug Administration (FDA or Agency) has determined that metaxalone tablets, 640 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for metaxalone tablets, 640 mg, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Peripheral Vascular Atherectomy DevicesPremarket Notification [510(k)] Submissions.'' This draft guidance provides recommendations for premarket submissions for a new or modified peripheral vascular atherectomy device. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.'' FDA does not expect to grant any additional orphan-drug designation to drugs for pediatric subpopulations of common diseases (i.e., diseases or conditions with an overall prevalence of 200,000 or greater). This will help resolve an unintended loophole in the Pediatric Research Equity Act (PREA) orphan exemption process where a sponsor holding a pediatric-subpopulation designation can submit a marketing application for use of its drug in the non-orphan adult population of that disease, get a pediatric- subpopulation designation for the pediatric subset of the disease, and, due to this designation, be exempt from conducting the pediatric studies normally required under PREA when seeking approval of the adult indication.

The Bureau of the Census (Census Bureau) requests nominations of individuals to the Census Scientific Advisory Committee. The Census Bureau will consider nominations received in response to this notice, as well as from other sources. The SUPPLEMENTARY INFORMATION section of this notice provides Committee and membership criteria.

This action removes Class E airspace extending upward from 700 feet above the surface at Clarendon Municipal Airport, Clarendon, TX. This action is due to the cancellation of the instrument procedures at the airport making this airspace no longer necessary.

In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is submitting its information collection, FERC-725G2 \1\ (Reliability Standards for the Bulk Power System: PRC Reliability Standards) to the Office of Management and Budget (OMB) for review of the information collection requirements. Any interested person may file comments directly with OMB and should address a copy of those comments to the Commission as explained below. The Commission previously issued a Notice in the Federal Register on May 16, 2018, requesting public comments. The Commission received no comments on the FERC-725G2 and is making this notation in its submittal to OMB.

This action modifies Class D airspace at Charles B. Wheeler Downtown Airport, Kansas City, MO; removes Class E airspace designated as an extension to Class D airspace at Charles B. Wheeler Downtown Airport; and modifies Class E airspace extending upward from 700 feet above the surface at Kansas City International Airport, Kansas City, MO, and Charles B. Wheeler Downtown Airport. This action is required due to the decommissioning of the Riverside VHF omnidirectional range (VOR) facility, which provided navigation guidance for the instrument procedures to Charles B. Wheeler Downtown Airport. The VOR has been decommissioned as part of the VOR Minimum Operational Network (MON) Program. Additionally, the geographic coordinates and airport name are being updated to coincide with the FAA's aeronautical database. This action is necessary for the safety and management of instrument flight rules (IFR) operations at these airports.

This action modifies Class E airspace extending upward from 700 feet above the surface at Ionia County Airport, Ionia, MI. This action as the result of an airspace review due to the decommissioning of the Lansing VHF omnidirectional range (VOR) navigation aid as part of the VOR Minimum Operational Network (MON) Program. The geographic coordinates of the airport are also updated to coincide with the FAA's aeronautical database.

We are adopting a new airworthiness directive (AD) for Pacific Aerospace Limited Model 750XL airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as airplane sound insulation materials attached to the aft face of the firewall not complying with the applicable burn testing criteria for materials on the cabin side of the firewall. We are issuing this AD to require actions to address the unsafe condition on these products.