June 2017 – Federal Register Recent Federal Regulation Documents

NMFS announces its intent to conduct 5-year reviews for the endangered Baiji/Chinese River Dolphin/Yangtze River Dolphin (Lipotes vexillifer), and the endangered Saimaa subspecies of ringed seal (Phoca hispida saimensis). NMFS is required by the ESA to conduct 5-year reviews to ensure that the listing classifications of the species are accurate. The 5-year reviews must be based on the best scientific and commercial data available at the time. We request submission of any such information on Baiji/Chinese River Dolphin/Yangtze River Dolphin and Saimaa ringed seal, particularly information on the status, threats, and recovery of the species that has become available since the previous status review for Baiji/Chinese River Dolphin/Yangtze River Dolphin in February 2012 and Saimaa seal in December 2010.

The Environmental Protection Agency is announcing a cost recovery settlement with the City of Beatrice, Nebraska and Centel Corporation, for the compromise of past response costs concerning the Beatrice Former Manufactured Gas Plant Superfund Site in Beatrice, Nebraska.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Use of Electronic Records and Electronic Signatures in Clinical Investigations under our regulationsQuestions and Answers.'' The draft guidance provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic records and electronic signatures under our regulations in clinical investigations of medical products. The draft guidance expands upon recommendations in the guidance for industry entitled ``Part 11, Electronic Records; Electronic SignaturesScope and Application'' issued in August 2003 (referred to as the 2003 part 11 guidance) for recommendations that pertain to FDA-regulated clinical investigations conducted under our regulations.

We propose to adopt a new airworthiness directive (AD) for certain Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702), Model CL-600-2D15 (Regional Jet Series 705), Model CL-600- 2D24 (Regional Jet Series 900), and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. This proposed AD was prompted by a report that a number of rubber bull gear (RBG) wheels installed in the horizontal stabilizer trim actuator (HSTA) were manufactured using an incorrect material specification. This proposed AD would require replacement of the affected RBG wheels. We are proposing this AD to address the unsafe condition on these products.

This action modifies five VHF Omnidirectional Range (VOR) Federal airways in the vicinity of Stevens Point, WI. The FAA is taking this action due to the planned decommissioning of the Stevens Point, WI (STE), VHF Omnidirectional Range/Tactical Air Navigation (VORTAC) navigation aid (NAVAID) which provides navigation guidance for portions of the ATS routes amended by this action. This action will enhance the safe and efficient management of aircraft in the Stevens Point, WI, area.

The inventions listed below are assigned to the United States Government, as represented by the Secretary of the Navy and are available for domestic and foreign licensing by the Department of the Navy. The following patents are available for licensing: Patent No. 9,647,343 (Navy Case No. 200337): PROCESS FOR ASSEMBLING DIFFERENT CATEGORIES OF MULTI-ELEMENT ASSEMBLIES TO PREDETERMINED TOLERANCES AND ALIGNMENTS USING A RECONFIGURABLE ASSEMBLING AND ALIGNMENT APPARATUS// and Patent No. 9,651,509 (Navy Case No. 103114): METHOD FOR INVESTIGATING EARLY LINER COLLAPSE IN A SHAPED CHARGE.

The Environmental Protection Agency (EPA) is taking direct final action to approve revisions to the Mojave Desert Air Quality Management District (MDAQMD), Northern Sierra Air Quality Management District (NSAQMD), and San Diego County Air Pollution Control District (SDCAPCD) portions of the California State Implementation Plan (SIP). These revisions concern aerospace assembly, rework, and component manufacturing operations; emissions statements and recordkeeping; and definitions, respectively. We are approving local rules that regulate these sources and issues under the Clean Air Act (CAA or the Act).

The Coast Guard is establishing two safety zones on the navigable waters of Newtown Creek, NY. The first safety zone is within 500 feet of the two barges and assist vessels to be used for the removal and loading of the existing center span from the Kosciuszko Bridge at mile 2.1. The second is from approximately 370 yards south (upstream) of the Kosciuszko Bridge at mile 2.1 and Newtown Creek's confluence with the East River at mile 0.0 during transport of the existing center span to an offsite location. This action is necessary to provide for the safety of life on these navigable waters during the lowering and securing of the existing bridge's center span onto two barges within the Federal navigation channel and during the barge's outbound transit through Newtown Creek to the East River, tentatively scheduled on June 21-22, 2017. This rulemaking prohibits persons and vessels from being in the safety zones unless authorized by the Captain of the Port New York or a designated representative.

The FAA is issuing this notice to advise the public of a meeting of Tenth RTCA SC-233 Plenary

Pursuant to the Federal Advisory Committee Act, notice is hereby given that the National Council on the Humanities will meet to advise the Chairman of the National Endowment for the Humanities (NEH) with respect to policies, programs and procedures for carrying out his functions; to review applications for financial assistance under the National Foundation on the Arts and Humanities Act of 1965 and make recommendations thereon to the Chairman; and to consider gifts offered to NEH and make recommendations thereon to the Chairman.

Pursuant to the Federal Advisory Committee Act, notice is hereby given that the Federal Council on the Arts and the Humanities will hold a meeting of the Arts and Artifacts Domestic Indemnity Panel.

The FAA is issuing this notice to advise the public of a meeting of Forty Seventh RTCA SC206 Aeronautical Information and Meteorological Data Link Services Plenary.

This notice is to advise interested parties of a three-year extension of a demonstration project entitled Defense Health Agency (DHA) Evaluation of Non-United States Food and Drug Administration (FDA) Approved Laboratory Developed Tests (LDTs) Demonstration Project. The original notice was published on June 18, 2014 (79 FR 34726-34729).

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection in the guidance on registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions.'' The Pre-Submission Facility Correspondence (PFC) process was identified as part of the performance goals and program enhancements for the Generic Drug User Fee Amendments reauthorization for Fiscal Years 2018-2022 (GDUFA II). A complete and accurate PFC allows the Agency to begin the facility assessment process in advance of the planned abbreviated new drug application (ANDA) submission. This draft guidance describes PFC content and format, as well as the Agency's approach to assessing this information.

The inventions listed below are assigned to the United States Government as represented by the Secretary of the Navy and are available for domestic and foreign licensing by the Department of the Navy. The following patents are available for licensing: U.S. Patent No. 9,180,933: INTEGRATED STERN BULB AND FLAP//U.S. Patent No. 9,228,805: CORRUGATED BLAST FREQUENCY CONTROL PANEL AND METHOD//U.S. Patent No. 9,230,717: UNIVERSAL CABLE JACKET REMOVAL TOOL//U.S. Patent No. 9,238,501: BILGE KEEL WITH POROUS LEADING EDGE//U.S. Patent No. 9,306,360: TORSION ELIMINATING COMPRESSION DEVICE AND METHOD//U.S. Patent No. 9,307,156: LONGWAVE INFRARED IMAGING OF A HIGH TEMPERATURE HIGH INTENSITY LIGHT SOURCE//U.S. Patent No. 9,340,284: CARGO SUSPENSION FRAME FOR AIRCRAFT//U.S. Patent No. 9,365,262: WIGGLE HULL DESIGN HAVING A CONCAVE AND CONVEX PLANING HULL//U.S. Patent No. 9,376,171: MOORING CLEAT WITH OPEN DESIGN FOR NON THREAD ENTRY//U.S. Patent No. 9,376,175: WATER VESSEL WITH INTEGRATED BUOYANCY BULB AND STERN RAMP//U.S. Patent No. 9,381,979: PORTABLE LIGHTWEIGHT APPARATUS AND METHOD FOR TRANSFERRING HEAVY LOADS//U.S. Patent No. 9,417,155: CALCAREOUS DEPOSIT WIPE TEST APPARATUS AND METHOD//U.S. Patent No. 9,421,618: CLAMPING DEVICE FOR SECURING CABLES TO SUBMERGED FERROUS HULL SURFACE.//