November 2015 – Federal Register Recent Federal Regulation Documents

The Coast Guard has issued a temporary deviation from the operating schedule that governs the S168 Bridge (Battlefield Boulevard) across the Atlantic Intracoastal Waterway, Albemarle and Chesapeake Canal, mile 12.0, at Chesapeake (Great Bridge), VA. This deviation allows the bridge to remain in the closed-to-navigation position to facilitate the annual Chesapeake Christmas Parade.

Pursuant to the Federal Advisory Committee Act (5 U.S.C. App.), the Assembly of the Administrative Conference of the United States will hold a meeting to consider three proposed recommendations and to conduct other business. This meeting will be open to the public.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on October 19, 2015, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Diebold, Incorporated of North Canton, Ohio and Diebold Self-Service Systems of North Canton, Ohio. A supplement to the complaint was filed November 6, 2015. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain automated teller machines, ATM modules, components thereof, and products containing the same by reason of infringement of certain claims of U.S. Patent No. 6,082,616 (``the '616 Patent''); U.S. Patent No. 7,121,461 (``the '461 Patent''); U.S. Patent No. 7,229,010 (``the '010 Patent''); U.S. Patent No. 7,249,761 (``the '761 Patent''); U.S. Patent No. 7,314,163 (``the '163 Patent''); and U.S. Patent No. 7,832,631 (``the '631 Patent''). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Department of Defense is publishing this notice to announce that the following Federal Advisory Committee meeting of the Reserve Forces Policy Board (RFPB) will take place.

Following receipt on November 5, 2015 of a request from the U.S. Trade Representative (USTR), the Commission has instituted investigation No. TPA-105-001, Trans-Pacific Partnership Agreement: Likely Impact on the U.S. Economy and on Specific Industry Sectors, under section 105(c) of the Bipartisan Congressional Trade Priorities and Accountability Act of 2015 (19 U.S.C. 4204(c)), for the purpose of assessing the likely impact of the Agreement on the U.S. economy as a whole and on specific industry sectors and the interests of U.S. consumers. In addition to the United States, the Agreement includes Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam.

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Board of Veterans' Appeals (BVA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and includes the actual data collection instrument.

The Committee is proposing to add a product and services to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), at the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to Omega Diagnostics Group PLC (``Omega''), a company incorporated under the laws of the United Kingdom, having an office in Alva, Scotland, an exclusive patent license to practice the following inventions embodied in the following patent applications: US Provisional Patent Application No.60/846,354, entitled, ``(S,S)-trans- 1,2-cyclopentane Diamine-modified and Gamma-lysine-modified Peptide Nucleic Acids as Probes for Nucleic Acid Detection: Synthesis and Applications,'' filed 22 Sep 2006 [HHS Ref No. E-308-2006/0-US-01]; US Provisional Patent Application No. 60/896,667, entitled, ``Synthesis of Trans-tert-butyl-2-aminocyclopentylcarbamate,'' filed 23 Mar 2007 [HHS Ref No. E-308-2006/1-US-01]; International Application PCT/US2007/ 020466, entitled, ``Synthesis of Trans-tert-butyl-2- aminocyclopentylcarbamate,'' filed 21 Sep 2007 [HHS Ref No. E-308-2006/ 2-PCT-01]; US Patent Application No. 12/441,925, filed 21 Sep 2007, [HHS Ref No. E-308-2006/2-US-02]; US Patent Application No. 12/409,159, entitled, ``Cross-Coupled Peptide Nucleic Acids for Detection of Nucleic Acids of Pathogens,'' filed 23 Mar 2009 [HHS Ref No. E-308- 2006/3-US-01]; US Patent No. 9,156,778, entitled, ``Cross-Coupled Peptide Nucleic Acids for Detection of Nucleic Acids of Pathogens,'' issued 13 Oct 2015 [HHS Ref No. E-308-2006/3-US-02]; US Provisional Patent Application No. 61/684,354, entitled, Cyclopentane-peptide Nucleic Acids for Qualitative and Quantitative Detection of Nucleic Acids,'' filed 17 Aug 2012 [HHS Ref No. E-260-2012/0-US-01]; International Application PCT/US2013/055252, filed 16 Aug 2013 [HHS Ref No. E-260-2012/0-PCT-02]; European Patent Application No. 13753962.3, filed 11 Feb 2015, [HHS Ref No E-260-2012/0-EP-03]; Korea Patent Application No. 10-2015-7006286, filed 11 Mar 2015, [HHS Ref No E-260- 2012/0-KR-04]; and US Patent Application No. 14/421,732, filed 13 Feb 2015, [HHS Ref No E-260-2012/0-US-05]. The patent rights in these inventions have been assigned to the United States of America. Omega is seeking a worldwide territory for this license. The field of use may be limited to use of the Patent Rights for the development and sale of trans-cyclopentane-modified peptide nucleic acids (PNA) in a diagnostic system incorporating an enzyme-linked immunosorbent assay or Omega's proprietary VISITECT[supreg] technology for the detection of diseases or pathogenic agents including viruses and microorganisms.

In accordance with the provisions of the Privacy Act, as amended, this notice announces a renewal of an existing computer matching program that we are currently conducting with IRS.

NMFS has received a request from Excelerate Energy, L.P. (Excelerate) and Tetra Tech, Inc. (Tetra Tech), on behalf of the Northeast Gateway[supreg] Energy BridgeTM, L.P. (Northeast Gateway or NEG) and Algonquin Gas Transmission, L.L.C. (Algonquin) for an authorization to take small numbers of 14 species of marine mammals, by Level B harassment, incidental to operating, maintaining, and repairing a liquefied natural gas (LNG) port and the Algonquin Pipeline Lateral (Pipeline Lateral) facilities by NEG and Algonquin, in Massachusetts Bay. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an authorization to NEG and Algonquin to incidentally take, by Level B harassment, small numbers of marine mammals during the specified activity for a period of 1 year. NMFS is also requesting comments, information, and suggestions concerning NEG's application and the structure and content of future regulations.

The Food and Drug Administration (FDA or Agency) has determined that LIPTRUZET (ezetimibe and atorvastatin) tablets, 10 milligrams (mg)/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 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 ezetimibe and atorvastatin tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA or the Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for electric positioning chair devices. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. These devices are used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions. This order exempts electric positioning chairs, class II devices, from premarket notification, subject to certain conditions for exemption. This exemption from premarket notification, subject to these conditions (and the limitations in the physical medicine devices limitations of exemptions from premarket notification section of the device regulations), is immediately in effect for electric positioning chairs. FDA is publishing this order in accordance with the exemption from class II premarket notification section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

In accordance with the Privacy Act of 1974, as amended (Privacy Act), the National Aeronautics and Space Administration (NASA) publishes this notice of a new system of records entitled ``The Office of Inspector General Advanced Data Analytics System (ADAS)'' (System Number NASA 10IGDA. This system will store individually identifying information from a variety of individuals who have applied for or received grants, contracts, loans, or payments from NASA, including current and former employees of NASA, contractors, and subcontractors, and others whose actions have affected NASA.

These special conditions are issued for the Boeing Model 747-8 airplane. This airplane, as modified by Associated Air Center, will have novel or unusual design features associated with side-facing seats and airbag-equipped shoulder belts for these side-facing seats. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for these design features. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

This request for information will aid in the design and development of a survey regarding patient and family member experiences with the care received in inpatient rehabilitation facilities (IRFs). Comment Date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on January 19, 2016.

The Commission is noticing a recent Postal Service filing concerning a Type 2 rate adjustment and the filing of a related negotiated service agreement with Korea Post. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

We propose to supersede Airworthiness Directive (AD) 2006-19- 12, which applies to certain The Boeing Model 777-200 and -300 series airplanes. AD 2006-19-12 currently requires inspecting the lower web of the aft fairing of the engine struts for any discoloration and doing any related investigative and corrective action if necessary; inspecting the heat shield castings for any damage and doing any corrective action if necessary; installing gap cover strips; and replacing insulation blankets with new insulation blankets. Since we issued AD 2006-19-12, we have received a report that an aft fairing lower spar web exceeded the allowable conductivity limits. This proposed AD would also require, depending on airplane configuration, one-time or repetitive detailed inspections for cracking and deformation, as applicable, of the aft fairing lower structure, and one-time or repetitive conductivity inspections of the aft fairing lower structure and related investigative and corrective actions if necessary. This proposed AD also adds airplanes to the applicability. We are proposing this AD to detect and correct degradation of the aft fairing lower web, which could lead to cracking of the web and could allow flammable fluids to leak into the heat shield pan castings, and consequent increased risk of an uncontained fire and subsequent structural damage.