December 13, 2017 – Federal Register Recent Federal Regulation Documents

This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.

We, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are approving an amendment to the Oklahoma regulatory program (Oklahoma program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Oklahoma proposed revisions to its regulations regarding: Permit eligibility for permits with violations on lands eligible for remining; permit suspension or rescission posting locations and appeal procedures; requiring GPS coordinates for aspects of permit maps; topsoil removal distances; blasting records requirements; annual reporting requirements; temporary cessation of operations requirements; casing and sealing temporary underground openings; right of entry requirements; surface drainage associated with auger mining; correcting reference errors; updating addresses; and correcting spelling and grammatical errors. Oklahoma intended to revise its program to be no less effective than the Federal regulations and to improve operational efficiency.

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. 9,459,079: LIGHTWEIGHT ARMOR WITH SLIDE REGION FOR SLIDABLY REDIRECTING PROJECTILES//U.S. Patent No. 9,499,890: HIGH-STRENGTH, HIGH-TOUGHNESS STEEL ARTICLES FOR BALLISTIC AND CRYOGENIC APPLICATIONS AND METHOD OF MAKING THEREOF//U.S. Patent No. 9,524,358: CORE-MODULAR INTEROPERABILITY ARCHITECTURE FOR MODELING AND SIMULATION//U.S. Patent No. 9,557,414: ULTRA-BROADBAND COHERENT RADAR TRANSPONDER FOR PRECISION TRACKING//U.S. Patent No. 9,588,011: SHIP RESISTANCE PREDICTION USING A TURBULENT SPOT INDUCER IN MODEL TESTING//U.S. Patent No. 9,628,314: DIGITAL I/Q REPROCESSING DEMODULATOR (DIRD)//U.S. Patent No. 9,630,812: LOAD TRANSFER ACCESSORY FOR DIMINISHING UNWANTED MOTION OF CYLINDRICAL CARGO DURING LOADING OPERATIONS//U.S. Patent No. 9,651,374: METHOD AND SYSTEM FOR MEASURING PHYSICAL PHENOMENA IN AN OPEN WATER ENVIRONMENT// U.S. Patent No. 9,666,864: VERTICALLY ORIENTED GRAPHENE-SUPPORTED ANODE//U.S. Patent No. 9,667,349: DYNAMIC RANGE EXTENSION OF HETERODYNE FIBER-OPTIC INTERFEROMETERS VIA INSTANTANEOUS CARRIER MEASUREMENT//

The Farm Credit Administration (FCA or we) issued a direct final rule adopting technical amendments to eliminate language that is obsolete, confusing, and unnecessary to determine the annual assessment amount of Farm Credit System institutions. In accordance with the law, the effective date of the rule is no earlier than 30 days from the date of publication in the Federal Register during which either or both Houses of Congress are in session.

The Coast Guard is establishing a special local regulation for the annual Gasparilla Marine Parade on the waters of Hillsborough Bay in the vicinity of Tampa, Florida. This event is expected to attract over 600 spectator craft along the parade route, with approximately 18 vessels participating in the official flotilla. The parade is scheduled to take place annually on the last Saturday in January. This regulation is necessary to ensure the safety of public, the official flotilla, and spectator vessels before, during, and after the conclusion of the parade.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Gluten in Drug Products and Associated Labeling Recommendations.'' This draft guidance is intended to convey to drug manufacturers FDA's recommendations on how certain oral drug products should be labeled regarding gluten, a matter of interest to individuals with celiac disease. Some individuals with celiac disease have faced difficulty when trying to determine whether specific drug products contain gluten. This draft guidance encourages drug manufacturers to have accurate information about their products' gluten content available so they can respond to questions from consumers and health care professionals.

Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (``ID'') (Order No. 6) granting a joint motion to terminate the consolidated advisory opinion proceeding in the above-captioned investigations based on a settlement agreement. The consolidated advisory opinion proceeding is terminated.

By this Notice, the Department of the Treasury is informing the public that it is conducting a mandatory survey of ownership of foreign securities by U.S. residents as of December 31, 2017. This Notice constitutes legal notification to all United States persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, this survey. The reporting form SHCA (2017) and instructions may be printed from the internet at: https://www.treasury.gov/resource-center/data-chart-center/ tic/Pages/forms-sh.aspx#shc. Definition: Pursuant to 22 U.S.C. 3102 a United States person is any individual, branch, partnership, associated group, association, estate, trust, corporation, or other organization (whether or not organized under the laws of any State), and any government (including a foreign government, the United States Government, a State or local government, and any agency, corporation, financial institution, or other entity or instrumentality thereof, including a government- sponsored agency), who resides in the United States or is subject to the jurisdiction of the United States. Who Must Report: The reporting panel is based upon the data submitted for the 2016 Benchmark survey and the June 2017 TIC report Aggregate Holdings of Long-Term Securities by U.S. and Foreign Residents (TIC SLT). Entities required to report will be contacted individually by the Federal Reserve Bank of New York. Entities not contacted by the Federal Reserve Bank of New York have no reporting responsibilities. What to Report: This report will collect information on holdings by U.S. residents of foreign securities, including equities, long-term debt securities, and short-term debt securities (including selected money market instruments). How to Report: Copies of the survey forms and instructions, which contain complete information on reporting procedures and definitions, may be obtained at the website address given above in the Summary. Completed reports can be submitted electronically or mailed to the Federal Reserve Bank of New York, Statistics Function, 4th Floor, 33 Liberty Street, New York, NY 10045-0001. Inquiries can be made to the survey staff of the Federal Reserve Bank of New York at (212) 720-6300 or email: SHC.help@ny.frb.org. Inquiries can also be made to Dwight Wolkow at (202) 622-1276, email: comments2TIC@do.treas.gov. When to Report: Data must be submitted to the Federal Reserve Bank of New York, acting as fiscal agent for the Department of the Treasury, by March 2, 2018. Paperwork Reduction Act Notice: This data collection has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act and assigned control number 1505-0146. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. The estimated average annual burden associated with this collection of information is 49 hours per respondent for end-investors and custodians that file Schedule 3 reports covering their securities entrusted to U.S. resident custodians, 146 hours per respondent for large end-investors filing Schedule 2 reports, and 546 hours per respondent for large custodians of securities filing Schedule 2 reports. Comments concerning the accuracy of this burden estimate and suggestions for reducing this burden should be directed to the Department of the Treasury, Attention: Administrator, International Portfolio Investment Data Reporting Systems, Room 5422, Washington, DC 20220, and to OMB, Attention: Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503.

The Confederated Tribes of the Grand Ronde Community of Oregon negotiated the Amendment to the Amended and Restated Tribal-State Compact for Regulation of Class III Gaming between the Confederated Tribes of the Grand Ronde Community of Oregon and the State of Oregon governing Class III gaming; this notice announces approval of the amended Compact.

This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Title 44, Part 65 of the Code of Federal Regulations (44 CFR part 65). The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals.

Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below. The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings.

This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Title 44, Part 65 of the Code of Federal Regulations (44 CFR part 65). The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals.

Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.

Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.

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 provisions of FDA's consultation procedures for foods derived from new plant varieties, including the information collection provisions in the guidance entitled, ``Guidance on Consultation Procedures: Foods Derived From New Plant Varieties,'' and in Form FDA 3665 entitled, ``Final Consultation For Food Derived From a New Plant Variety (Biotechnology Final Consultation),'' which developers may use to prepare the final consultation in a standard format.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of the Susceptibility Test Interpretive Criteria Website. The Susceptibility Test Interpretive Criteria Website will help to efficiently update susceptibility test interpretive criteria for antimicrobial drugs when necessary for public health and may allow for more efficient development and evaluation of antimicrobial susceptibility test (AST) devices. These changes may lead to better patient care and reduce antimicrobial resistance through improved antibiotic stewardship. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).