2018 – Federal Register Recent Federal Regulation Documents

Results 301 - 350 of 5,380
Establishment of Class E Airspace; Leitchfield, KY
Document Number: 2018-26800
Type: Rule
Date: 2018-12-14
Agency: Federal Aviation Administration, Department of Transportation
This action establishes Class E airspace extending upward from 700 feet above the surface at Leitchfield-Grayson County Airport, Leitchfield, KY, to accommodate new area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures serving the airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at this airport.
Amendment of Class D and Class E Airspace, and Removal of Class E Airspace; Lompoc, CA
Document Number: 2018-26799
Type: Rule
Date: 2018-12-14
Agency: Federal Aviation Administration, Department of Transportation
This action modifies Class D airspace, Class E airspace extending upward from 700 feet above the surface, and removes Class E airspace designated as an extension at Vandenberg Air Force Base (AFB), Lompoc, CA. This action also modifies Class E airspace extending upward from 700 feet above the surface at Lompoc Airport, Lompoc, CA, by enlarging the airspace and removing the part-time Notice to Airmen (NOTAM) status. This action amends the geographic coordinates of the airport to match the FAA's aeronautical database. These actions are necessary for the safety and management of instrument flight rules (IFR) operations at these airports. An editorial change removes the city associated with the airport name in the airspace designations and exclusionary language from the description. Additionally, this action replaces the outdated term ``Airport/Facility Directory'' with the term ``Chart Supplement''.
Amendment of Class E Airspace; Mesquite, NV
Document Number: 2018-26796
Type: Rule
Date: 2018-12-14
Agency: Federal Aviation Administration, Department of Transportation
This action modifies Class E airspace extending upward from 700 feet above the surface at Mesquite Airport, Mesquite, NV, by enlarging the area southwest of the airport and updating the airport's geographic coordinates to match the FAA's aeronautical database. These changes are necessary to accommodate new area navigation (RNAV) procedures at this airport.
Airworthiness Directives; Fokker Services B.V. Airplanes
Document Number: 2018-26630
Type: Rule
Date: 2018-12-14
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for all Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes. This AD was prompted by reports of electrical arcing between the auxiliary power unit (APU) starter motor positive terminal and the APU fuel drain line. This AD requires the removal of certain clamps and replacement of the flexible APU fuel drain line. We are issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; Dassault Aviation Model FALCON 2000 Airplanes
Document Number: 2018-26629
Type: Rule
Date: 2018-12-14
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for certain Dassault Aviation Model FALCON 2000 airplanes. This AD was prompted by a report of chafing of a wire bundle located at the bottom of the right hand (RH) electrical cabinet. This AD requires a one-time general visual inspection of the wiring bundle for damage, measurement of the clearance between the metallic plate and the wiring bundle, and corrective actions if necessary. We are issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; Airbus SAS Airplanes
Document Number: 2018-26536
Type: Rule
Date: 2018-12-14
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for certain Airbus SAS Model A350-941 airplanes. This AD was prompted by a determination that certain holes for the vertical tail plane (VTP) tension bolts connection are not properly protected against corrosion. This AD requires modifying the VTP tension bolts connection by adding sealant and protective treatment to the head of the connection, at the barrel nut cavities, and in the surrounding area. We are issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; The Boeing Company Airplanes
Document Number: 2018-26532
Type: Rule
Date: 2018-12-14
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 777-200 and -300 series airplanes equipped with Rolls-Royce Model RB211-Trent 800 engines. This AD was prompted by reports of inadequate clearance between the thermal protection system (TPS) insulation blankets and the electronic engine control (EEC) wiring, which resulted in damaged wires. This AD requires repetitive inspections of the EEC wire bundles and clips, and corrective actions if necessary. We are issuing this AD to address the unsafe condition on these products.
Air Plan and Operating Permit Program Approval: AL, GA and SC; Revisions to Public Notice Provisions in Permitting Programs
Document Number: 2018-26247
Type: Rule
Date: 2018-12-14
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is approving portions of State Implementation Plan (SIP) revisions and the Title V Operating Permit Program revisions submitted on May 19, 2017, by the State of Alabama, through the Alabama Department of Environmental Management (ADEM); submitted on November 29, 2017, by the State of Georgia, through the Georgia Environmental Protection Division (Georgia EPD); and submitted on September 5, 2017, by the State of South Carolina, through the South Carolina Department of Health and Environmental Control (SC DHEC). These revisions address the public notice rule provisions for the New Source Review (NSR) and Title V Operating Permit programs (Title V) of the Clean Air Act (CAA or Act) that remove the mandatory requirement to provide public notice of a draft air permit in a newspaper and that allow electronic notice (``e- notice'') as an alternate noticing option. EPA is approving these revisions pursuant to the CAA and implementing federal regulations.
[EPA-HQ-OPP-2017-0288 and EPA-HQ-OPP-2017-0283; FRL-9986-73] HEAD6-Benzyladenine; Pesticide Tolerances
Document Number: 2018-27047
Type: Rule
Date: 2018-12-13
Agency: Environmental Protection Agency
This regulation establishes tolerances for residues of 6- benzyladenine in or on avocados, peppers, tomatoes, cucumbers, melons, and squash. Interregional Research Project Number 4 and Valent BioSciences LLC have requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Single-Counterparty Credit Limits for Bank Holding Companies and Foreign Banking Organizations; Correction
Document Number: 2018-27044
Type: Rule
Date: 2018-12-13
Agency: Federal Reserve System, Agencies and Commissions
On August 6, 2018, the Board of Governors of the Federal Reserve System (Board) published a final rule in the Federal Register (83 FR 38460) regarding Single-Counterparty Credit Limits for Bank Holding Companies and Foreign Banking Organizations. That document included certain incorrect paragraph designations. This document corrects those typographical errors in subparts H and Q of Regulation YY.
Military Ocean Terminal Concord, CA; Restricted Area
Document Number: 2018-27031
Type: Rule
Date: 2018-12-13
Agency: Department of Defense, Department of the Army, Corps of Engineers
The U.S. Army Military Surface Deployment and Distribution Command (SDDC) requested that the U.S. Army Corps of Engineers (Corps) change the name of a restricted area from ``Suisun Bay at Naval Weapons Station, Concord; restricted area'' to ``Military Ocean Terminal Concord (MOTCO); restricted area.'' The restricted area is located in Suisun Bay, north of the City of Concord, California. The request to change the name of the restricted area is due to a transfer of real estate from the U.S. Navy to the U.S. Army SDDC. A Memorandum of Agreement between the U.S. Navy and the U.S. Army for the interagency transfer of base closure property and all associated environmental programs for portions of the Naval Weapons Station Seal Beach Detachment Concord was signed on January 24, 2007. The SDDC officially accepted the former U.S. Navy real estate in Fall 2008 to Winter 2009.
Pacific Ocean at Naval Base Guam Telecommunication Site, Finegayan Small Arms Range, on the Northwestern Coast of Guam; Danger Zone
Document Number: 2018-27028
Type: Proposed Rule
Date: 2018-12-13
Agency: Department of Defense, Department of the Army, Corps of Engineers
The U.S. Army Corps of Engineers (Corps) is proposing to revise the existing regulations to establish a danger zone at the U.S. Naval Base Guam Telecommunication Site in the Pacific Ocean, Guam. The Navy requested establishment of a danger zone extending over the Pacific Ocean adjacent to the Finegayan Small Arms Range. Establishment of a danger zone would intermittently restrict commercial, public, and private vessels from entering or lingering in the restricted safety zone to ensure public safety during small arms training activities. This danger zone is necessary to minimize potential conflicts between local populace activities and ongoing military training in the subject area.
The Standard for Determining Joint-Employer Status; Extension of Comment Period
Document Number: 2018-27024
Type: Proposed Rule
Date: 2018-12-13
Agency: National Labor Relations Board, Agencies and Commissions
The National Labor Relations Board (the Board) published a Notice of Proposed Rulemaking in the Federal Register of September 14, 2018, seeking comments from the public concerning the standard for determining joint-employer status under the National Labor Relations Act. The date to submit responses to the Notice of Proposed Rulemaking is again extended for 30 days.
Proposed Establishment of the Eastern Connecticut Highlands Viticultural Area
Document Number: 2018-27016
Type: Proposed Rule
Date: 2018-12-13
Agency: Alcohol and Tobacco Tax and Trade Bureau, Department of Treasury, Department of the Treasury
The Alcohol and Tobacco Tax and Trade Bureau (TTB) proposes to establish the approximately 1,246 square-mile ``Eastern Connecticut Highlands'' viticultural area in all or portions of Hartford, New Haven, Tolland, Windham, New London, and Middlesex Counties in Connecticut. The proposed viticultural area is not within and does not overlap any other established AVA. TTB designates viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase. TTB invites comments on this proposed addition to its regulations.
Suspension of Community Eligibility
Document Number: 2018-26998
Type: Rule
Date: 2018-12-13
Agency: Federal Emergency Management Agency, Department of Homeland Security
This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at https:// www.fema.gov/national-flood-insurance-program-community-statu s-book.
Drawbridge Operation Regulation; Sacramento River, Sacramento, CA
Document Number: 2018-26997
Type: Rule
Date: 2018-12-13
Agency: Coast Guard, Department of Homeland Security
The Coast Guard has modified a temporary deviation from the operating schedule that governs the Tower Drawbridge over the Sacramento River, mile 59.0, at Sacramento, CA. The modified deviation extends the period the bridge may remain in the closed-to-navigation position to allow the bridge owner to complete mechanical and electrical rehabilitation work on the bridge.
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Permit Renewal Applications
Document Number: 2018-26984
Type: Rule
Date: 2018-12-13
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS issues this final rule to implement administrative revisions to the renewal process for Federal vessel permits, licenses, and endorsements, and dealer permits in the NMFS Southeast Region. This final rule removes the regulatory requirement that NMFS must mail a renewal application to a permit holder whose Federal vessel, license, or endorsement, or dealer permit is expiring. NMFS will continue to provide notice of the upcoming expiration date to the permit holder. This final rule also removes the regulatory requirement that NMFS must notify an applicant of any deficiency in a renewal application only through sending a letter via traditional mail, such as through the U.S. Postal Service, which allows NMFS expanded options for notifying permit holders. The purpose of this final rule is to reduce the administrative costs and burden to NMFS of renewing Federal permits, while still maintaining the renewal notice, information, and services to the public.
Drawbridge Operation Regulation; Lake Washington Ship Canal, Seattle, WA
Document Number: 2018-26976
Type: Rule
Date: 2018-12-13
Agency: Coast Guard, Department of Homeland Security
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Ballard Bridge, mile 1.1, the Fremont Bridge, mile 2.6, and the University Bridge, mile 4.3, all crossing the Lake Washington Ship Canal at Seattle, WA. The deviation is necessary to accommodate re-routed roadway traffic while the Alaskan Way Viaduct is closed. This deviation allows the subject bridges to remain in the closed-to-navigation position to allow congested roadway traffic to move easier.
Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Non-American Fisheries Act Crab Vessels Operating as Catcher Vessels Using Pot Gear in the Western Regulatory Area of the Gulf of Alaska
Document Number: 2018-26971
Type: Rule
Date: 2018-12-13
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is prohibiting directed fishing for Pacific cod by non- American Fisheries Act (AFA) crab vessels that are subject to sideboard limits, and operating as catcher vessels (CVs) using pot gear, in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2018 Pacific cod sideboard limit established for non-AFA crab vessels that are operating as CVs using pot gear in the Western Regulatory Area of the GOA.
Impossible Foods, Inc.; Filing of Color Additive Petition
Document Number: 2018-26949
Type: Proposed Rule
Date: 2018-12-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Impossible Foods, Inc., proposing that the color additive regulations be amended to provide for the safe use of soy leghemoglobin as a color additive in plant-based, non-animal derived ground beef analogue products.
Air Plan Approval; Michigan; Revisions to Part 1 General Provisions Rules
Document Number: 2018-26924
Type: Proposed Rule
Date: 2018-12-13
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing to approve a request submitted by the Michigan Department of Environmental Quality (MDEQ) on December 12, 2017, and supplemented on August 9, 2018, as a revision to Michigan's state implementation plan (SIP). The SIP submission incorporates several revisions to Michigan's Air Pollution Control Rules entitled ``Part 1General Provisions.'' The revisions include administrative changes to the existing rule.
Air Plan Approval; Michigan; Michigan Minor New Source Review
Document Number: 2018-26923
Type: Proposed Rule
Date: 2018-12-13
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing to approve the rescission of Michigan rule 221 from the Michigan state implementation plan (SIP). Rule 221 exempted sources that had significant net emission increases of sulfur dioxide, particulate matter, and carbon monoxide from offset requirements. Michigan rescinded this rule effective November 14, 1990.
Revisions to California State Implementation Plan; South Coast Air Quality Management District, San Joaquin Valley Air Pollution Control District and Yolo-Solano Air Quality Management; Nonattainment New Source Review Requirements for the 2008 8-Hour Ozone Standard
Document Number: 2018-26921
Type: Rule
Date: 2018-12-13
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is finalizing action on three state implementation plan (SIP) revisions submitted by the State of California addressing the nonattainment new source review (NNSR) requirements for the 2008 8-hour ozone National Ambient Air Quality Standards (NAAQS). These SIP revisions address the South Coast Air Quality Management District (SCAQMD), San Joaquin Valley Air Pollution Control District (SJVAPCD) and Yolo-Solano Air Quality Management District (YSAQMD) portions of the California SIP.
Policy on No-Action Letters and the BCFP Product Sandbox
Document Number: 2018-26873
Type: Proposed Rule
Date: 2018-12-13
Agency: Bureau of Consumer Financial Protection
The Bureau of Consumer Financial Protection (Bureau or BCFP) invites the public to take this opportunity to comment on its proposed Policy on No-Action Letters and the BCFP Product Sandbox, which is intended to carry out certain of the Bureau's authorities under Federal consumer financial law; and a proposed information collection associated with applications submitted by applicants requesting admission to the BCFP Product Sandbox under the proposed Policy as required by the Paperwork Reduction Act of 1995.
Water Quality Standards; Establishment of a Numeric Criterion for Selenium for the State of California
Document Number: 2018-26781
Type: Proposed Rule
Date: 2018-12-13
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing to establish a federal Clean Water Act (CWA) selenium water quality criterion applicable to California that protects aquatic life and aquatic-dependent wildlife in the fresh waters of California. In 2016, the EPA published a revised recommended aquatic life selenium criterion for freshwater based on the latest scientific knowledge. The EPA is proposing to amend the California Toxics Rule to include a revised statewide chronic selenium water quality criterion for California fresh waters to protect aquatic life and aquatic-dependent wildlife which builds upon the science in the EPA's 2016 Final Aquatic Life Ambient Water Quality Criteria for SeleniumFreshwater.
Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to National Park Service's Research and Monitoring Activities in Southern Alaska National Parks
Document Number: 2018-26741
Type: Proposed Rule
Date: 2018-12-13
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS has received a request from the National Park Service (NPS) for authorization to take marine mammals incidental to research and monitoring activities in southern Alaska over the course of five years (2019-2024). These activities include glaucous-winged gull and climate monitoring activities in Glacier Bay National Park (GLBA NP), Alaska and marine bird and mammal survey activities conducted by the Southwest Alaska Inventory and Monitoring Network (SWAN) in national parks and adjacent lands. As required by the Marine Mammal Protection Act (MMPA), NMFS is proposing regulations to govern that take and requests comments on the proposed regulations.
Covered Investment Fund Research Reports
Document Number: 2018-26613
Type: Rule
Date: 2018-12-13
Agency: Securities and Exchange Commission, Agencies and Commissions
The Commission is adopting a new rule under the Securities Act of 1933 to establish a safe harbor for an unaffiliated broker or dealer participating in a securities offering of a covered investment fund to publish or distribute a covered investment fund research report. If the conditions in the rule are satisfied, the publication or distribution of a covered investment fund research report would be deemed not to be an offer for sale or offer to sell the covered investment fund's securities for purposes of sections 2(a)(10) and 5(c) of the Securities Act of 1933. The Commission is also adopting a new rule under the Investment Company Act of 1940 to exclude a covered investment fund research report from the coverage of section 24(b) of the Investment Company Act, except to the extent the research report is otherwise not subject to the content standards in self-regulatory organization rules related to research reports. We are also adopting a conforming amendment to rule 101 of Regulation M, and a technical amendment to Form 12b-25.
Information and Communication Technology
Document Number: 2018-26570
Type: Proposed Rule
Date: 2018-12-13
Agency: Department of State
The Department of State (the Department) updates and revises the rules that implement Section 508 of the Rehabilitation Act of 1973, consistent with a recent update to accessibility standards from the U.S. Access Board.
Proposed Establishment of the West Sonoma Coast Viticultural Area
Document Number: C1-2018-26321
Type: Proposed Rule
Date: 2018-12-12
Agency: Alcohol and Tobacco Tax and Trade Bureau, Department of Treasury, Department of the Treasury
Prevention of Alcohol Misuse and Prohibited Drug Use in Transit Operations
Document Number: 2018-26950
Type: Rule
Date: 2018-12-12
Agency: Federal Transit Administration, Department of Transportation
The Federal Transit Administration (FTA) is increasing the minimum random drug testing rate from 25 percent to 50 percent in calendar year 2019 for employers subject to the FTA's drug and alcohol rule. The minimum random alcohol testing rate will remain at 10 percent for calendar year 2019.
Notification of Replacement Public Meeting on Requirement for Helicopters To Use the New York North Shore Helicopter Route
Document Number: 2018-26934
Type: Proposed Rule
Date: 2018-12-12
Agency: Federal Aviation Administration, Department of Transportation
Due to inclement weather on November 15, 2018, the FAA announces a replacement public meeting to solicit feedback concerning the New York North Shore Helicopter Rule (``the Rule''). This meeting is being held pursuant to Section 182 of the FAA Reauthorization Act of 2018. The Rule requires civil helicopter pilots operating under Visual Flight Rules (VFR), whose route of flight takes them over the north shore of Long Island between the Visual Point Lloyd Harbor (VPLYD) waypoint and Orient Point (VPOLT), to use the North Shore Helicopter Route.
Snapper-Grouper Fishery of the South Atlantic; 2018 Recreational Accountability Measure and Closure for South Atlantic Red Grouper
Document Number: 2018-26897
Type: Rule
Date: 2018-12-12
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS implements accountability measures (AMs) for the red grouper recreational sector in the exclusive economic zone (EEZ) of the South Atlantic for the 2018 fishing year through this temporary rule. NMFS estimates recreational landings of red grouper in 2018 have exceeded the recreational annual catch limit (ACL). Therefore, NMFS closes the red grouper recreational sector in the South Atlantic EEZ at 12:01 a.m., local time, on December 12, 2018 for the remainder of the 2018 fishing year. This closure is necessary to protect the red grouper resource.
List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Multipurpose Canister Cask System, Certificate of Compliance No. 1014, Amendment Nos. 11 and 12
Document Number: 2018-26878
Type: Proposed Rule
Date: 2018-12-12
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its spent fuel storage regulations by revising the Holtec International HI-STORM 100 Multipurpose Canister Cask System (HI-STORM 100 System) listing within the ``List of approved spent fuel storage casks'' to include Amendment Nos. 11 and 12 to Certificate of Compliance No. 1014. Amendment Nos. 11 and 12 propose to revise multiple items in the Technical Specifications for multi-purpose canister models listed under Certificate of Compliance No. 1014; most of these revisions involve changes to the authorized contents. In addition, Amendment No. 11 makes several other editorial changes.
List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Multipurpose Canister Cask System, Certificate of Compliance No. 1014, Amendment Nos. 11 and 12
Document Number: 2018-26877
Type: Rule
Date: 2018-12-12
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is amending its spent fuel storage regulations by revising the Holtec International HI- STORM 100 Multipurpose Canister Cask System (HI-STORM 100 System) listing within the ``List of approved spent fuel storage casks'' to include Amendment Nos. 11 and 12 to Certificate of Compliance No. 1014. Amendment Nos. 11 and 12 revise multiple items in the Technical Specifications for multi-purpose canister models listed under Certificate of Compliance No. 1014; most of these revisions involve changes to the authorized contents. In addition, Amendment No. 11 makes several other editorial changes.
Safety Zone; Rocket Debris Control and Removal Operations, Atlantic Ocean, Cape Canaveral, FL
Document Number: 2018-26860
Type: Rule
Date: 2018-12-12
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a 1000-yard temporary moving safety zone around the Falcon 9 rocket in the Atlantic Ocean, in the vicinity of Port Canaveral Harbor, Cape Canaveral, FL. This safety zone is necessary to protect personnel, vessels, and the public from potential hazards associated with the control and removal of the rocket and any debris from navigable waters of the Atlantic Ocean. All persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the safety zone unless authorized by the Captain of the Port Jacksonville or a designated representative.
Allocation of Assets in Single-Employer Plans; Valuation of Benefits and Assets; Expected Retirement Age
Document Number: 2018-26843
Type: Rule
Date: 2018-12-12
Agency: Pension Benefit Guaranty Corporation, Agencies and Commissions
This rule amends the Pension Benefit Guaranty Corporation's regulation on Allocation of Assets in Single-Employer Plans by substituting a new table for determining expected retirement ages for participants in pension plans undergoing distress or involuntary termination with valuation dates falling in 2019. This table is needed to compute the value of early retirement benefits and, thus, the total value of benefits under a plan.
Definition of the Term “Biological Product”
Document Number: 2018-26840
Type: Proposed Rule
Date: 2018-12-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulation that defines ``biological product'' to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), and to provide its interpretation of the statutory terms ``protein'' and ``chemically synthesized polypeptide.'' Under that interpretation, the term protein would mean any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. A chemically synthesized polypeptide would mean any alpha amino acid polymer that is made entirely by chemical synthesis and is greater than 40 amino acids but less than 100 amino acids in size. This proposed rule is intended to clarify the statutory framework under which such products are regulated.
Temporary Extension of Applicability of Regulations Governing Conduct on Federal Property
Document Number: 2018-26812
Type: Rule
Date: 2018-12-12
Agency: Department of Homeland Security, Office of the Secretary
The Secretary of Homeland Security, pursuant to the Homeland Security Act of 2002, has temporarily extended the applicability and enforcement of certain regulations governing conduct on Federal property that is under the administrative jurisdiction and control of U.S. Customs and Border Protection (CBP) along the southwest border. This temporary administrative extension enables DHS to protect and secure Federal property along the southwest border within the control of CBP's San Diego Field Office, Tucson Field Office, Laredo Field Office and El Paso Field Office, and to carry out DHS's statutory obligations to protect and secure the nation's borders. The Federal property subject to this notice is limited to the specific geographic area within the administrative control of CBP along the length of the U.S. border with Mexico.
Child Nutrition Programs: Flexibilities for Milk, Whole Grains, and Sodium Requirements
Document Number: 2018-26762
Type: Rule
Date: 2018-12-12
Agency: Department of Agriculture, Food and Nutrition Service
This final rule will codify, with some extensions, three menu planning flexibilities temporarily established by the interim final rule of the same title published November 30, 2017. First, it will broaden the milk options in the National School Lunch Program and School Breakfast Program by allowing local operators to permanently offer flavored, low-fat milk. For consistency across nutrition programs, it will also allow flavored, low-fat milk in the Special Milk Program for Children and in the Child and Adult Care Food Program for participants ages 6 and older. Second, this final rule will require that half of the weekly grains in the school lunch and breakfast menu be whole grain-rich, thus ending the need for the exemption process. Third, it will provide schools in the lunch and breakfast programs more time for gradual sodium reduction by retaining Sodium Target 1 through the end of school year (SY) 2023- 2024, continuing to Target 2 in SY 2024-2025, and eliminating the Final Target that would have gone into effect in SY 2022-2023. By codifying these changes, USDA acknowledges the persistent menu planning challenges experienced by some schools, and affirms its commitment to give schools more control over food service decisions and greater ability to offer wholesome and appealing meals that reflect local preferences.
Magnuson-Stevens Act Provisions; Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; 2019-2020 Biennial Specifications and Management Measures
Document Number: 2018-26602
Type: Rule
Date: 2018-12-12
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
This final rule establishes the 2019-2020 harvest specifications and management measures for groundfish taken in the U.S. exclusive economic zone off the coasts of Washington, Oregon, and California, consistent with the Magnuson-Stevens Fishery Conservation and Management Act and the Pacific Coast Groundfish Fishery Management Plan. This final rule revises the management measures that are intended to keep the total catch of each groundfish stock or stock complex within the harvest specifications. These measures are intended to help prevent overfishing, rebuild overfished stocks, achieve optimum yield, and ensure that management measures are based on the best scientific information available.
Aviation Radio Service
Document Number: 2018-26413
Type: Rule
Date: 2018-12-12
Agency: Federal Communications Commission, Agencies and Commissions
In this document, the Federal Communications Commission (Commission or FCC) adopts a rule that prohibits the certification, and after a six-month transition period, the manufacture, importation, or sale of 121.5 MHz Emergency Locator Transmitters (ELTs), but declines to prohibit the use of 121.5 MHz ELTs. By accelerating the transition from 121.5 MHz ELTs to 406 MHz ELTs, this rule change will enhance the ability of search and rescue personnel to locate and bring aid to the victims of plane crashes.
Airworthiness Directives; Airbus SAS Airplanes
Document Number: 2018-24685
Type: Rule
Date: 2018-12-12
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for all Airbus SAS Model A330-200, A330-200 Freighter, and A330-300 series airplanes. This AD was prompted by reports of dual flight management system (FMS) resets with the loss of flight plan (F-PLN) data. This AD requires revising the airplane flight manual (AFM) to prohibit required navigation performance-authorization required (RNP-AR) operations using flight management guidance envelope computer (FMGEC) standard P5H3. This AD would also require modifying the FMS software of airplanes equipped with FMGEC standard P5H3. We are issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; The Boeing Company Airplanes
Document Number: R1-2018-26365
Type: Rule
Date: 2018-12-11
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for all The Boeing Company Model 737-8 and -9 airplanes. This emergency AD was sent previously to all known U.S. owners and operators of these airplanes. This AD requires revising certificate limitations and operating procedures of the airplane flight manual (AFM) to provide the flight crew with runaway horizontal stabilizer trim procedures to follow under certain conditions. This AD was prompted by analysis performed by the manufacturer showing that if an erroneously high single angle of attack (AOA) sensor input is received by the flight control system, there is a potential for repeated nose-down trim commands of the horizontal stabilizer. We are issuing this AD to address the unsafe condition on these products.
Air Plan Approval; Ohio; Revisions to Particulate Matter Rules
Document Number: 2018-26780
Type: Proposed Rule
Date: 2018-12-11
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing to approve assorted revisions to Ohio's particulate matter rules that the state requested EPA approve into the Ohio State Implementation Plan (SIP) under the Clean Air Act. One set of revisions address sources subject to a requirement for continuous opacity monitoring for which such monitoring is unreliable. The revisions add two alternatives; one alternative requires the source to conduct continuous emission monitoring, and the other alternative subjects the source to an alternative monitoring plan assessing compliance with limits specified for alternative parameters. Other revisions in the rule remove provisions for facilities that have shut down and make nonsubstantive revisions to the language of the rules.
Fisheries Off West Coast States; Modifications of the West Coast Recreational and Commercial Salmon Fisheries; Inseason Actions #12 through #37
Document Number: 2018-26720
Type: Rule
Date: 2018-12-11
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS announces 26 inseason actions in the ocean salmon fisheries. These inseason actions modified the commercial and recreational salmon fisheries in the area from the U.S./Canada border to the U.S./Mexico border.
Safety Zone; Menominee River, Marinette, WI
Document Number: 2018-26719
Type: Rule
Date: 2018-12-11
Agency: Coast Guard, Department of Homeland Security
The Coast Guard will enforce the safety zone on the Menominee River in Marinette WI on December 15, 2018 from 10 a.m. to 12 p.m. This action is necessary and intended to protect the safety of life and property on navigable waterways before, during and after the launch of a naval vessel from Marinette Marine on the Menominee River in Marinette, WI. During the enforcement period, the Coast Guard will enforce restrictions upon, and control movement of, vessels in the safety zone. No person or vessel may enter into, transit, or anchor within the safety zone while it is being enforced unless authorized by the Captain of the Port Lake Michigan or a designated representative.
List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness
Document Number: 2018-26712
Type: Rule
Date: 2018-12-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. Drug products appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the final rule adds two entries to this list of drug products.
Air Plan Approval; Oregon; Removal of Obsolete Regulations
Document Number: 2018-26688
Type: Rule
Date: 2018-12-11
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is approving the removal of outdated rules in the Code of Federal Regulations (CFR) for the State of Oregon because they are duplicative or obsolete. Removal of such material from the air program subparts is designed to improve cost effectiveness and usability of the CFR. The EPA is also approving non-substantive revisions to reflect updated citations and correcting a typographical error. This final action makes no substantive changes to the Oregon State Implementation Plan and imposes no new requirements.
Proposed Amendment of Multiple Air Traffic Service (ATS) Routes; Western United States
Document Number: 2018-26679
Type: Proposed Rule
Date: 2018-12-11
Agency: Federal Aviation Administration, Department of Transportation
This action proposes to amend three domestic Very High Frequency Omnidirectional Range (VOR) Federal Airways (V-113, V-137, and V-485) in the western United States. The modifications are necessary due to the planned decommissioning of Priest, CA, VOR navigation aid (NAVAID), which provides navigation guidance for portions of the affected air traffic service (ATS) routes. The Priest, CA, VOR is being decommissioned as part of the FAA's VOR Minimum Operational Network (MON) program.
Amendment of VOR Federal Airways V-318 and V-352; Northeastern United States
Document Number: 2018-26678
Type: Rule
Date: 2018-12-11
Agency: Federal Aviation Administration, Department of Transportation
This action modifies the descriptions of VHF Omnidirectional Range (VOR) Federal airways V-318 and V-352 to reflect the removal of certain route segments within Canadian airspace that were deleted by NAV CANADA. This rule modifies the above airway descriptions to match the current configuration of the routes.
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