2019 – Federal Register Recent Federal Regulation Documents
Results 7,401 - 7,450 of 27,329
Proposed Amendment of Area Navigation Routes Q-75 and Q-475, Northeast Corridor Atlantic Coast Routes; Northeastern United States
This action proposes to modify high altitude area navigation (RNAV) routes Q-75, and Q-475 in the northeastern United States. This action would support the Northeast Corridor Atlantic Coast Route (NEC ACR) Project. The modified routes were developed to improve the efficiency of the National Airspace System (NAS), expand the availability of area navigation (RNAV) routing, and reduce dependency of the NAS on ground-based navigational systems.
Proposed Amendment of VOR Federal Airway V-7 in the Vicinity of Sheboygan, WI
This action proposes to amend VHF Omnidirectional Range (VOR) Federal airway V-7 in the vicinity of Sheboygan, WI. The modifications are necessary due to the planned decommissioning of the VOR portion of the Falls, WI, VOR/Distance Measuring Equipment (VOR/DME) navigation aid (NAVAID), which provides navigation guidance for portions of the affected air traffic service (ATS) route. The Falls VOR is being decommissioned as part of the FAA's VOR Minimum Operational Network (MON) program.
Amendment of Class C Airspace; Lafayette, LA
This action modifies the Lafayette, LA, Class C airspace area by amending the legal description to contain the current airport name and updated airport reference point (ARP) information. Additionally, minor administrative edits to the legal description title and Chart Supplement reference are made for readability. This action does not change the boundaries, altitudes, or operating requirements of the Class C airspace area.
Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue To Be Available Over-the-Counter; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry (GFI) #263 entitled ``Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter.'' This draft guidance document, when finalized, will provide information to sponsors of medically important antimicrobial new animal drug products who are interested in changing the approved marketing status of these products from over-the-counter (OTC) to by veterinary prescription (Rx) consistent with FDA's recommendation that the use of such drugs in animals be limited to uses that include veterinary oversight to mitigate development of antimicrobial resistance. It also will recommend timeframes for stakeholders wishing to comply voluntarily with this guidance.
Privacy Act of 1974; System of Records
The U.S. Small Business Administration (SBA) proposes to update a system of records titled, Veteran Programs Training and Counseling Records (SBA 39), to its inventory of records systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended. Publication of this notice complies with the Privacy Act and the Office of Management and Budget (OMB) Circular A-130 requirement for agencies to publish a notice in the Federal Register whenever the agency establishes a new system of records. The SBA's Office of Veterans Business Development (OVBD) manages grant programs related to the counseling and training services for veterans. The OVBD maintains a System of Records including include registration forms, participant/ client surveys, interviews, resource partner surveys, which includes personal information such as name, gender, race, ethnicity, service, and pay grade, which are used to analyze the population of veterans who are seeking training.
Flight Attendant Duty Period Limitations and Rest Requirements
This action arises out of a statutory mandate in the FAA Reauthorization Act of 2018 that requires the FAA to increase the minimum rest period for flight attendants in domestic, flag, and supplemental operations who are scheduled for a duty period of 14 hours or less. Consistent with the statutory mandate, the FAA plans to amend its regulations to ensure that flight attendants scheduled to a duty period of 14 hours or less are given a scheduled rest period of at least 10 consecutive hours and that the rest period is not reduced under any circumstances. This document seeks input from the public to obtain more information about current domestic, flag, and supplemental operations with flight attendants and the potential benefits and costs to inform the rulemaking.
National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Partial Deletion of the Novak Sanitary Landfill Superfund Site
The Environmental Protection Agency (EPA) Region 3 announces the partial deletion of the Novak Sanitary Landfill Superfund Site (Site) located in South Whitehall Township, Pennsylvania, from the National Priorities List (NPL). The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the Commonwealth of Pennsylvania, through the Pennsylvania Department of Environmental Protection (PADEP), have determined that all appropriate response actions to address the groundwater portion of the Site, other than monitoring, operations and maintenance, and Five- Year Reviews (FYRs), have been completed. However, this deletion does not preclude future actions under Superfund. This partial deletion pertains only to the groundwater portion of the Site. The landfill and landfill gas components of the Site will remain on the NPL and are not being considered for deletion as part of this action.
Review Process To Determine Whether the Waste Isolation Pilot Plant Continues To Comply With the Disposal Regulations and Compliance Criteria
The Environmental Protection Agency (EPA, or the Agency) intends to evaluate whether the Waste Isolation Pilot Plant (WIPP) continues to comply with the Agency's environmental radiation protection standards for the disposal of radioactive waste. Pursuant to the 1992 WIPP Land Withdrawal Act (LWA), as amended, the U.S. Department of Energy (DOE, or the Department) must submit documentation of continued compliance with the EPA's standards for disposal and other statutory requirements every five years after the initial receipt of transuranic waste at WIPP. The Agency requests public comment on all aspects of the DOE's application.
Premarket Tobacco Product Applications and Recordkeeping Requirements
The Food and Drug Administration (FDA) is issuing a proposed rule that would set forth requirements for premarket tobacco product applications (PMTAs) and would require manufacturers to maintain records establishing that their tobacco products are legally marketed. The proposed rule would help to ensure that PMTAs contain sufficient information for FDA to determine whether a marketing order should be issued for a new tobacco product, including detailed information regarding the physical aspects of a tobacco product, as well as full reports of information to demonstrate the scope of, and details regarding, investigations that may show the potential health risks of the product. The proposed rule would codify the general procedures FDA would follow when evaluating PMTAs, including application acceptance, application filing, and inspections, and would also create postmarket reporting requirements for applicants that receive marketing orders. The proposed rule would allow for the submission of PMTAs in alternative formats in certain instances to reduce the burden of submitting a PMTA for modifications to a product that previously received a PMTA marketing order or resubmitting a PMTA to address deficiencies specified in a no marketing order. The proposed rule would also require tobacco product manufacturers to keep records regarding the legal marketing of certain tobacco products without a PMTA, such as documents showing that a tobacco product is not required to undergo premarket review or has received premarket authorization.
Air Plan Approval; Texas; Control of Air Pollution From Motor Vehicles
Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is approving revisions to the Texas State Implementation Plan (SIP) submitted by the Texas Commission on Environmental Quality (TCEQ or State). The revisions remove rules from the Texas SIP that address the Low Income Repair Assistance Program (LIRAP) for certain participating counties.
Official United States Standards for Grain
The United States Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) will not pursue changes to the United States (U.S.) Standards for Corn and Soybeans under the United States Grain Standards Act (USGSA).
Softwood Lumber Research, Promotion, Consumer Education and Industry Information Order; Change in Membership, Nominations, Procedures, and Continuance Referenda Period
This rule changes the membership, nominations, procedures, and continuance referenda period for the Softwood Lumber Board (Board) established under the Softwood Lumber Research, Promotion, Consumer Education and Industry Information Order (Order). The Board administers the Order with oversight by the U.S. Department of Agriculture (USDA). This action will also make administrative changes to other provisions of the Order.
Agency Information Collection Activities; Comment Request; Borrower Defenses Regulations
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
National Emission Standards for Hazardous Air Pollutants: Taconite Iron Ore Processing Residual Risk and Technology Review
This proposal presents the results of the U.S. Environmental Protection Agency's (EPA's) residual risk and technology reviews (RTRs) for the National Emission Standards for the Hazardous Air Pollutants (NESHAP) for Taconite Iron Ore Processing, as required under the Clean Air Act (CAA). Based on the results of the risk review, the EPA is proposing that risks from emissions of air toxics from this source category are acceptable and that the existing standards provide an ample margin of safety. Furthermore, under the technology review, the EPA identified no cost-effective developments in controls, practices, or processes to achieve further emissions reductions. Therefore, the EPA is proposing no revisions to the existing standards based on the RTRs. However, in this action the EPA is proposing: The removal of exemptions for periods of startup, shutdown, and malfunction (SSM) and clarifying that the emissions standards apply at all times; the addition of electronic reporting of performance test results and compliance reports; minor technical corrections and amendments to monitoring and testing requirements that would reduce the compliance burden on industry while continuing to be protective of the environment; and that regulation of a certain type compound emitted by one of the facilities, known as elongated mineral particulate, is not required under CAA section 112 because this compound is not a hazardous air pollutant (HAP) pursuant to the CAA. This action, if finalized, would result in improved monitoring, compliance, and implementation of the existing standards.
Fresh Tomatoes From Mexico: Suspension of Antidumping Duty Investigation
The Department of Commerce (Commerce) has suspended the antidumping duty (AD) investigation on fresh tomatoes from Mexico. The basis for this action is an agreement between Commerce and signatory producers/exporters accounting for substantially all imports of fresh tomatoes from Mexico that eliminates completely the injurious effects of exports of the subject merchandise to the United States.
Public Land Order No. 7884; El Paso Project 8, Hidalgo County, NM
This Order withdraws, subject to valid existing rights, approximately 43.32 acres of Federal lands from settlement, sale, location, and entry under the general land laws, including the United States mining laws, mineral leasing laws, and geothermal leasing laws, for a period of 3 years for use by the Department of the Army for border security purposes. This withdrawal also transfers administrative jurisdiction of the lands to the Department of the Army.
Public Land Order No. 7883; San Diego Project 4, San Diego County, CA
This Order withdraws, subject to valid existing rights, approximately 44 acres of Federal lands from settlement, sale, location, and entry under the general land laws, including the United States mining laws, mineral leasing laws, and geothermal leasing laws, for a period of 3 years for use by the Department of the Army for border security purposes. This withdrawal also transfers administrative jurisdiction of the lands to the Department of the Army.
Public Land Order No. 7887; Yuma Project 3, Yuma County, AZ
This Order withdraws, subject to valid existing rights, approximately 228 acres of Federal lands from settlement, sale, location, and entry under the general land laws, including the United States mining laws, mineral leasing laws, and geothermal leasing laws, for a period of 3 years for use by the Department of the Army for border security purposes. This withdrawal also transfers administrative jurisdiction of the lands to the Department of the Army.
Public Land Order No. 7885; El Paso Project 2, Luna and Hidalgo Counties, NM
This Order withdraws, subject to valid existing rights, approximately 176.23 acres of Federal lands from settlement, sale, location, and entry under the general land laws, including the United States mining laws, mineral leasing laws, and geothermal leasing laws, for a period of 3 years for use by the Department of the Army for border security purposes. This withdrawal also transfers administrative jurisdiction of the lands to the Department of the Army.
Public Land Order No. 7886; Yuma Project 6, Imperial County, CA, and Yuma County, AZ
This Order withdraws, subject to valid existing rights, approximately 68 acres of Federal lands from settlement, sale, location, and entry under the general land laws, including the United States mining laws, mineral leasing laws, and geothermal leasing laws, for a period of 3 years for use by the Department of the Army for border security purposes. This withdrawal also transfers administrative jurisdiction of the lands to the Department of the Army.
Permanent Closure of Grundy Municipal Airport
The Federal Aviation Administration (FAA) received written notice on September 4, 2019, from the town of Grundy advising that effective October 31, 2019, the town will be permanently closing Grundy Municipal Airport (GDY), Grundy, Virginia.
Research, Engineering, and Development Advisory Committee (REDAC); Notice of Public Meeting
This notice announces a meeting of the Research, Engineering, and Development Advisory Committee (REDAC).
National Environmental Education Advisory Council
The U.S. Environmental Protection Agency (EPA or Agency office of Public Engagement and Environmental Education is soliciting applications for environmental education professionals for consideration to serve on the National Environmental Education Advisory Council (NEEAC). There are two vacancies on the Advisory Council that must be filled. We are seeking applications to fill one State Department of Education and/or Natural Resources position and one Business and Industry position. Additional avenues and resources may be utilized in the solicitation of applications. In an effort to obtain nominations of diverse candidates, EPA encourages nominations of women and men of all racial and ethnic groups.
Notification of a Public Meeting of the Science Advisory Board All-Ages Lead Model Review Panel
The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff Office announces a public meeting of the SAB's All- Ages Lead Model (AALM) Panel. The Panel will meet to conduct a peer review the EPA's AALM External Review Draft Version 2.0, comprising the model's software, technical documentation, and user manual (hereafter referred to collectively as AALM 2.0). The AALM 2.0 was developed by EPA's Office of Research and Development.
Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation
The Food and Drug Administration (FDA, Agency, or we) 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 requirements relating to FDA regulations for human tissue intended for transplantation.
Solicitation of Nominations for Appointment to the Geriatrics and Gerontology Advisory Committee AMENDED
The Department of Veterans Affairs (VA), Office of Geriatrics and Extended Care, is seeking nominations of qualified candidates to be considered for appointment as a member of the Geriatrics and Gerontology Advisory Committee (herein-after in this section referred to as ``the Committee''). The Committee advises the VA Secretary and the Under Secretary for Health on all matters pertaining to geriatrics and gerontology.
Agency Information Collection Activities; Comment Request; Form for Maintenance of Effort Waiver Requests
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Determination That ATROPINE SULFATE ANSYR PLASTIC SYRINGE (Atropine Sulfate Solution) Intravenous, Intramuscular, Subcutaneous, and Endotracheal, 0.5 Milligram/5 Milliliters (0.1 Milligram/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that ATROPINE SULFATE ANSYR PLASTIC SYRINGE (atropine sulfate solution) intravenous, intramuscular, subcutaneous, and endotracheal, 0.5 milligram (mg)/5 milliliters (mL) (0.1 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for atropine sulfate solution intravenous, intramuscular, subcutaneous, and endotracheal, 0.5 mg/5 mL (0.1 mg/mL), if all other legal and regulatory requirements are met.
Accreditation and Approval of King Inspection and Testing, Inc. (Carson, CA) as a Commercial Gauger and Laboratory
Notice is hereby given, pursuant to CBP regulations, that King Inspection and Testing, Inc. (Carson, CA), has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of December 13, 2018.
Accreditation and Approval of Laboratory Service, Inc. (Carteret, NJ) as a Commercial Gauger and Laboratory
Notice is hereby given, pursuant to CBP regulations, that Laboratory Service, Inc. (Carteret, NJ), has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of January 17, 2018.
Accreditation and Approval of Inspectorate America Corporation (St. Rose, LA) as a Commercial Gauger and Laboratory
Notice is hereby given, pursuant to CBP regulations, that Inspectorate America Corporation (St. Rose, LA), has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of April 5, 2017.
Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) is establishing a public docket to collect comments related to the post-marketing pediatric-focused safety reviews of products posted between April 12, 2019, and September 23, 2019, on FDA's website but not presented at the September 26 or 27, 2019, Joint Pediatric Advisory Committee (PAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public.
Determination of Regulatory Review Period for Purposes of Patent Extension; Med-El Electric and Acoustic Stimulation Hybrid Hearing Prosthesis System
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MED-EL Electric and Acoustic Stimulation Hybrid Hearing Prosthesis System (MED-EL EAS) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Accreditation and Approval of Pan Pacific Surveyors, Inc. (Wilmington, CA) as a Commercial Gauger and Laboratory
Notice is hereby given, pursuant to CBP regulations, that Pan Pacific Surveyors, Inc. (Wilmington, CA), has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of November 16, 2018.
Accreditation and Approval of AmSpec LLC (Gonzales, LA) as a Commercial Gauger and Laboratory
Notice is hereby given, pursuant to CBP regulations, that AmSpec LLC (Gonzales, LA), has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of April 11, 2019.
Accreditation and Approval of AmSpec LLC (Davie, FL) as a Commercial Gauger and Laboratory
Notice is hereby given, pursuant to CBP regulations, that AmSpec LLC (Davie, FL), has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of August 9, 2018.
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product-Compliance Policy; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Wholesale Distributor Verification Requirement for Saleable Returned Drug ProductCompliance Policy.'' This guidance describes FDA's intention regarding enforcement of the Drug Supply Chain Security Act (DSCSA) provision requiring wholesale distributors to verify a product identifier prior to further distributing returned product beginning on November 27, 2019. Given concerns expressed by stakeholders and to minimize possible disruptions in the pharmaceutical distribution supply chain, FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2020, verify a product identifier prior to further distributing returned product as required under the DSCSA. This represents a 1-year delay in enforcement of this DSCSA requirement.
Accreditation and Approval of AmSpec LLC (Mickleton, NJ) as a Commercial Gauger and Laboratory
Notice is hereby given, pursuant to CBP regulations, that AmSpec LLC (Mickleton, NJ), has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of September 19, 2018.
Accreditation and Approval of AmSpec LLC (La Porte, TX) as a Commercial Gauger and Laboratory
Notice is hereby given, pursuant to CBP regulations, that AmSpec LLC (La Porte, TX), has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of April 10, 2019.
Accreditation and Approval of AmSpec LLC (Nederland, TX) as a Commercial Gauger and Laboratory
Notice is hereby given, pursuant to CBP regulations, that AmSpec LLC (Nederland, TX), has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of May 15, 2019.
Approval of AmSpec LLC (Kenai, AK), as a Commercial Gauger
Notice is hereby given, pursuant to CBP regulations, that AmSpec LLC (Kenai, AK), has been approved to gauge petroleum and certain petroleum products for customs purposes for the next three years as of April 11, 2019.
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