July 3, 2019 – Federal Register Recent Federal Regulation Documents

Results 101 - 126 of 126
Administrative Declaration of a Disaster for the State of Ohio
Document Number: 2019-14148
Type: Notice
Date: 2019-07-03
Agency: Small Business Administration, Agencies and Commissions
This is a notice of an Administrative declaration of a disaster for the State of Ohio dated 06/27/2019. Incident: Heavy Rainfall and Flooding. Incident Period: 05/17/2019.
Pharmaceutical Distribution Supply Chain Pilot Projects; Reopening of Comment Period; Request for Information
Document Number: 2019-14147
Type: Notice
Date: 2019-07-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notices (requests for information) that published in the Federal Register of April 15, 2016, and April 28, 2017. FDA is requesting comments regarding issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA). The information gathered from reopening of the comment period will allow supply chain stakeholders to share information about relevant piloting activities that are conducted outside of FDA's DSCSA Pilot Project Program to inform DSCSA implementation by FDA and supply chain stakeholders.
Determination That THAM Solution (Tromethamine) Injectable, 3.6 Grams/100 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2019-14146
Type: Notice
Date: 2019-07-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that THAM Solution (tromethamine) injectable, 3.6 grams (g)/ 100 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 tromethamine injectable, 3.6g/100 mL, if all other legal and regulatory requirements are met.
Presidential Declaration Amendment of a Major Disaster for the State of South Dakota
Document Number: 2019-14145
Type: Notice
Date: 2019-07-03
Agency: Small Business Administration, Agencies and Commissions
This is an amendment of the Presidential declaration of a major disaster for the State of South Dakota (FEMA-4440-DR), dated 06/ 07/2019. Incident: Severe Winter Storm, Snowstorm, and Flooding. Incident Period: 03/13/2019 through 04/26/2019.
Air Plan Approval; Alabama: PSD Replacement Units
Document Number: 2019-14142
Type: Rule
Date: 2019-07-03
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is finalizing approval of revisions to the Alabama State Implementation Plan (SIP), submitted by the State of Alabama, through the Alabama Department of Environmental Management (ADEM), via two letters dated May 7, 2012, and August 27, 2018. The SIP revisions relate to the State's Prevention of Significant Deterioration (PSD) permitting regulations. In particular, the revisions add a definition of ``replacement unit'' and provide that a replacement unit is a type of existing emissions unit under the definition of ``emissions unit.'' This action is being taken pursuant to the Clean Air Act (CAA or Act).
Patient Engagement Advisory Committee; Notice of Meeting
Document Number: 2019-14141
Type: Notice
Date: 2019-07-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (the Committee). The general function of the Committee is to provide advice to the Commissioner, or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients. The meeting will be open to the public.
Michelin North America, Inc., Receipt of Petition for Decision of Inconsequential Noncompliance
Document Number: 2019-14139
Type: Notice
Date: 2019-07-03
Agency: National Highway Traffic Safety Administration, Department of Transportation
Michelin North America, Inc. (MNA), has determined that certain BFGoodrich All-Terrain T/A KO2 replacement tires do not comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 139, New Pneumatic Radial Tires for Light Vehicles. MNA filed a noncompliance report dated November 13, 2018, and subsequently petitioned NHTSA on December 10, 2018, for a decision that the subject noncompliance is inconsequential as it relates to motor vehicle safety. This notice announces receipt of MNA's petition.
National Research Strategy for the President's Roadmap To Empower Veterans and End the National Tragedy of Suicide (PREVENTS)
Document Number: 2019-14138
Type: Notice
Date: 2019-07-03
Agency: Office of Science and Technology Policy
To advance the President's vision of a National Roadmap to Empower Veterans and End Suicide, OSTP and VA will lead development of a National Research Strategy to improve the coordination, monitoring, benchmarking, and execution of public- and private-sector research related to the factors that contribute to veteran suicide. Through this RFI, we seek input on ways to increase knowledge about factors influencing suicidal behaviors and ways to prevent suicide; inform the development of a robust and forward looking research agenda; coordinate relevant research efforts across the Nation; and measure progress on these efforts. The public input provided in response to this RFI will inform the Veteran Wellness, Empowerment, and Suicide Prevention Task Force, who will develop and implement the National Research Strategy.
DHL Laboratories Inc.; Withdrawal of Approval of a New Drug Application for Dextrose 5% Injection in Plastic Container, 5 Grams/100 Milliliters
Document Number: 2019-14137
Type: Notice
Date: 2019-07-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of new drug application (NDA) 019971 for Dextrose 5% Injection in Plastic Container, 5 grams (g)/100 milliliters (mL), held by DHL Laboratories Inc., 155 Medical Science Dr., Union, SC 23979. The basis for the withdrawal is that the holder of the NDA has repeatedly failed to file required annual reports for the NDA.
Air Plan Approval; North Carolina; Revision To Permit Term for Non-Title V Air Quality Permits
Document Number: 2019-14136
Type: Rule
Date: 2019-07-03
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is taking final action to approve a State Implementation Plan (SIP) revision provided by the State of North Carolina, through the North Carolina Department of Environmental Quality, Division of Air Quality (DAQ), on January 12, 2018. The SIP revision makes changes to the State's combined construction and operating permit program for non-Title V sources. EPA is proposing to approve the revision to the North Carolina SIP because it is consistent with the Clean Air Act (CAA or Act).
Letter to the Nuclear Energy Institute Entergy Services, Inc., and NextEra Energy Regarding the Clarification of Regulatory Path for Lead Test Assemblies
Document Number: 2019-14132
Type: Notice
Date: 2019-07-03
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is issuing a letter to the Nuclear Energy Institute (NEI), Entergy Services, Inc., and NextEra Energy to finalize the NRC staff's views on the regulatory positions regarding lead test assemblies (LTAs) previously discussed in the NRC's letter to NEI dated June 29, 2017.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-14131
Type: Notice
Date: 2019-07-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Statement of Policy on Performance Requirements for Operators of Aircraft That are Equipped With Automatic Dependent Surveillance-Broadcast (ADS-B) Out
Document Number: 2019-14127
Type: Rule
Date: 2019-07-03
Agency: Federal Aviation Administration, Department of Transportation
This action announces the FAA's policy on performance requirements for certain operations of aircraft with Automatic Dependent Surveillance-Broadcast (ADS-B) Out equipment in ADS-B airspace after January 1, 2020. Under the circumstances identified in this policy, the FAA is providing assurance to operators that it will not consider degradation in Global Positioning System performance due to conditions outside the operator's control that results in an operation falling below ADS-B rule requirements to constitute non- compliance, provided the operator has exercised appropriate due diligence prior to conducting an operation.
Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Electronic Bonds Online (eBonds) Access; Comment Request
Document Number: 2019-14126
Type: Notice
Date: 2019-07-03
Agency: Department of Homeland Security, U.s. Immigration and Customs Enforcement
In accordance with the Paperwork Reductions Act (PRA) of 1995 the Department of Homeland Security (DHS), U.S. Immigration and Customs Enforcement (ICE) will submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and clearance. This information collection was previously published in the Federal Register (84 FR 18299) on April 30, 2019, allowing for a 60-day comment period. ICE received one comment in connection with the 60-day notice. The purpose of this notice is to allow an additional 30 days for public comments.
Endangered and Threatened Species; Issuance of Enhancement of Survival and Incidental Take Permits for Safe Harbor Agreements, Candidate Conservation Agreements, and Habitat Conservation Plans, 2018; Issuance of Recovery Permits, July 1, 2017, Through December 31, 2018
Document Number: 2019-14125
Type: Notice
Date: 2019-07-03
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service, in accordance with the Endangered Species Act (ESA), provided a list to the public of certain permits issued under the ESA. With some exceptions, the ESA prohibits take of listed species unless a Federal permit is issued that authorizes or exempts the taking under the ESA. In a recent Federal Register notice announcing these permit issuances, we inadvertently made some errors, which we correct via this notice. We regret any inconvenience to the public.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2019-14124
Type: Notice
Date: 2019-07-03
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims (the Court) is charged by statute with responsibility for considering and acting upon the petitions.
Multiple Employer Plans
Document Number: 2019-14123
Type: Proposed Rule
Date: 2019-07-03
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
This document sets forth proposed regulations relating to the tax qualification of plans maintained by more than one employer. These plans, maintained pursuant to section 413(c) of the Internal Revenue Code (Code), are often referred to as multiple employer plans or MEPs. The proposed regulations would provide an exception, if certain requirements are met, to the application of the ``unified plan rule'' for a defined contribution MEP in the event of a failure by an employer participating in the plan to satisfy a qualification requirement or to provide information needed to determine compliance with a qualification requirement. These proposed regulations would affect MEPs, participants in MEPs (and their beneficiaries), employers participating in MEPs, and MEP plan administrators.
Calculation of Assumed Federal Income Tax
Document Number: 2019-14099
Type: Rule
Date: 2019-07-03
Agency: Postal Regulatory Commission, Agencies and Commissions
The Commission is adopting final rules amending its rules involving the calculation of the assumed Federal income tax on competitive products by the Postal Service each fiscal year.
Airworthiness Directives; Saab AB, Saab Aeronautics (Formerly Known as Saab AB, Saab Aerosystems) Airplanes
Document Number: 2019-14048
Type: Proposed Rule
Date: 2019-07-03
Agency: Federal Aviation Administration, Department of Transportation
The FAA proposes to adopt a new airworthiness directive (AD) for all Saab AB, Saab Aeronautics Model SAAB 2000 airplanes. This proposed AD was prompted by reports of cracks in the o-ring groove of magnetic fuel level indicators. This proposed AD would require a one- time detailed inspection of the magnetic fuel level indicator for cracks and replacement of cracked magnetic fuel level indicators. The FAA is proposing this AD to address the unsafe condition on these products.
Airworthiness Directives; Airbus SAS Airplanes
Document Number: 2019-14047
Type: Proposed Rule
Date: 2019-07-03
Agency: Federal Aviation Administration, Department of Transportation
The FAA proposes to adopt a new airworthiness directive (AD) for certain Airbus SAS Model A330-200, A330-200 Freighter, and A330-300 series airplanes. This proposed AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. This proposed AD would require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. The FAA is proposing this AD to address the unsafe condition on these products.
Airworthiness Directives; Airbus SAS Airplanes
Document Number: 2019-14046
Type: Proposed Rule
Date: 2019-07-03
Agency: Federal Aviation Administration, Department of Transportation
The FAA proposes to adopt a new airworthiness directive (AD) for certain Airbus SAS Model A330-202, -243, -243F, -302, -323, and - 343 airplanes. This proposed AD was prompted by a report that cracks have been found within the ring gears of the slat geared rotary actuators (SGRAs) due to a change in the manufacturing process and inadequate post-production non-destructive testing for potential cracking. This proposed AD would require an inspection to determine the part number and serial number of the SGRAs, and replacement of each affected SGRA with a serviceable part, as specified in an European Aviation Safety Agency (EASA) AD, which will be incorporated by reference. The FAA is proposing this AD to address the unsafe condition on these products.
Rules Regarding Delegation of Authority: Delegation of Authority to the Secretary of the Board, Director of the Division of Supervision of Regulation, and Federal Reserve Banks
Document Number: 2019-13970
Type: Rule
Date: 2019-07-03
Agency: Federal Reserve System, Agencies and Commissions
The Board is amending its rules regarding delegation of authority to delegate to Federal Reserve Banks authority to approve certain types of applications, notices, and requests. Under the rule, Federal Reserve Banks are delegated authority to waive a requirement to file certain applications under the Bank Holding Company Act and the Home Owners' Loan Act; grant or deny requests for modifying certain commitments; authorize a state member bank to make a public welfare investment in accordance with section 9 of the Federal Reserve Act under certain circumstances; and approve certain requests, applications, and notices relating to international banking operations filed pursuant to the Board's Regulation K. The rule also modifies the delegation rules by authorizing the Federal Reserve Banks to approve applications and notices concerning mergers and acquisitions that do not exceed the Board's delegation criteria for competition after including deposits of qualifying credit unions weighted at 50 percent and deposits of ``commercially active'' thrift institutions weighted in most cases at 100 percent. In a limited number of cases, deposits of all thrifts would be weighted at 100 percent. To ensure the Board's delegation rules are consistent, the rule also revises or rescinds, as appropriate, certain existing delegations to the Federal Reserve Banks, the Secretary of the Board, and the Director of the Division of Supervision and Regulation.
Guidance on the Determination of the Section 4968 Excise Tax Applicable to Certain Private Colleges and Universities
Document Number: 2019-13935
Type: Proposed Rule
Date: 2019-07-03
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
This document contains proposed regulations for determining the excise tax applicable to the net investment income of certain private colleges and universities, as provided by the Tax Cuts and Jobs Act. These regulations affect applicable educational institutions and their related organizations.
Availability of Funds and Collection of Checks (Regulation CC)
Document Number: 2019-13668
Type: Rule
Date: 2019-07-03
Agency: Federal Reserve System, Agencies and Commissions, Bureau of Consumer Financial Protection
The Board and the Bureau (Agencies) are amending Regulation CC, which implements the Expedited Funds Availability Act (EFA Act), to implement a statutory requirement in the EFA Act to adjust the dollar amounts under the EFA Act for inflation. The Agencies are also amending Regulation CC to incorporate the Economic Growth, Regulatory Relief, and Consumer Protection Act (EGRRCPA) amendments to the EFA Act, which include extending coverage to American Samoa, the Commonwealth of the Northern Mariana Islands, and Guam, and making certain other technical amendments.
Interior Parts and Components Fire Protection for Transport Category Airplanes
Document Number: 2019-13646
Type: Proposed Rule
Date: 2019-07-03
Agency: Federal Aviation Administration, Department of Transportation
The FAA is proposing to amend certain airworthiness regulations for fire protection of interior compartments on transport category airplanes. This proposal would convert those flammability regulations from detailed, prescriptive requirements into simpler, performance-based standards. This proposal would divide these standards into two categories: Those designed to protect the airplane and its occupants from the hazards of in-flight fires, and those designed to protect the airplane and its occupants from the hazards caused by post- crash fires. In addition, this proposal would remove test methods from the regulations and allow applicants, in certain cases, to demonstrate compliance either without conducting tests or by providing independent substantiation of the flammability characteristics of a proposed material. This action is necessary to eliminate unnecessary testing, increase standardization, and improve safety. This proposal includes conforming changes to parts 27, 29, 91, 121, 125, and 135.
Use of Truncated Taxpayer Identification Numbers on Forms W-2, Wage and Tax Statement, Furnished to Employees
Document Number: 2019-11500
Type: Rule
Date: 2019-07-03
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
This document contains final regulations under sections 6051 and 6052 of the Internal Revenue Code (Code). To aid employers' efforts to protect employees from identity theft, these regulations amend existing regulations to permit employers to voluntarily truncate employees' social security numbers (SSNs) on copies of Forms W-2, Wage and Tax Statement, that are furnished to employees so that the truncated SSNs appear in the form of IRS truncated taxpayer identification numbers (TTINs). These regulations also amend the regulations under section 6109 to clarify the application of the truncation rules to Forms W-2 and to add an example illustrating the application of these rules. Additionally, these regulations delete obsolete provisions and update cross references in the regulations under sections 6051 and 6052. These regulations affect employers who are required to furnish Forms W-2 and employees who receive Forms W-2.
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