December 26, 2017 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Medicare Shared Savings Program: Extreme and Uncontrollable Circumstances Policies for Performance Year 2017
This interim final rule with comment period establishes policies for assessing the financial and quality performance of Medicare Shared Savings Program (Shared Savings Program) Accountable Care Organizations (ACOs) affected by extreme and uncontrollable circumstances during performance year 2017, including the applicable quality reporting period for the performance year. Under the Shared Savings Program, providers of services and suppliers that participate in ACOs continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. ACOs in performance-based risk agreements may also share in losses. This interim final rule with comment period establishes extreme and uncontrollable circumstances policies for the Shared Savings Program that will apply to ACOs subject to extreme and uncontrollable events, such as Hurricanes Harvey, Irma, and Maria, and the California wildfires, effective for performance year 2017, including the applicable quality data reporting period for the performance year.
Application of the Definition of Machinegun to “Bump Fire” Stocks and Other Similar Devices
The Department of Justice anticipates issuing a Notice of Proposed Rulemaking (NPRM) that would interpret the statutory definition of ``machinegun'' in the National Firearms Act of 1934 and Gun Control Act of 1968 to clarify whether certain devices, commonly known as ``bump fire'' stocks, fall within that definition. Before doing so, the Department and ATF need to gather information and comments from the public and industry regarding the nature and scope of the market for these devices.
Community Right-To-Know; Adopting 2017 North American Industry Classification System (NAICS) Codes for Toxics Release Inventory (TRI) Reporting; Final Rule
In the Federal Register of August 17, 2017, EPA published both a direct final rule and a proposed rule to update the list of North American Industry Classification System (NAICS) codes subject to reporting under the Toxics Release Inventory (TRI) to reflect the Office of Management and Budget (OMB) 2017 NAICS code revision. As noted in the direct final rule, if EPA received relevant adverse comment on the proposed update, the Agency would publish a timely withdrawal of the direct final rule in the Federal Register informing the public that the direct final action will not take effect, and instead proceed to issue a final rule based on the parallel proposed rule. The Agency did receive a relevant adverse comment on the proposed update, and withdrew the direct final rule. This final rule addresses the comment made on EPA's proposed rulemaking previously published for this action.
Alpha-cypermethrin; Proposed Pesticide Tolerance
This document proposes to amend existing tolerances for residues of alpha-cypermethrin in or on fruit, citrus, group 10-10 and hog fat under the Federal Food, Drug, and Cosmetic Act (FFDCA). This proposal sets an expiration date for the existing tolerances while establishing new lower tolerance levels that will cover the same commodities when the current tolerances expire. EPA is proposing these changes to correct an error in a previous rulemaking that established these tolerances at an unintended level.
2-Propenoic acid, 2-methyl-, dodecyl ester, polymer with 1-ethenyl-2-pyrrolidinone and a-(2-methyl-1-oxo-2-propen-1-yl)-w-methoxypoly(oxy-1,2-ethanediyl); Tolerance Exemption
This regulation establishes an exemption from the requirement of a tolerance for residues of 2-propenoic acid, 2-methyl-, dodecyl ester, polymer with 1-ethenyl-2-pyrrolidinone and a-(2-methyl-1-oxo-2- propen-1-yl)-w-methoxypoly(oxy-1,2-ethanediyl); when used as an inert ingredient in a pesticide chemical formulation. Spring Trading Company on behalf of Ashland Specialty Ingredients, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 2-propenoic acid, 2-methyl-, dodecyl ester, polymer with 1- ethenyl-2-pyrrolidinone and a-(2-methyl-1-oxo-2-propen-1-yl)-w- methoxypoly(oxy-1,2-ethanediyl) on food or feed commodities.
National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Deletion of the C&D Recycling Superfund Site
The Environmental Protection Agency (EPA) Region III is issuing a Notice of Intent to Delete the C&D Recycling Superfund Site (Site) located in Foster Township, Pennsylvania, from the National Priorities List (NPL) and requests public comments on this proposed action. 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 under CERCLA, have been completed. However, this deletion does not preclude EPA from taking future actions at the Site under Superfund.
National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Deletion of the C&D Recycling Superfund Site
The Environmental Protection Agency (EPA) Region III is publishing a direct final Notice of Deletion of the C&D Recycling Superfund Site (Site), located in Foster 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). This direct final deletion is being published by EPA with the concurrence of the Commonwealth of Pennsylvania (Commonwealth), through the Pennsylvania Department of Environmental Protection (PADEP), because EPA has determined that all appropriate response actions under CERCLA have been completed. However, this deletion does not preclude EPA from taking future actions at the Site under Superfund.
Protection of Stratospheric Ozone: Refrigerant Management Regulations for Small Cans of Motor Vehicle Refrigerant
The Environmental Protection Agency (EPA) received adverse comment on the direct final rule titled ``Protection of Stratospheric Ozone: Refrigerant Management Regulations for Small Cans of Motor Vehicle Refrigerant,'' published on September 28, 2017. Therefore, through this document we are withdrawing that direct final rule.
National Emission Standards for Hazardous Air Pollutants for Wool Fiberglass Manufacturing; Rotary Spin Lines Technology Review and Revision of Flame Attenuation Lines Standards
This action completes the final residual risk and technology reviews (RTR) that the Environmental Protection Agency (EPA) conducted for the Wool Fiberglass Manufacturing source category regulated under the national emission standards for hazardous air pollutants (NESHAP). In this action, the EPA is readopting the existing emission limits for formaldehyde, establishing emission limits for methanol, and a work practice standard for phenol emissions from bonded rotary spin (RS) lines at wool fiberglass manufacturing facilities. In addition, the EPA is revising the emission standards promulgated on July 29, 2015, for flame attenuation (FA) lines at wool fiberglass manufacturing facilities by creating three subcategories of FA lines and establishing emission limits for formaldehyde and methanol emissions, and either emission limits or work practice standards for phenol emissions for each subcategory of FA lines.
Approval and Promulgation of Air Quality Implementation Plans; Maryland; Continuous Opacity Monitoring Requirements for Municipal Waste Combustors; Withdrawal of Direct Final Rule
Due to the receipt of an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the November 6, 2017 direct final rule (DFR) that approved revisions to the State of Maryland's Clean Air Act (CAA) section 111(d)/129 State Plan for municipal waste combustors (MWCs). The revisions contain Maryland's amendments to Regulations .07 and .08 under the Code of Maryland Regulations (COMAR) 26.11.08. This withdrawal action is being taken under sections 129 and 111(d) of the CAA.
Full Withdrawal of Approval and Promulgation of State Air Quality Plans for Designated Facilities and Pollutants; City of Philadelphia; Control of Emissions From Existing Sewage Sludge Incineration Units
Due to the receipt of an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the October 26, 2017 direct final rule (DFR) that approved a negative declaration submitted by the City of Philadelphia. The negative declaration certified that no existing sewage sludge incineration (SSI) units exist within the City of Philadelphia. EPA stated in the direct final rule that if EPA received adverse comments by November 27, 2017, the rule would be withdrawn and not take effect. EPA subsequently received an adverse comment. This withdrawal action is being taken under sections 129 and 111(d) of the Clean Air Act.
National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Partial Deletion of the Pacific Coast Pipe Lines Superfund Site
The Environmental Protection Agency (EPA) Region 9 is issuing a Notice of Intent for Partial Deletion of the surface soil portion of the Pacific Coast Pipe Lines (PCPL) Superfund Site (Site) located in Fillmore, California, from the National Priorities List (NPL) and requests public comments on this proposed action. 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). EPA and the State of California, through the Department of Toxic Substances Control (DTSC), have determined that there is no exposure to contaminated soil at the Site and that all appropriate response actions at the identified parcel under CERCLA, other than maintenance, monitoring and five-year reviews, have been completed. However, this deletion does not preclude future actions under Superfund. This partial deletion pertains to the surface soil; a map indicating the area to be deleted is in the public docket. The groundwater will remain on the NPL and is not being considered for deletion as part of this action.
Akzo Nobel Surface Chemistry AB; Filing of Food Additive Petition (Animal Use); Reopening of the Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of petition, published in the Federal Register of September 21, 2017, revising food additive regulations to provide for the safe use of glyceryl polyethylene glycol (200) ricinoleate as an emulsifier in animal food that does not include food for cats, dogs, vitamin premixes, or aquaculture. FDA is reopening the comment period to allow additional time for comments on environmental impacts.
Zinpro Corp.; Filing of Food Additive Petition (Animal Use); Reopening of the Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of petition that appeared in the Federal Register of September 22, 2017, proposing that the food additive regulations be amended to provide for the safe use of chromium DL-methionine as a nutritional source of chromium in cattle feed. FDA is reopening the comment period to allow additional time for comments on environmental impacts.
Medical Devices; Anesthesiology Devices; Classification of the External Negative Pressure Airway Aid
The Food and Drug Administration (FDA or we) is classifying the external negative pressure airway aid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external negative pressure airway aid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Special Conditions: Light Helicopter Turbine Engine Company (LHTEC), CTS800-4AT; 30-Minute All Engines Operating Power Rating
These special conditions are issued for the Light Helicopter Turbine Engine Company (LHTEC), CTS800-4AT turboshaft engine model. This engine model will have a novel or unusual design feature associated with a 30-minute all engines operating (AEO) power rating. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972
The Department of the Navy (DoN) is amending its certifications and exemptions under the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), to reflect that the Deputy Assistant Judge Advocate General (DAJAG) (Admiralty and Maritime Law) has determined that USS TULSA (LCS 16) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with certain provisions of the 72 COLREGS without interfering with its special function as a naval ship. The intended effect of this rule is to warn mariners in waters where 72 COLREGS apply.
Energy Conservation Program: Energy Conservation Standards for Rough Service Lamps and Vibration Service Lamps
The U.S. Department of Energy (DOE) is publishing this final rule in order to codify in the Code of Federal Regulations certain backstop requirements for rough service lamps and vibration service lamps that Congress prescribed in the Energy Policy and Conservation Act. These backstop requirements apply as a result of the subject lamps exceeding sales thresholds specified in the statute. In particular, this rule applies a statutorily-established 40-watt maximum energy use and packaging limitation to rough service lamps and vibration service lamps.
Drawbridge Operation Regulation; Atlantic Intracoastal Waterway, Alligator River, Columbia, NC
The Coast Guard has modified a temporary deviation from the operating schedule that governs the US 64/Alligator River Bridge which carries US 64 over the Atlantic Intracoastal Waterway (AICW), Alligator River, mile 84.2, near Columbia, NC. The deviation is necessary to facilitate bridge maintenance. This deviation allows the bridge to remain in the closed-to-navigation position.
Change of Address; Technical Amendments
The Federal Election Commission (``FEC'' or ``Commission'') will relocate to a building with a different street address in 2018 and is amending its regulations referencing its current street address to reflect this change in location.
Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments
This rule amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide for the safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments
This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments
This rule amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide for the safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments
This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
Rules of General Application
The United States International Trade Commission (``Commission'') amends provisions of its Rules of Practice and Procedure concerning the Privacy Act. The amendment is designed to delete certain exemptions that pertain only to systems of records that the Commission has removed and to add exemptions that pertain to a new system of records.
Center for Devices and Radiological Health; Medical Devices and Combination Products; Voluntary Malfunction Summary Reporting Program for Manufacturers
The Food and Drug Administration's (FDA, Agency, or we) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research, is announcing a proposed program for manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary formthe Voluntary Malfunction Summary Reporting Program. This proposed voluntary program reflects goals for streamlining malfunction reporting outlined in the commitment letter agreed to by FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments Act of 2017 (MDUFA IV Commitment Letter). These goals include permitting manufacturers of devices in certain product codes to report malfunctions on a quarterly basis and in a summary format. In addition, this proposed program reflects FDA's findings from a pilot program the Agency conducted to study summary reporting formats for malfunction MDRs.
Approval of Louisiana's Request To Relax the Federal Reid Vapor Pressure (RVP) Gasoline Volatility Standard for Several Parishes
The Environmental Protection Agency (EPA) is taking final action to approve an April 10, 2017 request from the Louisiana Department of Environmental Quality (LDEQ) to relax the Federal Reid Vapor Pressure (RVP) standard applicable to gasoline introduced into commerce from June 1 to September 15 of each year for the following parishes: Beauregard, Calcasieu, Jefferson, Lafayette, Lafourche, Orleans, Pointe Coupee, St. Bernard, St. Charles, St. James, and St. Mary. Specifically, EPA is approving amendments to the regulations to allow the gasoline RVP standard for these 11 parishes to rise from 7.8 pounds per square inch (psi) to 9.0 psi. EPA has determined that this change to the Federal gasoline RVP volatility regulation is consistent with the applicable provisions of the Clean Air Act (CAA). LDEQ has also requested that EPA relax gasoline volatility requirements for the 5-parish Baton Rouge area, and EPA will address that request in a separate rulemaking in the future.
Finding of Failure To Submit a Section 110 State Implementation Plan for Interstate Transport for the 2012 Annual National Ambient Air Quality Standards for Fine Particles; Massachusetts
The Environmental Protection Agency (EPA) is taking final action finding that Massachusetts failed to submit an infrastructure State Implementation Plan (SIP) to satisfy certain interstate transport requirements of the Clean Air Act (CAA) with respect to the 2012 annual fine particles (PM2.5) national ambient air quality standard (NAAQS). Specifically, these requirements pertain to significant contribution to nonattainment, or interference with maintenance, of the 2012 annual PM2.5 NAAQS in other states. This finding of failure to submit establishes a 2-year deadline for the EPA to promulgate a Federal Implementation Plan (FIP) to address the interstate transport SIP requirements pertaining to significant contribution to nonattainment, interference with maintenance, interference with Prevention of Significant Deterioration, and interference with visibility protection, unless, prior to the EPA promulgating a FIP, the state submits, and the EPA approves, a SIP that meets these requirements.
Denial of Petition To List Concentrated Animal Feeding Operations Under Clean Air Act
The U.S. Environmental Protection Agency (EPA) is providing notice that it has responded to a petition for rulemaking titled ``Petition To List Concentrated Animal Feeding Operations under Clean Air Act Section 111(b)(1)(A) of the Clean Air Act, and To Promulgate Standards of Performance Under Clean Air Act Sections 111(b)(1)(B) and 111(d).'' The Administrator denied the request in a separate letter to the petitioners. The letter, which provides a full explanation of the agency's rationale for the denial, is in the docket for this action.
Confidentiality Determinations for Hazardous Waste Export and Import Documents
The Environmental Protection Agency (EPA or the Agency) is amending existing regulations regarding the export and import of hazardous wastes from and into the United States. Specifically, this rule applies a confidentiality determination such that no person can assert confidential business information (CBI) claims for documents related to the export, import, and transit of hazardous waste and export of excluded cathode ray tubes (CRTs). EPA is making these changes to apply a consistent approach in addressing confidentiality claims for export and import documentation. The rule will result in cost-savings and greater efficiency for EPA and the regulated community as well as facilitate transparency with respect to the documents that are within the scope of this rulemaking. However, EPA is not finalizing the proposed internet posting requirement in the proposed rule.
Nondiscrimination on the Basis of Disability; Notice of Withdrawal of Four Previously Announced Rulemaking Actions
The Department of Justice is announcing the withdrawal of four previously announced Advance Notices of Proposed Rulemaking (ANPRMs), pertaining to title II and title III of the Americans with Disabilities Act (ADA), for further review.
Approval and Promulgation of Air Quality Implementation Plans; New Mexico; Infrastructure and Interstate Transport for the 2012 Fine Particulate Matter National Ambient Air Quality Standard and Revised Statutes
The Environmental Protection Agency (EPA) is proposing to approve State Implementation Plan (SIP) revisions submitted by the State of New Mexico to address the requirements of section 110(a)(1) and (2) of the Clean Air Act (CAA or Act) for 2012 fine particulate matter (PM2.5) National Ambient Air Quality Standard (NAAQS). The revisions address how the existing SIP provides for implementation, maintenance, and enforcement of PM2.5 (infrastructure SIP or i-SIP). Under CAA sections 110(a)(1) and 110(a)(2), each state is required to submit a SIP that provides for the implementation, maintenance, and enforcement of a revised primary or secondary NAAQS. CAA section 110(a)(1) and (2) require each state to make a new SIP submission within three years after EPA promulgates a new or revised NAAQS for approval into the existing SIP to assure that the SIP meets the applicable requirements for such new and revised NAAQS. This type of SIP submission is commonly referred to as an ``infrastructure SIP or ``i-SIP.'' We propose approval of this action under Section 110 of the Act. EPA is also proposing to approve a SIP revision to update the New Mexico statutes incorporated into the SIP.
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