December 26, 2017 – Federal Register Recent Federal Regulation Documents

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.

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.

The Environmental Protection Agency (``EPA'') is providing notice, of disclosure of potential confidential business information in litigation.

This notice announces EPA's order for the cancellations and amendments to terminate uses, voluntarily requested by the registrants and accepted by the Agency, of the products listed in Table 1A, Table 1B and Table 2 of Unit II, pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This cancellation order follows an October 3, 2017 Federal Register Notice of Receipt of Requests from the registrants listed in Table 3 of Unit II to voluntarily cancel and amend to terminate uses of these product registrations. The cancellations of products listed in Table 1B would terminate the last Spirodiclofen products registered for use in the United States. In the October 3, 2017 notice, EPA indicated that it would issue an order implementing the cancellations and amendments to terminate uses, unless the Agency received substantive comments within the 30-day comment period that would merit its further review of these requests, or unless the registrants withdrew their requests. The Agency received 5 comments on the notice but none merited its further review of the requests. Further, the registrants did not withdraw their requests. Accordingly, EPA hereby issues in this notice a cancellation order granting the requested cancellations and amendments to terminate uses. Any distribution, sale, or use of the products subject to this cancellation order is permitted only in accordance with the terms of this order, including any existing stocks provisions.

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.

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.

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.

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.

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.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.'' This guidance finalizes recommendations for sponsors of investigational new drug applications (INDs), and applicants who submit new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications for immediate-release (IR) solid oral dosage forms, and who wish to request a waiver of an in vivo bioavailability (BA) and/or bioequivalence (BE) study requirement.

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.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Indiana Advisory Committee (Committee) will hold a meeting on Friday January 5, 2018, at 3:00 p.m. EST for the purpose of preparing for its public meeting on voting rights issues in the state.

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.

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR)NSPS for Electric Utility Steam Generating Units, EPA ICR No. 1053.12, OMB Control No. 2060-0023to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through December 31, 2017. Public comments were requested previously via the Federal Register (82 FR 29552) on June 29, 2017, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to a collection of information, unless it displays a currently valid OMB control number.

This notice announces EPA's approval of the State of New Mexico's request to revise/modify certain of its EPA-authorized programs to allow electronic reporting.

For the Understanding Rapid Re-housing Study, the Department of Housing and Urban Development's (HUD) Office of Policy Development and Research (PD&R) is partnering with an external research team to collect new data to analyze the current status of the rapid re-housing (RRH) programs and the experiences of RRH participants. The project will provide HUD with a deeper understanding of how RRH programs operate and the experiences of households that use them. The Understanding Rapid Re-housing Study will synthesize existing research on RRH programs, extend the analysis of data from the Family Options Study (2016), provide a detailed examination of all rapid re-housing programs nationwide, and conduct qualitative research with a small sample of families and individuals who receive RRH. The study will collect contact information from Continuums of Care (CoCs) for RRH programs, as well as personal information from participating RRH households. In accordance with the Privacy Act of 1974, HUD/PD&R proposes to establish a new system of records titled, ``HUD/Understanding Rapid Re- housing.'' This system of records allows HUD/PD&R to collect and maintain records on rapid re-housing program participants who volunteer to participate in the study as well as Continuums of Care and rapid re- housing program staff. This newly established system will be included in HUD's inventory of systems.

The Department of the Interior (Department) gives notice that the Principal Deputy Assistant SecretaryIndian Affairs, exercising the authority of the Assistant SecretaryIndian Affairs has determined that the Georgia Tribe of Eastern Cherokee (GTEC) is not an Indian Tribe within the meaning of Federal law. This notice is based on a determination that affirms the reasoning, analysis, and conclusions in the Proposed Finding (PF) that the petitioner does not satisfy the seven mandatory criteria for acknowledgment set forth in the applicable regulations. Therefore, it does not meet the requirements for a government-to-government relationship with the United States. Based on the limited nature and extent of comments, and consistent with prior practices, the Government is not producing a separate detailed report or other summary under the criteria to accompany this Final Determination (FD), because neither the petitioner nor interested parties have submitted significant new evidence or analysis that changes the conclusions in the PF. The PF, as supplemented by this notice, is affirmed. This notice constitutes the FD.

NIOSH announces the availability of the final National Occupational Research Agenda for Cancer, Reproductive, Cardiovascular and Other Chronic Disease Prevention (CRC).