January 5, 2018 – Federal Register Recent Federal Regulation Documents

Medical Devices; Radiology Devices; Classification of the Absorbable Perirectal Spacer
Document Number: 2018-00051
Type: Rule
Date: 2018-01-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the absorbable perirectal spacer 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 absorbable perirectal spacer'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.
Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs; Guidance for Industry; Availability
Document Number: 2018-00050
Type: Rule
Date: 2018-01-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs.'' This guidance states agency compliance policy regarding certain entities and/or activities related to the ``farm'' definition, written assurances, food contact substances, and human food by-products for use as animal food.
Air Plan Approval and Air Quality Designation; MO; Redesignation of the Missouri Portion of the St. Louis Missouri-Illinois Area to Attainment of the 1997 Annual Standard for Fine Particulate Matter and Approval of Associated Maintenance Plan
Document Number: 2018-00037
Type: Proposed Rule
Date: 2018-01-05
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is issuing this Advanced Notice of Proposed Rulemaking (ANPR) to inform the public of currently available information that will be used by the Administrator to issue a subsequent action to propose redesignation of the Missouri portion of the St. Louis MO-IL nonattainment area for the 1997 PM2.5 NAAQS, (hereafter referred to as the ``St. Louis area'' or ``area''). On September 2, 2011, Missouri, through the Missouri Department of Natural Resources (MDNR) submitted a request for EPA to redesignate the Missouri portion of the St. Louis MO-IL nonattainment area to attainment for the 1997 Annual National Ambient Air Quality Standards (NAAQS) for fine particulate matter (PM2.5) and approve a state implementation plan (SIP) revision containing a maintenance plan for the Missouri portion of the area. In advance of any potential rulemaking to address the state of Missouri's request, EPA is specifically requesting early input and comments on its interpretation that currently available data support a finding that the area will be attaining the 1997 Annual PM2.5 NAAQS based on air quality monitoring data from 2015- 2017, and on EPA's advanced notice of its expectation that the state's plan for maintaining the 1997 Annual PM2.5 NAAQS for the St. Louis Area (maintenance plan) including the associated motor vehicle emission budgets (MVEBs) for nitrogen oxides (NOX) and PM2.5 for the years 2008-2025 is approvable. EPA will take any information received from this ANPR into consideration when developing a proposed action for redesignating the Missouri portion of the St. Louis Area to attainment for the 1997 Annual PM2.5 NAAQS.
EPA Responses to Certain State Designation Recommendations for the 2015 Ozone National Ambient Air Quality Standards: Notice of Availability and Public Comment Period
Document Number: 2018-00024
Type: Proposed Rule
Date: 2018-01-05
Agency: Environmental Protection Agency
Notice is hereby given that the Environmental Protection Agency (EPA) has posted on our public electronic docket and internet website responses to certain state and tribal area designation recommendations for the 2015 Ozone National Ambient Air Quality Standards (NAAQS) (2015 Ozone NAAQS). These responses include our intended designations for the affected areas. The EPA invites the public to review and provide input on our intended designations during the comment period specified in the DATES section. The EPA sent its responses directly to the states and tribes on or about December 20, 2017. The EPA intends to make final designation determinations for the areas of the country addressed by these responses no earlier than 120 days from the date the EPA notified states and tribes of the agency's intended designations.
Fees for the Unified Carrier Registration Plan and Agreement
Document Number: 2017-28509
Type: Rule
Date: 2018-01-05
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
This rule establishes reductions in the annual registration fees collected from motor carriers, motor private carriers of property, brokers, freight forwarders, and leasing companies for the Unified Carrier Registration (UCR) Plan and Agreement for the registration years 2018, 2019 and subsequent years. For the 2018 registration year, the fees will be reduced below the current level by approximately 9.10% to ensure that fee revenues do not exceed the statutory maximum, and to account for the excess funds held in the depository. For the 2019 registration year and subsequent years, the fees will be reduced below the current level by approximately 4.55% to ensure the fee revenues in that and future years do not exceed the statutory maximum.
Pears Grown in Oregon and Washington; Increased Assessment Rate for Processed Pears
Document Number: 2017-28505
Type: Rule
Date: 2018-01-05
Agency: Agricultural Marketing Service, Department of Agriculture
This rule implements a recommendation from the Processed Pear Committee (Committee) to increase the assessment rate established for the 2017-2018 and subsequent fiscal periods from $7.00 to $8.00 per ton of ``summer/fall'' pears for canning. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated. This rule also makes administrative revisions to the subpart headings to bring the language into conformance with the Office of Federal Register requirements.
Onions Grown in South Texas; Increased Assessment Rate
Document Number: 2017-28504
Type: Rule
Date: 2018-01-05
Agency: Agricultural Marketing Service, Department of Agriculture
This rule implements a recommendation from the South Texas Onion Committee (Committee) to increase the assessment rate established for the 2017-18 and subsequent fiscal periods from $0.05 to $0.065 per 50-pound equivalent of onions handled under the Marketing Order (Order). The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated.
Federal Travel Regulation; Transportation Network Companies (TNC), Innovative Mobility Technology Companies, and Reporting Travel, Transportation, and Relocation Costs
Document Number: 2017-28503
Type: Rule
Date: 2018-01-05
Agency: General Services Administration, Agencies and Commissions
GSA is amending the Federal Travel Regulation (FTR) by adding terms and definitions for ``innovative mobility technology company'', ``taxi'', and ``transportation network company (TNC)'', and designating ``innovative mobility technology company'' and ``TNC'' as forms of special conveyances. In addition, this direct final rule adds a due date by which agencies must report travel, transportation, and relocation costs and data to GSA. These actions are required by the Modernizing Government Travel Act.
Airworthiness Directives; Fokker Services B.V.
Document Number: 2017-28487
Type: Rule
Date: 2018-01-05
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for certain Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes. This AD requires contacting the FAA to obtain instructions for addressing the unsafe condition on these products, and doing the actions specified in those instructions. This AD was prompted by an evaluation by the design approval holder (DAH) indicating that the fuselage frames are subject to widespread fatigue damage (WFD). We are issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; Fokker Services B.V. Airplanes
Document Number: 2017-28486
Type: Rule
Date: 2018-01-05
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for certain Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes. This AD requires contacting the FAA to obtain instructions for addressing the unsafe condition on these products, and doing the actions specified in those instructions. This AD was prompted by a report of an engine multiple fan blade release event. We are issuing this AD to address the unsafe condition on these products.
Definition of “Employer” Under Section 3(5) of ERISA-Association Health Plans
Document Number: 2017-28103
Type: Proposed Rule
Date: 2018-01-05
Agency: Employee Benefits Security Administration, Department of Labor
This document contains a proposed regulation under Title I of the Employee Retirement Income Security Act (ERISA) that would broaden the criteria under ERISA section 3(5) for determining when employers may join together in an employer group or association that is treated as the ``employer'' sponsor of a single multiple-employer ``employee welfare benefit plan'' and ``group health plan'' as those terms are defined in Title I of ERISA. By treating the association itself as the employer sponsor of a single plan, the regulation would facilitate the adoption and administration of such arrangements. The regulation would modify the definition of ``employer,'' in part, by creating a more flexible ``commonality of interest'' test for the employer members than the Department of Labor (DOL or Department) had adopted in sub- regulatory interpretive rulings under ERISA section 3(5). At the same time, the regulation would continue to distinguish employment-based plans, the focal point of Title I of ERISA, from mere commercial insurance programs and administrative service arrangements marketed to employers. For purposes of Title I of ERISA, the proposal would also permit working owners of an incorporated or unincorporated trade or business, including partners in a partnership, to elect to act as employers for purposes of participating in an employer group or association sponsoring a health plan and also to be treated as employees with respect to a trade, business or partnership for purposes of being covered by the employer group's or association's health plan. The goal of the rulemaking is to expand access to affordable health coverage, especially among small employers and self-employed individuals, by removing undue restrictions on the establishment and maintenance of association health plans under ERISA. The proposed regulation would affect such association health plans, health coverage under these health plans, groups and associations of employers sponsoring such plans, participants and beneficiaries with health coverage under these plans, health insurance issuers, and purchasers of health insurance not purchased through association health plans.
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