April 24, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 23 of 23
Guidance Under Section 851 Relating to Investments in Stock and Securities; Correction
This document contains corrections to final regulations (TD 9851) that were published in the Federal Register on Tuesday, March 19, 2019. The final regulations provide guidance relating to the income test used to determine whether a corporation may qualify as a regulated investment company (RIC) for Federal income tax purposes.
Compliance Policy for Combination Product Postmarketing Safety Reporting; Immediately in Effect Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of an update to the immediately in effect guidance for industry entitled ``Compliance Policy for Combination Product Postmarketing Safety Reporting.'' This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety reporting. FDA is updating this guidance by extending the period of time during which FDA does not intend to enforce certain combination product postmarketing safety reporting requirements.
Natural Resources Defense Council et al.: Response to the Objections and Denial of the Requests for a Public Hearing
The Food and Drug Administration (FDA or we) is overruling the objections and is denying the requests for a public hearing, submitted by the Environmental Defense Fund, Natural Resources Defense Council, Center for Food Safety, Clean Water Action, Center for Science in the Public Interest, Breast Cancer Prevention Partners, Center for Environmental Health, Environmental Working Group, and Improving Kids' Environment.
General and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers
The Food and Drug Administration (FDA or the Agency) is proposing to reclassify surgical staplers for internal use (currently regulated under the classification for ``manual surgical instrument for general use'' and assigned the product code GAG) from class I (general controls) into class II (special controls) and subject to premarket review. FDA is identifying the proposed special controls for surgical staplers for internal use that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. As part of this reclassification, FDA is also proposing to amend the existing classification for ``manual surgical instrument for general use'' to remove staplers and to create a separate classification regulation for surgical staplers that distinguishes between surgical staplers for internal use and external use.
Payments of Amounts Due Mentally Incompetent Members of the Naval Service
This final rule removes the Department of the Navy (DON) regulation concerning Payments of Amounts Due Mentally Incompetent Members of the Naval Service. Removal is appropriate because the regulation does not affect how the public engages the DON regarding these payments and does not place obligations on the public. The Department of Defense, the Secretary of the Navy, and the Bureau of Medicine and Surgery (BUMED) issue internal instructions that establish requirements for competency boards, the process for determining mental incompetence, and the process and requirements for making payments within the parameters established by many controlling statutes. These internal instructions do not require publication in the Code of Federal Regulations.
Hydroelectric Licensing Regulations Under the America's Water Infrastructure Act of 2018
In this final rule, the Federal Energy Regulatory Commission (Commission) is establishing an expedited process for issuing original licenses for qualifying facilities at existing nonpowered dams and for closed-loop pumped storage projects, pursuant to sections 3003 and 3004 of the America's Water Infrastructure Act of 2018. Under the expedited licensing process, the Commission will seek to ensure that a final decision is issued no later than two years after the Commission receives a completed license application. The final rule will be codified in a new part that will be added to the Commission's regulations.
Critical Infrastructure Protection Reliability Standard CIP-012-1-Cyber Security-Communications Between Control Centers
The Federal Energy Regulatory Commission (Commission) proposes to approve Reliability Standard CIP-012-1 (Cyber Security Communications between Control Centers). The North American Electric Reliability Corporation (NERC), the Commission-certified Electric Reliability Organization, submitted the proposed Reliability Standard for Commission approval in response to a Commission directive. In addition, the Commission proposes to direct that NERC develop certain modifications to Reliability Standard CIP-012-1 to require protections regarding the availability of communication links and data communicated between bulk electric system control centers and, further, to clarify the types of data that must be protected.
Safety Zone; Cocos Lagoon, Merizo, GU
The Coast Guard is establishing a temporary safety zone for navigable waters within Cocos Lagoon. This safety zone will encompass the designated swim course for the Cocos Crossing swim event in the waters of Cocos Lagoon, Merizo, Guam. This action is necessary to protect all persons and vessels participating in this marine event from potential safety hazards associated with vessel traffic in the area. Race participants, chase boats, and organizers of the event will be exempt from the safety zone. Entry of persons or vessels into the safety zone is prohibited unless authorized by the Captain of the Port Guam (COTP).
Definition of Private Carrier for Premium PO Box Delivery
The Postal Service seeks customer and other stakeholder feedback to define the phrase ``packages from private carriers,'' as used in connection with PO Box Street Addressing. The Postal Service is contemplating an amendment to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM[supreg]) to clarify the Street Addressing Additional Service available at many Premium Post Office Box Service locations.
Initiation of Voluntary Recalls Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.'' The draft guidance, if finalized, would establish guidance for industry and FDA staff regarding timely initiation of voluntary recalls of FDA-regulated products. The draft guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead to a recall; and to promptly issue recall communications and press releases or other public notices. It also discusses preparations that firms in a distribution chain should consider making to ensure timely responses to a recall communication. In addition, it discusses how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA.
Marketing Order Regulating the Handling of Spearmint Oil Produced in the Far West; Revision of the Salable Quantity and Allotment Percentage for Class 3 (Native) Spearmint Oil for the 2018-2019 Marketing Year
This rule implements a recommendation from the Far West Spearmint Oil Administrative Committee (Committee) to increase the quantity of Class 3 (Native) spearmint oil that handlers may purchase from, or handle on behalf of, producers during the 2018-2019 marketing year. The Committee recommended this action to ensure that the Native spearmint oil market is adequately supplied through the end of the current marketing year.
Olives Grown in California; Increased Assessment Rate
This proposed rule would implement a recommendation from the California Olive Committee (Committee) to increase the assessment rate established for the 2019 fiscal year and subsequent fiscal years. The assessment rate would remain in effect indefinitely unless modified, suspended, or terminated.
Mushroom Promotion, Research, and Consumer Information Order; Reallocation of Council Membership
This rule reallocates the membership of the Mushroom Council (Council) under the Agricultural Marketing Service's (AMS) regulations regarding a national research and promotion program for mushrooms. The Council administers the regulations with oversight by the U.S. Department of Agriculture (USDA). This rule was recommended by the Council after a review of the geographic distribution of the volume of mushroom production throughout the United States and the volume of imports. This rule revises the number of Council members in two of the four geographic regions under the program. This action is necessary to provide for equitable representation of producers and importers on the Council.
Tomatoes Grown in Florida; Redistricting and Reapportionment of Producer Districts
This proposed rule would implement a recommendation from the Florida Tomato Committee (Committee) to redistrict and reapportion producer representation on the Committee currently prescribed under the marketing order for tomatoes grown in Florida. This action would reduce the number of districts from four to two and reapportion producer membership on the Committee to provide equitable representation from both districts.
Airworthiness Directives; Airbus SAS Airplanes
We propose to supersede Airworthiness Directive (AD) 2015-17- 14, which applies to all Airbus SAS Model A319 series airplanes; Model A320-211, -212, -214, -231, -232, and -233 airplanes, and Model A321- 111, -112, -131, -211, -212, -213, -231, and -232 airplanes. AD 2015- 17-14 requires repetitive rototest inspections of the open tack holes and rivet holes at the cargo floor support fittings of the fuselage, including doing all applicable related investigative actions, and repair if necessary. Since we issued AD 2015-17-14, further analysis and widespread fatigue damage (WFD) evaluations identified the need to reduce the initial compliance times and repetitive intervals for the inspections for certain airplanes, and to add work for certain airplanes. This proposed AD would continue to require the actions of AD 2015-17-14, would add actions for certain airplanes, and would reduce the compliance times for certain airplanes, as specified in an European Aviation Safety Agency (EASA) AD, which will be incorporated by reference. This proposed AD would also reduce the applicability. We are proposing this AD to address the unsafe condition on these products.
Approval and Promulgation of Air Quality Implementation Plans; Maryland; Infrastructure Requirements for the 2015 Ozone National Ambient Air Quality Standards
The Environmental Protection Agency (EPA) is proposing to approve a state implementation plan (SIP) revision submittal from the State of Maryland for the 2015 ozone national ambient air quality standard (NAAQS or standard). Whenever EPA promulgates a new or revised NAAQS, states are required to make a SIP submission showing how the existing approved SIP has all the provisions necessary to meet the requirements of the new or revised NAAQS, or to add any needed provisions necessary to meet the revised NAAQS. The SIP revision is required to address basic program elements, including, but not limited to, regulatory structure, monitoring, modeling, legal authority, and adequate resources necessary to assure attainment and maintenance of the standards. These elements are referred to as infrastructure requirements. Maryland has made a submittal addressing the infrastructure requirements for the 2015 ozone NAAQS. EPA is proposing to approve Maryland's SIP revision addressing the infrastructure requirements for the 2015 ozone NAAQS in accordance with the requirements of section 110(a) of the Clean Air Act (CAA).
Air Plan Approval; KY; Jefferson County Existing and New Miscellaneous Metal Parts and Products Surface Coating Operations
The Environmental Protection Agency (EPA) is proposing to approve two revisions to the Jefferson County portion of the Kentucky State Implementation Plan (SIP), provided by the Commonwealth of Kentucky, through the Kentucky Division of Air Quality (KDAQ), through a letter dated March 15, 2018. The revisions were submitted by KDAQ on behalf of the Louisville Metro Air Pollution Control District (LMAPCD) (also referred to herein as Jefferson County) and add a recordkeeping provision for certain sources of volatile organic compounds (VOC) along with other administrative changes. EPA is proposing to approve the changes because they are consistent with the Clean Air Act (CAA or Act).
Air Plan Approval and Designation of Areas; FL; Redesignation of the Nassau County 2010 1-Hour Sulfur Dioxide Nonattainment Area to Attainment
In a letter dated June 7, 2018, the State of Florida, through the Florida Department of Environmental Protection (FDEP), submitted a request for the Environmental Protection Agency (EPA) to redesignate the Nassau County sulfur dioxide (SO2) nonattainment area (hereinafter referred to as the ``Nassau County Area'' or ``Area'') to attainment for the 2010 1-hour SO2 primary national ambient air quality standard (NAAQS) and to approve an accompanying state implementation plan (SIP) revision containing a maintenance plan for the Area. The submittal was received by EPA on June 12, 2018. EPA is taking final action to determine that the Nassau County Area attained the 2010 1-hour SO2 NAAQS by its applicable attainment date of October 4, 2018; to approve the SIP revision containing the State's plan for maintaining attainment of the 2010 1-hour SO2 standard and to incorporate the maintenance plan into the SIP; and to redesignate the Nassau County Area to attainment for the 2010 1-hour SO2 NAAQS.
Airworthiness Directives; Northrop Grumman LITEF GmbH LCR-100 Attitude and Heading Reference System Units
We are adopting a new airworthiness directive (AD) for Northrop Grumman LITEF GmbH LCR-100 Attitude and Heading Reference System (AHRS) units installed on various aircraft. This AD requires removing certain LCR-100 AHRS units from service. This AD was prompted by test results showing loss of or invalid data. The actions of this AD are intended to prevent an unsafe condition on these products.
Other Real Estate Owned and Technical Amendments
The OCC is inviting comment on a proposed rule that would clarify and streamline its regulation on other real estate owned (OREO) for national banks and update the regulatory framework for OREO activities at Federal savings associations. The OCC is also proposing to remove outdated capital rules for national banks and Federal savings associations, which include provisions related to OREO, and make conforming edits to other rules that reference those capital rules.
Medicare Program; Inpatient Rehabilitation Facility (IRF) Prospective Payment System for Federal Fiscal Year 2020 and Updates to the IRF Quality Reporting Program
This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2020. As required by the Social Security Act (the Act), this proposed rule includes the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups (CMGs) and a description of the methodologies and data used in computing the prospective payment rates for FY 2020. We are proposing to rebase and revise the IRF market basket to reflect a 2016 base year rather than the current 2012 base year. Additionally, we are proposing to replace the previously finalized unweighted motor score with a weighted motor score to assign patients to CMGs and remove one item from the score beginning with FY 2020 and to revise the CMGs and update the CMG relative weights and average length of stay values beginning with FY 2020, based on analysis of 2 years of data (FY 2017 and FY 2018). We are proposing to update the IRF wage index to use the concurrent FY inpatient prospective payment system (IPPS) wage index beginning with FY 2020. We are soliciting comments on stakeholder concerns regarding the appropriateness of the wage index used to adjust IRF payments. We are proposing to amend the regulations to clarify that the determination as to whether a physician qualifies as a rehabilitation physician (that is, a licensed physician with specialized training and experience in inpatient rehabilitation) is made by the IRF. For the IRF Quality Reporting Program (QRP), we are proposing to adopt two new measures, modify an existing measure, and adopt new standardized patient assessment data elements. We also propose to expand data collection to all patients, regardless of payer, as well as proposing updates related to the system used for the submission of data and related regulation text.
Acquisition Regulation: Removal of Outdated References
The Department of the Interior is issuing a proposed rule amending the Department of the Interior Acquisition Regulation (DIAR) to implement Section 15(k) of the Small Business Act and remove outdated references and/or obsolete information.
Air Plan Approval; New Mexico; Albuquerque/Bernalillo County; Minor New Source Review (NSR) Preconstruction Permitting Program Revisions
The Environmental Protection Agency (EPA) is proposing to convert its June 29, 2017 conditional approval of revisions to the New Mexico State Implementation Plan (SIP) for the City of Albuquerque- Bernalillo County minor New Source Review (NSR) program to full approval. The January 18, 2018 SIP submittal satisfies New Mexico's commitment which was the basis of our conditional approval of the minor NSR Preconstruction Permitting Program. Final approval of this SIP submittal will convert our earlier conditional approval to full approval. We are taking this action in accordance with the Clean Air Act (CAA, the Act) requirements.
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