September 2019 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 2,238
Airworthiness Directives; Embraer S.A. Airplanes
The FAA proposes to adopt a new airworthiness directive (AD) for certain Embraer S.A. Model ERJ 190-100 STD, -100 LR, -100 IGW, -200 STD, -200 LR, and -200 IGW airplanes. This proposed AD was prompted by reports of structural cracks in the wing lower skin stringers on both half wings. This proposed AD would require repetitive inspections of the lower skin stringers on both half wings for cracking or fuel leakage, and applicable related investigative and corrective actions, as specified in an Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil (ANAC) Brazilian AD, which will be incorporated by reference. The FAA is proposing this AD to address the unsafe condition on these products.
Energy Conservation Program: Test Procedure for Ceiling Fans
The U.S. Department of Energy (DOE) proposes to amend its test procedures for ceiling fans established under the Energy Policy and Conservation Act. On July 25, 2016, DOE published a final rule amending the test procedure for ceiling fans to support the ceiling fans energy conservation standards rulemaking. In this notice of proposed rulemaking (NOPR), DOE proposes to: Interpret the term ``suspended from a ceiling'' in the EPCA definition of ceiling fan to mean offered for mounting only on a ceiling; specify that very small-diameter (VSD) ceiling fans that do not also meet the definition of low-speed small- diameter (LSSD) ceiling fan are not required to be tested pursuant to the DOE test method; for LSSD and VSD ceiling fans, increase the tolerance for the stability criteria for the average air velocity measurements in low speed to reduce test burden; specify that large- diameter ceiling with blade spans greater than 24 feet do not need to be tested pursuant to the DOE test method; codify current guidance on calculating several values reported on the U.S. Federal Trade Commission's (FTC) EnergyGuide label for LSSD and VSD ceiling fans using results from the ceiling fan test procedures; and amend certification requirements and product-specific enforcement provisions to reflect the current test procedures and recently amended energy conservation standards for ceiling fans.
Safety Zone, Saint Simons Sound, GA
On September 08, 2019, the Captain of the Port (COTP) Savannah issued an Emergency Safety Zone in response to the grounding/capsizing of the M/V GOLDEN RAY (31[deg]07'39.66 North, 081[deg]24'10.58 West, between Saint Simons Lighthouse and the north end of Jekyll Island, in the vicinity of green buoy #19). This Emergency Safety Zone prohibited all vessels from approaching within 0.5 nautical miles of M/V GOLDEN RAY, unless authorized by the COTP. As of September 13, 2019, this Emergency Safety Zone remained in effect for all vessels of 500 GT and above. No vessels 500 GT and above were able to transit within 0.5 nautical miles of the M/V GOLDEN RAY unless specifically authorized by the COTP. For all other vessels, the Emergency Safety Zone was enforced for 150 yards surrounding the site. No vessel could transit within 150 yards of the M/V GOLDEN RAY unless specifically authorized by the COTP. As of September 19, 2019, USCG Captain of the Port Savannah has adjusted the safety zone surrounding the M/V GOLDEN RAY, so that no vessel is authorized access within 150 yards of the M/V GOLDEN RAY, unless authorized by the Captain of the Port. The previous safety zone established on September 12, 2019 is terminated.
Special Local Regulation; Kailua Bay, Ironman World Championship, Kailua-Kona, Hawaii
The Coast Guard will enforce a special local regulation for the Ironman Ho'ala practice swim and Ironman World Championship Triathlon on October 6 and October 12, 2019, to provide for the safety of life on navigable waterways during this event. Our regulation for marine events within the Fourteenth Coast Guard District identifies the regulated area for this event on certain waters of Kailua Bay, Kailua- Kona, Hawaii. During the enforcement periods, the operator of any vessel in the regulated area must comply with directions from the Patrol Commander or any Official Patrol displaying a Coast Guard ensign.
Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Fire Safety Requirements for Certain Dialysis Facilities; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care
This final rule reforms Medicare regulations that are identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. This final rule also increases the ability of health care professionals to devote resources to improving patient care by eliminating or reducing requirements that impede quality patient care or that divert resources away from furnishing high quality patient care. Additionally, this rule updates fire safety standards for Medicare and Medicaid participating End-Stage Renal Disease (ESRD) facilities by adopting the 2012 edition of the Life Safety Code and the 2012 edition of the Health Care Facilities Code. Finally, this final rule updates the requirements that hospitals and Critical Access Hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These requirements are intended to conform to current standards of practice and support improvements in quality of care, reduce barriers to care, and reduce some issues that may exacerbate workforce shortage concerns.
Safety Zone; Mackinaw City Fall Colors Fireworks, Mackinaw City, MI
The Coast Guard is establishing a temporary safety zone in the Straits of Mackinac near Mackinac City, MI. The temporary safety zone is needed to protect vessels and spectators from the hazards associated with a fireworks show during the Mackinaw City Fall Colors Fireworks. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sector Sault Sainte Marie or a designated representative.
Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies, and Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility, and Improvement in Patient Care
This final rule empowers patients to be active participants in the discharge planning process and complements efforts around interoperability that focus on the seamless exchange of patient information between health care settings by revising the discharge planning requirements that Hospitals (including Short-Term Acute-Care Hospitals, Long-Term Care Hospitals (LTCHs), Rehabilitation Hospitals, Psychiatric Hospitals, Children's Hospitals, and Cancer Hospitals), Critical Access Hospitals (CAHs), and Home Health Agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. This final rule also implements discharge planning requirements which will give patients and their families access to information that will help them to make informed decisions about their post-acute care, while addressing their goals of care and treatment preferences, which may ultimately reduce their chances of being re-hospitalized. It also updates one provision regarding patient rights in hospitals, intended to promote innovation and flexibility and to improve patient care.
Safety Zone; Leif Erickson Day Row and Run, Charlevoix, MI
The Coast Guard is establishing a temporary safety zone in Lake Charlevoix, Charlevoix, MI. This temporary safety zone is needed to protect 40 participating paddlers in the Leif Erickson Day Row and Run. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sector Sault Sainte Marie or a designated representative.
Air Plan Approval; North Carolina: Amendments of Air Quality Rules
The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision submitted by the North Carolina Department of Environmental Quality, Division of Air Quality (DAQ), through a letter dated March 21, 2018, readopting and amending air quality rules related to transportation conformity requirements in the state of North Carolina. EPA has determined that North Carolina's March 21, 2018, SIP revision is consistent with the federal transportation conformity requirements and the Clean Air Act (CAA or Act).
Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Redesignation Requests and Maintenance Plans for Delaware County and Lebanon County 2012 Fine Particulate Matter Areas
The Environmental Protection Agency (EPA) is approving requests for redesignation to attainment status as well as state implementation plan (SIP) revisions submitted by the Commonwealth of Pennsylvania. On January 23, 2019 and February 11, 2019, respectively, the Pennsylvania Department of Environmental Protection (PADEP) submitted requests for EPA to redesignate the Delaware County and Lebanon County nonattainment areas (the Delaware and Lebanon Areas or the Areas) to attainment of the 2012 annual fine particulate matter (PM2.5) national ambient air quality standards (NAAQS). EPA is granting PADEP's requests and determining that the Delaware and Lebanon Areas meet the 2012 annual PM2.5 NAAQS, based on the most recent three years of certified air quality data. The effect of this action is to change the designation status of the Delaware and Lebanon Areas from nonattainment to attainment for the 2012 annual PM2.5 NAAQS, thereby removing the requirement for a nonattainment new source review (NNSR) permitting program and stopping the sanctions clock associated with a finding of failure to submit NNSR updates for the 2012 annual PM2.5 NAAQS. EPA is also approving PADEP's plans to ensure that the Delaware and Lebanon Areas continue to meet the 2012 PM2.5 NAAQS through 2030 (maintenance plans) as revisions to the Pennsylvania SIP. The maintenance plans for the Delaware and Lebanon Areas include 2014, 2022, and 2030 motor vehicle emissions budgets (MVEBs) for mobile sources of PM2.5 and nitrogen oxides (NOX). Finally, EPA is finding these 2014, 2022, and 2030 MVEBs for PM2.5 and NOX adequate and is approving these MVEBs into the Pennsylvania SIP for transportation conformity purposes. This action is being taken under the Clean Air Act (CAA).
Fisheries of the Northeastern United States; Scup Fishery; Adjustment to the 2019 Winter II Quota
NMFS adjusts the 2019 Winter II commercial scup quota and per- trip Federal landing limit. This action is intended to comply with Framework Adjustment 3 to the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan that established the rollover of unused commercial scup quota from the Winter I to Winter II period. This document is intended to inform the public of this quota and trip limit change.
Air Plan Approval; Missouri; Infrastructure State Implementation Plan Requirements for the 2015 Ozone National Ambient Air Quality Standard
The Environmental Protection Agency (EPA) is approving elements of a State Implementation Plan (SIP) revision submission from the State of Missouri addressing the applicable requirements of section 110 of the Clean Air Act (CAA) for the 2015 Ozone (O3) National Ambient Air Quality Standard (NAAQS). Section 110 requires that each state adopt and submit a SIP revision to support the implementation, maintenance, and enforcement of each new or revised NAAQS promulgated by the EPA. These SIPs are commonly referred to as ``infrastructure'' SIPs. The infrastructure requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities under the CAA. The EPA is also approving a request from the State to exempt all counties in the Metropolitan Kansas City Interstate Air Quality Control Region (Kansas City AQCR) and all of Jefferson and most of Franklin (except Boles Township) counties in the Metropolitan St. Louis Interstate (St. Louis AQCR) from needing an ozone contingency plan meeting the EPA's requirements.
Approval of Air Quality Improvement Plan, Operating Permits Program, and 112(l) Plan; Missouri; Operating Permits
The Environmental Protection Agency (EPA) is taking final action to approve revisions to the State Implementation Plan (SIP), the Operating Permit Program (OPP), and the 112(l) plan submitted on March 7, 2019, by the State of Missouri. The submission revises Missouri's regulations relating to the requirement for sources of air contaminants to obtain operating permits and to establish procedures for sources of air contaminants to obtain and comply with operating permits. These revisions are primarily administrative in nature and do not impact the stringency of the SIP, the OPP, or the 112(l) plan. Specifically, the revisions correct references, change the term ``regulated pollutant'' to ``regulated air pollutant'', removes unnecessary words, and add definitions. Approval of these revisions will not impact air quality and ensures Federal enforceability of the State's rules.
Special Local Regulation; Kailua Bay, Ironman World Championship, Kailua-Kona, Hawaii
The Coast Guard is establishing a recurring special local regulation for certain waters of Kailua Bay, Hawaii. This action is necessary to provide for the safety of life on these navigable waters located at Kailua-Kona, HI, during the swim portion of the Ironman World Championship Triathlon and practice swim held on consecutive weekends annually in October. On both days, the swim events are held from 3:45 a.m. to 11 a.m. This rulemaking prohibits persons and vessels from being in the regulated area each day of the event unless authorized by the Captain of the Port Honolulu.
Determination of Active Military Service and Discharge for Civilian or Contractual Groups
This final rule removes the Department of the Air Force's regulation containing procedures for processing discharge applications of civilians or contractors claiming prior active military service with the Air Force or a predecessor organization. The content of this part is addressed in a DoD-level regulation, and it is unnecessary.
General Technical, Organizational, Conforming, and Correcting Amendments to the Federal Motor Carrier Safety Regulations
FMCSA amends its regulations by making technical corrections throughout the Federal Motor Carrier Safety Regulations. The Agency makes minor changes to correct inadvertent errors and omissions, remove or update obsolete references, and improve the clarity and consistency of certain regulatory provisions. The Agency also makes nondiscretionary, ministerial changes that are statutorily mandated.
Proposed Rescission of Policy Statements
In an ongoing effort to streamline issuances by the FDIC to the public and to ensure that such issuances are timely, relevant, and effective, the FDIC initiated a comprehensive review of its Statements of Policy to identify those that could be rescinded. Additionally, the FDIC, in the 2017 report required by the Economic Growth and Regulatory Paperwork Reduction Act, committed to reviewing published guidance to identify any guidance that should be revised or rescinded because it is out-of-date or otherwise no longer relevant.
Completing the Transition to Electronic Filing, Licenses and Authorizations, and Correspondence in the Wireless Radio Services
This Notice of Proposed Rulemaking (NPRM) builds upon the Commission's recent efforts to modernize its legacy filing, communications, and information retention systems by improving electronic access to data and digitizing Commission communications in a wide variety of services. Specifically, this NPRM proposes to make all filings to the Universal Licensing System (ULS) completely electronic; expand electronic filing and correspondence elements for related systems; and require applicants to provide an email address on the FCC Forms related to these systems. This NPRM also seeks comment on additional rule changes that would further expand the use of electronic filing and electronic service. Together, these proposals will facilitate the remaining steps to transition these systems from paper to electronic, reducing regulatory burdens and environmental waste, and making interaction with these systems more accessible and efficient for those who rely on them.
Rules of Conduct and Standards of Responsibility for Appointed Representatives; Correction
On July 2, 2018, we published final rules in the Federal Register revising our rules of conduct and standards of responsibility for representatives. Those final rules reduced the amount of time to request Appeals Council review of a hearing officer's decision from 30 days to 14 business days, but we inadvertently failed to make the same change in the parallel sections of the CFR, which details when the Appeals Council will dismiss a request for review. This document corrects the omitted sections and makes our regulations consistent.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Coal Mine Dust Sampling Devices
The Department of Labor (DOL) is submitting the Mine Safety and Health Administration (MSHA) sponsored information collection request (ICR) titled, ``Coal Mine Dust Sampling Devices,'' to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
Application of the Employer Shared Responsibility Provisions and Certain Nondiscrimination Rules to Health Reimbursement Arrangements and Other Account-Based Group Health Plans Integrated With Individual Health Insurance Coverage or Medicare
This document sets forth proposed regulations to clarify the application of the employer shared responsibility provisions and certain nondiscrimination rules under the Internal Revenue Code (Code) to health reimbursement arrangements (HRAs) and other account-based group health plans integrated with individual health insurance coverage or Medicare (individual coverage HRAs), and to provide certain safe harbors with respect to the application of those provisions to individual coverage HRAs. The proposed regulations are intended to facilitate the adoption of individual coverage HRAs by employers, and taxpayers generally are permitted to rely on the proposed regulations. The proposed regulations would affect employers, employees and their family members, and plan sponsors.
Magnuson-Stevens Act Provisions; General Provisions for Domestic Fisheries; Pacific Coast Groundfish Fishery; Application for an Exempted Fishing Permit
The Assistant Regional Administrator for Sustainable Fisheries, West Coast Region, NMFS, has made a preliminary determination that an exempted fishing permit application titled, ``Annual Vessel Limit Pooling for Groundfish IFQ Vessels Operating Under a Collective Enforcement Agreement in 2019-2020,'' contains all of the required information and warrants further consideration. The application, submitted by the Fort Bragg Association and the Half Moon Bay Groundfish Marketing Association, requests approval to test the use of a voluntary collective agreement to manage a pool of annual vessel limits of cowcod quota pounds using a risk pooling model. This exempted fishing permit project would allow individual vessels participating in the California Groundfish Collective to exceed their annual vessel limit for cowcod, however the collective pooled annual vessel limit would not be exceeded. The primary goal of this exempted fishing permit project is to reduce the operational risk of catching cowcod for participating vessels, while allowing participating vessels to increase landings of more abundant groundfish stocks. Regulations under the Magnuson-Stevens Fishery Conservation and Management Act require publication of this notification to provide interested parties the opportunity to comment on applications for proposed exempted fishing permit projects.
Filing of Plats of Survey: Alaska
The plats of survey of lands described in this notice are scheduled to be officially filed in the Bureau of Land Management (BLM), Alaska State Office, Anchorage, Alaska. These surveys were executed at the request of the BLM, and are necessary for the management of these lands.
Results of Soybean Request for Referendum
The results of the Agricultural Marketing Service's (AMS) Request for Referendum indicate that too few soybean producers wanted a referendum on the Soybean Promotion and Research Order (Order) for one to be conducted. The Request for Referendum was conducted from May 6, 2019, through May 31, 2019, at the U.S. Department of Agriculture's (USDA) Farm Service Agency county offices. To trigger a referendum, 51,501 soybean producers, 10 percent of the total nationwide soybean producers, needed to complete a valid Request for Referendum. The total number of soybean producers participating in the referendum was 794. The number of valid petitions received was 708.
Notice of OFAC Sanctions Actions
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them. Additionally, OFAC is publishing the names of one or more persons that have been removed from the SDN List. Their property and interests in property are no longer blocked, and U.S. persons are no longer generally prohibited from engaging in transactions with them.
Information Collection; Application for Permit for Use of Roads, Trails, or Areas Restricted by Regulation or Order
In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comment from all interested individuals and organizations on the extension with no revisions of a currently approved information collection, OMB 0596-0016), Application for Permit for Use of Roads, Trails, or Areas Restricted by Regulation or Order (form FS-7700-40). The Forest Service is also seeking renewal of an associated existing, form FS-7700-48, Permit for Use of Roads, Trails, or Areas Restricted by Regulation or Order, and renewal of an associated existing information collection, form FS-7700-41, Non- Federal Commercial Road Use Permit.
Open Commission Meeting, Thursday, September 26, 2019
The Commission will consider a Report and Order that would allocate $950 million in fixed and mobile high-cost universal service support for Stage 2 of the Uniendo a Puerto Rico Fund and the Connect USVI Fund to expand, improve, and harden communications networks in Puerto Rico and the U.S. Virgin Islands. The Commission will also consider an Order on Reconsideration that would dispose of two petitions related to Uniendo a Puerto Rico Fund and Connect USVI Fund advance support and Stage 1 support.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Application for Approval To Participate in Federal Student Aid Programs
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Information Collections Being Reviewed by the Federal Communications Commission Under Delegated Authority
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Information Collections Being Submitted for Review and Approval to Office of Management and Budget
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Pursuant to the Small Business Paperwork Relief Act of 2002, the FCC seeks specific comment on how it might ``further reduce the information collection burden for small business concerns with fewer than 25 employees.'' The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Record of Decision for Final Environmental Impact Statement for Remediation of Area IV and the Northern Buffer Zone of the Santa Susana Field Laboratory, California
The U.S. Department of Energy (DOE) announces its decision to demolish the 18 buildings it owns in Area IV of the Santa Susana Field Laboratory (SSFL) and dispose of or recycle the materials off site. This action will be taken in accordance with applicable federal, state, and local requirements. (The demolition of five of the eighteen buildings and the disposal of the resulting debris will be accomplished pursuant to closure plans approved by the California Department of Toxic Substances Control.) This action will also be taken consistent with agreements and decisions resulting from interagency consultations conducted in accordance with applicable federal, state, and local requirements, including the Programmatic Agreement executed with the California State Historic Preservation Officer pursuant to the National Historic Preservation Act and the Biological Opinion issued by the U.S. Fish and Wildlife Service pursuant to the Endangered Species Act.
Stakeholder Input on Best Practices for Establishment and Operation of Local Community Advisory Boards in Response to a Portion of the Nuclear Energy Innovation and Modernization Act
The U.S. Nuclear Regulatory Commission (NRC) is undertaking activities to develop a report identifying best practices for establishment and operation of local community advisory boards (CABs) associated with decommissioning activities, including lessons learned from existing boards, as required by the Nuclear Energy Innovation and Modernization Act (NEIMA). As part of developing the report, the NRC is hosting 11 public meetings and a public webinar to consult with host States, communities within the emergency planning zone of an applicable nuclear power reactor, and existing local CABs. In addition to these public meetings and public webinar, the NRC has developed a questionnaire to collect information regarding the areas identified in NEIMA with respect to the creation and operation of CABs. The results of the meetings, along with any other data received as a result of the NRC's information collection activities associated with the NEIMA Section 108, will be captured in a best practices report that will be submitted to Congress.
Certain Frozen Warmwater Shrimp From India: Notice of Final Results of Antidumping Duty Changed Circumstances Review
On August 12, 2019, the Department of Commerce (Commerce) published the preliminary results of the changed circumstances review of the antidumping duty order on certain frozen warmwater shrimp (shrimp) from India. For these final results, Commerce continues to find that Sunrise Seafoods India Private Limited (SSIPL) is the successor-in-interest to Sunrise Aqua Food Exports (SAFE).
National Express Transit Corporation-Acquisition of Control-Fox Bus Lines, Inc.
On August 30, 2019, National Express Transit Corporation (National Express), an intrastate passenger motor carrier, filed an application for National Express to acquire control of Fox Bus Lines, Inc. (Fox), an interstate passenger motor carrier, from Fox's shareholders, Brian A. Fox, Stephen J. Fox, Catherine Fox, and William L. Fox, Jr. (collectively, Sellers). The Board is tentatively approving and authorizing the transaction, and, if no opposing comments are timely filed, this notice will be the final Board action. Persons wishing to oppose the application must follow the rules.
Dried Tart Cherries From the Republic of Turkey: Preliminary Affirmative Countervailing Duty Determination
The Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers and exporters of dried tart cherries (cherries) from the Republic of Turkey (Turkey). The period of investigation is January 1, 2018 through December 31, 2018. Interested parties are invited to comment on this preliminary determination.
Hardwood Plywood Products From the People's Republic of China: Rescission of Antidumping Duty New Shipper Review; 2019
The Department of Commerce is rescinding the new shipper review of the antidumping duty order on hardwood plywood products from the People's Republic of China for the period January 1, 2019, through June 30, 2019, based on the timely withdrawal of the request for review.
Dried Tart Cherries From the Republic of Turkey: Preliminary Affirmative Determination of Sales at Less Than Fair Value
The Department of Commerce (Commerce) preliminarily determines that dried tart cherries (cherries) from the Republic of Turkey (Turkey) are being, or are likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is April 1, 2018 through March 31, 2019. Interested parties are invited to comment on this preliminary determination.
Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act.'' This guidance provides clarity on FDA's current thinking regarding changes made by the 21st Century Cures Act (Cures Act) to the definition of a medical device and the resulting effect on guidances related to medical device software.
Clinical Decision Support Software; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Clinical Decision Support Software.'' This guidance clarifies the types of clinical decision support (CDS) functions that do not meet the definition of a device as amended by the 21st Century Cures Act (Cures Act). This guidance describes a risk-based approach for regulatory oversight of CDS software functions that remain devices using the categories defined by the International Medical Device Regulators Forum (IMDRF) final document entitled ``Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations.'' The guidance also provides clarity on the types of CDS software functions on which FDA intends to focus its regulatory oversight for health care providers, patients, and caregivers. This draft guidance is not final nor is it in effect at this time.
Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Marine Site Characterization Surveys Off of Delaware and Maryland
NMFS has received a request from Skipjack Offshore Energy, LLC (Skipjack) for authorization to take marine mammals incidental to marine site characterization surveys offshore of Delaware in the area of the Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf (OCS-A 0519) and along potential submarine cable routes to a landfall location in Delaware or Maryland. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-year renewal that could be issued under certain circumstances and if all requirements are met, as described in Request for Public Comments at the end of this notice. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorizations and agency responses will be summarized in the final notice of our decision.
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