June 2020 – Federal Register Recent Federal Regulation Documents

Huawei Technologies Co., Ltd. (Huawei) and 114 of its foreign affiliates were added to the Entity List by the Bureau of Industry and Security (BIS) in 2019, but continue to participate in many important international standards organizations in which U.S. companies also participate. As international standards serve as the building blocks for product development and help ensure functionality, interoperability, and safety of the products, it is important to U.S. technological leadership that U.S. companies be able to work in these bodies in order to ensure that U.S. standards proposals are fully considered. Since Huawei's addition to the Entity List, organizations have consequently sought clarity about U.S. industry participation in standards development. BIS is amending the Export Administration Regulations (EAR) to authorize the release of certain technology to Huawei and its affiliates on the Entity List without a license if such release is made for the purpose of contributing to the revision or development of a ``standard'' in a ``standards organization.'' For the purpose of this interim final rule, a ``standard'' is as defined in Office of Management and Budget (OMB) Circular A-119: Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities, and a ``standards organization,'' is the equivalent of a ``voluntary consensus standards body'' as defined in Office of Management and Budget (OMB) Circular A- 119: Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities. This interim final rule does not change the assessment of whether ``technology'' is subject to the EAR. BIS is requesting comments on the impact of these revisions.

The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed reinstatement of a currently approved collection, and allow 60 days for public comment in response to the notice.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with FDA research in obtaining information from pharmacists and other management at outsourcing facilities as well as at related compounding businesses to support a comprehensive analysis of the outsourcing facility sector that will inform ongoing FDA work in this area.

The FAA proposes to supersede Airworthiness Directive (AD) 2007-26-51, which applies to certain Airbus Helicopters Deutschland GmbH Model EC135 helicopters. AD 2007-26-51 requires an inspection of the tail rotor control rod (control rod) and ball pivot and, depending on findings, replacing these parts. Since the FAA issued AD 2007-26-51, the manufacturer developed a new control rod, which the FAA has determined must be installed in order to address the identified unsafe condition. This proposed AD would require an inspection of certain ball pivots, application of corrosion preventative compound on the ball pivot, and corrective action, as applicable. This proposed AD would also require replacement of the control rod with the newly developed control rod. The FAA is proposing this AD to address the unsafe condition on these products.

The Environmental Protection Agency (EPA) is proposing approval of a State Implementation Plan (SIP) revision submitted by the State of Rhode Island. The SIP revision consists of a demonstration that Rhode Island meets the requirements of reasonably available control technology (RACT) for the two precursors for ground-level ozone, oxides of nitrogen (NOX) and volatile organic compounds (VOCs), set forth by the Clean Air Act (CAA or Act) with respect to the 2008 and 2015 ozone National Ambient Air Quality Standards (NAAQSs or standards). Additionally, we are proposing approval of specific regulations that implement the RACT requirements by limiting air emissions of NOX and VOC pollutants from sources within the State. This action is being taken in accordance with the Clean Air Act.

This regulation establishes an exemption from the requirement of a tolerance for residues of fulvic acid when used as an inert ingredient (carrier) in pesticide formulations applied to growing crops and to raw agricultural commodities after harvest. Nutri Ag Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of fulvic acid when used in accordance with the terms of the exemption.

The Acting Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule N,N-diethyl-2-(2-(4 isopropoxybenzyl)-5-nitro-1H- benzimidazol-1-yl)ethan-1-amine (commonly known as isotonitazene), including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible, in schedule I of the Controlled Substances Act. When it is issued, the temporary scheduling order will impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle isotonitazene.

NMFS announces management measures for the 2020 summer flounder recreational fishery. The implementing regulations for this fishery require NMFS to publish recreational measures for the fishing year. The intent of this action is to achieve, but not exceed, the 2020 summer flounder recreational harvest limit and thereby prevent overfishing on the summer flounder stock.

This regulation establishes and amends tolerances for residues of fenpyroximate in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

In this document the Commission adopts changes to its rules and procedures for broadcast station applicants to provide public notice of application filings to the principal area that is served or to be served by the station. The changes are designed to improve, streamline, and standardize the notices, including replacing notice by newspaper with online notice. The changes are further designed to enhance rule compliance and public participation in the application process, increase public access to filed applications, and reduce applicant burdens.

The U.S. Department of Agriculture, Forest Service, is giving notice of intent to issue an order closing the Beattie Gulch Trailhead and McConnell Fishing Access areas north and west of Gardiner, Montana to the discharge of firearms in advance of the public comment period for the proposed closure. At the end of the notice of intent period, the Forest Service will solicit public comments, as specified in this notice, on the proposed forest order.

NMFS is opening the Summer Herring Savings Area 2 in the Bering Sea subarea of the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent the underharvest of the 2020 pollock total allowable catch (TAC) and facilitate pollock harvest by the American Fisheries Act (AFA) inshore sector, AFA mothership sector, and Community Development Quota (CDQ) program in the Bering Sea subarea of the BSAI.

NMFS and the Assessment Oversight Panel will convene the Management Track Assessment Peer Review Meeting for the purpose of reviewing Atlantic Herring, Butterfish, Atlantic Surf Clam, and Longfin Inshore Squid. The Management Track Assessment Peer Review is a formal scientific peer-review process for evaluating and presenting stock assessment results to managers for fish stocks in the offshore U.S. waters of the northwest Atlantic. Assessments are prepared by Stock Assessment Workshop (SAW) working groups and reviewed by an independent panel of stock assessment experts called the Assessment Oversight Panel (AOP). The public is invited to attend the presentations and discussions between the review panel and the scientists who have participated in the stock assessment process.

On June 9, 2020, the Department of Commerce, published a 30- day public comment period notice in the Federal Register with FR Document Number 2020-12413 (Pages 35257-35258), and on March 24, 2020, published a 60-day public comment period notice with FR Document Number 2020-06174 (Page 16612) seeking public comments for an information collection entitled, ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.'' This document referenced incorrect information in the DATA section, and Commerce hereby issues a correction notice as required by the Paperwork Reduction Act of 1995.

Free Atlantic Shark Identification Workshops and Safe Handling, Release, and Identification Workshops will be held in July, August, and September of 2020. Certain fishermen and shark dealers are required to attend a workshop to meet regulatory requirements and to maintain valid permits. Specifically, the Atlantic Shark Identification Workshop is mandatory for all federally permitted Atlantic shark dealers. The Safe Handling, Release, and Identification Workshop is mandatory for vessel owners and operators who use bottom longline, pelagic longline, or gillnet gear, and who have also been issued shark or swordfish limited access permits. Additional free workshops will be conducted during 2020 and will be announced in a future notice.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on March 9, 2020. The document announced the withdrawal of approval (as of April 8, 2020) of 16 abbreviated new drug applications (ANDAs) from multiple applicants. The document indicated that FDA was withdrawing approval of the following four ANDAs after receiving a withdrawal request from Lupin Pharmaceuticals, Inc., 111 South Calvert St., Harborplace Tower, 21st Floor, Baltimore, MD 21202: ANDA 065488, Azithromycin Oral Suspension, Equivalent to (EQ) 100 milligrams (mg) base/5 milliliters (mL); EQ 200 mg base/5 mL; ANDA 078410, Topiramate Tablets, 25 mg, 50 mg, 100 mg, and 200 mg; ANDA 090441, Imipramine Hydrochloride Tablets, 10 mg, 25 mg, and 50 mg; and ANDA 200563, Ciprofloxacin Oral Suspension, 250 mg/5 mL and 500 mg/5 mL. Before FDA withdrew the approval of these ANDAs, Lupin Pharmaceuticals, Inc., informed FDA that it did not want the approval of the ANDAs withdrawn. Because Lupin Pharmaceuticals, Inc., timely requested that approval of these ANDAs not be withdrawn, the approval of ANDAs 065488, 078410, 090441, and 200563 is still in effect.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry.'' The revised guidance provides blood establishments that collect blood and blood components with FDA's recommendations to reduce the risk of transfusion-transmitted malaria. The recommendations contained in this guidance apply to the collection of Whole Blood and blood components, except Source Plasma. Blood establishments are not required to assess Source Plasma donors for malaria risk. The guidance announced in this notice supersedes the guidance entitled ``Recommendations for Donor Questioning, Deferral, Reentry, and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry'' dated August 2013 and updated August 2014.

This notice informs the public that the Assistant Secretary Indian Affairs proclaimed approximately 114 acres, more or less, an addition to the reservation of the Shakopee Mdewakanton Sioux Community of Minnesota on June 3, 2020.

This notice announces that the Model Tribal Gaming Compact between the United Keetoowah Band of Cherokee Indians in Oklahoma and the State of Oklahoma (Compact), and the Extension of State-Tribal Gaming Compact between the State Of Oklahoma and the United Keetoowah Band of Cherokee Indians in Oklahoma (Extension), are taking effect.

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 Ohio Advisory Committee (Committee) will hold a series of web based hearings to hear testimony regarding COVID-19 and health disparities in the state.

This notice sets forth the schedule and proposed agenda of a forthcoming meeting of the ACVETEO. The ACVETEO will discuss the DOL core programs and services that assist veterans seeking employment and raise employer awareness as to the advantages of hiring veterans. There will be an opportunity for individuals or organizations to address the committee. Any individual or organization that wishes to do so should contact Mr. Gregory Green at 202-693-4734. Additional information regarding the Committee, including its charter, current membership list, annual reports, meeting minutes, and meeting updates may be found at https://www.dol.gov/agencies/vets/about/advisorycommittee. Individuals who will need accommodations for a disability in order to attend the meeting (e.g., interpreting services, assistive listening devices, and/or materials in alternative format) should notify the Advisory Committee no later than Monday, July 13, 2020 by contacting Mr. Gregory Green at 202-693-4734. Requests made after this date will be reviewed, but availability of the requested accommodations cannot be guaranteed. The meeting site is accessible to individuals with disabilities. This Notice also describes the functions of the ACVETEO. Notice of this meeting is required under Section 10(a) (2) of the Federal Advisory Committee Act. This document is intended to notify the general public.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components.'' The guidance provides blood establishments that collect blood and blood components with revised recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components. The recommendations in the guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma. The guidance finalizes the draft guidance of the same title dated January 2020, and supersedes the document entitled ``Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products, Guidance for Industry,'' dated May 2010, and updated January 2016.