October 1, 2020 – Federal Register Recent Federal Regulation Documents

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Santa Barbara Museum of Natural History has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present- day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the Santa Barbara Museum of Natural History. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), this notice announces the Agricultural Marketing Service's (AMS) intention to request approval from the Office of Management and Budget (OMB) for an extension of the currently approved information collection used to compile and generate the Federally Inspected Estimated Daily Slaughter Report. Upon approval of this information collection, AMS will request approval from the OMB to merge this collection, ``Plan for Estimating Daily Livestock Slaughter Under Federal Inspection'' (OMB 0581-0050), with the currently approved information collection titled ``Livestock, Poultry, and Grain Market News'' (OMB 0186-0033). Both collections are directed and authorized by the Agricultural Marketing Act of 1946 (7 U.S.C. 1621-1627), and rely on voluntary cooperation with the livestock industry to collect and disseminate marketing information, utilizing the same information gathering tactics.

FMCSA announces its decision to renew exemptions for 14 individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these hard of hearing and deaf individuals to continue to operate CMVs in interstate commerce.

The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice (Notice) of receipt of an application (Application), filed on September 3, 2020, by Sabine Pass Liquefaction, LLC (SPL). SPL seeks to amend the export term set forth in its current authorizations to export liquefied natural gas (LNG) to non-free trade agreement countries, DOE/FE Order Nos. 2961-A, 3669, and 3792, to a term ending on December 31, 2050. SPL filed the Application under the Natural Gas Act (NGA) and DOE's policy statement entitled, ``Extending Natural Gas Export Authorizations to Non-Free Trade Agreement Countries Through the Year 2050'' (Policy Statement). Protests, motions to intervene, notices of intervention, and written comments on the requested term extension are invited.

The Advisory Committee on Commercial Remote Sensing (``ACCRES'') will meet for 2 half-day meetings on October 27 and October 28, 2020.

Applicant seeks an order declaring that it has ceased to be an investment company. On April 24, 2020, applicant made liquidating distributions to its shareholders based on net asset value. Expenses of $6,295 incurred in connection with the liquidation were paid by the applicant, and the applicant's investment adviser. Filing Dates: The application was filed on July 1, 2020, and amended on September 18, 2020. Applicant's Address: swellman@bmtc.com.

Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Digital Imaging Devices and Products Containing the Same and Components Thereof, DN 3494; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.

The Commission hereby gives notice that it has instituted reviews pursuant to the Tariff Act of 1930 (``the Act''), as amended, to determine whether revocation of the countervailing duty order on carbazole violet pigment 23 from India and the antidumping duty orders on carbazole violet pigment 23 from China and India would be likely to lead to continuation or recurrence of material injury. Pursuant to the Act, interested parties are requested to respond to this notice by submitting the information specified below to the Commission.

The Commission hereby gives notice that it has instituted a review pursuant to the Tariff Act of 1930 (``the Act''), as amended, to determine whether revocation of the antidumping duty order on barium chloride from China would be likely to lead to continuation or recurrence of material injury. Pursuant to the Act, interested parties are requested to respond to this notice by submitting the information specified below to the Commission.

The Department of Labor (DOL) is submitting this Bureau of Labor Statistics (BLS)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.

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 Maine Advisory Committee (Committee) will hold a meeting on Thursday, October 15, 2020, at 12:00 p.m. (EDT) for the purpose of meeting is to discuss next steps for its digital equity project.

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 (FACA) that a teleconference meeting of the Hawai'i Advisory Committee (Committee) to the Commission will be held at 10:00 a.m. on Friday, October 16, 2020 (Hawaiian Time). The purpose of the meeting will be to continue planning for their webhearings on COVID-19 and Pacific Islander communities.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``The Use of Physiologically Based Pharmacokinetic AnalysesBiopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls.'' This guidance provides general recommendations regarding the development, evaluation, and use of physiologically based pharmacokinetic (PBPK) analyses for biopharmaceutics applications employed by sponsors of investigational new drug applications, new drug applications, or abbreviated new drug applications, and supplements to these applications, for oral drug product development, manufacturing changes, and controls. The guidance covers how to develop, evaluate, and apply PBPK models for biopharmaceutics-related uses, such as establishing clinically relevant dissolution specifications and quality risk assessment for postapproval manufacturing changes.

The FAA proposes to adopt a new airworthiness directive (AD) for all Airbus SAS Model A318 series airplanes; Model A319-111, A319- 112, A319-113, A319-114, A319-115, A319-131, A319-132, A319-133, A319- 151N, and A319-153N airplanes; Model A320 series airplanes; and Model A321 series airplanes. This proposed AD was prompted by the results of laboratory tests on non-rechargeable lithium batteries installed in emergency locator transmitters (ELT), which highlighted a lack of protection against certain currents that could lead to thermal runaway and a battery fire. This proposed AD would require modifying a certain ELT by installing a diode in the airplane circuit connecting the ELT battery, as specified in a European Union Aviation Safety Agency (EASA) AD, which will be incorporated by reference. The FAA is proposing this AD to address the unsafe condition on these products.

The FAA proposes to adopt a new airworthiness directive (AD) for certain Bell Helicopter Textron Canada Limited Model 429 helicopters. This proposed AD was prompted by the introduction of a new life limit for the centrifugal force bearing (CFB). This proposed AD would require determining the accumulated retirement index number (RIN) and removing each affected CFB from service before it accumulates 8,000 total RIN. The FAA is proposing this AD to address the unsafe condition on these products.

The Secretary of HHS has determined that establishment of the Medicaid Reentry Stakeholder Group, as required by the Medicaid Reenty Act, is desirable to provide advice and consultation to the Secretary on innovative strategies to help individuals who are inmates of public institutions, and otherwise eligible for Medicaid, ensure continuity of coverage and seamless transitions back to the community. HHS is soliciting nominations for non-Federal members of the Stakeholder Group.

The FAA proposes to supersede Airworthiness Directive (AD) 2016-07-14, which applies to certain Airbus Model A319-111, -112, -113, -114, -115, -131, -132, and -133 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 2016-07-14 requires replacing the clips, shear webs, and angles, related investigative actions, and repair if necessary. Since the FAA issued AD 2016-07-14, it has been determined that the fatigue life associated with the clips, shear webs, and angles is not sufficient to reach the limit of validity (LOV) in certain configurations; therefore, additional modifications to the airplane are required. The FAA has also determined that additional airplanes are subject to the unsafe condition. This proposed AD would retain the actions of AD 2016-07-14, and require modifying (replacing) the clips, shear webs, and angles at a certain rear fuselage area with new parts, as specified in a European Union Aviation Safety Agency (EASA) AD, which will be incorporated by reference. The FAA is proposing this AD to address the unsafe condition on these products.

The FAA proposes to supersede Airworthiness Directive (AD) 2020-01-10, which applies to certain Airbus SAS Model A350-941 airplanes. AD 2020-01-10 requires installing flight control and guidance system (FCGS) software (SW) X11 Standard (STD). Since the FAA issued AD 2020-01-10, Airbus has developed a modification that forces the air generation system (AGS) ram air outlet doors to be flush in cases of total engine flameout or loss of the main electrical supply. Because of this additional modification, certain airplanes that were excluded from the applicability of AD 2020-01-10 are included in the applicability of this proposed AD. This proposed AD would retain the requirements of AD 2020-01-10, require modifying the electrical power supply of the AGS ram air outlet door actuators, and expand the applicability by adding airplanes, as specified in a European Union Aviation Safety Agency (EASA) AD, which will be incorporated by reference. The FAA is proposing this AD to address the unsafe condition on these products.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act.'' This guidance describes recommended procedures to obtain a National Drug Code (NDC) for certain FDA-approved prescription drugs that are imported into the United States in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), which would provide an additional avenue through which these drugs could be sold at a lower cost in the U.S. market. This guidance is intended to address certain challenges in the private market faced by manufacturers seeking to sell their drugs at lower costs. This guidance finalizes the draft guidance issued on December 23, 2019.