November 27, 2020 – Federal Register Recent Federal Regulation Documents

In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Education (BIE) is proposing to renew an information collection with revisions.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #242 entitled ``In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products.'' The purpose of in-use stability testing is to establish a period of time during which a multiple-dose drug product may be used while retaining acceptable quality specifications once the container is opened (e.g., after a container has been needle-punctured). This guidance reflects the Agency's current thinking on how to formulate in-use statements, as well as how to design and carry out in-use stability studies to support these in-use statements, for multiple-dose injectable drug products intended for use in animals. This current thinking pertains to both generic drug products and pioneer drug products regardless of whether the pioneer reference listed new animal drug (RLNAD) currently has an in-use statement on the labeling.

Noramco Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

Meridian Medical Technologies has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

The Commodity Futures Trading Commission (CFTC) is announcing an opportunity for public comment on the proposed renewal of a 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. This notice solicits comments on requirements relating to Gross Collection of Exchange-Set Margins for Omnibus Accounts.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research and development.

This Federal Register Notice (FRN) serves as notice of the adoption by the U.S. Army Research Institute for the Behavioral and Social Sciences (ARI) of the personnel demonstration project flexibilities implemented by the Combat Capabilities Development Command (CCDC) Command, Control, Communications, Computers, Cyber, Intelligence, Surveillance, and Reconnaissance (C5ISR) Center (previously designated as the U.S. Army CommunicationsElectronics Research, Development and Engineering Center and the U.S. Army CommunicationsElectronics Command, Research, Development and Engineering), the CCDC Chemical Biological Center (CBC) (previously designated as the Edgewood Chemical Biological Center), and the CCDC Soldier Center (SC) (previously designated as the Natick Soldier Research, Development and Engineering Center). The majority of flexibilities and administrative procedures are adopted without changes. However, modifications were made when necessary to address ARI's specific organizational, management structure, workforce, and approval needs and to conform to changes in applicable law and regulations after the publication of the adopted personnel demonstration project flexibilities. In addition, changes were made based on current law, best practices, and administrative guidance.

FMCSA announces its decision to renew exemptions for 44 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these individuals to continue to operate CMVs in interstate commerce without meeting the vision requirement in one eye.

FMCSA announces receipt of applications from three individuals for an exemption from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. If granted, the exemptions will enable these individuals to operate CMVs in interstate commerce without meeting the vision requirement in one eye.

The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.

This notice identifies Schedule A, B, and C appointing authorities applicable to a single agency that were established or revoked from March 1, 2020 to March 31, 2020.

The Bureau of Land Management (BLM) intends to dispose of the reversionary interest held by the United States in a 10-acre parcel of public land in Pershing County, Nevada, pursuant to Section 203 and Section 209 of the Federal Land Policy and Management Act of October 21, 1976 (FLPMA), as amended, through a non-competitive direct sale to Pershing County. The BLM has found the reversionary interest and conveyance of the mineral interest suitable for disposal under the authority of Section 203 and Section 209 of FLPMA.

The U.S. Nuclear Regulatory Commission (NRC) is soliciting for nominations for the Patients' Rights Advocate representative position on the Advisory Committee of the Medical Uses of Isotopes (ACMUI). Patients' Rights Advocate nominees should have professional or personal experience with and/or knowledge about patient advocacy. Also, involvement or leadership with patient advocacy organizations is preferred.

The U.S. Department of Energy (DOE) invites public comment on its Request for Information (RFI) number DE-FOA-0002389 regarding offshore wind transmission system integration research needs. The DOE's Wind Energy Technologies Office (WETO) is seeking information from the public on research needs regarding the integration of large-scale offshore wind energy generation into the transmission grid. In addition to input on overall research priorities, focus areas include considerations of technical means to enhance transmission utilization and mitigate congestion; updates to system integration studies and analyses in view of anticipated offshore wind additions; and priorities for improvements to data, models, and analytical tools. This RFI is intended to inform WETO's strategic planning on research aimed at lowering the cost of integrating offshore wind power into the grid, while enhancing system reliability and resiliency.

The Commission hereby gives notice of the scheduling of the final phase of antidumping and countervailing duty investigation Nos. 701-TA-643 and 731-TA-1493 (Final) pursuant to the Tariff Act of 1930 (``the Act'') to determine whether an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of small vertical shaft engines from China, provided for in subheadings 8407.90.10, 8409.91.99, 8433.11.00, 8424.30.90, and 8407.90.90 of the Harmonized Tariff Schedule of the United States, preliminarily determined by the Department of Commerce (``Commerce'') to be subsidized and sold at less-than-fair-value.

The Mid-Atlantic Fishery Management Council (Council) will hold public meetings of the Council.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Ag Chem Resources, LLC, proposing that the food additive regulations be amended to provide for the safe use of tannic acid as a flavoring agent in animal feed.

The FAA proposes to adopt a new airworthiness directive (AD) for certain Yabor[atilde] Ind[uacute]stria Aeron[aacute]utica S.A. Model EMB-135, EMB-145, -145ER, -145MR, -145LR, -145XR, -145MP, and - 145EP airplanes. This proposed AD was prompted by reports that calculations provided by the automatic takeoff thrust control system (ATTCS) are incorrect under certain conditions. This proposed AD would require updating the software of the installed full authority digital engine control (FADEC) systems, as specified in an Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil (ANAC) AD, which will be incorporated by reference. The FAA is proposing this AD to address the unsafe condition on these products.

NMFS issues a final rule under the authority of the Magnuson- Stevens Fishery Conservation and Management Act (MSA) to approve and implement rebuilding plans recommended by the Pacific Fishery Management Council (Council) for two overfished salmon stocks: Klamath River fall-run Chinook salmon (KRFC) and Sacramento River fall-run Chinook salmon (SRFC). NMFS determined in 2018 that these stocks were overfished under the MSA, due to spawning escapement falling below the required level for the three-year period 2015-2017. The MSA requires overfished stocks to be rebuilt, generally within 10 years.

This interim final rule with comment period (IFC) implements the Most Favored Nation (MFN) Model, a new Medicare payment model under section 1115A of the Social Security Act (the Act). The MFN Model will test whether more closely aligning payment for Medicare Part B drugs and biologicals (hereafter, referred to as ``drugs'') with international prices and removing incentives to use higher-cost drugs can control unsustainable growth in Medicare Part B spending without adversely affecting quality of care for beneficiaries.

The Immediate Office of the Secretary (IOS) is issuing this Request for Information (RFI) to assist the Department in identifying redundant, overlapping, or inconsistent regulations.