2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OXERVATE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of July 7, 2020. The document announced the dates that support and requirement will begin for version 1.7 of the Clinical Data Interchange Standards Consortium (CDISC) for Study Data Tabulation Model (SDTM) Implementation Guide (IG) 3.3, and for version 2.1 of the Define-Extensible Markup Language (Define-XML). The document provided the incorrect dates for these electronic study data standards. This document corrects those errors.

The Tennessee Valley Authority (TVA) has completed an inventory of associated funerary objects, in consultation with the appropriate Indian Tribes, and has determined that a cultural affiliation between the associated funerary objects and present-day Indian Tribes can reasonably be traced. Lineal descendants or representatives of any Indian Tribe not identified in this notice that wish to request transfer of control of the associated funerary objects should submit a written request to the TVA. If no additional requestors come forward, transfer of control of the associated funerary objects to the Indian Tribes stated in this notice may proceed.

The Tennessee Valley Authority (TVA) has completed an inventory of associated funerary objects, in consultation with the appropriate Federally-recognized Indian Tribes, and has determined that a cultural affiliation between the associated funerary objects and present-day Federally-recognized Indian Tribes can reasonably be traced. Lineal descendants or representatives of any Federally- recognized Indian Tribe not identified in this notice that wish to request transfer of control of the associated funerary objects should submit a written request to the TVA. If no additional requestors come forward, transfer of control of the associated funerary objects to the Federally-recognized Indian Tribes stated in this notice may proceed.

The University of Massachusetts Amherst, Department of Anthropology, has completed an inventory of human remains, 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 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 should submit a written request to the University of Massachusetts Amherst. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.

The Peabody Museum of Archaeology and Ethnology, Harvard University has completed an inventory of human remains, in consultation with the appropriate Indian Tribes, and has determined that there is a cultural affiliation between the human remains and present-day Indian Tribes. Representatives of any Indian Tribe that believes itself to be culturally affiliated with the human remains may contact the Peabody Museum of Archaeology and Ethnology, Harvard University. Repatriation of the human remains to the Indian Tribes stated below may occur if no additional claimants come forward.

The San Francisco District, U.S. Army Corps of Engineers (USACE), intends to prepare a feasibility study integrated with an environmental assessment (EA) or environmental impact statement (EIS) to evaluate coastal storm and flood risk management alternatives along 7.5 miles of the San Francisco Waterfront, from Aquatic Park to Herons Head Park, in the City of San Francisco, San Francisco County, California. The Port of San Francisco is the non-federal partner for the study. USACE will conduct early scoping to solicit public participation and input to inform the environmental analyses and to assist with determining the appropriate level of NEPA documentation required for the study.

Pursuant to the provisions of the Privacy Act of 1974, notice is hereby given that the Farm Credit Administration (FCA or Agency) is proposing to establish a new system of records. The Non-Payroll Employee Administrative Records System will collect information used for non-payroll personnel actions and human resources administrative purposes, including administering supplemental benefits, employee assistance programs, and work life programs.

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 Florida Advisory Committee (Committee) will hold a series of meetings via teleconference on Monday, September 14, and Wednesday, September 30, 2020 at 2:00 p.m. Eastern Time. The Committee will review and finalize its report to the Commission on voting rights in the state.

The Administration for Children and Families' (ACF) Administration for Native Americans (ANA) is requesting a revision to the information collection: Ongoing Progress Report (OPR) and the Objective Work Plan (OWP) (OMB #0970-0452). Changes are proposed to reduce the burden on the public by combining ANA's Annual Data Report (OMB #0970-0475) with the OPR.

The National Highway Traffic Safety Administration (NHTSA) invites public comments about our intention to request approval from the Office of Management and Budget (OMB) to reinstate a previously- approved information collection. Before a Federal agency can collect certain information from the public, it must receive approval from OMB. Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections. This document describes one collection of information for which NHTSA intends to seek OMB approval.

NHTSA has received almost identical petitions from 13 final- stage manufacturers of ``entertainer-type motorcoaches,'' seeking temporary exemption from a shoulder belt requirement of Federal Motor Vehicle Safety Standard (FMVSS) No. 208, ``Occupant crash protection,'' for side-facing seats on motorcoaches. The petitioners seek to install Type 1 seat belts (lap belt only) at side-facing seating positions, instead of Type 2 seat belts (lap and shoulder belts) required by FMVSS No. 208. Each petitioner states that, absent the requested exemption, it will otherwise be unable to sell a vehicle whose overall level of safety or impact protection is at least equal to that of a nonexempted vehicle. NHTSA is publishing this document to notify the public of the receipt of the petitions and to request comment on them, in accordance with statutory and administrative provisions.

The Environmental Protection Agency (EPA) is requesting comment on an application from Honda Motor Company (``Honda'') for off- cycle carbon dioxide (CO2) credits under EPA's light-duty vehicle greenhouse gas emissions standards. ``Off-cycle'' emission reductions can be achieved by employing technologies that result in real-world benefits, but where that benefit is not adequately captured on the test procedures used by manufacturers to demonstrate compliance with emission standards. EPA's light-duty vehicle greenhouse gas program acknowledges these benefits by giving automobile manufacturers several options for generating ``off-cycle'' CO2 credits. Under the regulations, a manufacturer may apply for CO2 credits for off-cycle technologies that result in off-cycle benefits. In these cases, a manufacturer must provide EPA with a proposed methodology for determining the real-world off-cycle benefit. Honda has submitted an application that describes a methodology for determining off-cycle credits from technologies described in their application. Pursuant to applicable regulations, EPA is making this off-cycle credit calculation methodology available for public comment.

In accordance with the Oil Pollution Act of 1990 (OPA); the National Environmental Policy Act of 1969 (NEPA); the Final Programmatic Damage Assessment Restoration Plan and Final Programmatic Environmental Impact Statement (Final PDARP/PEIS) and Record of Decision; and the Consent Decree, the federal and state natural resource trustee agencies for the Louisiana Trustee Implementation Group (LA TIG) have prepared the Louisiana Trustee Implementation Group Draft Restoration Plan #7 and Environmental Assessment: Wetlands, Coastal and Nearshore Habitats; and Birds (RP/EA #7). In the Draft RP/ EA #7, the LA TIG proposes projects to help restore bird habitat and marshes injured as a result of the Deepwater Horizon (DWH) oil spill in the Louisiana Restoration Area under the ``Wetlands, Coastal and Nearshore Habitats'' and ``Birds'' restoration types described in the Final PDARP/PEIS. The approximate cost to implement the LA TIG's proposed project with five preferred alternatives is $234,100,000. We invite public comments on the Draft RP/EA #7.

The U.S. Army Corps of Engineers Sacramento District (USACE), as the lead agency under the National Environmental Policy Act (NEPA), will prepare an Environmental Impact Statement (EIS) for construction of the Delta Conveyance Project. The California Department of Water Resources (DWR) is the project proponent and will be referred to hereafter as the Applicant. The EIS will analyze the Applicant's proposed action to construct new conveyance facilities in the Sacramento-San Joaquin Delta (Delta) which includes intake facilities on the Sacramento River, tunnel reaches and tunnel shafts, a southern forebay and pumping plant, and south Delta Conveyance facilities that would connect to the existing State Water Project (SWP) infrastructure.

In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension of a currently approved information collection, Disposal of Mineral Materials.

NMFS announces a public meeting of the Permanent Advisory Committee (PAC) to advise the U.S. Commissioners to the Commission for the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (WCPFC) on October 14-16, 2020. Meeting topics are provided under the SUPPLEMENTARY INFORMATION section of this notice.

The Environmental Protection Agency (EPA) is extending the public comment period for the document titled, ``Availability of the IRIS Assessment Plan for Oral Exposure to Vanadium and Compounds.'' The original Federal Register document announcing the public comment period was published on July 24, 2020. The public science webinar will still convene on August 19, 2020.

The Acting Administrator of the Drug Enforcement Administration is issuing this 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. This action is based on a finding by the Acting Administrator that the placement of isotonitazene in schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or propose to handle isotonitazene.

This notice is a request for comments from the public to assist the Secretary of Labor and the United States Trade Representative in preparing a report on labor capacity-building efforts under Chapter 16 (``the Labor Chapter'') and Annex 16.5 of the Dominican Republic-Central America-United States Free Trade Agreement (``CAFTA-DR''). Comments are also welcomed on efforts made by the CAFTA-DR countries to implement the labor obligations under the Labor Chapter and the recommendations contained in a paper entitled, ``The Labor Dimension in Central America and the Dominican RepublicBuilding on Progress: Strengthening Compliance and Enhancing Capacity'' (the ``White Paper''). This report is required under the Dominican Republic- Central America-United States Free Trade Agreement Implementation Act (CAFTA-DR Implementation Act). The reporting function and the responsibility for soliciting public comments required under this Act were assigned to the Secretary of Labor in consultation with the United States Trade Representative (USTR). The upcoming report will consolidate reporting periods to cover January 1, 2016, through February 29, 2020. Public comments received in response to the November 21, 2017, Federal Register Notice soliciting input on labor capacity- building efforts under the CAFTA-DR will be taken under consideration for this upcoming report.