June 24, 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZOLGENSMA 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 Department of Commerce (Commerce) determines that producers and/or exporters subject to this administrative review did not make sales of finished carbon steel flanges from India at prices below normal value during the period of review (POR), August 1, 2018, through July 31, 2019. In addition, Commerce determines that Silbo Industries, Inc. (Silbo) had no shipments during the POR.

The Missile Defense Agency (MDA), as lead agency, and the Department of the Air Force (DAF), as a cooperating agency, are issuing this joint Record of Decision (ROD) to implement changes in operational concept for the Long Range Discrimination Radar (LRDR) located at Clear Air Force Station (CAFS), Alaska. This decision includes modification of the LRDR operational requirements and procedures to reflect continuous operations in response to emerging threats. This action will enable the MDA to meet its congressional mandate to fully support the primary mission of the layered Missile Defense System (MDS) to provide continuous and precise tracking and discrimination of long- range missile threats launched against the United States (U.S.).

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA).

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA).

The Department of Labor (DOL) is submitting this Employee Benefits Security Administration (EBSA)-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.

The Department of Labor (DOL) is submitting this Employment and Training Administration (ETA)-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.

This announcement provides notice that the Department of Commerce (DOC) has received a ``Notice of Appeal'' filed by Norwalk Cove Marina, Inc. (Appellant), requesting that the Secretary override an objection by the New York State Department of State to a consistency certification for a proposed project to dispose of dredged material in the Central Long Island Sound Dredged Material Site.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention.'' FDA is issuing this guidance to assist sponsors developing master protocols for trials evaluating drugs and biological products for the treatment or prevention of COVID-19. This guidance primarily focuses on the trial design and conduct as well as statistical considerations for master protocols intended to generate substantial evidence of effectiveness and adequate characterization of safety for COVID-19. Additionally, this guidance provides administrative and procedural recommendations to sponsors of master protocols for COVID-19. Given the public health emergency presented by COVID-19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance document entitled ``Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products.'' The guidance is intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA). The guidance describes general and administrative information on evaluating and reporting changes and recommendations for reporting categories based on a tiered-reporting system for specific changes. The guidance announced in this notice finalizes the draft guidance, ``Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products,'' dated December 2017 and supersedes the document entitled ``Guidance for Industry: Changes to an Approved Application: Biological Products,'' dated July 1997 (July 1997 guidance).

FMCSA announces receipt of applications from four individuals for an exemption from the prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs) against persons with a clinical diagnosis of epilepsy or any other condition that is likely to cause a loss of consciousness or any loss of ability to control a commercial motor vehicle (CMV) to drive in interstate commerce. If granted, the exemptions would enable these individuals who have had one or more seizures and are taking anti-seizure medication to operate CMVs in interstate commerce.

The SEDAR 72 stock assessment process for Gulf of Mexico gag grouper will consist of a series of data and assessment webinars. See SUPPLEMENTARY INFORMATION.

The Caribbean Fishery Management Council's (Council) Scientific and Statistical Committee (SSC) will hold a public virtual meeting to address the items contained in the tentative agenda included in the SUPPLEMENTARY INFORMATION.

The South Atlantic Fishery Management Council (Council) will host a presentation on Release Mortality Estimation of South Atlantic Reef Fishes via webinar July 13, 2021.

The Department of Commerce (Commerce) determines that certain steel nails (nails) from the People's Republic of China (China) were sold in the United States at less than normal value (NV) during the period of review (POR) August 1, 2018, through July 31, 2019.

The Secretary announces deadline dates for the receipt of documents and other information from applicants and institutions participating in certain Federal student aid programs authorized under title IV of the Higher Education Act of 1965, as amended (HEA), for the 2021-2022 award year. These programs, administered by the Department of Education (Department), provide financial assistance to students attending eligible postsecondary educational institutions to help them pay their educational costs. The Federal student aid programs (title IV, HEA programs) covered by this deadline date notice are the Pell Grant, Direct Loan, TEACH Grant, Iraq and Afghanistan Service Grant, and campus-based (FSEOG and FWS) programs. Assistance Listing Numbers: 84.007 FSEOG Program; 84.033 FWS Program; 84.063 Pell Grant Program; 84.268 Direct Loan Program; 84.379 TEACH Grant Program; 84.408 Iraq and Afghanistan Service Grant Program.

In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection, FERC-516G (Electric Rates Schedules and Tariff Filings), as it would be revised in this information collection request. The Commission will submit this request to the Office of Management and Budget (OMB) for review.

The Food and Drug Administration (FDA or Agency) is announcing the following public workshop entitled ``Considerations for Progressive Multifocal Leukoencephalopathy Clinical Trial Designs.'' The purpose of the public workshop is to discuss the challenges and clinical trial design considerations for developing therapeutic products for the treatment of progressive multifocal leukoencephalopathy (PML).

The Toxic Substances Control Act (TSCA) requires EPA to publish in the Federal Register a statement of its findings after its review of certain TSCA notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to premanufacture notices (PMNs), microbial commercial activity notices (MCANs), and significant new use notices (SNUNs) submitted to EPA under TSCA. This document presents statements of findings made by EPA on such submissions during the period from February 1, 2021 to February 28, 2021.

In accordance with the Paperwork Reduction Act of 1995, the Bureau of Land Management (BLM) proposes to renew an information collection.

The Toxic Substances Control Act (TSCA) requires EPA to publish in the Federal Register a statement of its findings after its review of certain TSCA notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to premanufacture notices (PMNs), microbial commercial activity notices (MCANs), and significant new use notices (SNUNs) submitted to EPA under TSCA. This document presents statements of findings made by EPA on such submissions during the period from March 1, 2021 to March 31, 2021.