May 2021 – Federal Register Recent Federal Regulation Documents

The Environmental Protection Agency (EPA) is proposing to approve a revision to the South Coast Air Quality Management District (SCAQMD or ``District'') portion of the California State Implementation Plan (SIP). We are also proposing to determine that the submitted SIP revision fulfills the District's and the State's commitment to adopt and submit a specific enforceable contingency measure to address Clean Air Act (CAA) requirements for the 2006 24-hour fine particulate matter (PM2.5) national ambient air quality standards (NAAQS) and the 2012 annual PM2.5 NAAQS. We are taking comments on this proposal and plan to follow with a final action.

This action proposes to amend Class E airspace extending upward from 700 feet above the surface in Muscle Shoals, AL, due to the decommissioning of the Muscle Shoals Very High Frequency Omni- Directional Radio Range Tactical Air Navigation Aid (VORTAC), and cancellation of the associated approach at Northwest Alabama Regional Airport. This action would also update the airport name under the Class E surface airspace. This action would also make an editorial change replacing the term Airport/Facility Directory with the term Chart Supplement in the legal descriptions of associated Class E airspace. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations in the area.

The FAA is revising a notice of proposed rulemaking (NPRM) to supersede AD 2002-08-16, which applies to certain Eurocopter France SA341G, SA342J, and SA-360C helicopters. The NPRM proposed to require removing certain main rotor head torsion tie bars (tie bars) from service and revising the limitations section of the existing maintenance manual for your helicopter by adding life limits for those tie bars. The NPRM was prompted by the determination that another part- numbered tie bar was affected by the same unsafe condition. This action reopens the comment period because a significant amount of time has elapsed since the NPRM was published. This action also revises the NPRM by updating the type certificate holder's name, updating the estimated cost information, clarifying the requirements and compliance times, and adding parts installation prohibitions. The FAA is proposing this airworthiness directive (AD) to address the unsafe condition on these products. Since these actions would impose an additional burden over those in the NPRM, the agency is requesting comments on this SNPRM.

The U.S. Department of Energy (``DOE'') proposes to amend the test procedures for commercial prerinse spray valves to incorporate by reference the current version of the relevant industry standard, i.e., ASTM F2324. ASTM F2324 (2019) is a reaffirmation of the industry standard currently incorporated by reference in the DOE test procedure for commercial prerinse spray valves and as such, this proposal would not substantively change the current test procedure. DOE also proposes to amend the commercial prerinse spray valves definition to codify existing guidance on the application of the definition. DOE is seeking comment from interested parties on the proposal.

The Department of Veterans Affairs (VA) proposes to amend the regulations pertaining to the name of the Chapter 31 Vocational Rehabilitation and Employment program. VA provides benefits and services under the program name of ``Vocational Rehabilitation and Employment''. VA is proposing to amend the name to ``Veteran Readiness and Employment'' (VR&E). VA further proposes that the references to the position of ``Vocational Rehabilitation and Employment Officer'' be amended to ``Veteran Readiness and Employment Officer'' and the position of ``Director of Vocational Rehabilitation and Employment'' be amended to ``Executive Director of Veteran Readiness and Employment''.

On May 6, 2021, the U.S. Court of International Trade (CIT) issued its final judgment in Clearon Corporation et al v. United States, Consol. Court No. 17-00171, sustaining the Department of Commerce (Commerce)'s final remand results pertaining to the administrative review of the countervailing duty (CVD) order on chlorinated isocyanurates (chlorinated isos) from the People's Republic of China (China) covering the period February 4, 2014, through December 31, 2014. Commerce is notifying the public that the CIT's final judgment is not in harmony with Commerce's final results of the administrative review, and that Commerce is amending the final results with respect to the countervailable subsidy rate assigned to Heze Huayi Chemical Co., Ltd. (Heze Huayi).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention.'' This guidance addresses FDA's current thinking regarding clinical trials for drugs for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adults, including recommendations for trial population, trial design, efficacy considerations, and clinical outcome assessments. This guidance details a recent change in our recommendations regarding the necessary evidence and recommended endpoint assessments needed to support a determination of efficacy for the indication of the prevention of CINV. Previously, drug development programs seeking an indication for the prevention of CINV typically selected a primary efficacy endpoint of complete response, defined as no vomiting and no use of rescue antiemetic medication, with additional direct evaluation of nausea frequency and severity positioned as exploratory assessments. To promote consistency and interpretability in the assessment of nausea both within and across development programs, FDA now recommends sponsors analyze a primary endpoint of complete response (i.e., a binary endpoint defined as no vomiting and no use of rescue antiemetic medication) and a secondary endpoint of the absence of nausea (i.e., a binary endpoint defined as no reported nausea and no use of rescue antiemetic medication) by evaluating the difference in the proportions of responders across treatment arms to establish efficacy for the prevention of CINV.

The National Oceanic and Atmospheric Administration is seeking nominations of qualified candidates to be considered for appointment as a member of the Marine Debris Foundation Board of Directors (Board). The Board shall consist of 13 Directors, including the Under Secretary of Commerce for Oceans and Atmosphere.

NMFS has received a request from the U.S. Navy (Navy) for authorization to take small numbers of marine mammals incidental to construction activities including bulkhead replacement and pile driving activities at Naval Station Newport over the course of 5 years from the date of issuance. Pursuant to regulations implementing the Marine Mammal Protection Act (MMPA), NMFS is announcing receipt of the Navy's request for the development and implementation of regulations governing the incidental taking of marine mammals. NMFS invites the public to provide information, suggestions, and comments on the Navy's application and request.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``FDA Public Meeting on Financial Efficiency of Human Drug User Fee Programs.'' The topic to be discussed is the financial transparency and efficiency of the Prescription Drug User Fee Act, the Biosimilar User Fee Act, and Generic Drug User Fee Amendments.

The Gulf of Mexico (GMFMC) and South Atlantic Fishery Management (SAFMC) Councils will hold a joint workgroup for Section 102 for the Modernizing Recreational Fisheries Management Act of 2018.

In compliance with the Paperwork Reduction Act of 1995 (PRA), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Information and Regulatory Affairs (OIRA), of the Office of Management and Budget (OMB), for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.

The Department of Veterans Affairs (VA) is seeking Tribal consultation to assist VA in implementing the requirements of section 3004 of the Johnny Isakson and David P. Roe, M.D. Veterans Health Care and Benefits Improvement Act of 2020 (the Act), The Act amended the statutory authorities of two VA programs (the State Veterans Home Construction Grant Program and the State Home Per Diem Program) so that Indian tribes were included in definitions for ``state'' and ``state home.'' VA is required to consult with Indian tribes to determine if any legislative or administrative action is necessary to modify these state home programs to function efficiently in support of state Veterans homes operated by Indian tribes pursuant to the amendments made by section 3004 of the Act. VA seeks input on the legislative, regulatory and administrative modifications that may be necessary to support State Veterans Homes operated by American Indian and Alaska Native tribes in response to these amendments.

The Economic Development Administration (EDA) has received petitions for certification of eligibility to apply for Trade Adjustment Assistance from the firms listed below. Accordingly, EDA has initiated investigations to determine whether increased imports into the United States of articles like or directly competitive with those produced by each of the firms contributed importantly to the total or partial separation of the firms' workers, or threat thereof, and to a decrease in sales or production of each petitioning firm.

The Food and Drug Administration (FDA, Agency, or we) has determined that ISOPTIN (verapamil hydrochloride) tablets, 40 milligrams (mg), 80 mg, and 120 mg, and CALAN (verapamil hydrochloride) tablets, 40 mg, 80 mg, 120 mg, and 160 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ISOPTIN (verapamil hydrochloride) tablets, 40 mg, 80 mg, and 120 mg, and CALAN (verapamil hydrochloride) tablets, 40 mg, 80 mg, 120 mg, and 160 mg, if all other legal and regulatory requirements are met.

The U.S. Nuclear Regulatory Commission (NRC) invites public comment on the renewal of Office of Management and Budget (OMB) approval for an existing collection of information. The information collection is entitled, ``Requirements for Renewal of Operating Licenses for Nuclear Power Plants.''

The IRS published a document in the Federal Register on April 20, 2021 (86 FR 20611), correcting a Recruitment Notice for their Taxpayer Advocacy Panel. The IRS has a need for correction.

The Coast Guard will enforce the safety zone for the FKCC Swim Around Key West, Key West, Florida from 9 a.m. until 5 p.m. on June 12, 2021. Our regulation for recurring safety zones within the Captain of the Port Key West Zone identifies the regulated area for this event. This action is necessary to ensure the safety of event participants and spectators. During the enforcement period, no person or vessel may enter, transit through, anchor in, or remain within the regulated area without approval from the Captain of the Port Key West or a designated representative.