May 19, 2021 – Federal Register Recent Federal Regulation Documents

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention.''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.

The Coast Guard will enforce the safety zone for the 45th Annual Swim Around Key West, Key West, Florida from 8 a.m. until 4 p.m. on June 26, 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.

The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance 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 (PRA95). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents is properly assessed. Currently, DOL is soliciting comments concerning the collection of data about the Transition Assistance Program Employment Navigator and Partnership Pilot evaluation. A copy of the proposed Information Collection Request (ICR) can be obtained by contacting the office listed below in the addressee section of this notice.

In this notice, OSHA announces the final decision to expand the scope of recognition for CSA Group Testing & Certification Inc., as a Nationally Recognized Testing Laboratory (NRTL). Additionally, OSHA announces the final decision to add four new test standards to the NRTL Program's List of Appropriate test standards.