July 2023 – Federal Register Recent Federal Regulation Documents

Based on a request from the Committee Overseeing Action for Lumber International Trade Investigations or Negotiations (the petitioner), the U.S. Department of Commerce (Commerce) is initiating a changed circumstances review (CCR) of the countervailing duty (CVD) order on certain softwood lumber from Canada.

NMFS approves and implements the 2023-2025 specifications for the Mackerel, Squid, and Butterfish Fishery Management Plan as recommended by the Mid-Atlantic Fishery Management Council. This action sets the 2023-2025 chub mackerel specifications, the 2023-2024 butterfish specifications, and the 2023 Illex squid specifications. This action also reaffirms the 2023 longfin squid specifications.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of New York (FEMA- 4723-DR), dated 07/22/2023. Incident: Severe Storms and Flooding. Incident Period: 07/09/2023 through 07/10/2023.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``CDER's Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality.'' This guidance describes a program at FDA's Center for Drug Evaluation and Research (CDER) to make public a comprehensive listing of recognized voluntary consensus standards related to pharmaceutical quality. This program facilitates submissions by external stakeholders and FDA staff proposing voluntary consensus standards related to pharmaceutical quality for recognition. CDER believes that this program will help promote innovation in pharmaceutical development and manufacturing and streamline the preparation and assessment of marketing applications for products regulated by CDER. This guidance finalizes the draft guidance of the same title issued on February 14, 2019.

The Environmental Protection Agency (EPA) is announcing an opportunity for public input on the Safer Choice and Design for the Environment (DfE) programs' potential expansion of their certification to new product categories. Safer Choice helps consumers, businesses, and purchasers find products that perform and contain ingredients that are safer for human health and the environment. DfE is a similar program currently used by EPA for the purpose of helping consumers and commercial buyers identify antimicrobial products that meet the health and safety standards of the normal pesticide registration process required by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) as well as other rigorous criteria required by the EPA. The Agency will hold a listening session webinar and request stakeholder comment on which new product categories Safer Choice and DfE could expand into and how the potential expansion could offer significant benefits to human health and the environment. Safer Choice and DfE certifications would likely not expand to certify materials. The availability of EPA certified products would help give consumers a choice of products that meet EPA's high standard for human and environmental health and, as part of meeting these criteria, would not contain intentionally added per- and polyfluoroalkyl substances (PFAS).

The U.S. Department of Commerce (Commerce) preliminarily determines that certain corrosion-resistant steel products (CORE) from the Republic of Korea (Korea) were not sold in the United States at less than normal value (NV) during the period of review (POR), July 1, 2021, through June 30, 2022. Interested parties are invited to comment on these preliminary results.

The U.S. Department of Commerce (Commerce) determines that imports of aluminum sheet produced from aluminum alloy 4017 (4017 aluminum sheet) produced in the People's Republic of China (China) and exported to the United States constitutes merchandise altered in form or appearance in such minor respects that it should be included within the scope of the antidumping duty (AD) and countervailing duty (CVD) orders on common alloy aluminum sheet (CAAS) from China. As a result, 4017 aluminum sheet will be subject to suspension of liquidation effective August 26, 2022.

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Diana Daffin from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Daffin was convicted of a felony under Federal law for conduct that relates to the regulation of any drug product under the FD&C Act. Ms. Daffin was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of April 2, 2023 (30 days after receipt of the notice), Ms. Daffin has not responded to the notice. Ms. Daffin's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of her right to a hearing concerning this action.

The Environmental Protection Agency (EPA) is announcing the availability of and requesting public comment on a draft revision to the risk determination for 1,4-dioxane following a risk evaluation issued under TSCA. EPA published a risk evaluation for 1,4-dioxane in December 2020 and a draft supplement to the risk evaluation in July 2023. This draft revision to the 1,4-dioxane risk determination reflects policy changes announced in June 2021, to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by science and the law, as well as information from the 2023 Draft Supplement to the risk evaluation. In this draft revision to the risk determination EPA has preliminarily determined that 1,4-dioxane, as a whole chemical substance, presents an unreasonable risk of injury to health when evaluated under its conditions of use. This draft risk determination considers the occupational and consumer exposures from the December 2020 Risk Evaluation, as well as the occupational, general population, and fenceline community exposures in the draft supplement to the risk evaluation, including exposures that result from conditions of use where 1,4-dioxane is present due to production as a byproduct and the risks from general population and fenceline communities' exposures to 1,4-dioxane released under the conditions of use to drinking water sourced from surface and ground water and ambient air. In addition, this revised risk determination does not reflect an assumption that all workers always appropriately wear personal protective equipment (PPE). EPA understands that there could be adequate occupational safety protections in place at certain workplace locations; however, not assuming use of PPE reflects EPA's recognition that unreasonable risk may exist for subpopulations of workers that may be highly exposed because they are not covered by Occupational Safety and Health Administration (OSHA) standards, or their employers are out of compliance with OSHA standards, or because many of OSHA's chemical- specific permissible exposure limits largely adopted in the 1970's are described by OSHA as being ``outdated and inadequate for ensuring protection of worker health,'' or because EPA finds unreasonable risk for purposes of TSCA notwithstanding OSHA requirements. This revision, when final, would supersede the condition of use-specific no unreasonable risk determinations in the December 2020 1,4-dioxane risk evaluation (and withdraw the associated order) and would make a revised determination of unreasonable risk for 1,4-dioxane as a whole chemical substance.

In compliance with the Paperwork Reduction Act of 1995, DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof. DoD invites comments on: whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; the accuracy of DoD's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology. The Office of Management and Budget (OMB) has approved this information collection for use under Control Number 0704-0332 through November 30, 2023. DoD proposes that OMB approve an extension of the information collection requirement, to expire three years after the approval date.

The Coast Guard is establishing a permanent special local regulation for certain waters of Henderson Bay in Henderson Harbor, NY, in support of the Christmas in July festival. This action is necessary to provide for the safety of life on these navigable waters near Henderson Bay, Henderson Harbor, NY, during a boat parade. This rulemaking will prohibit persons and vessels from entering, transiting through, anchoring, blocking, or loitering within the event area adjacent to the city of Henderson Harbor, unless authorized by the Captain of the Port Buffalo or a designated representative.

The DoD has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

The DoD has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

The DoD has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

The United States Patent and Trademark Office (USPTO), as required by the Paperwork Reduction Act of 1995, invites comments on the extension of an existing information collection: 0651-0065 Global Intellectual Property Academy (GIPA) Surveys. The purpose of this notice is to allow 60 days for public comment preceding submission of the information collection to OMB.

In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Fish and Wildlife Service (Service), are proposing to renew an information collection without change.