September 2023 – Federal Register Recent Federal Regulation Documents

The National Oceanic and Atmospheric Administration (NOAA) designated the Wisconsin Shipwreck Coast National Marine Sanctuary (WSCNMS) on June 23, 2021, and the final rule became effective on August 16, 2021. However, as discussed in the final rule, the provision that prohibits grappling into or anchoring on shipwreck sites (grappling and anchoring provision) was to go into effect on October 1, 2023. This action delays the effectiveness of the grappling and anchoring provision of the final rule until October 1, 2024.

Eligible citizens, nationals, and passport holders from designated Visa Waiver Program countries may apply for admission to the United States at U.S. ports of entry as nonimmigrant noncitizens for a period of ninety days or less for business or pleasure without first obtaining a nonimmigrant visa, provided that they are otherwise eligible for admission under applicable statutory and regulatory requirements. The Secretary of Homeland Security, in consultation with the Secretary of State, has designated Israel as a country that is eligible to participate in the Visa Waiver Program. Accordingly, this rule updates the list of countries designated for participation in the Visa Waiver Program by adding Israel.

In accordance with the Federal Advisory Committee Act of 1972, the National Park Service (NPS) is hereby giving notice that the Advisory Committee on Reconciliation in Place Names (Committee) will meet as noted below.

The U.S. Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers and exporters of certain non-refillable steel cylinders (steel cylinders) from India for the period of investigation (POI) April 1, 2022, through March 31, 2023. Interested parties are invited to comment on this preliminary determination.

We propose to expand the definition of a public assistance (PA) household for purposes of our programs, particularly the Supplemental Security Income (SSI) program, to include the Supplemental Nutrition Assistance Program (SNAP) as an additional means-tested public income maintenance (PIM) program. In addition, we seek public comment on expanding the definition to include households in which any other (as opposed to every other) member receives public assistance. We expect that the proposed rule would decrease the number of SSI applicants and recipients charged with in-kind support and maintenance (ISM). In addition, we expect that this proposal would decrease the amount of income we would deem to SSI applicants or recipients because we would no longer deem income from ineligible spouses and parents who receive SNAP benefits and live in the same household. These policy changes would reduce administrative burden for low-income households and SSA.

The Department of Transportation (DOT) invites public comments about our intention to request Office of Management and Budget (OMB) approval to renew information collection 2105-0529, Procedures for Transportation Drug and Alcohol Testing Program (ICR 2105-0529). The information to be collected will be used to document tests conducted and actions taken to ensure safety in the workplace and/or are necessary under the Omnibus Transportation Employee Testing Act of 1991, which requires DOT to implement a drug and alcohol testing program in various transportation-related industries. DOT is required to publish this notice in the Federal Register in accordance with the Paperwork Reduction Act of 1995.

The U.S. Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers and exporters of brass rod from Israel. The period of investigation is January 1, 2022, through December 31, 2022. Interested parties are invited to comment on this preliminary determination.

Veterans Benefits Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of a currently approved collection, and allow 60 days for public comment in response to the notice.

The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning Form 8835, Renewable Electricity Production Credit.

Pursuant to its authority under title VII of the Tariff Act of 1930, as amended (the Act), the U.S. Department of Commerce (Commerce) is modifying its regulations governing procedures related to administrative protective orders (APO) and service of documents submitted in antidumping (AD) and countervailing duty (CVD) proceedings. Specifically, Commerce is making certain changes to its procedures governing the filing of documents (including public documents, business proprietary documents, and public versions of business proprietary documents), as well as service of documents. Commerce is also making additional clarifications and corrections to other procedural aspects of its AD/CVD regulations, including updates to the scope, circumvention, and covered merchandise referral regulations. Lastly, Commerce is deleting from its regulations two provisions that have been invalidated by the United States Court of Appeals for the Federal Circuit (Federal Circuit).

The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a priority review voucher for fiscal year (FY) 2024. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, authorizes FDA to determine and collect priority review user fees for certain applications for review of human drug or biological products when those applications use a tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) priority review voucher. These vouchers are awarded to the sponsors of tropical disease, rare pediatric disease, or material threat MCM product applications, respectively, that meet the requirements of the FD&C Act, upon FDA approval of such applications. The amount of the fee for using a priority review voucher is determined each fiscal year, based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the FY 2024 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a rare pediatric disease, material threat MCM, or tropical disease priority review voucher and outlines the payment procedures for such fees.

For fiscal year 2023, HRSA will provide additional supplemental funds for the Emergency Medical Services for Children Innovation and Improvement Center to continue to provide assistance to a Pediatric Mental Health Care Access (PMHCA) award recipient so that they can improve access to PMHCA program activities in emergency departments.

The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning procedures for requesting competent authority assistance under tax treaties.

The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments concerning the burden associated with the continuation sheet for Item # 16 (Additional Information) for Form OF-306, Declaration for Federal Employment.

The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning generic clearance for the collection of qualitative feedback on agency service delivery.

The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning the 2020, 2021, and 2022 Wage and Investment Strategies and Solutions Behavioral Laboratory Customer Surveys and Support.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Graft- versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs, biological products, and certain devices for the prevention or treatment of acute graft-versus-host disease (aGVHD) or chronic graft- vs-host disease (cGVHD). Specifically, this guidance addresses FDA's current thinking regarding the overall clinical development program and critical design elements for early and late phase trials for the intended populations. This guidance focuses on clinical trial design, statistical analysis, or other issues specific to aGVHD or cGVHD, and it does not contain a discussion of the general principles regarding statistical analysis, clinical trial design, or drug development. Additionally, this guidance is not intended to provide advice on the technical aspects of therapeutic or cell-processing devices.

This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2024. The calendar year 2024 AIC threshold amounts are $180 for ALJ hearings and $1,840 for judicial review.

FRA is issuing Safety Advisory 2023-06 to emphasize the importance of rules and procedures regarding the safety of roadway workers who operate or work near roadway maintenance machines (RMM). This safety advisory recommends that railroads and contractors review and update their rules regarding the safety of roadway workers who operate or work near RMMs, communicate those changes to their employees, and monitor their employees for compliance with existing rules and procedures and updated rules and procedures, if implemented. In addition, this safety advisory recommends that railroads and contractors conduct additional safety briefings to raise workers' awareness of the hazards associated with operating and working around RMMs.