August 3, 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Fixed- Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of HIV-1 Under PEPFAR.'' This draft guidance provides recommendations for applications for single-entity antiretroviral (ARV) and ARV fixed-combination (FC) drug products for the treatment or prevention of human immunodeficiency virus-one (HIV-1) infection that are intended for procurement under the President's Emergency Plan for AIDS Relief (PEPFAR). Specifically, this draft guidance addresses versions of ARV drug products for which the individual ARV drug product components are already FDA-approved and for which substantial evidence of safety and efficacy of the specific drug product or combination drug product already exists. When finalized, this draft guidance will replace the previous final guidance for industry entitled ``Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV'' issued in October 2006.

In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. The meeting will be held for the purpose of soliciting, from the scientific community and other persons, scientific and technical information relevant to program planning.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), Department of Justice (DOJ), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

FMCSA announces its decision to renew exemptions for seven individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these hard of hearing and deaf individuals to continue to operate CMVs in interstate commerce.

The U.S. Department of Commerce (Commerce) preliminary determines that Hankook Tire Mfg Co. Ltd. (Hankook) and Nexen Tire Corporation (Nexen) made sales of passenger vehicle and light truck tires (passenger tires) from the Republic of Korea (Korea) at prices below normal value (NV) during the period of review (POR), January 6, 2021, through June 30, 2022. We invite interested parties to comment on these preliminary results.

The FAA is adopting a new airworthiness directive (AD) for certain Embraer S.A. Model ERJ 190-300 and -400 airplanes. This AD was prompted by reports of missing parts on the main landing gear (MLG) side stay upper spindle assembly. This AD requires inspection of the left-hand (LH) and right-hand (RH) MLG side stay upper spindle assembly attachments, and corrective actions if necessary, as specified in an Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil (ANAC) AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.

In this document, the Wireline Competition Bureau and the Office of Economics and Analytics (WCB and OEA) adopt an Order defining the contours and specific requirements of the forthcoming 2023 Mandatory Data Collection for incarcerated people's communications services.

The U.S. Nuclear Regulatory Commission (NRC) is amending its spent fuel storage regulations by revising the NAC Multi-Purpose Canister (NAC-MPC) System listing within the ``List of approved spent fuel storage casks'' to renew, for 40 years, the initial certificate and Amendment Nos. 1 through 8 of Certificate of Compliance No. 1025. The renewal of the initial certificate and Amendment Nos. 1 through 8 revises the certificate of compliance's conditions and technical specifications to address aging management activities related to the structures, systems, and components important to safety of the dry storage system to ensure that these will maintain their intended functions during the period of extended storage operations.

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, we are seeking comment on the development of the following proposed Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery '' for approval under the Paperwork Reduction Act (PRA). This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection. Also, we are using this notice to announce our intent to ask OMB to renew our use of the OGIS FOIA Program Compliance Review, NPRC Survey of Customer Satisfaction, National Outreach Program Initiative (NOPI), and Training and Event Evaluations. The public is encouraged to comment.

DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to restructure and update the regulations to focus on current environmental and sustainability matters and to implement a requirement for agencies to procure sustainable products and services to the maximum extent practicable.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

The U.S. Department of Commerce (Commerce) is conducting an administrative review of the antidumping duty (AD) order on polyethylene terephthalate film, sheet, and strip (PET film) from India. The period of review (POR) is July 1, 2021, through June 30, 2022. This review covers the following producers and exporters from India: Jindal Poly Films Ltd. (Jindal) and SRF Limited (SRF). We preliminarily find that SRF did not sell PET film in the United States below normal value (NV). Interested parties are invited to comment on these preliminary results.

The Environmental Protection Agency (EPA) is correcting a final rule that appeared in the Federal Register on July 12, 2023. The final rule determined the applicable volume requirements and percentage standards for the Renewable Fuel Standard (RFS) for 2023 through 2025 for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel, established the second supplemental standard addressing the judicial remand of the 2016 standard-setting rulemaking, and made several regulatory changes to the RFS program. This document corrects several amendatory instructions in the regulatory text in the final rule, but does not make any substantive changes.

The FAA is adopting a new airworthiness directive (AD) for all Safran Helicopter Engines, S.A. (Safran) Model Arrius 2B2 engines. This AD is prompted by the manufacturer revising the airworthiness limitations section (ALS) of the existing engine maintenance manual (EMM), introducing new and more restrictive tasks and limitations for certain life-limited parts. This AD requires revising the ALS of the existing EMM or instructions for continued airworthiness (ICA) and the existing approved maintenance or inspection program, as applicable, by incorporating the actions and associated thresholds and intervals, including life limits, as specified in a European Union Aviation Safety Agency (EASA) AD, which is incorporated by reference (IBR). The FAA is issuing this AD to address the unsafe condition on these products.

The Food and Drug Administration (FDA or Agency) has determined that K-TAB (potassium chloride) extended-release tablets, 10 milliequivalents and 20 milliequivalents, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for potassium chloride extended-release tablets, 10 milliequivalents (meqs) and 20 meqs, if all other legal and regulatory requirements are met.

The Department of Commerce (Commerce) has received requests to conduct administrative reviews of various antidumping duty (AD) and countervailing duty (CVD) orders with June anniversary dates. In accordance with Commerce's regulations, we are initiating those administrative reviews.