2023 – Federal Register Recent Federal Regulation Documents

The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding the submission of the collection to OMB.

The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.

The Food and Drug Administration (FDA or the Agency) is withdrawing approval of 11 abbreviated new drug applications (ANDAs) from Dr. Reddy's Laboratories, Inc. The applicant notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

This action extends the comment period for the NPRM titled ``Modernization of Special Airworthiness Certification,'' that was published on July 24, 2023. In that document, the FAA proposed to amend rules for the manufacture, certification, operation, maintenance, and alteration of light-sport aircraft. The proposed amendments would enable enhancements in safety and performance and would increase privileges under a number of sport pilot and light-sport aircraft rules. These enhancements include increasing suitability for flight training, limited aerial work, and personal travel. This proposed rule would expand what aircraft sport pilots may operate. The NPRM also proposed to amend the special purpose operations for restricted category aircraft; amend the duration, eligible purposes, and operating limitations for experimental aircraft; and add operating limitations applicable to experimental aircraft engaged in space support vehicle flights to codify statutory language. The FAA is extending the comment period for this NPRM to allow commenters additional time to analyze the proposed rule and prepare a response.

On September 21, 2022, the Commonwealth of Kentucky, through the Kentucky Energy and Environment Cabinet (Cabinet), Division of Air Quality (DAQ), submitted a request for the Environmental Protection Agency (EPA) to redesignate the Northern Kentucky portion (hereinafter referred to as the ``Northern Kentucky Area'' or ``Area'') of the Cincinnati, Ohio- Kentucky, 2015 8-hour ozone nonattainment area (hereinafter referred to as the ``Cincinnati, OH-KY Area'') to attainment for the 2015 8-hour ozone National Ambient Air Quality Standards (NAAQS or standards) and to approve a State Implementation Plan (SIP) revision containing a maintenance plan for the Area. The Cabinet submitted this request and SIP revision through a letter dated September 20, 2022, and supplemented it on November 22, 2022. EPA is approving the Commonwealth's plan for maintaining attainment of the 2015 8-hour ozone standard in the Northern Kentucky Area, including the motor vehicle emission budgets (budgets) for nitrogen oxides (NOX) and volatile organic compounds (VOCs) for the years of 2026 and 2035 for the Area, incorporating the maintenance plan into the SIP, and redesignating the Area to attainment for the 2015 8-hour ozone NAAQS. EPA previously approved the redesignation request and maintenance plan for the Ohio portion of the Cincinnati, OH-KY Area. Additionally, EPA finds the 2026 and 2035 budgets for the Area adequate for the purpose of transportation conformity.

The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), is proposing to amend the regulation governing the National Institute on Minority Health and Health Disparities (NIMHD) Research Endowment Programs (REP) to update the heading of the regulation to reflect the new name of the program, the eligibility requirements for the program to indicate the new expanded eligibility for research endowment awards that is mandated by statute, the heading of one section of the regulation, and certain references to regulations and policies cited in the regulation that apply to program grant awards.

The Bureau of Ocean Energy Management (BOEM) is amending its renewable energy regulations to update the definition of Outer Continental Shelf and add the definition of State in conformity with the Inflation Reduction Act.

This NPRM proposes to adopt and replace regulations relating to the key aspects of the placement, care, and services provided to unaccompanied children referred to the Office of Refugee Resettlement (ORR), pursuant to ORR's responsibilities for coordinating and implementing the care and placement of unaccompanied children who are in Federal custody by reason of their immigration status under the Homeland Security Act of 2002 (HSA) and the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (TVPRA). ORR intends to promulgate a final rule that would establish a foundation for the Unaccompanied Children Program (UC Program) that is consistent with its statutory duties, for the benefit of unaccompanied children and to enhance public transparency as to the policies governing the operation of the UC Program. ORR also proposes this rule for the purpose of implementing the 1997 Flores Settlement Agreement (FSA), which remains in effect as a court-ordered consent decree to which the UC Program is subject. As modified in 2001, the FSA provides that it will terminate forty-five days after publication of final regulations implementing the agreement. ORR anticipates that any termination of the settlement based on the adoption of this proposal as a final rule would only be effective for those provisions that affect ORR and would not terminate provisions of the FSA for other Federal Government agencies.

In accordance with the Federal Land Policy and Management Act of 1976 and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management's (BLM) Wyoming Resource Advisory Council (Council) will meet as follows.

The Coast Guard will enforce the regulated areas in the navigable waters of the San Francisco Bay for the San Francisco Bay Navy Fleet Week Parade of Ships and Blue Angels Survey Flight and Demonstration days from October 5 through October 8, 2023. This action is necessary to ensure the safety of event participants and spectators. During the enforcement period, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the regulated area, unless authorized by the Patrol Commander (PATCOM). This notification of enforcement (NOE) announces the dates and times for enforcement.

Under the Privacy Act of 1974, as amended, the Department of the Housing and Urban Development (HUD), Office of the Chief Financial Officer (OCFO), is issuing a public notice of its intent to create a new system of records, Voice of the Customer (VoC). HUD has developed VoC system of records to satisfy the Executive Order 14058, on Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government, issued on December 13, 2021. The VoC platform provides customers with the ability to share their likes and dislikes about HUD's products or services. Customers feedback lets HUD focus on improving areas that would result in customer satisfaction and improve trust in the Federal Government.

The Environmental Protection Agency (EPA) is proposing to approve State Implementation Plan (SIP) revisions submitted by New York State Department of Environmental Conservation (NYSDEC) for the purpose of enhancing an existing emission statement program for stationary sources in New York State. The SIP revision consists of amendments to regulations in New York's Codes, Rules and Regulations (NYCRR) applicable to the emission statements. This SIP revision was submitted by NYSDEC to satisfy the ozone nonattainment provision of the Clean Air Act (Act or CAA). These provisions establish electronic reporting requirements for annual emission statements filed by facilities subject to Title V operating permits of the Act beginning in 2022 (for calendar year 2021 emission reporting). The intended effect is to obtain improved emissions related data from facilities located in New York State, allowing NYSDEC to more effectively plan for, and attain, the national ambient air quality standards (NAAQS). The Emission Statement rule also improves EPA's and the public's access to facility specific emission related data.

This document is a request for information (RFI) regarding the application of the preventive services requirements under section 2713 of the Public Health Service Act (PHS Act) to over-the-counter (OTC) preventive items and services available without a prescription by a health care provider. The Department of the Treasury, the Department of Labor, and the Department of Health and Human Services (the Departments) are issuing this RFI to gather input from the public regarding the potential benefits and costs of requiring non- grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage to cover OTC preventive items and services without cost sharing and without a prescription by a health care provider; seek comment on any potential challenges associated with providing such coverage; understand whether and how providing such coverage would benefit consumers; and assess any potential burden that plans and issuers would face if required to provide such coverage.