Department of Health and Human Services October 4, 2023 – Federal Register Recent Federal Regulation Documents

This document corrects technical and typographical errors in the final rule that appeared in the August 28, 2023 Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2024 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Rural Emergency Hospital and Physician-Owned Hospital Requirements; and Provider and Supplier Disclosure of Ownership; and Medicare Disproportionate Share Hospital (DSH) Payments: Counting Certain Days Associated with Section 1115 Demonstrations in the Medicaid Fraction'' (referred to hereafter as the ``FY 2024 IPPS/LTCH PPS final rule'').

In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of the re-establishment of a matching program between CMS and State-Based Administering Entities (AEs), titled ``Determining Eligibility for Enrollment in Applicable State Health Subsidy Programs Under the Patient Protection and Affordable Care Act.''

ACF, ORR, Refugee Program announces the intent to award an unsolicited cooperative agreement in the amount of up to $1,984,144 to Church World Services (CWS) in New York, NY. The purpose of this award is to provide enhanced refugee housing solutions for Afghan and Ukrainian humanitarian parolees and other ORR-eligible populations. This proposal seeks to create a local resources directory for housing, increase access to housing resources for vulnerable refugee and humanitarian parolee populations, expand innovative and replicable solutions through capacity building and key partnerships, address challenges to identifying and securing safe, affordable housing options, and provide a bank of housing resources for both refugees and community sponsors.

This document corrects technical and typographical errors in the final rule that appeared in the August 2, 2023 Federal Register entitled ``Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2024 and Updates to the IRF Quality Reporting Program'' (referred to hereafter as the ``FY 2024 IRF final rule''). The effective date of the FY 2024 IRF final rule is October 1, 2023.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``TeamSTEPPS 3.0 Training Assessment.'' In accordance with the Paperwork Reduction Act of 1995, AHRQ invites the public to comment on this proposed information collection.

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Becton, Dickinson and Co., for the BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site). FDA revoked this Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document.

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.

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.

The Food and Drug Administration (FDA) is providing notice that the courier address for the U.S. Bank will change. This change has a direct impact on the Fiscal Year 2024 Federal Register notices for the following FDA User Fee programs: Prescription Drug User Fee Amendments (PDUFA), Medical Device User Fee Amendments (MDUFA), Generic Drug User Fee Amendments (GDUFA), Biosimilar User Fee Amendments (BsUFA), Food Safety Modernization Act (FSMA), and Compounding Quality Act (CQA). The new physical address will be 3180 Rider Trail South, Earth City, MO 63045.

The U.S. Department of Health and Human Services (HHS) announces the next meeting of the President's Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders (Commission) and the solicitation of written comments regarding the advancement of equity, justice, and opportunity for Asian American, Native Hawaiian, and Pacific Islander (AA and NHPI) communities. The meeting is open to the public and will be held in Washington, DC on October 25 and October 26, 2023. Virtual attendance will be available through livestream. The Commission is working to accomplish its mission to provide independent advice and recommendations to the President on ways to advance equity, justice, and opportunity for AA and NHPI communities.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Mental Health and Occupational Stress in the Emergency Medical Service and 911 Workforce, which is currently being conducted by the AHRQ's Evidence- based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.