Department of Health and Human Services August 2022 – Federal Register Recent Federal Regulation Documents

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. On August 9, 2022, the Secretary determined pursuant to his authority under section 564 of the FD&C Act that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad that involves monkeypox virus. On the basis of this determination, he also declared that circumstances exist justifying the authorization of emergency use of vaccines for use against monkeypox virus pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.

In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Infant and Maternal Mortality (ACIMM) has scheduled a public meeting. Information about ACIMM and the agenda for this meeting can be found on the ACIMM website at https://www.hrsa.gov/advisory-committees/infant-mortality/ index.html.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute of General Medical Sciences (NIGMS), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry GFI #111 (VICH GL19(R1)) entitled ``Effectiveness of Anthelmintics: Specific Recommendations for Canines (Revision 1).'' This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #109 (VICH GL15(R1)) entitled ``Effectiveness of Anthelmintics: Specific Recommendations for Equines (Revision 1).'' This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry GFI #114 (VICH GL21(R1)) entitled ``Effectiveness of Anthelmintics: Specific Recommendations for ChickensGallus gallus (Revision 1).'' This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes. This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #90 (VICH GL7(R1)) entitled ``Effectiveness of Anthelmintics: General Recommendations (Revision 1).'' This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this draft guidance is to provide study design recommendations that will facilitate the universal acceptance of the generated effectiveness data to fulfill the national/ regional requirements for anthelmintic drugs in animal species. This revision updates data analysis and isolate characterization recommendations, outlines how to approach new indications, and makes additional clarifying changes.

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 Cervical Degenerative Disease Treatment, 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.

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to Thomas Jefferson University, located in Philadelphia, Pennsylvania to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Access to Areas Outside the Poultry House): Questions and Answers Regarding the Final Rule.'' The guidance is intended to provide information to egg producers on certain provisions contained in FDA's final rule entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation'' (the egg rule) that reference the ``poultry house.'' Specifically, the document provides guidance to shell egg producers whose production systems provide laying hens with access to areas outside of a ``poultry house'' as that term is defined in the egg rule.

This final rule will: revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). In addition it will establish new requirements and revise existing requirements for eligible hospitals and critical access hospitals (CAHs) participating in the Medicare Promoting Interoperability Program; and update policies for the Hospital Readmissions Reduction Program, Hospital Inpatient Quality Reporting (IQR) Program, Hospital VBP Program, Hospital- Acquired Condition (HAC) Reduction Program, PPS-Exempt Cancer Hospital Reporting (PCHQR) Program, and the Long-Term Care Hospital Quality Reporting Program (LTCH QRP). It will also revise the hospital and critical access hospital (CAH) conditions of participation (CoPs) for infection prevention and control and antibiotic stewardship programs; and codify and clarify policies related to the costs incurred for qualified and non-qualified deferred compensation plans. Lastly, this final rule will provide updates on the Rural Community Hospital Demonstration Program and the Frontier Community Health Integration Project.

On June 15, 2022, the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) published a document in the Federal Register concerning a notice of award to fund the ICMR Institutions: National Institute of Virology (NIV), Pune and National Institute of Epidemiology (NIE), Chennai. Those awards are cancelled in their entirety.

This document announces the suspension of prior authorization for specified orthoses items on the Required Prior Authorization List that require prior authorization as a condition of payment under certain circumstances when reported with certain modifiers. Items subject to face-to-face encounter and written order prior to delivery requirements are not impacted by this document.

This advisory is to alert certain clinicians who are Qualifying APM participants (QPs) and eligible to receive an Alternative Payment Model (APM) Incentive Payment that CMS does not have the current billing information needed to disburse the payment. This advisory provides information to these clinicians on how to update their billing information to receive this payment.