Department of Health and Human Services April 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration is correcting a notice entitled ``Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments'' that appeared in the Federal Register of April 11, 2023. The document announced a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The document was published with the incorrect docket number. This document corrects that error.

This proposed rule would implement the Electronic Health Record (EHR) Reporting Program provision of the 21st Century Cures Act by establishing new Conditions and Maintenance of Certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program). This proposed rule would also make several updates to certification criteria and implementation specifications recognized by the Program, including a revised certification criterion for decision support and revised certification criteria for patient demographics and observations and electronic case reporting. This proposed rule would establish a new baseline version of the United States Core Data for Interoperability (USCDI). Additionally, this proposed rule would provide enhancements to support information sharing under the information blocking regulations. The implementation of these provisions would advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information. The proposed rule would also update the Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs.

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment.

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.

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining the teleconference (information below). The audio conference line has 150 ports for callers.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Advisory Council for the Elimination of Tuberculosis (ACET). ACET consists of 10 experts including the Chair in fields associated with public health, epidemiology, immunology, infectious diseases, pulmonary disease, pediatrics, tuberculosis, microbiology, and preventive health care delivery.

The Departments of Health and Human Services and Agriculture announce the second meeting of the 2025 Dietary Guidelines Advisory Committee (Committee). This meeting will be open to the public virtually.

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in response to an outbreak of mpox. FDA has issued an Authorization for an in vitro diagnostic device as requested by Cue Health, Inc. The Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the August 9, 2022, determination by the Secretary of Health and Human Services (HHS) 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 U.S. citizens living abroad, and that involves monkeypox virus. On the basis of such determination, the Secretary of HHS declared, on September 7, 2022, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, pursuant to the FD&C Act, subject to terms of any authorization issued under that section. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

The National Institutes of Health (NIH), Office of the Director, Office of Disease Prevention (ODP) is requesting public comment on its draft strategic plan for Fiscal Years 2024-2028 (FY24- 28), Prevention Research: Creating a Healthier Future for All. ODP invites feedback on its proposed priorities from prevention researchers in academia and industry, health care providers, patient advocacy organizations, community-based organizations, health service organizations, scientific or professional organizations, trainees and early-stage investigators, federal agencies, those employed by NIH or at institutions receiving NIH support, and the general public. Organizations are strongly encouraged to submit a single response that reflects the views of the organization and membership as a whole.

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public workshop entitled ``Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for Rare Disease Drug Development.'' Convened by the Duke-Robert J. Margolis, MD Center for Health Policy (Duke-Margolis) and supported by a cooperative agreement between FDA and Duke-Margolis, the workshop will include discussions of the Rare Disease Endpoint Advancement (RDEA) Pilot Program and novel endpoint development for rare disease drug development.

On April 10, 2023, we published a collection of information notice in the Federal Register concerning our revised Managed Care Rate Setting Guidance. The notice included an incorrect web address for obtaining copies of the supporting statement, the revised guide, and supporting documents.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty CathetersPremarket Notification (510(k)) Submissions.'' FDA is issuing this final guidance document to provide recommendations for 510(k) submissions for peripheral percutaneous transluminal angioplasty (PTA) balloons and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-stent restenosis (ISR), scoring/cutting balloons).

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

This notice announces the final Federal share (FS) disproportionate share hospital (DSH) allotments for Federal fiscal year (FY) 2020 and FY 2021, and the preliminary FS DSH allotments for FY 2022 and FY 2023. This notice also announces the final FY 2020 and FY 2021 and the preliminary FY 2022 and FY 2023 limitations on aggregate DSH payments that States may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of States' FY DSH allotments.

This notice announces new dates for a public meeting of the Ground Ambulance and Patient Billing (GAPB) Advisory Committee on May 2 and 3, 2023. The GAPB Advisory Committee will make recommendations with respect to the disclosure of charges and fees for ground ambulance services and insurance coverage, consumer protection and enforcement authorities of the Departments of Labor, Health and Human Services, and the Treasury (the Departments) and relevant States, and the prevention of balance billing to consumers. The recommendations shall address options, best practices, and identified standards to prevent instances of balance billing; steps that can be taken by State legislatures, State insurance regulators, State attorneys general, and other State officials as appropriate, consistent with current legal authorities regarding consumer protection; and legislative options for Congress to prevent balance billing. This notice also updates the GAPB Advisory Committee membership roster.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

Findings of research misconduct have been made against Carlo Spirli, Ph.D. (Respondent), who was an Assistant Professor of Medicine, Department of Digestive Diseases, Yale University (YU). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grants R01 DK079005 and P30 DK034989. The administrative actions, including debarment for a period of four (4) years, were implemented beginning on March 28, 2023, and are detailed below.

This document is to inform the public that four Notifications of Enforcement Discretion (``Notifications'') issued by the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) regarding how the Privacy, Security, and Breach Notification Rules (``HIPAA Rules'') promulgated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act will be applied to certain violations during the COVID-19 nationwide public health emergency (``COVID-19 PHE''), will expire upon expiration of the COVID-19 PHE, which is currently scheduled for 11:59 p.m. on May 11, 2023. Accordingly, upon expiration of the COVID-19 PHE, the Notifications will not provide a basis for OCR to exercise enforcement discretion with respect to imposing penalties for violations of the HIPAA Rules. OCR will continue to exercise enforcement discretion consistent with the Notifications for violations of the HIPAA Rules that occurred during the period that each Notification was in effect. In addition, OCR is affording covered health care providers a 90- calendar day transition period to come into compliance with the HIPAA Rules with respect to their provision of telehealth using non-public facing remote communication technologies.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.'' This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitization (I/S) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS). The recommendations in this revised draft guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The revised draft guidance is intended to clarify FDA's recommendations and expectations related to in vivo skin I/S studies. This guidance revises the October 2018 draft guidance entitled ``Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.''