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

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Vector Surveillance and Control Assessment: Post-Zika Response and Tick Capacities. This study is designed to determine the vector control capabilities of local jurisdictions within the District of Columbia, territories, and 50 states that responded to Zika virus (ZIKV) outbreaks.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Gabriel J. Letizia, Jr. from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Letizia was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Letizia was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why he should not be debarred within the timeframe prescribed by regulation. Mr. Letizia has not responded to the notice. Mr. Letizia's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the availability of the final systematic review report titled ``Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).'' The report is accompanied by a summary of public comments.

In accordance with provisions of Title 5 U.S.C. 10, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the World Trade Center Health Program Scientific/ Technical Advisory Committee (WTCHP-STAC). This virtual meeting is open to the public. Time will be available for public comment.

The Food and Drug Administration (FDA or Agency) is announcing the following public workshop entitled ``Understanding the Use of Negative Controls to Assess the Validity of Non-Interventional Studies of Treatment Using Real-World Evidence.'' Convened by the Duke-Margolis Center for Health Policy and supported by a cooperative agreement between FDA and Duke-Margolis, the purpose of this public workshop is to discuss existing negative control methodologies for studies based on real-world data and to outline advantages and disadvantages of the use of negative controls for evaluating the safety and effectiveness of regulated medical products. Additionally, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research will propose projects to develop negative control methods and implement new tools for use in the Sentinel System, Biologics Effectiveness and Safety (BEST) System, and with Federal Partners.

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a 3-year extension of the forms OCSE-21- U4: Transmittal and Notice of Approval of State Plan Material for: Title IV-D of the Social Security Act, and OCSE-100: State Plan (Office of Management and Budget (OMB) # 0970-0017, expiration July 31, 2023). No changes are proposed.

In accordance with the World Trade Center (WTC) Health Program's regulations, which establish procedures for adding a new condition to the list of covered health conditions, this final rule adds malignant neoplasms of corpus uteri and uterus, part unspecified (uterine cancer) to the List of WTC-Related Health Conditions.

The Food and Drug Administration (FDA, Agency, or we) is classifying the prognostic test for assessment of liver related disease progression into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the prognostic test for assessment of liver related disease progression's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.

The Administration for Children and Families (ACF) Office of Planning, Research, and Evaluation (OPRE) is proposing a new primary data collection to examine the experiences, strengths, resources, and strategies used by home-based child care providers to serve and support equitable outcomes for children and families. The Home-Based Child Care Practices and Experiences study will explore the experiences of a particular group of home-based child care providers who are legally exempt from state licensing or other state regulations that apply to non-custodial care of children in the provider's own home; these providers are commonly referred to as family, friend, and neighbor providers.