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

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee (the Committee). The general function of the Committee 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.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the Advisory Committee to the Director (ACD). The ACD consists of up to 15 experts knowledgeable in areas pertinent to the CDC mission, such as public health, global health, health disparities, biomedical research, and other fields, as applicable.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.

This final rule makes several clarifications and updates the definitions currently used to determine whether a consumer is eligible to enroll in a Qualified Health Plan (QHP) through an Exchange; a Basic Health Program (BHP), in States that elect to operate a BHP; and for Medicaid and Children's Health Insurance Programs (CHIPs). Specifically, Deferred Action for Childhood Arrivals (DACA) recipients and certain other noncitizens will be included in the definitions of "lawfully present" that are used to determine eligibility to enroll in a QHP through an Exchange, for Advance Payments of the Premium Tax Credit (APTC) and Cost-Sharing Reductions (CSRs), or for a BHP.

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) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Adam Paul Runsdorf 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. Runsdorf 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. Runsdorf was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of February 25, 2024 (30 days after receipt of the notice), Mr. Runsdorf has not responded. Mr. Runsdorf's failure to respond and request a hearing constitutes a waiver of Mr. Runsdorf's right to a hearing concerning this matter.

The Food and Drug Administration's (FDA), Center for Devices and Radiological Health's (CDRH), Office of Product Evaluation and Quality (OPEQ) has modified their organizational structure. The new organizational structure was approved by the Secretary of Health and Human Services on December 21, 2023, and it became effective on January 22, 2024.

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 and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Comprehensive Evaluations of the Division for Heart Disease and Stroke Prevention Programs (WISEWOMAN, National CVH Program, Innovative CVH Program). The purpose of the data collection is to evaluate the implementation of evidence-based strategies within these programs, measure their impact on cardiovascular disease (CVD) prevention and management, and to identify strategies that are most effective in reaching populations disproportionately affected by CVD.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies to take this opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Data Collection for the Residential Care Community and Adult Day Services Center Components of the National Post-Acute and Long-Term Care Study. The purpose is to collect data for the residential care community and adult day services center components for the 2024 wave of the National Post-Acute and Long-Term Care Study.

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 Assessing Sexual and Gender Minority (SGM) Occupational Well- Being from The PRIDE Study. This project aims to describe the SGM workforce population, their health and well-being experiences, and their work-related health and well-being determinants and outcomes.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #290 (VICH GL61) entitled "Pharmaceutical Development." 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 draft guidance describes the suggested contents for the Pharmaceutical Development section, which provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management to the development of a product and its manufacturing process.

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 (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.