Department of Health and Human Services May 11, 2023 – Federal Register Recent Federal Regulation Documents

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.

The Food and Drug Administration (FDA or Agency) is announcing the publication of a discussion paper entitled ``Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products.'' To fulfill its mission of protecting, promoting, and advancing public health, FDA's Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER) and Center for Devices and Radiological Health (CDRH), including the Digital Health Center of Excellence (DHCoE), is issuing this document to facilitate a discussion with stakeholders on the use of artificial intelligence (AI) and machine learning (ML) in drug development to help inform the regulatory landscape in this area.

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with FDA's Voluntary Qualified Importer Program.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory 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.

The Administration for Children and Families (ACF), in partnership with the Health Resources and Services Administration, both of the U.S. Department of Health and Human Services (HHS), is proposing to collect data as part of the elementary school phase of the Mother and Infant Home Visiting Program Evaluation (MIHOPE). MIHOPE is a longitudinal study of the effects of Maternal, Infant, and Early Childhood Home Visiting (MIECHV)-funded home visiting on child and family outcomes. The purpose of the MIHOPE Long-Term Follow-Up, Third grade (MIHOPE-3G) data collection, which will focus on children when they are in approximately third grade, is to assess the long-term effects of MIECHV-funded home visiting on families and children when participating children are in elementary school.