Department of Health and Human Services October 2, 2024 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers." The guidance provides information for sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations of foods, medical products, tobacco products, and new animal drugs. The guidance provides recommendations regarding the requirements in our regulations, pursuant to which FDA considers electronic systems, electronic records, and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. This guidance finalizes the draft guidance of the same title issued on March 16, 2023, and supersedes the guidance for industry entitled "Computerized Systems Used in Clinical Investigations" issued in May 2007.

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 document corrects technical and typographical errors in the final rule that appeared in the August 28, 2024 Federal Register titled "Medicare and Medicaid Programs and the Children's Health Insurance Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2025 Rates; Quality Programs Requirements; and Other Policy Changes" (referred to hereafter as the "FY 2025 IPPS/LTCH PPS final rule").

This document corrects technical errors in the final action that appeared in the August 7, 2024 Federal Register titled "Medicare Program; FY 2025 Inpatient Psychiatric Facilities Prospective Payment SystemRate Update".

The Food and Drug Administration (FDA or Agency) is publishing this notice to announce the establishment of the Center for Drug Evaluation and Research (CDER) Quantitative Medicine Center of Excellence (QM CoE). Quantitative medicine (QM) is used to inform premarket product review, post-market product assessment, policy development, and policy implementation within several CDER offices. The QM CoE will act as a coordinating body that drives innovation and facilitates integration of QM methodologies and principles across CDER. To realize this purpose, the QM CoE will introduce new activities and coordinate existing activities in key areas, including multidisciplinary education and exchange, development and implementation of applied science policy, knowledge management, and community engagement.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with a proposed study entitled "Promotion of Prescription Drugs Within a Talk Show Format."

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic 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.