Department of Health and Human Services August 31, 2023 – Federal Register Recent Federal Regulation Documents

HRSA is providing supplemental funds not to exceed $1,500,000 to the Supporting Maternal Health Innovation Program, also referred to as the Maternal Health Learning and Innovation Center (MHLIC), in fiscal year (FY) 2023 to provide support and capacity building to HRSA's new maternal health award recipients under the State Maternal Health Innovation (MHI) Program (HRSA-23-108).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act.'' This guidance clarifies the enhanced drug distribution security requirements listed in the Federal Food, Drug, and Cosmetic Act (FD&C Act). In addition, this guidance outlines and makes recommendations on the system attributes necessary to enable secure tracing of product at the package level, including allowing for the use of verification, inference, and aggregation, as necessary. This guidance finalizes the draft guidance of the same title issued on June 4, 2021.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.'' FDA is issuing this guidance as part of its Real-World Evidence (RWE) Program for drugs and to satisfy, in part, the mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance about the use of RWE in regulatory decision making. This guidance discusses the applicability of FDA's investigational new drug application (IND) regulations to various clinical study designs that utilize real-world data (RWD) and clarifies the Agency's expectations regarding clinical studies using RWD submitted to FDA in support of a regulatory decision regarding the effectiveness or safety of a drug that are not subject to the IND regulations. This guidance finalizes the draft guidance of the same title issued on December 9, 2021.

This document establishes requirements for mandatory annual State reporting of the Core Set of Children's Health Care Quality Measures for Medicaid and the Children's Health Insurance Program (CHIP), the behavioral health measures on the Core Set of Adult Health Care Quality Measures for Medicaid, and the Core Sets of Health Home Quality Measures for Medicaid.