Department of Health and Human Services September 9, 2022 – Federal Register Recent Federal Regulation Documents

HRSA plans to move forward in implementing temporary changes to the method of calculating poverty-based allocations under Title V of the Social Security Act for HRSA's State Title V Maternal and Child Health (MCH) Services Block Grant, beginning in Fiscal Year (FY) 2023. Since FY 2017, the poverty-based allocation has been based on the U.S. Census Bureau's 3-year American Community Survey (ACS) estimates using three pooled 1-year estimates. However, due to the COVID-19 pandemic, there were disruptions in the ACS data collection in 2020 resulting in data quality issues that prevented the Census Bureau from releasing standard 1-year ACS estimates; instead, the Census Bureau released experimental estimates. The ACS 2020 experimental estimates will be excluded from calculating Title V MCH Services Block Grant allocations, and the FY 2023 funding allocation will be based on the same poverty data used in the FY 2022 allocation (i.e., pooled 1-year estimates for 2017, 2018, and 2019 ACS). Funding allocations for FY 2024 and FY 2025 will continue to incorporate the latest 1-year ACS data while skipping 2020 (i.e., for FY 2024, the 2018, 2019, and 2021 ACS data will be used; for FY 2025, the 2019, 2021, and 2022 ACS data will be used). In FY 2026, the temporary change to the method for calculating allocations will no longer be necessary, and HRSA will resume pooling of three consecutive 1-year estimates (2021-2023).

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ORILISSA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human drug product.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products.'' This draft guidance is intended to assist industry in providing information in labeling about the quantities at which sodium, potassium, and phosphorus as constituents of active or inactive drug ingredients are present in human over-the-counter (OTC) and prescription drug products.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products.'' To facilitate FDA's internal tracking of submissions to the Agency that include real-world data (RWD) and real- world evidence (RWE), this guidance encourages sponsors and applicants to identify in their submission cover letters certain uses of RWD/RWE. This guidance does not address FDA's substantive review of the RWD/RWE submitted as part of the Agency's standard review process. This guidance finalizes the draft guidance entitled ``Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics'' issued on May 9, 2019.

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Becton, Dickinson and Company (BD) for the BD SARS-CoV-2/Flu for BD MAX System, and Talis Biomedical Corporation (Talis) for the Talis One COVID-19 Test System. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.