Department of Health and Human Services October 22, 2015 – Federal Register Recent Federal Regulation Documents

This document provides the methodology and data sources necessary to determine federal payment amounts made in program years 2017 and 2018 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits coverage to low- income individuals otherwise eligible to purchase coverage through Affordable Insurance Marketplaces.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use.'' This guidance has been developed to provide industry with FDA's recommendations on the selection of appropriate package type terms and selection of appropriate discard statements for injectable medical products for human use, packaged in multiple-dose, single-dose, and single-patient- use containers. This guidance provides FDA's revised definitions for single-dose and multiple-dose containers, and introduces the definition of a new package type term, ``single-patient-use'' container. Marketing applications for such products include: New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Biologics License Applications (BLAs), Premarket Approval Applications (PMAs), and Premarket Notifications under section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).