Department of Health and Human Services March 21, 2018 – Federal Register Recent Federal Regulation Documents

This document corrects technical errors in the DATES section of the notice that appeared in the Federal Register on February 28, 2018 entitled ``Medicare Program; Public Meetings in Calendar Year 2018 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations.''

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Postmarketing Safety Reporting for Combination Products.'' This draft guidance addresses certain means by which applicants may comply with the final rule on postmarketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016. Combination products are products composed of two or more different types of medical products (drug, device, and/or biological product). Although the PMSR regulations for drugs, devices, and biological products share many similarities, each set of regulations establishes distinct postmarketing reporting requirements, standards, and timeframes. The final rule provides clarity on the PMSR requirements for combination products to ensure consistent and complete reporting while avoiding duplication. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information related to the role that flavors play in tobacco products. Specifically, this ANPRM is seeking comments, data, research results, or other information about, among other things, how flavors attract youth to initiate tobacco product use and about whether and how certain flavors may help adult cigarette smokers reduce cigarette use and switch to potentially less harmful products. FDA is seeking this information to inform regulatory actions FDA might take with respect to tobacco products with flavors, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). Potential regulatory actions include, but are not limited to, tobacco product standards and restrictions on sale and distribution of tobacco products with flavors.