Department of Health and Human Services January 17, 2017 – Federal Register Recent Federal Regulation Documents

The Administration on Disability is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995.

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.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Compliance Policy for Required Warning Statements on Small-Packaged Cigars.'' The draft guidance, when finalized, is intended to assist any person who manufacturers, packages, sells, offers to sell, distributes, or imports cigars in small packages, in complying with the warning statement requirements in FDA's regulations deeming all other products that meet the statutory definition of a tobacco product to be subject to Chapter IX of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The draft guidance describes FDA's compliance policy for cigars in packaging that is too small or otherwise unable to accommodate a label with sufficient space to bear the required warning statements. The draft guidance explains that FDA does not intend to take enforcement action with respect to cigars that do not comply with the size and placement requirements in the regulation when the information and specifications required under the regulation appear on the carton or other outer container or wrapper that could accommodate the required warning statements, or on a tag otherwise firmly and permanently affixed to the cigar package.

The Food and Drug Administration (FDA or we) is announcing a public hearing regarding FDA initiatives for enhancing the safety of foods (for humans and animals) imported into the United States. The hearing will focus on partnerships to improve safety capabilities through capacity building; partnerships that incorporate information from private entities and foreign competent authorities to inform risk- based decisionmaking; partnerships that recognize commodity-specific export programs; and partnerships that recognize the robustness of a nation's entire food safety system. In addition, we are seeking information from a variety of viewpoints, including from competent authorities in other countries and from private entities, to help inform FDA regarding risk-based decisionmaking, commodity-specific export control programs in other countries, and systems recognition.

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Control of Listeria monocytogenes in Ready-To-Eat Foods.'' The revised draft guidance is intended for any person who is subject to our regulation entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food'' and who manufactures, processes, packs, or holds ready-to-eat (RTE) foods. The revised draft guidance is intended to help such persons comply with the requirements of that regulation with respect to measures that can significantly minimize or prevent the contamination of RTE food with L. monocytogenes whenever a RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to L. monocytogenes) that would significantly minimize L. monocytogenes.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.'' This draft guidance is intended to assist potential applicants who plan to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic combination product that includes both a drug constituent part and a delivery device constituent part.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops.'' This draft guidance provides FDA's interpretation of, and a compliance policy for, the requirement that the label of tobacco products contain an accurate statement of the percentage of foreign and domestic grown tobacco under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance document is also intended to assist retailers who sell newly deemed products by explaining whether engaging in certain activities subjects such establishments to additional requirements of the FD&C Act and the limited circumstances under which FDA does not intend to enforce compliance.