Department of Health and Human Services July 25, 2017 – Federal Register Recent Federal Regulation Documents

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 Office of the National Coordinator for Health Information Technology (ONC) is seeking applications to the Health Information Technology Advisory Committee.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Voluntary Medical Device Manufacturing and Product Quality Program.'' The purpose of the public workshop is to announce the proposed framework and preliminary outline of a voluntary pilot program that recognizes an independent assessment of manufacturing and product quality. The workshop is intended to discuss the framework of the voluntary pilot program, information on the independent assessment, details of participation, rules of engagement, monitoring and performance expectations, as well as potential modifications to FDA's oversight actions in response to demonstrated manufacturing quality performance. FDA is soliciting public feedback to aid in the development of science-based approaches to regulatory decision making for assessing manufacturing quality, extent of manufacturing related submissions, and how to better allocate resources to lower the regulatory burden on manufacturers and FDA.

The Food and Drug Administration is correcting a document entitled ``Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Comment Period'' that appeared in the Federal Register of July 3, 2017. The document extended the comment period for the interim final rule that appeared in the Federal Register of May 4, 2017. The document was published with an incorrect RIN number. This document corrects that error.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry (GFI) #170 entitled ``Animal Drug User Fees and Fee Waivers and Reductions.'' This revised guidance document describes the types of fees that FDA is authorized to collect under the Animal Drug User Fee Act of 2003, as amended, and how to request waivers and reductions of these fees.

The Food and Drug Administration (FDA or Agency) is amending a civil money penalty regulation to correct a statutory reference to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and to ensure accuracy and clarity in the Agency's regulations.