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

The Administration for Community Living (ACL) recently announced the awarding of the University of Minnesota to the Residential Information System Project (RISP). The University of Minnesota will maintain and continue the longitudinal study of annual state-by-state and national statistics on residential services and supports for people with intellectual and developmental disabilities.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self- Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance.'' The Generic Drug User Fee Amendments of 2012 (GDUFA) are designed to speed the delivery of safe and effective generic drugs to the public and to improve the review process for abbreviated new drug applications (ANDAs). This guidance is intended to provide answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding the requirements and commitments of GDUFA. This guidance finalizes the draft guidance originally issued in August 2012 and issued in revised draft form in September 2013.

The Food and Drug Administration (FDA or we) is announcing that Zinpro Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of zinc-L- selenomethionine as a nutritional source of selenium in complete feed for laying hens and for the safe use of the approved food additive silicon dioxide as an anticaking agent for use with zinc-L- selenomethionine as a feed component.

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.

The U.S. Department of Health and Human Services published a notice in the Federal Register, dated Monday, July 17, 2017, to announce its intent to establish the Tick-Borne Disease Working Group (Working Group) and to invite nominations for membership. This notice contained incorrect information.

This notice announces a public meeting to discuss ideas for a potential behavioral health payment model to improve health care quality and access, while lowering the cost of care for Medicare, Medicaid, or Children's Health Insurance Program (CHIP) beneficiaries with behavioral health conditions.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services announces the intent to extend the fund to Special Olympics Inc. To improve knowledge and awareness about the usefulness and effectiveness of health promotion programs and policy, systems and environmental improvements for people with intellectual disabilities.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is announcing its intent to establish a pilot project program under the Drug Supply Chain Security Act (the DSCSA Pilot Project Program) to assist in development of the electronic, interoperable system that will identify and trace certain prescription drugs as these are distributed within the United States. Under this program, FDA will work with stakeholders to establish one or more pilot projects to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. Participation in the DSCSA Pilot Project Program will be voluntary and will be open to pharmaceutical distribution supply chain members. FDA will be particularly interested in participation reflecting the diversity of the supply chain, including large and small entities from all industry sectors. This notice describes the proposed DSCSA Pilot Project Program, including proposed instructions for submitting a request to participate. FDA is soliciting comments on the proposed collection of information associated with establishment of the DSCSA Pilot Project Program before submitting the proposed collection to the Office of Management and Budget (OMB) for approval. FDA does not intend to begin the proposed DSCSA Pilot Project Program or accept requests to participate in the program until OMB has approved the proposed collection of information.

This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 to implement changes arising from our continuing experience with these systems and certain provisions under the 21st Century Cures Act (Pub. L. 114-255). In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program.