Department of Health and Human Services March 2, 2018 – Federal Register Recent Federal Regulation Documents

This notice announces the next meeting of the Advisory Panel on Outreach and Education (APOE) (Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning CMS programs, initiatives, and priorities. This meeting is open to the public.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical AmendmentsSmall Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with a final rule we issued in the Federal Register of May 27, 2016, entitled ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments.'' The final rule is designed to ensure that serving sizes are based on more recent consumption data and that consumers have serving size information on the Nutrition Facts label that will assist them in maintaining healthy dietary practices.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Proper Labeling of Honey and Honey Products.'' The guidance advises firms on the proper labeling of honey and honey products to help ensure that honey and honey products are not adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30).'' The guidance describes our views on the scientific evidence needed and the approach to evaluating the scientific evidence on the physiological effects to human health of isolated or synthetic non-digestible carbohydrates that are added to foods.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``E18 Genomic Sampling and Management of Genomic Data.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This guidance focuses on the general principles of collecting, processing, transporting, storing, and disposing of genomic samples or data in clinical studies. The guidance is intended to provide harmonized principles of genomic sampling and of management of genomic data in clinical studies to foster interactions amongst stakeholders, including drug developers, investigators, and regulators; and to encourage genomic research within clinical studies.

The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification from NCH Healthcare System of the voluntary relinquishment of its status as a PSO and has delisted it accordingly.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Standardization of Data and Documentation Practices for Product Tracing.'' The draft guidance elaborates on the standards for the interoperable exchange of transaction information, transaction history, and transaction statements (product tracing information) provided under the drug supply chain security provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance is intended to assist trading partners in standardizing the data contained in the product tracing information that trading partners must provide, capture, and maintain under the FD&C Act. In addition, this guidance includes recommendations for documentation practices that a trading partner can use to meet its product tracing obligations, including in situations where a trading partner is permitted by law to provide other trading partners with product tracing information that omits certain elements that would otherwise be required.