Department of Health and Human Services September 20, 2018 – Federal Register Recent Federal Regulation Documents

In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a new computer matching program between CMS and the Department of Homeland Security (DHS)/United States Citizenship and Immigration Services (USCIS), ``Verification of United States Citizenship and Immigration Status Data for Eligibility Determinations.'' In this matching program, DHS/USCIS provides CMS with immigrant, nonimmigrant, and naturalized or derived citizenship status information needed to make enrollment and exemption eligibility determinations as required by the Patient Protection and Affordable Care Act (ACA).

The National Institutes of Health (NIH) announces Policy Manual Chapter: 1311Preventing and Addressing Harassment and Inappropriate Conduct and a new Policy Statement addressing Personal Relationships in the Workplace. These policies apply to federal employees, contractors, trainees, and fellows who perform work for the NIH. The NIH expects that organizations receiving NIH funds have in place similarly rigorous policies and related procedures for their employees, contractors, trainees, and fellows who engage in agency- funded activities.

The Food and Drug Administration FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers.'' This draft guidance intends to clarify questions relating to product identifiers that are required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA) for packages and homogenous cases of certain drug products. Sections of the FD&C Act require manufacturers and repackagers to affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce beginning November 27, 2017, and November 28, 2018, respectively. This draft guidance intends to clarify these requirements.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing.'' The United States Pharmacopeia (USP) drug substance monograph for Heparin Sodium, and drug product monographs for Heparin Lock Flush Solution and Heparin Sodium Injection, recently have undergone several revisions following serious and fatal events related to the use of heparin sodium products. Investigation of heparin product overdose errors identified the expression of drug strength in the labels as a major contributing factor in these errors. This guidance document addresses these safety concerns by clarifying new expectations for labeling with regard to the revised heparin USP monographs, as well as outlining safety testing recommendations.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Product Identifier Requirements Under the Drug Supply Chain Security Act Compliance Policy.'' This guidance describes FDA's intention with regard to enforcement of the Drug Supply Chain Security Act (DSCSA) provision requiring manufacturers to begin affixing or imprinting product identifiers on their products beginning November 27, 2017. This guidance finalizes the draft guidance issued on July 3, 2017.

This proposed rule would reform Medicare regulations that are identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. This proposed rule would increase the ability of health care professionals to devote resources to improving patient care by eliminating or reducing requirements that impede quality patient care or that divert resources away from furnishing high quality patient care.