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

The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HRSA published a final rule on January 5, 2017, that set forth the calculation of the 340B ceiling price and application of civil monetary penalties. On June 5, 2018, HRSA published a final rule that delayed the effective date of the 340B ceiling price and civil monetary rule until July 1, 2019, to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking. After further consideration of the issue, the Department of Health and Human Services (HHS or Department) proposes to cease any further delay of the rule and change the effective date from July 1, 2019, to January 1, 2019.

HRSA provided supplemental grant funds to a currently funded National Training and Technical Assistance Cooperative Agreement (NCA) award recipient to coordinate and provide training and technical assistance (T/TA) to health centers that serve migrant and seasonal agricultural workers (MSAW) and their families through three regional forums.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, limited only by the space available. The meeting space accommodates approximately 150 people and the audio conference line has 150 ports for callers. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference (information below).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs and biologics for the treatment of chronic hepatitis B virus (HBV) infection from the initial investigational new drug application (IND) through the new drug application (NDA)/biologics license application (BLA) and postmarketing phases.

This proposed notice acknowledges the receipt of an application from the Accreditation Commission for Health Care, Inc., for recognition as a national accrediting organization for End Stage Renal Disease Facilities that wish to participate in the Medicare or Medicaid programs.

This document announces the extension of the timeline for publication of the ``Medicare and Medicaid Program; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies'' final rule. We are issuing this document in accordance with section 1871(a)(3)(B) of the Social Security Act (the Act), which requires notice to be provided in the Federal Register if there are exceptional circumstances that cause us to publish a final rule more than 3 years after the publication date of the proposed rule. In this case, the complexity of the rule and scope of public comments warrants the extension of the timeline for publication.