Department of Health and Human Services May 4, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is withdrawing approval of nine abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

This notice announces the annual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2018. The purpose of the Panel is to advise the Secretary of Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights as well as hospital outpatient therapeutic services supervision issues. The advice provided by the Panel will be considered as we prepare the annual updates for the hospital outpatient prospective payment system.

The Indian Health Service published a notice in the Federal Register (FR) on April 17, 2018, for the Negotiation Cooperative Agreement, Funding Announcement Number: HHS-2018-IHS-TSGN-0001. The Application Due Date has been modified.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting for the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). This meeting is open to the public; however, visitors must be processed in accordance with established federal policies and procedures. For foreign nationals or non-U.S. citizens, pre-approval is required (please contact Gwen Mustaf, 301-458-4500, glm4@cdc.gov, or Charles Rothwell, (301) 458- 4500, cjr4@cdc.gov at least 10 days in advance for requirements). All visitors are required to present a valid form of picture identification issued by a state, federal or international government. As required by the Federal Property Management Regulations, all persons entering in or on Federal controlled property and their packages, briefcases, and other containers in their immediate possession are subject to being x-rayed and inspected. Federal law prohibits the knowing possession or the causing to be present of firearms, explosives and other dangerous weapons and illegal substances. The meeting room accommodates approximately 78 people.

The Food and Drug Administration is correcting a notice entitled ``Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals'' that appeared in the Federal Register of April 9, 2018. The document announced a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. The document was published with an incorrect docket number. This document corrects that error.

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2018, relating to the Medicare and Medicaid programs and other programs administered by CMS.