Department of Health and Human Services March 30, 2018 – Federal Register Recent Federal Regulation Documents

This notice announces the appointment of three new members to the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) and the next public meeting for the Panel, which is scheduled on Monday, July 16, 2018 and Tuesday, July 17, 2018. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on issues related to clinical diagnostic laboratory tests.

This notice announces a public meeting to receive comments and recommendations (including accompanying data on which recommendations are based) from the public on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System (HCPCS) codes being considered for Medicare payment under the clinical laboratory fee schedule (CLFS) for calendar year (CY) 2019. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests. The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (Advisory Panel on CDLTs) will participate in this Annual Laboratory Public Meeting by gathering information and asking questions to presenters, and will hold its next public meeting on July 16 and 17, 2018. The public meeting for the Advisory Panel on CDLTs will focus on discussion of and recommendations for test codes presented during the June 25, 2018 Annual Laboratory Public Meeting. The Panel meeting also will address other CY 2019 CLFS issues that are designated in the Panel's charter and specified on the meeting agenda may also be discussed.

In compliance with the Paperwork Reduction Act (PRA) of 1995, which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917- XXXX, titled, Purchased/Referred Care (PRC) Proof of Residency. The purpose of this notice is to allow 60 days for public comment to be submitted directly to OMB. A copy of the draft supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_0001).

In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. A 60-day Federal Register Notice was published on January 9, 2018. There were no comments. OMB will accept further comments from the public during the review and approval period.

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the withdrawal of approval of applications, changes of sponsorship of applications, and a change of a sponsor's name and address, and to make technical amendments to improve the accuracy of the regulations.