Department of Health and Human Services March 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.

The inventions listed below are owned by an agency of the U.S. Government.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The invention named in this notice is owned by agencies of the United States Government and is available for licensing in accordance with the U.S. Federal Technology Transfer Act of 1986. Related data for 510(k) submission is available as part of the licensing package. The technology and related data are being licensed to achieve expeditious commercialization of federally funded research and development. A U.S. Provisional patent application has been filed to extend market coverage. CDC also seeks collaboration partners with interest in adapting the test for different equipment, point-of-care, or more rapid processing.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry on generic doxycycline hyclate oral delayed-release tablets, entitled ``Product- Specific Guidance for Doxycycline Hyclate.'' The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for doxycycline hyclate oral delayed-release tablets.

The Food and Drug Administration (FDA, the Agency, or we) is announcing an additional public workshop on medical gas regulation entitled ``Medical Gas Regulation: Workshop III.'' FDA has previously held two public workshops entitled ``Medical Gas Regulation: Workshop I'' and ``Medical Gas Regulation: Workshop II.'' The topic to be discussed is potential areas of Federal drug regulation that should be revised with respect to medical gases.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements for a voluntary survey for the U.S. Department of Health and Human Services (HHS), the U.S. Department of Agriculture (USDA), and the U.S. Department of Homeland Security (DHS), which will inform the FDA Food Safety Modernization Act (FSMA), National Agriculture and Food Defense Strategy (NAFDS) Report to Congress that is required by April 2019. The proposed survey will be used to determine what food defense activities, if any, State Agencies have completed to date.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Food and Drug Administration (FDA or Agency) is amending its regulations to reflect organizational change for the Office of Regulatory Policy, Center for Drug Evaluation and Research (CDER), Office of Medical Products and Tobacco. FDA is taking this action to ensure accuracy and clarity in the Agency's regulations.

The Food and Drug Administration (FDA) is announcing the renewal of the Gastrointestinal Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Gastrointestinal Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until March 3, 2020.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #255 entitled ``Elemental Impurities in Animal Drug ProductsQuestions and Answers.'' This guidance is intended to assist sponsors of animal drug products in addressing changes in the United States Pharmacopeia (USP) requirements for the control of elemental impurities in drug products marketed in the United States.