Department of Health and Human Services March 18, 2016 – Federal Register Recent Federal Regulation Documents

Pursuant to the court's October 6, 2015 order in Shands Jacksonville Medical Center, Inc., v. Sebelius, No. 14-263 (D.D.C.) and consolidated cases that challenge the 0.2 percent reduction in FY 2014 inpatient prospective payment systems (IPPS) rates to account for the estimated $220 million in additional FY 2014 expenditures resulting from the 2-midnight policy, we are currently scheduled to publish a notice in the Federal Register responding to comments we have received on these issues, including those received in response to the December 1, 2015 notice with comment period (80 FR 75107). We have moved the court for an extension of the March 18, 2016 deadline until April 27, 2016. We anticipate publishing the notice on or before April 27, 2016.

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces the webinar series, ``Alternative Approaches for Acute Inhalation Toxicity to Address Global Regulatory and Non-Regulatory Data Requirements.'' Webinar speakers will discuss the state of the science of alternative approaches for identifying acute systemic toxicants due to inhalation exposure, and identify knowledge and data gaps that need to be addressed prior to implementation of those approaches.

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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.

The Food and Drug Administration (FDA or we) is issuing a final rule prohibiting the use of certain cattle material to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. We have designated the following items as prohibited cattle materials: Specified risk materials (SRMs), the small intestine from all cattle (unless the distal ileum has been removed), material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated (MS) (Beef). We are taking this action to minimize human exposure to certain cattle material that could potentially contain the BSE agent.

The U.S. Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Wesley A. McQuerry from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. McQuerry was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product and otherwise relating to the regulation of a drug product under the FD&C Act. Mr. McQuerry was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. McQuerry failed to respond. Mr. McQuerry's failure to respond constitutes a waiver of his right to a hearing concerning this action.

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) will hold a public forum to share information and facilitate direct communication of ideas and suggestions from stakeholders. Interested persons may attend in person or remotely by webcast. Time will be set aside for public statements and questions on the topics discussed. Registration is requested for both public attendance and oral statements, and required for remote access. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/iccvamforum-2016.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on January 14, 2016, Vol. 81 pp. 1985 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute, National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.