Department of Health and Human Services February 2019 – Federal Register Recent Federal Regulation Documents

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.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), in cooperation with the General Services Administration (GSA), announces the availability of a Draft Environmental Impact Statement (EIS) for the proposed acquisition of a site in Mace, West Virginia, and the development of this site into a replacement for the National Institute for Occupational Safety and Health (NIOSH) Underground Safety Research Program facility (Proposed Action). The proposed acquisition and development would replace the former Lake Lynn Experimental Mine in Fayette County, Pennsylvania, and would support research programs focused on miner health and safety issues. The site being considered for acquisition and development includes 461.35 acres located off U.S. Route 219 in Randolph and Pocahontas Counties near Mace, West Virginia (Site). The Draft EIS and this notice are published pursuant to the requirements of the National Environmental Policy Act of 1969 (NEPA) as implemented by the Council on Environmental Quality (CEQ) Regulations (40 CFR parts 1500-1508). In parallel with the NEPA process, CDC is also conducting consultation under Section 106 of the National Historic Preservation Act to evaluate the potential effects, if any, of the Proposed Action on historic properties. A Notice of Intent for this Draft EIS was published in the Federal Register on June 14, 2018 (83 FR 27781).

The Secretary's National Advisory Committee on Rural Health and Human Services (NACRHHS) has scheduled a public meeting. Information about NACRHHS and the agenda for this meeting can be found on the NACRHHS website at https://www.hrsa.gov/advisory-committees/ rural-health/.

The Food and Drug Administration (FDA) is withdrawing approval of new drug application (NDA) 202799 for OMONTYS (peginesatide) Injection, held by Takeda Pharmaceuticals U.S.A., Inc. (Takeda USA). Takeda Development Center America, Inc., on behalf of Takeda USA, requested withdrawal of approval of this application under relevant FDA regulations and, in so doing, has waived its opportunity for a hearing.

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of Ebola virus (species Zaire ebolavirus and hereafter referred to as Ebola virus) in response to the Ebola virus outbreak in the Democratic Republic of the Congo. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Chembio Diagnostic Systems, Inc. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic devices for detection of Ebola virus, subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XADAGO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain comment on a report as required by agency rules that relate to the transmission of passenger, crew, and flight/voyage information for public health purposes. The report can be found at https://www.cdc.gov/quarantine/final-rule-communicable-diseas es.html. Interested members of the public may submit comment regarding this report.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.