Department of Health and Human Services August 15, 2018 – Federal Register Recent Federal Regulation Documents

Statement of Organizations, Functions, and Delegations of Authority The Administration for Children and Families (ACF) has realigned the Office of Human Services Emergency Preparedness and Response (OHSEPR). OHSEPR will be a direct report to the Deputy Assistant Secretary for External Affairs. ACF will transfer the U.S. Repatriation Program from the Office of Refugee Resettlement (ORR) to OHSEPR. The OHSEPR mission statement has been revised to include the Repatriation Program and responsibility for business continuity planning. It renames the Division of Disaster Case Management to the Division of Response and Recovery Operations and the Division of Emergency Planning, Policy and Operations to the Division of Emergency Policy and Planning. Lastly, it changes the reporting relationship of the Office of Communications from a direct report to the Deputy Assistant Secretary for External Affairs to a direct report to the Assistant Secretary for Children and Families.

ACF, ORR, announces the intent to issue one OPDIV-Initiated Supplement to BCFS Health and Human Services, San Antonio, TX in the amount of up to $19,011,218. ORR has been identifying additional capacity to provide shelter for potential increases in apprehensions of Unaccompanied Children at the U.S. Southern Border. Planning for increased shelter capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter for Unaccompanied Alien Children referred to its care by the Department of Homeland Security (DHS). To ensure sufficient capacity to provide shelter to unaccompanied children referred to HHS, BCFS proposed to provide ORR with 700 beds in an expedited manner.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that CRYSVITA (burosamab-twza), manufactured by Ultragenyx Pharmaceutical, Inc., meets the criteria for a priority review voucher.

The Food and Drug Administration (FDA or Agency) is reopening the comment period for the notice of availability that published in the Federal Register on March 27, 2018. In that document, FDA requested comments on the draft guidance for industry (GFI) #255 entitled ``Elemental Impurities in Animal Drug ProductsQuestions and Answers.'' The Agency is taking this action in response to requests for an extension to allow interested parties additional time to develop and submit comments.

This proposed notice acknowledges the receipt of an application from the Joint Commission (TJC) for continued recognition as a national accrediting organization for psychiatric hospitals that wish to participate in the Medicare or Medicaid programs.