Department of Health and Human Services July 1, 2019 – Federal Register Recent Federal Regulation Documents
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Announcement of the Intent To Issue One OPDIV-Initiated Supplement to BCFS Health and Human Services Under the Standing Announcement for Residential (Shelter) Services for Unaccompanied Alien Children, HHS-2017-ACF-ORR-ZU-1132
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), announces the intent to issue one OPDIV- Initiated Supplement to BCFS Health and Human Services, San Antonio, Texas in the amount of up to $300,800,000. ORR announces the issuance of the first installment for 60 days in the amount of up to $50,000,000. ORR has been identifying additional capacity to provide shelter for potential increases in apprehensions of Unaccompanied Alien 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 alien children referred to HHS, ORR is requesting that BCFS provide up to 1,300 temporary shelter beds at Carrizo Springs, Texas over a graduated timeframe.
Request for Nominations on Device Good Manufacturing Practice Advisory Committee
The Food and Drug Administration (FDA or Agency) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to fill an upcoming vacancy on DGMPAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for an upcoming vacancy effective with this notice.
Availability of Toxicological Profiles for Tetrachloroethylene and Trichloroethylene
The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS), announces the release of the final Toxicological Profiles for Tetrachloroethylene and Trichloroethylene. The present profiles supersede any previously released drafts.
Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations.'' The purpose of this guidance is to assist sponsors with the development of drugs for treatment or prevention of the serious cutaneous manifestations of the heterogeneous group of disorders collectively known as epidermolysis bullosa (EB). This guidance focuses on drug development and trial design issues specific to the treatment of EB, including FDA's current thinking on clinical trial endpoint considerations. There is not yet sufficient clinical trial experience to establish definitive endpoints. This guidance incorporates the comments received for and finalizes the draft guidance of the same name issued on June 18, 2018.
Partnership Opportunity To Develop New Designs of Powered Air-Purifying Respirators for Healthcare Workers
The National Institute for Occupational Safety and Health (NIOSH), of the Centers for Disease Control and Prevention (CDC), announces the opportunity for inventors, researchers, and/or respirator manufacturers to participate, through a collaborative agreement, in a project titled ``New Generation Powered Air-Purifying Respirators,'' to develop new designs of powered air-purifying respirators (PAPRs) for healthcare workers.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
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 KANUMA (sebelipase alfa), manufactured by Alexion Pharmaceuticals Inc., meets the criteria for a priority review voucher.
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