Opportunity
Federal Register #2026-15964
Legal Services for Unaccompanied Alien Children and Emergency Use Authorization for Seegene Diagnostic Device
Buyer
Food and Drug Administration
Posted
August 06, 2026
Identifier
2026-15964
NAICS
541110, 541199, 339112
This opportunity involves two distinct actions by the Department of Health and Human Services (HHS): - The Administration for Children and Families, Office of Refugee Resettlement (ORR), intends to award a single-source cooperative agreement to Burke Law Group, PLLC for legal services supporting unaccompanied alien children (UACs) - Services include legal orientation, consultation, attorney-of-record representation during immigration proceedings before EOIR and USCIS, and limited discharge-related legal continuity planning - The agreement is valued up to $150 million - The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Allplex HSV-1&2/VZV/MPXV Assay - OEM: Seegene USA, Inc. is the manufacturer of the diagnostic device - The assay enables simultaneous qualitative detection and differentiation of monkeypox virus (MPXV clade I/II and II), herpes simplex virus types 1 and 2 (HSV1, HSV2), and varicella-zoster virus (VZV) - The EUA is in response to the public health emergency caused by the monkeypox outbreak - No specific product quantities or part numbers are provided for the diagnostic device - The legal services and diagnostic device procurement are separate actions under HHS, with the legal services focused on UACs and the diagnostic device authorized for emergency use in viral detection
Description
This notice announces the issuance of an Emergency Use Authorization (EUA) for an in vitro diagnostic device named Allplex HSV-1&2/VZV/MPXV Assay. The device is authorized for the simultaneous qualitative detection and differentiation of viral nucleic acid from monkeypox virus, herpes simplex virus types 1 and 2, and varicella-zoster virus. The authorization is in response to a public health emergency declared due to the monkeypox outbreak. The EUA is effective as of July 9, 2026, and includes conditions on the emergency use of the authorized product.