3 new federal notices

New in the Federal Register

Rules, proposed rules, and notices from the FDA and USDA that touch food, labels, and organic.

• Notice · Health and Human Services Department Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ATEBRIOZ (Zilurgisertib)

  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) 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...

• Notice · Health and Human Services Department Issuance of Priority Review Voucher; Rare Pediatric Disease Product; EMCITATE (Tiratricol)

  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) 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...

• Notice · Health and Human Services Department Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure (MCM) Priority Review Voucher; Bixlenvo (Bictegravir and Lenacapavir)

  The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a material threat MCM priority review voucher. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish...

Summaries are the agencies' own words. Read the full document before you act on it.