Federal Register #2026-20769

FDA Voucher Announcement and HRSA Applicant Identifier Form Notice

This HHS notice combines an FDA regulatory voucher announcement with an HRSA proposed information-collection notice. - Government agencies: Department of Health and Human Services (HHS), including the Food and Drug Administration (FDA) and the Health Resources and Services Administration (HRSA). - FDA announcement: FDA issued a rare pediatric disease priority review voucher to the sponsor of ZANVASTRO (zilganersen), manufactured by Ionis Pharmaceuticals, Inc. The injection is indicated to treat Alexander disease in pediatric and adult patients. This is a regulatory voucher award, not a purchase of the medicine. - HRSA information collection: HRSA seeks review of the Applicant Organizational National Provider Identifiers and Centers for Medicare & Medicaid Services Certification Numbers Form for organizations applying for HRSA award funding through Grants.gov. - The proposed form collects organizational Type 2 National Provider Identifiers (NPIs) and/or CMS Certification Numbers (CCNs) from organizations that already have them. - These identifiers are not required to apply for or receive HRSA funding. - Procurement scope: No products, quantities, contract value, or period of performance are specified.

Description

The Food and Drug Administration announces issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. FDA determined that ZANVASTRO (zilganersen), approved September 3, 2026, and manufactured by Ionis Pharmaceuticals, Inc., meets the criteria for a voucher. The source states that ZANVASTRO injection is indicated for treating Alexander disease in pediatric and adult patients. This notice concerns the voucher award and does not describe a procurement solicitation.

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