# Federal Register #2026-20769

FDA Voucher Announcement and HRSA Applicant Identifier Form Notice

**Buyer:** Food and Drug Administration
**Posted:** October 09, 2026
**Identifier:** 2026-20769

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.

[View original listing](https://www.federalregister.gov/documents/2026/10/09/2026-20769/issuance-of-priority-review-voucher-rare-pediatric-disease-product-zanvastro-zilganersen)