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Routine Notice Amended Final

FDA Amends CNPV Voucher Pilot Program Hearing, Changes Dates

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Summary

The FDA has amended its March 23, 2026 notice of public hearing for the Commissioner's National Priority Voucher (CNPV) Pilot Program. The hearing date has been moved from June 12, 2026 to June 4, 2026, 1:00 p.m. to 4:00 p.m. Eastern Time, with both in-person and virtual participation options. Requests for participation must now be received by April 24, 2026. Contact information has been updated to Mallika Mundkur, Deputy Chief Medical Officer, Office of the Commissioner. No other substantive changes have been made to the original notice.

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GovPing monitors FR: Health and Human Services Department for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 57 changes logged to date.

What changed

The FDA has issued an amendment to its earlier notice announcing a public hearing on the Commissioner's National Priority Voucher (CNPV) Pilot Program. The primary change is the hearing date, moved up from June 12, 2026 to June 4, 2026, from 1:00 p.m. to 4:00 p.m. Eastern Time. The format remains hybrid (in-person and virtual). The participation request deadline has been set as April 24, 2026. Contact details have been updated to reflect Mallika Mundkur, Deputy Chief Medical Officer, as the point of contact. All other aspects of the original notice remain unchanged.

Pharmaceutical and biotechnology companies interested in the priority review voucher program should note the revised hearing date and ensure timely registration. The CNPV Pilot Program is designed to incentivize development of treatments for rare pediatric diseases and material threat medical countermeasures. Entities planning to participate or submit comments should prepare requests before the April 24, 2026 deadline.

What to do next

  1. Register for the public hearing by April 24, 2026 through the meeting registration page
  2. Submit written requests for participation by April 24, 2026, 11:59 p.m. Eastern Time to CNPVPublicMeeting@fda.hhs.gov

Hearing

Date
2026-06-04 at 13:00 – 16:00
Location
Hybrid

Archived snapshot

Apr 23, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Notice

You may be interested in this older document that published on 03/23/2026 with action 'Public hearing; request for comments.' View Document

Commissioner's National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments; Amendment

A Notice by the Food and Drug Administration on 04/23/2026

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  • Public Inspection Published Document: 2026-07916 (91 FR 21822) Document Headings ###### Department of Health and Human Services
Food and Drug Administration
  1. [Docket No. FDA-2026-N-2366]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing an amendment to the notice of the public hearing related to the Commissioner's National Priority Voucher (CNPV) Pilot Program. This meeting was announced in the Federal Register of March 23, 2026. The amendment is being made to reflect a change in the DATES, ADDRESSES, FOR FURTHER INFORMATION CONTACT, and IV. Participating in Public Hearing portions of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT:

Mallika Mundkur, Deputy Chief Medical Officer, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-8800, CNPVPublicMeeting@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

In the Federal Register of March 23, 2026, 91 FR 13849, FDA announced that a public hearing related to the CNPV Pilot Program would be held on June 12, 2026. On page 13849, in the third column, the DATES portion of the document is changed to read as follows:

Deputy Commissioner for Policy, Legislation, and International Affairs.

[FR Doc. 2026-07916 Filed 4-22-26; 8:45 am]

BILLING CODE 4164-01-P

Published Document: 2026-07916 (91 FR 21822)

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Last updated

Classification

Agency
Health and Human Services Department
Published
April 23rd, 2026
Compliance deadline
April 24th, 2026 (1 days)
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
91 FR 21822 / Docket No. FDA-2026-N-2366
Docket
Docket No. FDA-2026-N-2366

Who this affects

Applies to
Pharmaceutical companies Medical device makers Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Public hearing participation Priority review vouchers Regulatory process amendment
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Regulatory Affairs
Topics
Pharmaceuticals Medical Devices

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