FDA Amends CNPV Voucher Pilot Program Hearing, Changes Dates
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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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
- Register for the public hearing by April 24, 2026 through the meeting registration page
- 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, 2026GovPing 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
- [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:
The public hearing will be held with an in-person and virtual option (i.e., hybrid) on June 4, 2026, from 1:00 p.m. to 4:00 p.m. Eastern Time. Meeting registration, including requests for participation in the public hearing, can be found at the following website: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/commissioners-national-priority-voucher-cnpv-pilot-program-public-hearing-06042026. All requests for participation, including those who wish to present during the public hearing, must be received by April 24, 2026, through the meeting registration page. Questions about meeting registration and participation should be sent to CNPVPublicMeeting@fda.hhs.gov and include the title of this notice: “Commissioner's National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments”).
On page 13850, in the first column, the second and third paragraphs of the ADDRESSES portion of the document are changed to read as follows:Additional details, such as any changes to the time of the public hearing and registration information, will be posted at https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/commissioners-national-priority-voucher-cnpv-pilot-program-public-hearing-06042026. The online web conference meeting link can be accessed at https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/commissioners-national-priority-voucher-cnpv-pilot-program-public-hearing-06042026 on the day of the meeting.
All written requests for participation in the pilot program must be received by April 24, 2026 (email to: CNPVPublicMeeting@fda.hhs.gov).
On page 13850, in the third column, the FOR FURTHER INFORMATION CONTACT portion of the document is changed to read as follows: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.
On page 13852, in the second column, the IV. Participating in Public Hearing portion of the SUPPLEMENTARY INFORMATION section is changed to read as follows:Registration: To register to attend or participate in the free public hearing, please visit the following website: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/commissioners-national-priority-voucher-cnpv-pilot-program-public-hearing-06042026.
Written Notice of Participation: All written requests for participation must be received by April 24, 2026, 11:59 p.m. Eastern Time (email to: CNPVPublicMeeting@fda.hhs.gov).
Transcripts: A link to the transcript will also be available on the internet at https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/commissioners-national-priority-voucher-cnpv-pilot-program-public-hearing-06042026.
Grace R. Graham,
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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