SUPPLEMENTARY INFORMATION:

I. Background

On June 17, 2025, FDA Commissioner Makary announced the launch of the Commissioner's National Priority Voucher (CNPV) Pilot Program, which is designed to significantly reduce review times for qualifying new drug applications (NDAs), biologics license applications (BLAs), and manufacturing or efficacy supplements from the standard 10-12 months to a target of 1-2 months through enhanced regulatory engagement and streamlined review procedures to address critical public health needs by providing an ultra-fast review pathway for drug and biological products of strategic national importance. The program is intended to expedite approvals for products that align with critical U.S. national health priorities—including public health crisis response, innovative breakthrough therapies, large unmet medical needs, onshoring and supply chain resilience initiatives, and affordability improvements—while maintaining FDA's rigorous scientific and regulatory standards.

FDA's authority for the CNPV Pilot Program stems from its general authority to implement the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301 et seq.) and the Public Health Service Act (PHS Act) (42 U.S.C. 201 et seq.). This program is consistent with FDA's mission to promote and protect the public health, including with respect to the review of applications submitted for approval of drugs under section 505 of the FD&C Act (21 U.S.C. 355) or biological products under section 351 of the PHS Act (42 U.S.C. 262). ( printed page 13851)

The CNPV Pilot Program provides a nontransferable “voucher” to recipients that grants expedited FDA review of a single application with enhanced regulatory engagement for a product aligned with the FDA Commissioner's national public health priorities. Key features of the program include:

• Expedited pre-filing period and target of 1-2 months from filing to action (versus 4-10 months filing-to-action for many other expedited programs).
• Nontransferable vouchers: Cannot be sold or used for a different application, unlike traditional priority review vouchers.
• Enhanced presubmission engagement: Facilitates earlier correction of issues ( e.g., chemistry, manufacturing, and controls (CMC) and inspection) that can lead to review cycle extensions.
• Multidisciplinary review approach: “Tumor board style” discussion with senior leadership through the CNPV Review Council meeting.

The CNPV Pilot Program complements existing expedited programs ( e.g., Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review) by addressing products of strategic national importance with enhanced review speed and regulatory engagement.

At the time of this notice, the CNPV Pilot Program involves FDA's Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Oncology Center of Excellence (OCE). The program is coordinated by the Deputy Chief Medical Officer within the Office of the Commissioner.

As a pilot program, processes and procedures may be revised based on the circumstances of specific applications and will be improved and refined iteratively as the CNPV Pilot Program progresses.

II. Notice of Hearing Under Part 15

FDA will hold a public hearing consistent with part 15 (21 CFR part 15) to provide the opportunity for the public to present information and views on the CNPV Pilot Program. The hearing will be conducted by a presiding officer, who will be accompanied by FDA panelists, including subject matter experts from the Office of the Commissioner, CDER, CBER, and OCE. As provided in § 15.30(f) (21 CFR 15.30(f)), the hearing is informal, and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members can pose questions; they can question any person during or at the conclusion of each presentation. Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (21 CFR part 10, subpart C). Under 21 CFR 10.205, representatives of the media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearing will be transcribed as provided in § 15.30(b) (see also Transcripts). To the extent that the conditions for the hearing, as described in this notice, conflict with any provisions set out in part 15, this notice acts as a waiver of those provisions as specified in § 15.30(h).

III. Topics for Discussion at the Public Hearing

FDA is interested in the public's views, information, and any supporting data on the CNPV Pilot Program, including the following topics:

• Eligible Applications/Scope, including any comments on:

○ The five identified national priority areas (public health crisis response, innovative breakthrough therapies, large unmet medical needs, onshoring and supply chain resilience initiatives, and affordability improvements).

○ The types of applications eligible (NDAs, BLAs, manufacturing or efficacy supplements) and the exclusion of medical device applications (although combination products that include a device component but have a drug or biological product primary mode of action are eligible for inclusion).

○ Potential changes to the scope of the program, such as modifying priorities, expanding or limiting eligibility to certain applications, product types or development stages.

• The Voucher Selection Process, as outlined in the FDAStaff Manual Guide on Commissioner's National Priority Voucher Review Council,^[1] including any comments on:

○ FDA's practice of accepting internal nominations by FDA review divisions and external statements of interest submitted by sponsors and applicants.

○ FDA's requested format for brief statements of interest submitted by sponsors and applicants.

○ Factors considered in voucher selection, including alignment with national priorities, anticipated public health impact, readiness indicators, resource and timing considerations, and known risks or uncertainties.

○ Other aspects of selection.

• The Enhanced Regulatory Engagement Requirements for sponsors and applicants accepting CNPV vouchers, including any comments on:

○ The expectation for rapid response to FDA information requests (typically within 24-48 hours).

○ Availability for ad hoc meetings with FDA staff during business hours.

○ Facilitation of FDA inspections to verify regulatory compliance.

○ Submission of complete application packages within mutually agreed timeframes.

○ Labeling negotiations ideally limited to maximum two rounds.

○ FDA is interested in the feasibility of these requirements for sponsors, particularly smaller companies.

• The Presubmission and Rolling Submissions Requirements, including any comments on:

○ Presubmission informational meetings with review divisions to review the expectations and coordinate submissions timeline.

○ Rolling submission of CMC information and of proposed labeling at least 60 days before final module submission.

○ The recommended presubmission process including:

Limiting the number of manufacturing facilities to no more than 2-3 per submission with justification for any additional sites.

Submission of all available data related to the application ( e.g., raw data, toxicology data, nonclinical data, clinical and safety data, and any completed application components) and submission of the information described in Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions to facilitate inspection planning for clinical investigators, sponsors, and contract research organizations.

• The CNPV Review Timeline and Process,^[2] including any comments on:

○ The target review timeline of 1-2 months after the complete application submission filing action.

○ The proposed filing review timeline of 14-21 days after receipt of the final application component submission. ( printed page 13852)

○ The flexibility built into the review timeline, including the ability for review divisions to request review clock extensions to ensure reviews of the highest scientific quality.

○ The relationship between CNPV Pilot Program target timelines and PDUFA goal dates.

○ The use of optional tools ( e.g., review templates, AI tools) to facilitate review or tracking of applications.

• The CNPV Review Council, as outlined in the FDAStaff Manual Guide on Commissioner's National Priority Voucher Review Council,¹ including any comments on:

○ The role of the CNPV Review Council in providing recommendations to the relevant Center Director regarding application approvability with respect to the part(s) of the application presented to the Council for consideration.

○ The “tumor board style” meeting format, including application presentation, discussion, primary review team recommendation, Council vote, and Center Director recommendation.

• The Sponsor Responsibilities and Expectations, including any comments on the following processes/procedures:

○ FDA's request for written acknowledgment and confirmation of sponsor or applicant's agreement to participate within two weeks of voucher issuance.

○ FDA's clarity of communication regarding the fact that a voucher does not guarantee approval or a 1-2 month timeframe.

○ FDA's expectation that the intent to redeem voucher should ideally be acknowledged within 2 weeks of official issuance date.

○ FDA's expectation that sponsors submit complete application within 2 years of official voucher issuance date.

○ FDA's request for sponsors to share public announcements related to the CNPV Pilot Program with FDA prior to release.

• The Program Evaluation and Future Directions, including any comments on

○ Metrics or outcomes FDA should consider in evaluating the program's success.

○ What the Agency should consider for continuing, modifying, or expanding the program based on pilot results.

• Other topics, issues, or concerns related to the CNPV Pilot Program that stakeholders wish to address, such as suggestions for improving the program design, implementation, or communication, and potential unintended consequences of the program and how they might be mitigated.

IV. Participating in Public Hearing

Registration: To register to attend or participate in the free public hearing, please visit the following website: https://www/​fda.gov/​news-events/​commissioners-national-priority-voucher-cnpv-pilot-program-public-hearing-06122026.

Registration will open on April 1, 2026. Live closed captioning will be provided during the public hearing. Additional information on requests for special accommodations due to a disability will be provided during registration.

Written Notice of Participation: During online registration you may indicate if you wish to present information and views at the hearing (oral statements without slides). FDA will do its best to accommodate requests to make public presentations. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and request time for a joint presentation. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin and will notify participants ahead of the hearing. All written requests for participation must be received by May 1, 2026, 11:59 p.m. Eastern Time (email to: CommissionerVoucher@fda.hhs.gov). No commercial or promotional material will be permitted to be presented or distributed at the public hearing.

Transcripts: Please be advised that as soon as a transcript of the public hearing is available, it will be accessible at https://www.regulations.gov. Once available, the transcript may be viewed at the Dockets Management Staff (see ADDRESSES ). A link to the transcript will also be available on the internet at https://www.fda.gov/​industry/​commissioners-national-priority-voucher-cnpv-pilot-program.

91 FR 13849