Notice2026-05573
Commissioner's National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments
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Published
March 23, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public hearing related to 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 through enhanced regulatory engagement and streamlined review procedures. The CNPV Pilot Program is intended to expedite approvals for products that align with critical U.S. national health priorities while maintaining FDA's rigorous scientific and regulatory standards. We are holding this public hearing to obtain feedback and perspectives regarding the CNPV Pilot Program, including feedback on the eligibility criteria, voucher selection processes, sponsor responsibilities, FDA review procedures, and program implementation.
Full Text
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<title>Federal Register, Volume 91 Issue 55 (Monday, March 23, 2026)</title>
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[Federal Register Volume 91, Number 55 (Monday, March 23, 2026)]
[Notices]
[Pages 13849-13852]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-05573]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-2366]
Commissioner's National Priority Voucher (CNPV) Pilot Program;
Public Hearing; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Public hearing; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a public hearing related to 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 through enhanced regulatory engagement and
streamlined review procedures. The CNPV Pilot Program is intended to
expedite approvals for products that align with critical U.S. national
health priorities while maintaining FDA's rigorous scientific and
regulatory standards. We are holding this public hearing to obtain
feedback and perspectives regarding the CNPV Pilot Program, including
feedback on the eligibility criteria, voucher selection processes,
sponsor responsibilities, FDA review procedures, and program
implementation.
DATES: The public hearing will be held with an in-person and virtual
option (i.e., hybrid) on June 12, 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/<a href="http://fda.gov/news-events/commissioners-national-priority-voucher-cnpv-pilot-program-public-hearing-06122026">fda.gov/news-events/commissioners-national-priority-voucher-cnpv-pilot-program-public-hearing-06122026</a>. All
requests for participation, including for those who wish to present
during the public hearing, must be received by 11:59 p.m., May 1, 2026,
through the meeting registration page. Questions about meeting
registration and participation should be sent to
<a href="/cdn-cgi/l/email-protection#5b183436363228283234353e290d342e38333e291b3d3f3a75333328753c342d"><span class="__cf_email__" data-cfemail="1e5d717373776d6d7771707b6c48716b7d767b6c5e787a7f3076766d30797168">[email protected]</span></a>, and include the title of this notice:
``Commissioner's National Priority Voucher (CNPV) Pilot Program; Public
Hearing; Request for Comments''). See the SUPPLEMENTARY INFORMATION
section for attendance and registration information.
Either electronic or written comments on this public hearing will
be accepted
[[Page 13850]]
after the public hearing until June 29, 2026. See the SUPPLEMENTARY
INFORMATION section for registration date and information.
ADDRESSES: Location: The public hearing will be held at the White Oak
Great Room, 10903 New Hampshire Ave., Silver Spring, MD 20993. Entrance
for the public meeting participants (non-FDA employees) is through
Building 1 where routine security check procedures will be performed.
For security and parking information, please refer to <a href="https://www.fda.gov/about-fda/visitor-information/public-meeting-information">https://www.fda.gov/about-fda/visitor-information/public-meeting-information</a>
and <a href="https://www.fda.gov/about-fda/visitor-information/visitor-parking-and-campus-map">https://www.fda.gov/about-fda/visitor-information/visitor-parking-and-campus-map</a>.
Additional details, such as any changes to the time of the public
hearing and registration information, will be posted at <a href="https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program">https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program</a>. The online web conference meeting link can be accessed
at <a href="https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program">https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program</a> on the day of the meeting.
All written requests for participation in the pilot program must be
received by May 1, 2026 (email to: <a href="/cdn-cgi/l/email-protection#80c3efedede9f3f3e9efeee5f2d6eff5e3e8e5f2c0e6e4e1aee8e8f3aee7eff6"><span class="__cf_email__" data-cfemail="52113d3f3f3b21213b3d3c3720043d27313a3720123436337c3a3a217c353d24">[email protected]</span></a>).
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a>
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of June 29, 2026. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2026-N-2366 for ``Commissioner's National Priority Voucher (CNPV)
Pilot Program; Public Hearing; Request for Comments.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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,
<a href="/cdn-cgi/l/email-protection#f8bb979595918b8b9197969d8aae978d9b909d8ab89e9c99d690908bd69f978e"><span class="__cf_email__" data-cfemail="5e1d313333372d2d3731303b2c08312b3d363b2c1e383a3f7036362d70393128">[email protected]</span></a>.
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).
[[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:
<bullet> 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).
<bullet> Nontransferable vouchers: Cannot be sold or used for a
different application, unlike traditional priority review vouchers.
<bullet> Enhanced presubmission engagement: Facilitates earlier
correction of issues (e.g., chemistry, manufacturing, and controls
(CMC) and inspection) that can lead to review cycle extensions.
<bullet> 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 Sec. 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 Sec. 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 Sec. 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:
<bullet> Eligible Applications/Scope, including any comments on:
[cir] 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).
[cir] 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).
[cir] Potential changes to the scope of the program, such as
modifying priorities, expanding or limiting eligibility to certain
applications, product types or development stages.
<bullet> The Voucher Selection Process, as outlined in the FDA
Staff Manual Guide on Commissioner's National Priority Voucher Review
Council,\1\ including any comments on:
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\1\ FDA [Internet]. SMG 2010.23. FDA Staff Manual Guides (SMG),
Volume III--General Administration FDA Councils and Committees.
Commissioner's National Priority Voucher Review Council. Available
from: <a href="https://www.fda.gov/media/190099/download?attachment">https://www.fda.gov/media/190099/download?attachment</a> (Accessed
March 6, 2026).
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[cir] FDA's practice of accepting internal nominations by FDA
review divisions and external statements of interest submitted by
sponsors and applicants.
[cir] FDA's requested format for brief statements of interest
submitted by sponsors and applicants.
[cir] 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.
[cir] Other aspects of selection.
<bullet> The Enhanced Regulatory Engagement Requirements for
sponsors and applicants accepting CNPV vouchers, including any comments
on:
[cir] The expectation for rapid response to FDA information
requests (typically within 24-48 hours).
[cir] Availability for ad hoc meetings with FDA staff during
business hours.
[cir] Facilitation of FDA inspections to verify regulatory
compliance.
[cir] Submission of complete application packages within mutually
agreed timeframes.
[cir] Labeling negotiations ideally limited to maximum two rounds.
[cir] FDA is interested in the feasibility of these requirements
for sponsors, particularly smaller companies.
<bullet> The Presubmission and Rolling Submissions Requirements,
including any comments on:
[cir] Presubmission informational meetings with review divisions to
review the expectations and coordinate submissions timeline.
[cir] Rolling submission of CMC information and of proposed
labeling at least 60 days before final module submission.
[cir] The recommended presubmission process including:
[ssquf] Limiting the number of manufacturing facilities to no more
than 2-3 per submission with justification for any additional sites.
[ssquf] 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.
<bullet> The CNPV Review Timeline and Process,\2\ including any
comments on:
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\2\ FDA [Internet]. The Commissioner's National Priority Voucher
(CNPV) Pilot Program. CDER, CBER, OCE Town Hall. February 3, 2026.
Office of the Chief Medical Officer, Office of the Commissioner.
Available from <a href="https://www.fda.gov/media/190927/download?attachment">https://www.fda.gov/media/190927/download?attachment</a>
(Accessed March 6, 2026).
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[cir] The target review timeline of 1-2 months after the complete
application submission filing action.
[cir] The proposed filing review timeline of 14-21 days after
receipt of the final application component submission.
[[Page 13852]]
[cir] 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.
[cir] The relationship between CNPV Pilot Program target timelines
and PDUFA goal dates.
[cir] The use of optional tools (e.g., review templates, AI tools)
to facilitate review or tracking of applications.
<bullet> The CNPV Review Council, as outlined in the FDA Staff
Manual Guide on Commissioner's National Priority Voucher Review
Council,\1\ including any comments on:
[cir] 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.
[cir] The ``tumor board style'' meeting format, including
application presentation, discussion, primary review team
recommendation, Council vote, and Center Director recommendation.
<bullet> The Sponsor Responsibilities and Expectations, including
any comments on the following processes/procedures:
[cir] FDA's request for written acknowledgment and confirmation of
sponsor or applicant's agreement to participate within two weeks of
voucher issuance.
[cir] FDA's clarity of communication regarding the fact that a
voucher does not guarantee approval or a 1-2 month timeframe.
[cir] FDA's expectation that the intent to redeem voucher should
ideally be acknowledged within 2 weeks of official issuance date.
[cir] FDA's expectation that sponsors submit complete application
within 2 years of official voucher issuance date.
[cir] FDA's request for sponsors to share public announcements
related to the CNPV Pilot Program with FDA prior to release.
<bullet> The Program Evaluation and Future Directions, including
any comments on
[cir] Metrics or outcomes FDA should consider in evaluating the
program's success.
[cir] What the Agency should consider for continuing, modifying, or
expanding the program based on pilot results.
<bullet> 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/
<a href="http://fda.gov/news-events/commissioners-national-priority-voucher-cnpv-pilot-program-public-hearing-06122026">fda.gov/news-events/commissioners-national-priority-voucher-cnpv-pilot-program-public-hearing-06122026</a>.
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: <a href="/cdn-cgi/l/email-protection#6724080a0a0e14140e08090215310812040f021527010306490f0f1449000811"><span class="__cf_email__" data-cfemail="f5b69a98989c86869c9a9b9087a39a80969d9087b5939194db9d9d86db929a83">[email protected]</span></a>). 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program">https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-05573 Filed 3-20-26; 8:45 am]
BILLING CODE 4164-01-P
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