Notice2025-16245
Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment; Public Meeting; Request for Comments
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Published
August 25, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled "Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment." The topic to be discussed is a hiring and retention assessment which was performed by an independent contractor.
Full Text
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<title>Federal Register, Volume 90 Issue 162 (Monday, August 25, 2025)</title>
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[Federal Register Volume 90, Number 162 (Monday, August 25, 2025)]
[Notices]
[Pages 41395-41397]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16245]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2962]
Prescription Drug User Fee Act and Biosimilar User Fee Amendments
Hiring and Retention Assessment; Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public meeting entitled ``Prescription Drug
User Fee Act and Biosimilar User Fee Amendments Hiring and Retention
Assessment.'' The topic to be discussed is a hiring and retention
assessment
[[Page 41396]]
which was performed by an independent contractor.
DATES: The public meeting will be held in person and virtually on
September 24, 2025, from 9 a.m. to 12 p.m. Eastern Time. Either
electronic or written comments on this public meeting must be submitted
by October 24, 2025. See the SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be held in person at the FDA White
Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the
Great Room, Silver Spring, MD 20993-0002 and virtually using the
Microsoft Teams platform. Participants must be REAL ID compliant to
access federal facilities. For additional information regarding REAL
ID, refer to <a href="https://www.dhs.gov/real-id/real-id-faqs">https://www.dhs.gov/real-id/real-id-faqs</a>. Entrance for the
public meeting participants (non-FDA employees) is through Building 1
where routine security check procedures will be performed. For parking
and security information, please refer to <a href="https://www.fda.gov/about-fda/visitor-information">https://www.fda.gov/about-fda/visitor-information</a>. Any changes to the public meeting location and
remote information, as appropriate, will be posted to <a href="https://www.fda.gov/drugs/news-events-human-drugs/prescription-drug-user-fee-act-and-biosimilar-user-fee-amendments-hiring-and-retention-assessment">https://www.fda.gov/drugs/news-events-human-drugs/prescription-drug-user-fee-act-and-biosimilar-user-fee-amendments-hiring-and-retention-assessment</a>
in advance of the meeting.
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 October 24, 2025. 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-2025-N-2962 for ``Prescription Drug User Fee Act and Biosimilar
User Fee Amendments Hiring and Retention Assessment; Public Meeting;
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: Thamar Bailey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 4103, Silver Spring, MD 20993-0002, 301-
796-6645, <a href="/cdn-cgi/l/email-protection#c68582839496b4a9a1b4a7ab83b0a7aab3a7b2afa9a886a0a2a7e8aeaeb5e8a1a9b0"><span class="__cf_email__" data-cfemail="bbf8fffee9ebc9d4dcc9dad6fecddad7cedacfd2d4d5fbdddfda95d3d3c895dcd4cd">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is holding a public meeting to meet performance commitments
included in the Prescription Drug User Fee Act (PDUFA VII) and the
Biosimilar User Fee Amendments (BsUFA III). These user fee programs
were reauthorized for fiscal years 2023-2027 as part of the FDA User
Fee Reauthorization Act of 2022 (Pub. L. 117-180) enacted on September
30, 2022. The complete set of performance goals for each program is
available at:
<bullet> PDUFA VII program: <a href="https://www.fda.gov/media/151712/download">https://www.fda.gov/media/151712/download</a>
<bullet> BsUFA III program: <a href="https://www.fda.gov/media/152279/download">https://www.fda.gov/media/152279/download</a>
During the public meeting, FDA will share high-level findings from
a recently completed assessment of FDA's hiring and retention of staff
for the human drug review program. This assessment was conducted by a
qualified, independent contractor with expertise in assessing Human
Resource (HR) and Human Capital (HC) operations as agreed to in the
PDUFA VII and BsUFA III commitment letters. Previously, as part of
PDUFA VI and BsUFA II, independent contractors conducted a series of
three assessments that aimed to capture the status of FDA's HR and HC
operations, identify challenges, and provide actionable
recommendations. The previous reports are available at:
[[Page 41397]]
<bullet> Initial assessment report: <a href="https://www.fda.gov/media/108866/download">https://www.fda.gov/media/108866/download</a>
<bullet> Interim assessment report: <a href="https://www.fda.gov/media/138662/download">https://www.fda.gov/media/138662/download</a>
<bullet> Final assessment report: <a href="https://www.fda.gov/media/154873/download">https://www.fda.gov/media/154873/download</a>
The initial assessment served as a baseline, evaluated the state of
FDA human resource operations, identified root causes of challenges,
and provided recommendations related to recruitment and hiring. Unlike
the subsequent evaluations, the initial assessment did not evaluate
employee retention efforts. The interim and final assessments
documented progress from the previous assessment(s) related to
recommendations from the initial assessment, program milestones,
metrics, and other aggregated feedback from internal HR/HC customers
and participants and provided additional recommendations. The current
assessment builds upon the findings from the three previous assessments
with a focus on changes that have improved FDA's hiring and retention
outcomes and challenges that remain. The current assessment also
expands beyond the scope of the previous assessments to include the
pre-employment onboarding process. This assessment report includes
metrics related to recruiting and retention in the human drug review
program, including specific targeted scientific disciplines, attrition,
and utilization of pay authorities. The report also includes the
contractor's findings and recommendations on further enhancements to
hiring and retention of staff for the human drug review program. To
view the assessment report, please visit: <a href="https://www.fda.gov/media/188083">https://www.fda.gov/media/188083</a>.
II. Topics for Discussion at the Public Meeting
This public meeting will provide FDA the opportunity to update
interested public stakeholders on topics related to hiring and
retention in the FDA human drug review program. The independent
contractor will present their findings and recommendations that are
outlined in the hiring and retention assessment report, and FDA will
provide its perspective on the independent contractor's findings and
recommendations. To view the assessment report, please visit: <a href="https://www.fda.gov/media/188083">https://www.fda.gov/media/188083</a>.
III. Participating in the Public Meeting
Registration: To register for this hybrid public meeting, please
visit the following website: <a href="https://FDAPublicMeeting_PDUFAVII_BsUFAIII_HiringandRetention.eventbrite.com">https://FDAPublicMeeting_PDUFAVII_BsUFAIII_HiringandRetention.eventbrite.com</a>.
Please provide complete contact information for each attendee,
including attendance format (in-person or virtual), name, title,
affiliation, and email.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending the public
meeting must register by September 15, 2025, 11:59 p.m. Eastern Time.
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted. If time and space permit, onsite registration on the day of
the public meeting will be provided beginning at 8 a.m.
If you need special accommodations due to a disability, please
contact Thamar Bailey, 301-796-6645, <a href="/cdn-cgi/l/email-protection#1d5e59584f4d6f727a6f7c70586b7c71687c697472735d7b797c3375756e337a726b"><span class="__cf_email__" data-cfemail="581b1c1d0a082a373f2a39351d2e39342d392c313736183e3c397630302b763f372e">[email protected]</span></a>
no later than September 15, 2025, 11:59 p.m. Eastern Time.
Opportunity for Public Comment: During online registration, you may
indicate if you wish to present during a public comment session, and
which topic(s) you wish to address. We will do our best to accommodate
requests to make public comments. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations and request time for a joint presentation. All requests
to make oral presentations during the meeting must be received via
registration by September 15, 11:59 p.m. Eastern Time. Onsite
registration for public comments on the day of the public meeting will
not be provided. 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 select and notify
participants by September 17, 2025. If selected to present at the
public comment session, any presentation materials must be emailed to
<a href="/cdn-cgi/l/email-protection#e9aaadacbbb99b868e9b8884ac9f88859c889d808687a98f8d88c781819ac78e869f"><span class="__cf_email__" data-cfemail="400304051210322f2732212d0536212c352134292f2e002624216e2828336e272f36">[email protected]</span></a> by September 19, 11:59 p.m. Eastern
Time. No commercial or promotional material will be permitted to be
presented or distributed at the public meeting.
Streaming Webcast of the Public Meeting: This public meeting will
also be webcast to registered attendees. To view the webcast of this
public meeting, please register at <a href="https://FDAPublicMeeting_PDUFAVII_BsUFAIII_HiringandRetention.eventbrite.com">https://FDAPublicMeeting_PDUFAVII_BsUFAIII_HiringandRetention.eventbrite.com</a>
(see ``Registration''). Please provide complete contact information for
each attendee, including, name, title, affiliation, and email.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. It 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/drugs/news-events-human-drugs/prescription-drug-user-fee-act-and-biosimilar-user-fee-amendments-hiring-and-retention-assessment">https://www.fda.gov/drugs/news-events-human-drugs/prescription-drug-user-fee-act-and-biosimilar-user-fee-amendments-hiring-and-retention-assessment</a>.
Notice of this meeting is given pursuant to 21 CFR 10.65.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16245 Filed 8-22-25; 8:45 am]
BILLING CODE 4164-01-P
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