Notice2025-07574
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug User Fee Program
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Published
May 1, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 90 Issue 83 (Thursday, May 1, 2025)</title>
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[Federal Register Volume 90, Number 83 (Thursday, May 1, 2025)]
[Notices]
[Pages 18673-18675]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-07574]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4467]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Prescription Drug
User Fee Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by June 2, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0297. Also include the FDA docket
number found in brackets in the heading of this document.
[[Page 18674]]
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#b1e1e3f0e2c5d0d7d7f1d7d5d09fd9d9c29fd6dec7"><span class="__cf_email__" data-cfemail="dd8d8f9c8ea9bcbbbb9dbbb9bcf3b5b5aef3bab2ab">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Prescription Drug User Fee Program
OMB Control Number 0910-0297--Revision
This information collection supports implementation of the FDA
Prescription Drug User Fee program (called ``PDUFA'' in reference to
the Prescription Drug User Fee Act). Under the prescription drug user
fee provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(sections 735 and 736 (21 U.S.C. 379g and 379h)), we have the authority
to assess and collect annual program fees for prescription drug
products approved under certain new drug applications (NDAs) and
biologics license applications (BLAs). Also under this authority,
pharmaceutical companies pay an application fee for certain NDAs and
BLAs submitted to FDA for review. Because the submission of user fees
concurrently with applications is required, review of an application by
FDA cannot begin until the fee is submitted.
PDUFA must be reauthorized every 5 years. The FDA User Fee
Reauthorization Act of 2022 (PDUFA VII) included the reauthorization of
PDUFA through September 30, 2027 (<a href="https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027">https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027</a>). PDUFA VII provides for the continued timely review of NDAs and
BLAs. Since the initial passage of PDUFA, user fees have played an
important role in expediting the drug review and approval process.
PDUFA VII reauthorization also includes commitments to meet certain
performance goals and procedures. The commitment goals represent the
product of FDA's discussions with the regulated industry and public
stakeholders, as mandated by Congress.
We are revising the collection to include our current commitment
goals, as set forth in the document ``PDUFA Reauthorization Performance
Goals and Procedures Fiscal Years 2023 Through 2027,'' found on our
website at <a href="https://www.fda.gov/media/151712/download?attachment">https://www.fda.gov/media/151712/download?attachment</a>. The
commitment goals represent the product of FDA's discussions with the
regulated industry and public stakeholders, as mandated by Congress.
FDA is committed to meeting these goals and to continuous operational
improvements associated with PDUFA implementation. The commitment goals
provide for the development and issuance of topic-specific guidance. We
maintain a searchable guidance database on our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. In
publishing the respective notices of availability for each guidance
document, we include an analysis under the PRA and invite public
comment on the associated information collection recommendations. In
addition, all Agency guidance documents are issued in accordance with
our Good Guidance Practices regulations in 21 CFR 10.115, which provide
for public comment at any time.
To assist respondents with the information collection, we developed
Form FDA 3397 entitled ``Prescription Drug User Fee Cover Sheet.''
Additional information and associated instructions may be found on our
website at <a href="https://www.fda.gov/industry/fda-user-fee-programs">https://www.fda.gov/industry/fda-user-fee-programs</a>. The
cover sheet (Form FDA 3397) is submitted for original NDAs, BLAs, and
resubmissions of these original applications after withdrawal before
filing or refusal to file actions. The form is not submitted for
certain FDA-regulated products. The list of exempted products is
included under the instructions to Form FDA 3397.
Relatedly, sections 735 and 736 of the FD&C Act also provide for
waiver, reduction, exemption, and refund requests. We developed the
guidance document entitled ``Guidance for Industry--Prescription Drug
User Fee Act Waivers, Reductions, and Refunds for Drug and Biological
Products,'' and Form FDA 3971 (Small Business Waiver and Refund
Request), which can be found on our website at <a href="https://www.fda.gov/media/131797/download">https://www.fda.gov/media/131797/download</a>.
To assist respondents in understanding user fees associated with
the information collection, we have developed the guidance document
entitled ``Assessing User Fees Under the Prescription Drug User Fee
Amendments of 2022'' (July 2023). The guidance explains the various fee
assessments, procedures for payments and refunds, as well as other
topics, and is available on our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-user-fees-under-prescription-drug-user-fee-amendments-2022">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-user-fees-under-prescription-drug-user-fee-amendments-2022</a>.
The PDUFA information collection and all user fee cover sheets,
including the ``Prescription Drug User Fee Cover Sheet'' (Form FDA
3397), are accessed and submitted electronically, as required by
statute, through FDA's electronic systems such as the Document
Archiving Reporting and Regulatory Tracking System (DARRTS), Electronic
Submission Gateway (ESG), and Panorama.
In the Federal Register of November 18, 2024 (89 FR 90705), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received one comment on the information
collection indicating general support for the program. The commenter
requested better reporting of additional information that is not
currently collected for the PDUFA program and additional reports of new
drug and biologic application review metrics, improved electronic
submissions, and automated data exchange. We will consider the comment
in future PDUFA negotiations.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total
Prescription drug user fee Number of responses per annual Average burden per Total
activity respondents respondent responses response hours
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Sections 735 and 736 of the 99 1.828 181 17......................... 3,077
FD&C Act (PDUFA waivers and
exemptions, not including
small business waiver
requests).
Section 736(d)(1)(C) of the 35 1 35 2.......................... 70
FD&C Act and Form FDA 3971
(small business waivers).
Reconsideration Requests..... 13 1.69 22 24......................... 528
Appeal Requests.............. 4 1.5 6 12......................... 72
[[Page 18675]]
User Fee Cover Sheet Form FDA 132 1.24 164 0.5 (30 minutes)........... 82
3397 submission with
original NDAs and BLAs.
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Total.................... ............ .............. 408 ........................... 3,829
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of Agency records, we estimate that the number of
initial waiver requests submitted annually (excluding small business
waiver requests under section 736(d)(1)(C) of the FD&C Act) is 181,
submitted by 99 different applicants.
We estimate that 35 respondents will each submit a small business
waiver request annually. We have included in the burden estimate the
time for preparation and submission of application fee waivers for
small businesses, including completion of Form FDA 3971. Small
businesses requesting a waiver must submit documentation to FDA,
including the number of their employees, as well as information that
their application is their first human drug application, within the
meaning of the FD&C Act, to be submitted to the Agency for approval.
We estimate receiving 22 requests for reconsideration annually
(including small business waiver reconsiderations) and assume the
average burden for preparing and submitting each request is 24 hours.
In addition, we estimate receiving six requests annually for appeal of
user fee waiver determinations, and assume the time needed to prepare
an appeal is 12 hours. We have included in this estimate both the time
needed to prepare the request for appeal to the Chief Scientist and
User Fee Appeals Officer within the Office of the Commissioner, and the
time needed to create and send a copy of the request for an appeal to
the Director Division of User Fee Management within the Office of
Management at FDA's Center for Drug Evaluation and Research.
We assume a total of 82 hours of burden for completing and
submitting the 164 forms FDA 3397 (Prescription Drug User Fee
Coversheet) along with submission of NDAs or BLAs. The burdens
associated with submission of NDAs and BLAs are included in OMB control
numbers 0910-0001 and 0910-0338, respectively.
The information collection reflects changes and adjustments. We
have clarified that the scope of the collection includes provisions
found in our current commitment goals letter, negotiated with industry,
pertaining to the assessment of fees, waivers, refunds, and exemptions
under PDUFA VII. We have also included relevant Agency guidance
documents that provide instruction in this regard and for which we
attribute attendant burden. Cumulatively, these adjustments have
resulted in a total decrease of 3 responses and an overall increase of
203 burden hours annually since the prior renewal of the information
collection. We attribute the minor changes in the numbers to normal
fluctuations in numbers of waivers, exemptions, reconsideration
requests, and appeals received for assessed PDUFA fees. We do not
attribute a change in the burden related to the revision request to
include the Agency's commitment goals.
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07574 Filed 4-30-25; 8:45 am]
BILLING CODE 4164-01-P
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