[Federal Register Volume 89, Number 222 (Monday, November 18, 2024)]
[Notices]
[Pages 90705-90708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26801]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4467]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Prescription Drug User Fee Program
AGENCY: Food and Drug Administration, HHS.
[[Page 90706]]
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection associated with
FDA's Prescription Drug User Fee program.
DATES: Either electronic or written comments on the collection of
information must be submitted by January 17, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 17, 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:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
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 https://www.regulations.gov.
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:
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.
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-2024-N-4467 for ``Prescription Drug User Fee Program.'' 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 https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
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 https://www.regulations.gov.
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov 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: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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
[[Page 90707]]
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. On September 30, 2022,
the President signed into law the FDA User Fee Reauthorization Act of
2022, which includes the reauthorization of PDUFA through September 30,
2027 (https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027). 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 https://www.fda.gov/media/151712/download?attachment. 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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 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 https://www.fda.gov/industry/fda-user-fee-programs. 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 https://www.fda.gov/media/131797/download, as mandated by Congress.
We also developed Form FDA 4068, ``Prescription Drug User Fee Act;
Waivers, Refunds, and Exemptions,'' along with accompanying
instructions, to enable sponsors of designated orphan products to
request an exemption from applicable fees under PDUFA and included the
form in the information collection when the prior renewal was submitted
for approval. Use of the form will provide the information required for
analysis and application of the orphan exemption from user fees,
organizing the requested information for easier data collection and
streamlining the review request. We find, however, with this renewal,
that use of the form has not been implemented yet, pending development
of the OneNexus system for management of the user fee systems. Use of
the form is anticipated once the OneNexus system is developed and
implemented for the PDUFA program.
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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Prescription drug user fee Number of responses per Total 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
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
[[Page 90708]]
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. Cumulatively these changes and adjustments have
resulted in an increase of three responses and 203 burden hours
annually since the prior renewal of the information collection. We
attribute this to the steady state of incoming requests for waivers and
reconsiderations and normal fluctuations in types of submissions or
waivers received.
Dated: October 30, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-26801 Filed 11-15-24; 8:45 am]
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