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[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.
                                --------------------------------------------------------------------------------
    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]
BILLING CODE 4164-01-P
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