[Federal Register Volume 87, Number 26 (Tuesday, February 8, 2022)]
[Notices]
[Pages 7186-7187]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02617]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-N-0101]


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 (PRA).

DATES: Submit written comments (including recommendations) on the 
collection of information by March 10, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. 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.

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#5e0e0c1f0d2a3f38381e383a3f7036362d70393128"><span class="__cf_email__" data-cfemail="17474556446376717157717376397f7f6439707861">[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 Food and 
Drug Administration Prescription Drug User Fee Act (PDUFA) program. 
PDUFA was enacted in 1992 and authorizes FDA to collect fees from 
companies that produce certain human drug and biological products. 
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 user fees for 
certain new drug applications (NDAs) and new biologics license 
applications (BLAs). Under this authority, pharmaceutical companies pay 
a fee for certain new NDAs and BLAs submitted to FDA for review. We 
have established a PDUFA page on our website at https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ that includes resources 
and information regarding PDUFA topics at FDA.
    Because the submission of user fees concurrently with applications 
is required, review of an application by FDA cannot begin until the fee 
is submitted. To assist respondents in this regard, we developed Form 
FDA 3397 entitled ``PDUFA 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) need not be submitted for certain FDA-regulated products, e.g., 
generic drugs, and whole blood and blood components for transfusion. 
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, refund, and reconsideration 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.
    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 2018 Through 2022,'' also found on 
our website at https://www.fda.gov/media/99140/download. PDUFA is 
currently authorized through September 30, 2022, with reauthorization 
activities currently underway. 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

[[Page 7187]]

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 practice regulations in 
21 CFR 10.115, which provide for public comment at any time.
    In the Federal Register of November 30, 2021 (86 FR 67958), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of the 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    Total hours
            activity                respondents     respondent       responses     per response
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Sections 735 and 736 of the FD&C             112            1.68             189              17           3,213
 Act (PDUFA waivers, not
 including small business
 waivers).......................
Section 736(d)(1)(C) of the FD&C              37               1              37               2              74
 Act and Form FDA 3971 (small
 business waivers)..............
Reconsideration Requests........               6            1.67              10              24             240
Appeal Requests.................               1               1               1              12              12
User Fee Cover Sheet Form FDA                174               1             174         0.5 (30              87
 3397...........................                                                        minutes)
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    Total.......................  ..............  ..............             411  ..............            3626
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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) will be 
189, submitted by 112 different applicants; and that 37 respondents 
annually will each submit a small business waiver request. 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 the application is the first human drug 
application, within the meaning of the FD&C Act, to be submitted to the 
Agency for approval.
    We estimate receiving 10 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 1 request annually for appeal of 
user fee waiver determination, 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 87 hours of burden for completing and submitting Form FDA 
3397 (Prescription Drug User Fee Coversheet) for submission of a new 
drug application or biologics license application.
    The information collection reflects an overall increase since our 
last request for OMB review and approval. We attribute this to expected 
fluctuations in submissions to the Agency.

    Dated: February 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02617 Filed 2-7-22; 8:45 am]
BILLING CODE 4164-01-P


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