[Federal Register Volume 86, Number 227 (Tuesday, November 30, 2021)]
[Notices]
[Pages 67958-67960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26079]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collections; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collections 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: Submit either electronic or written comments on the collection 
of information by January 31, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 31, 2022. The https://www.regulations.gov electronic filing system will accept

[[Page 67959]]

comments until 11:59 p.m. Eastern Time at the end of January 31, 2022. 
Comments received by mail/hand delivery/courier (for written/paper 
submissions) will be considered timely if they are postmarked or the 
delivery service acceptance receipt is 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-2005-N-0101 for ``Agency Information Collection Activities; 
Proposed Collections; Comment Request; 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: 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, 
[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 Food and 
Drug Administration Prescription Drug User Fee (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 (the 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, ``Prescription Drug User Fee

[[Page 67960]]

Cover Sheet.'' Associated instructions may be found on our website at 
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119184.htm. 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--User Fee 
Waivers, Reductions, and Refunds for Drug and Biological Products,'' 
and Form FDA 3971 (Small Business Waivers and Refund Requests), 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 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-document. 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.
    We estimate the burden of the information collection 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              87
 3397...........................                                                    (30 minutes)
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    Total.......................  ..............  ..............             411  ..............           3,626
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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: November 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26079 Filed 11-29-21; 8:45 am]
BILLING CODE 4164-01-P