Notice2021-26079
Agency Information Collection Activities; Proposed Collections; Comment Request; Prescription Drug User Fee Program
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Published
November 30, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 227 (Tuesday, November 30, 2021)</title>
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[Federal Register Volume 86, Number 227 (Tuesday, November 30, 2021)]
[Notices]
[Pages 67958-67960]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
<bullet> Docket: For access to the docket to read background
documents or the electronic and written/paper comments received, go to
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#0b5b594a587f6a6d6d4b6d6f6a25636378256c647d"><span class="__cf_email__" data-cfemail="84d4d6c5d7f0e5e2e2c4e2e0e5aaececf7aae3ebf2">[email protected]</span></a>.
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 <a href="https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/">https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/</a> 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
<a href="https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119184.htm">https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119184.htm</a>. 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 <a href="https://www.fda.gov/media/131797/download">https://www.fda.gov/media/131797/download</a>.
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 <a href="https://www.fda.gov/media/99140/download">https://www.fda.gov/media/99140/download</a>. 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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-document">https://www.fda.gov/regulatory-information/search-fda-guidance-document</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
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
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