Notice2022-02617
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug User Fee Program
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 8, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 87 Issue 26 (Tuesday, February 8, 2022)</title>
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[Federal Register Volume 87, Number 26 (Tuesday, February 8, 2022)]
[Notices]
[Pages 7186-7187]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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#f9a9abb8aa8d989f9fb99f9d98d791918ad79e968f"><span class="__cf_email__" data-cfemail="c292908391b6a3a4a482a4a6a3ecaaaab1eca5adb4">[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 <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 ``PDUFA Cover Sheet.'' Additional information and
associated instructions may be found on our website at <a href="https://www.fda.gov/industry/fda-user-fee-programs">https://www.fda.gov/industry/fda-user-fee-programs</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--
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
<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
[[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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</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.
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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