Notice2021-25294
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic 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
November 19, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) 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 Generic Drug User Fee Program.
Full Text
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<title>Federal Register, Volume 86 Issue 221 (Friday, November 19, 2021)</title>
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[Federal Register Volume 86, Number 221 (Friday, November 19, 2021)]
[Notices]
[Pages 64945-64947]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-25294]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3404]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Drug User Fee Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) 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 Generic Drug User Fee Program.
DATES: Submit either electronic or written comments on the collection
of information by January 18, 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 18, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 18, 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-2018-N-3404 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Generic 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: https://
[[Page 64946]]
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 <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#b9e9ebf8eacdd8dfdff9dfddd897d1d1ca97ded6cf"><span class="__cf_email__" data-cfemail="a1f1f3e0f2d5c0c7c7e1c7c5c08fc9c9d28fc6ced7">[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.
Generic Drug User Fee Program
OMB Control Number 0910-0727--Revision
This information collection supports implementation of FDA's
Generic Drug User Fee program. The Generic Drug User Fee Amendments
(GDUFA) (Pub. L. 112-144, Title 111) were enacted to speed the delivery
of safe and effective generic drugs to the public and reduce costs to
industry. GDUFA authorizes FDA to assess user fees to fund critical and
measurable enhancements to the performance of FDA's generic drugs
program, bringing greater predictability and timeliness to the review
of generic drug applications. GDUFA is currently authorized through
September 30, 2022, with reauthorization activities currently underway.
For more information regarding GDUFA and ongoing implementation, we
invite you to visit our website at <a href="https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments">https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments</a>.
GDUFA is based on an agreement negotiated by FDA and
representatives of the generic drug industry intended to address
continuing regulatory challenges. GDUFA reflects input received during
an open process that includes regular public meetings, posting of
meeting minutes, and consideration of comments from a public docket. We
are revising the information collection to include the current GDUFA
agreement, or ``goals letter,'' as reflected in the document ``GDUFA
Reauthorization Performance Goals and Program Enhancements Fiscal Years
2018-2022,'' available for download from our website at <a href="https://www.fda.gov/media/101052/download">https://www.fda.gov/media/101052/download</a>. The performance goals and program
enhancements specified in the goals letter apply to aspects of the
generic drug review program that are important for facilitating timely
access to quality, affordable generic medicines. FDA is committed to
meeting the performance goals specified in the goals letter and to
continuous improvement of its performance.
Included among the performance goals is the issuance of topic-
specific guidance documents. 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 have developed Form FDA 3794, the Generic Drug User Fee Cover
Sheet, available at <a href="https://www.ipqpubs.com/wp-content/uploads/2012/09/GDUFA-cover-sheet.pdf">https://www.ipqpubs.com/wp-content/uploads/2012/09/GDUFA-cover-sheet.pdf</a>, which requests the minimum necessary information
from generic drug applicants to account for and track user fees and to
determine the amount of the fee required. Applicants complete and
submit the cover sheets to accompany payments. While applicants may
submit payment through multiple means, all cover sheets are prepared
using FDA's web-based electronic User Fee System. Upon submitting the
completed cover sheet, the User Fee System generates a user fee
identification number, which is provided to applicants at the bottom of
the cover sheet. It also notes the correct fiscal year user fee
assessment that is due for the submission or program. FDA requests that
applicants submit a copy of this completed cover sheet along with the
abbreviated new drug application, as well as other additional GDUFA
fees, so FDA can verify that the applicant has paid the correct user
fee and their account is current.
Respondents to the information collection are potential or actual
generic drug application holders or related active pharmaceutical
ingredient and finished dosage form manufacturers. Companies with
multiple user fee obligations may submit a cover sheet for each user
fee obligation.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden\1\
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Number of
Form FDA 3794 Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Generic Drug User Fee Cover Sheet............ 500 7.616 3,808 0.5 (30 minutes)......................... 1,904
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information
[[Page 64947]]
Based on a review of the information collection, we have retained
the currently approved burden estimate.
Dated: November 12, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25294 Filed 11-18-21; 8:45 am]
BILLING CODE 4164-01-P
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