Document ID: FDA-2018-N-3404-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Program
Posted Date: 2021-11-19T05:00Z

[Federal Register Volume 86, Number 221 (Friday, November 19, 2021)]
[Notices]
[Pages 64945-64947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25294]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://www.regulations.gov 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:
     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-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 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://

[[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 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.

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 https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments.
    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 https://www.fda.gov/media/101052/download. 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 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 have developed Form FDA 3794, the Generic Drug User Fee Cover 
Sheet, available at https://www.ipqpubs.com/wp-content/uploads/2012/09/GDUFA-cover-sheet.pdf, 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                Form FDA 3794                     Number of    responses  per   Total annual          Average burden  per response          Total hours
                                                 respondents      respondent      responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Generic Drug User Fee Cover Sheet............             500           7.616           3,808  0.5 (30 minutes).........................           1,904
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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