Document ID: FDA-2018-N-3404-0006
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Drug User Fee Program
Posted Date: 2022-02-09T05:00Z

[Federal Register Volume 87, Number 27 (Wednesday, February 9, 2022)]
[Notices]
[Pages 7473-7474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02689]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3404]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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.

DATES: Submit written comments (including recommendations) on the 
collection of information by March 11, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. 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 0910-0727. 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

[[Page 7474]]

20852, 301-796-5733, [email protected].

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.

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-documents. 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.fda.gov/industry/fda-user-fee-programs 
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.
    In the Federal Register of November 19, 2021 (86 FR 64945), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information 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.

    Based on a review of the information collection, we have retained 
the currently approved burden estimate.

    Dated: February 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02689 Filed 2-8-22; 8:45 am]
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