Notice2022-02689
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
February 9, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 27 (Wednesday, February 9, 2022)</title>
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[Federal Register Volume 87, Number 27 (Wednesday, February 9, 2022)]
[Notices]
[Pages 7473-7474]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 0910-0727. 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, <a href="/cdn-cgi/l/email-protection#de8e8c9f8daabfb8b89eb8babff0b6b6adf0b9b1a8"><span class="__cf_email__" data-cfemail="58080a190b2c393e3e183e3c397630302b763f372e">[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.
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-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.
We have developed Form FDA 3794, the Generic Drug User Fee Cover
Sheet, available at <a href="https://www.fda.gov/industry/fda-user-fee-programs">https://www.fda.gov/industry/fda-user-fee-programs</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.
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]
BILLING CODE 4164-01-P
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