Notice2025-07759
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
May 5, 2025
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
<html>
<head>
<title>Federal Register, Volume 90 Issue 85 (Monday, May 5, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 85 (Monday, May 5, 2025)]
[Notices]
[Pages 18983-18984]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-07759]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5890]
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.
-----------------------------------------------------------------------
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 June 4, 2025.
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 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#d080829183a4b1b6b690b6b4b1feb8b8a3feb7bfa6"><span class="__cf_email__" data-cfemail="77272536240316111137111316591f1f0459101801">[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 helps support implementation of FDA's
Generic Drug User Fee Program (GDUFA), most recently reauthorized
September 30, 2022. It includes information collections discussed in
the document, ``GDUFA Reauthorization Performance Goals And Program
Enhancements Fiscal Years 2023-2027,'' commonly referred to as the
``Goals Letter'' or ``Commitment Letter.'' The Commitment Letter
represents the product of FDA discussions with the regulated industry
and public stakeholders, as mandated by Congress. The Goals Letter
identifies current GDUFA program objectives and general procedures for
communicating with FDA. Agency guidance, as outlined in the Goals
Letter, are utilized in the information collection. All Agency guidance
documents are issued consistent with our Good Guidance Practice
regulations (21 CFR 10.115), which provide for public comment at any
time, as well as regulatory authority found in 21 CFR 314.445 (Guidance
documents), currently approved in OMB control number 0910-0001.
The information collection also includes Form FDA 3974, the Generic
Drug User Fee Cover Sheet and associated instructions, available for
download at <a href="https://userfees.fda.gov/OA_HTML/GDUFAFacilityCScreation.pdf">https://userfees.fda.gov/OA_HTML/GDUFAFacilityCScreation.pdf</a>. Form FDA 3974 is used to provide a uniform
format for the submission of information necessary to account for and
track user fees, and to determine the amount of the fee required.
As we communicate on our website, potential applicants are
encouraged to contact the FDA Generic Drugs Program with questions at
any point in their development and application preparation processes.
We have revised the information collection to include the submission of
``controlled correspondence'' within the scope of activity, including
covered product authorizations (CPAs) provided for under the Creating
and Restoring Equal Access to Equivalent Samples Act of 2019 (CREATES
Act) (Pub. L. 116-94). Historically, and under the terms of the GDUFA,
a controlled correspondence may be submitted by or on behalf of a
generic drug manufacturer or related industry prior to submitting an
abbreviated new drug application (ANDA). To provide respondents with
assistance regarding the submission of controlled correspondence, we
continue to develop and issue topic-specific Agency guidance, including
the following documents:
<bullet> Controlled Correspondence Related to Generic Drug
Development (Controlled Correspondence Guidance) (<a href="https://www.fda.gov/media/164111/download">https://www.fda.gov/media/164111/download</a>, March 2024).
<bullet> Product-Specific Guidance Meetings Between FDA and ANDA
Applicants Under GDUFA (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-specific-guidance-meetings-between-fda-and-anda-applicants-under-gdufa">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-specific-guidance-meetings-between-fda-and-anda-applicants-under-gdufa</a>, February 2023).
<bullet> Formal Meetings Between FDA and ANDA Applicants of Complex
Products Under GDUFA (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-anda-applicants-complex-products-under-gdufa-guidance-industry">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-anda-applicants-complex-products-under-gdufa-guidance-industry</a>, October
2022).
<bullet> Competitive Generic Therapies Guidance (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/competitive-generic-therapies">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/competitive-generic-therapies</a>, October 2022).
<bullet> Cover Letter Attachments for Controlled Correspondences
and ANDA Submissions (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cover-letter-attachments-controlled-correspondences-and-anda-submissions">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cover-letter-attachments-controlled-correspondences-and-anda-submissions</a>, June 2023).
<bullet> How to Obtain Covered Product Authorization (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-obtain-covered-product-authorization">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-obtain-covered-product-authorization</a>, September 2022).
Each guidance document may be downloaded from our website where we
maintain a searchable database 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 the Federal Register of January 14, 2025 (90 FR 3225), we
published a 60-day notice soliciting comment on the proposed collection
of information. Two comments were received, one pertaining to product
pricing and the other pertaining to plant-based ingredients. FDA
appreciates these public comments; however, neither is responsive to
the four information collection topics solicited under 5 CFR 1320.8(d)
and therefore not discussed in this notice. We have made no adjustments
in our estimated burden in response to the public comment.
We estimate the burden of this collection of information as
follows:
[[Page 18984]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Total
Information collection; Number of responses per annual Average burden per Total hours
activity respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Submission of Generic Drug User 500 7.616 3,808 0.5 (30 minutes)........ 1,904
Fee Cover Sheet.
Submission of Controlled 400 12.5 5,000 5....................... 25,000
Correspondence as Discussed in
Agency Topic-Specific Guidance
Documents.
--------------------------------------------------------------------------------
Total...................... ........... .............. 8,808 ........................ 26,904
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our estimated is based on available Agency data. Our burden
estimate reflects an overall increase attributable to the inclusion of
controlled correspondence and new generic drug product CPA requests.
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07759 Filed 5-2-25; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on May 5, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.