[Federal Register Volume 90, Number 8 (Tuesday, January 14, 2025)]
[Notices]
[Pages 3225-3227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00564]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5890]
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 or Agency) 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 our
generic drug user fee program.
DATES: Either electronic or written comments on the collection of
information must be submitted by March 17, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 17, 2025. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received 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-2024-N-5890 for ``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
[[Page 3226]]
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://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 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 https://userfees.fda.gov/OA_HTML/GDUFAFacilityCScreation.pdf. 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:
Controlled Correspondence Related to Generic Drug
Development (Controlled Correspondence Guidance), (https://www.fda.gov/media/164111/download, March 2024)
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, February 2023)
Formal Meetings Between FDA and ANDA Applicants of Complex
Products Under GDUFA (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-anda-applicants-complex-products-under-gdufa-guidance-industry, October
2022)
Competitive Generic Therapies Guidance (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/competitive-generic-therapies, October 2022)
Cover Letter Attachments for Controlled Correspondences
and ANDA Submissions (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cover-letter-attachments-controlled-correspondences-and-anda-submissions, June 2023)
How to Obtain Covered Product Authorization (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-obtain-covered-product-authorization, September 2022)
Each guidance document may be downloaded from our website where we
maintain a searchable database at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
FDA estimates the burden of the information collection as follows:
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Table 1--Estimated Annual Reporting Burden \1\
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Number of
Information collection activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Submission of Generic Drug User 500 7.616 3,808 0.5 1,904
Fee Cover Sheet................ (30 minutes)
Submission of Controlled 400 12.5 5000 5 25,000
Correspondence as Discussed in
Agency Topic-Specific Guidance
Documents......................
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Total....................... .............. .............. 8,808 .............. 26,904
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\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: January 7, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-00564 Filed 1-13-25; 8:45 am]
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