```

[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]

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

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.

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

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:

[[Page 3227]]

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
 Information collection activity     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
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......................
                                 -------------------------------------------------------------------------------
    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: January 7, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-00564 Filed 1-13-25; 8:45 am]
BILLING CODE 4164-01-P
```