Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Program, 3225-3227 [2025-00564]
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<![CDATA[
3225
Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices
ANNUAL BURDEN ESTIMATES
Total number
of
respondents
Instrument
Average
burden hours
per response
Total burden
hours
Annual burden
hours
Implementation Plan Guidance for Development and Implementation Grantees .....................................................
DIG Community Needs and Readiness Assessment ..........
27
27
1
1
450
450
12,150
12,150
4,050
4,050
Totals: ...........................................................................
........................
........................
........................
24,300
8,100
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: Title V of the Social
Security Act, sections 511(e)(8)(A) &
511(h)(2)(A)
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.
Either electronic or written
comments on the collection of
information must be submitted by
March 17, 2025.
DATES:
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.
ADDRESSES:
Mary C. Jones,
ACF/OPRE Certifying Officer.
Electronic Submissions
[FR Doc. 2025–00556 Filed 1–13–25; 8:45 am]
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’’).
BILLING CODE 4184–77–P
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.
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
SUMMARY:
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Total number
of responses
per
respondent
VerDate Sep<11>2014
22:42 Jan 13, 2025
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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
E:\FR\FM\14JAN1.SGM
14JAN1
khammond on DSK9W7S144PROD with NOTICES
3226
Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices
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-201509-18/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, PRAStaff@
fda.hhs.gov.
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
VerDate Sep<11>2014
22:42 Jan 13, 2025
Jkt 265001
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
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Fmt 4703
Sfmt 4703
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-meetingsbetween-fda-and-anda-applicantsunder-gdufa, February 2023)
• Formal Meetings Between FDA and
ANDA Applicants of Complex Products
Under GDUFA (https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/formal-meetingsbetween-fda-and-anda-applicantscomplex-products-under-gdufaguidance-industry, October 2022)
• Competitive Generic Therapies
Guidance (https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/competitivegeneric-therapies, October 2022)
• Cover Letter Attachments for
Controlled Correspondences and ANDA
Submissions (https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/cover-letterattachments-controlledcorrespondences-and-andasubmissions, June 2023)
• How to Obtain Covered Product
Authorization (https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/how-obtaincovered-product-authorization,
September 2022)
Each guidance document may be
downloaded from our website where we
maintain a searchable database at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments.
FDA estimates the burden of the
information collection as follows:
E:\FR\FM\14JAN1.SGM
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Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Information collection activity
Total
annual
responses
Average
burden
per
response
Total hours
Submission of Generic Drug User Fee Cover Sheet ..........
500
7.616
3,808
0.5
(30 minutes)
1,904
Submission of Controlled Correspondence as Discussed
in Agency Topic-Specific Guidance Documents ..............
400
12.5
5000
5
25,000
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Physician-Focused Payment Model
Technical Advisory Committee;
Meetings
ACTION:
Notice of meetings.
This notice announces the
2025 meetings of the Physician-Focused
Payment Model Technical Advisory
Committee (PTAC). These meetings
include deliberation and voting on
proposals for physician-focused
payment models (PFPMs) submitted by
individuals and stakeholder entities and
may include discussions on topics
related to current or previously
submitted PFPMs. All meetings are
open to the public.
DATES: The 2025 PTAC meetings will
occur on the following dates:
D Monday–Tuesday, March 3–4, 2025,
from 9 a.m. to 5 p.m. ET
D Tuesday–Wednesday, June 3–4, 2025,
from 9 a.m. to 5 p.m. ET
D Monday–Tuesday, September 8–9,
2025, from 9 a.m. to 5 p.m. ET
D Tuesday–Wednesday, December 9–10,
2025, from 9 a.m. to 5 p.m. ET
Please note that times are subject to
change. If the times change, the ASPE
PTAC website will be updated (https://
aspe.hhs.gov/ptac-physician-focusedpayment-model-technical-advisorycommittee) and registrants will be
notified directly via email.
ADDRESSES: All PTAC meetings will be
held virtually and/or in the Great Hall
SUMMARY:
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Number of
responses per
respondent
VerDate Sep<11>2014
22:42 Jan 13, 2025
Jkt 265001
of the Hubert H. Humphrey Building,
200 Independence Avenue SW,
Washington, DC, 20201.
FOR FURTHER INFORMATION CONTACT: Lisa
Shats, Designated Federal Officer at
Lisa.Shats@hhs.gov (202) 875–0938.
SUPPLEMENTARY INFORMATION:
Agenda and Comments. PTAC will
hear presentations on proposed PFPMs
that have been submitted by individuals
and stakeholder entities and/or
discussion on topics related to current
or previously submitted PFPMs.
Regarding proposed PFPMs, following
each presentation, PTAC will deliberate
on the proposed PFPM. If PTAC
completes its deliberation, PTAC will
vote on the extent to which the
proposed PFPM meets criteria
established by the Secretary of Health
and Human Services and on an overall
recommendation to the Secretary (if
applicable). Time will be allocated for
public comments. The agenda and other
documents will be posted on the PTAC
section of the ASPE website, https://
aspe.hhs.gov/ptac-physician-focusedpayment-model-technical-advisorycommittee, prior to the meeting. The
agenda is subject to change. If the
agenda does change, registrants will be
notified directly via email, the website
will be updated, and notification will be
sent out through the PTAC email
listserv (https://list.nih.gov/cgi-bin/
wa.exe?A0=PTAC to subscribe).
Meeting Attendance. These meetings
are open to the public and may be
hosted in-person or virtually. We intend
that in-person meetings will be held in
the Great Hall of the Hubert H.
Humphrey Building. The public may
attend in person, when feasible,
virtually, or view the meeting via
livestream at www.hhs.gov/live.
Information about how to access the
meeting virtually or via livestream will
be sent to registrants prior to the
meeting; and a telephone number will
be sent to registrants participating via
the dial-in only option prior to the
meeting. Space may be limited, and
registration is preferred. When
PO 00000
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Fmt 4703
Sfmt 4703
registration opens, a link to the
registration page will be available at
https://aspe.hhs.gov/collaborationscommittees-advisory-groups/ptac/ptacmeetings prior to the meeting.
Registrants will receive a confirmation
email shortly after completing the
registration process.
Special Accommodations. If sign
language interpretation or other
reasonable accommodation for a
disability is needed, please contact
PTAC@hhs.gov, no later than two weeks
prior to the scheduled meeting.
Authority. 42 U.S.C. 1395(ee); section
101(e)(1) of the Medicare Access and
CHIP Reauthorization Act of 2015;
section 51003(b) of the Bipartisan
Budget Act of 2018.
PTAC is governed by provisions of the
Federal Advisory Committee Act, as
amended (5 U.S.C app.), which sets
forth standards for the formation and
use of federal advisory committees.
Dated: January 3, 2025.
Tisamarie B. Sherry,
Deputy Assistant Secretary for Behavioral
Health, Disability and Aging Policy,
Performing the Delegable Duties of the
Assistant Secretary for Planning and
Evaluation.
[FR Doc. 2025–00612 Filed 1–13–25; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
E:\FR\FM\14JAN1.SGM
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]]>Agencies
[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
