Post-Warning Letter Meetings Under Generic Drug User Fee Amendments; Guidance for Industry; Availability, 26309-26311 [2025-11323]
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26309
Federal Register / Vol. 90, No. 117 / Friday, June 20, 2025 / Notices
listed on the ICSSL are safe.
Respondents will have already
independently collected samples at a
given location/time (our request is for
an additional sample to be collected and
sent to FDA for analysis) and, in some
cases (for requested existing analytical
results), conducted tests associated with
information submitted as part of
samples and analytical results.
Regarding the collection of samples,
FDA will provide shipping materials for
transport and will bear any shipping
costs.
The information collection also
includes respondents providing to FDA
documents demonstrating compliance
with the NSSP. When a competent
authority in another country conducts
an evaluation to determine whether the
U.S. food safety control measures for
bivalve molluscan shellfish are
equivalent to its own system of controls,
the competent authority may require
FDA to provide information and records
demonstrating compliance with the
provisions of the NSSP. Only those
firms that comply with the NSSP would
be permitted to export bivalve
molluscan shellfish to a country whose
competent authority determined that the
U.S. system of controls is equivalent to
their own controls. FDA uses the
information collection to support the
export of U.S. shellfish to countries
whose competent authorities have
determined the U.S. system of food
safety controls to be equivalent to their
own system of controls by
demonstrating that the exporter follows
the U.S. system of controls specified in
the NSSP.
For example, to implement the
European Commission’s (EC)
determination that the U.S. system of
food safety controls for raw bivalve
molluscan shellfish is equivalent to the
European Union’s (EU) system of
controls, the EC requires FDA to provide
documentation collected from NSSPparticipating shellfish control
authorities for firms seeking to export
raw molluscan shellfish to the EU. This
documentation includes, but is not
limited to:
• a list of growing areas with an
approved classification;
• the most recent sanitary survey for
each growing area with an approved
classification; and
• the most recent inspection report
for each dealer seeking to export bivalve
molluscan shellfish to the EU.
The examples above are illustrative.
Some competent authorities may require
additional information to conduct an
equivalence assessment or to implement
an equivalence determination, or both.
We provide respondents with
information about the specific
documentation that is required for each
equivalence assessment. For those
competent authorities that recognize the
U.S. system as equivalent, additional
documentation may be needed to
implement that determination.
Form FDA 3038 may be submitted on
paper or submitted electronically by
State or international officials. These
officials securely log into a shellfish
shippers account to fill out Form FDA
3038 electronically. The information
obtained from the form has been
entirely automated. The forms
transmitted by the States, after approval
by an FDA official, are entered into an
FDA computer database program that
allows the addition, deletion, download,
and generation of the Interstate Certified
Shellfish Shippers List, published
monthly in PDF format, and may be
updated daily when new data is
available.
Description of Respondents:
Respondents to this collection are
participating State regulatory agencies
and foreign nations.
In the Federal Register of December
19, 2024 (89 FR 103832), we published
a 60-day notice soliciting comment on
the proposed collection of information.
Although one comment was received
offering support for FDA’s efforts in
ensuring the safety of shellfish, it
referenced proposed rulemaking and
therefore we are clarifying that this
notice pertains to FDA information
collection activities subject to OMB
review and clearance under the PRA of
1995.
We estimate the burden of the
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per response
Total hours
Submission of Interstate Shellfish Dealer’s Certificate.
Submission of NSSP Compliance Documentation.
Submission of Samples and
Analytical Results.
3038
40
57
2,280
0.10 (6 minutes) .....................
228
N/A
13
1
13
0.25 (15 minutes) ...................
3
N/A
35
2
70
0.50 (30 minutes) ...................
35
Total .................................
................
........................
........................
........................
.................................................
266
1 There
ddrumheller on DSK120RN23PROD with NOTICES1
FDA form
No.
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have increased our
burden estimate by 35 hours and 70
responses due to the program change of
collecting samples and analytical
results. We attribute the burden change
to an increase in responses. This
estimate is based on our experience
with this information collection and the
number of certificates received in the
past 3 years.
Dated: June 13, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2025–11328 Filed 6–18–25; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–3370]
Post-Warning Letter Meetings Under
Generic Drug User Fee Amendments;
Guidance for Industry; Availability
AGENCY:
ACTION:
VerDate Sep<11>2014
20:05 Jun 18, 2025
Jkt 265001
PO 00000
Food and Drug Administration,
HHS.
Frm 00044
Fmt 4703
Sfmt 4703
E:\FR\FM\20JNN1.SGM
Notice of availability.
20JNN1
26310
Federal Register / Vol. 90, No. 117 / Friday, June 20, 2025 / Notices
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘PostWarning Letter Meetings Under
GDUFA.’’ This guidance provides
information on the implementation of
the Post-Warning Letter Meeting process
for certain drug manufacturing facilities,
a program enhancement agreed upon by
the Agency and industry as part of the
negotiations relating to the
reauthorization of the Generic Drug User
Fee Amendments (GDUFA), as
described in ‘‘GDUFA Reauthorization
Performance Goals and Program
Enhancements Fiscal Years 2023–2027’’
(GDUFA III commitment letter).
Specifically, this guidance describes the
process detailed in the GDUFA III
commitment letter for how an eligible
facility may request a Post-Warning
Letter Meeting with FDA regarding the
facility’s ongoing remediation efforts to
address current good manufacturing
practice (CGMP) deficiencies described
in a warning letter, how to prepare and
submit a complete meeting package, and
how FDA intends to conduct the PostWarning Letter Meeting.
SUMMARY:
The announcement of the
guidance is published in the Federal
Register on June 20, 2025.
DATES:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
ddrumheller on DSK120RN23PROD with NOTICES1
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
VerDate Sep<11>2014
20:05 Jun 18, 2025
Jkt 265001
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–
2023–D–3370 for ‘‘Post-Warning Letter
Meetings Under GDUFA.’’ Received
comments 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
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://
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Rebecca Frey-Cooper, Office of
Manufacturing Quality, Center for Drug
Evaluation and Research (HFD–003),
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993–0002, 240–402–4127,
Rebecca.Frey-Cooper@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘PostWarning Letter Meetings Under
GDUFA.’’ This guidance provides
information on the implementation of
the Post-Warning Letter Meeting
process, a program enhancement agreed
upon by the Agency and industry as
part of the negotiations relating to the
reauthorization of GDUFA, as described
in the GDUFA III commitment letter.
Specifically, this guidance describes the
process in the GDUFA III commitment
letter for how an eligible facility may
request a Post-Warning Letter Meeting
with FDA regarding the facility’s
ongoing remediation efforts to address
CGMP deficiencies described in a
warning letter, how to prepare and
submit a complete meeting package, and
how FDA intends to conduct the PostWarning Letter Meeting.
This guidance finalizes the draft
guidance entitled ‘‘Post-Warning Letter
Meetings Under GDUFA’’ issued on
September 5, 2023 (88 FR 60686). FDA
considered comments received on the
draft guidance as the guidance was
finalized. Though no significant changes
were made, the final guidance includes
editorial changes made for clarity.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
E:\FR\FM\20JNN1.SGM
20JNN1
Federal Register / Vol. 90, No. 117 / Friday, June 20, 2025 / Notices
thinking of FDA on ‘‘Post-Warning
Letter Meetings Under GDUFA.’’ It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
FDA considered the applicability of
Executive Order 14192, per Office of
Management and Budget (OMB)
guidance in M–25–20, and finds this
action to be deregulatory in nature.
II. Paperwork Reduction Act of 1995
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: June 13, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
ddrumheller on DSK120RN23PROD with NOTICES1
BILLING CODE 4164–01–P
VerDate Sep<11>2014
20:05 Jun 18, 2025
Jkt 265001
Food and Drug Administration
[Docket No. FDA–2020–E–2185]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; EXEM FOAM
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for EXEM FOAM and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
SUMMARY:
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the OMB under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3521). The collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001. The collections of
information in 21 CFR parts 210 and
211 pertaining to CGMP has been
approved under OMB control number
0910–0139. The collections of
information in 21 CFR part 11 for
electronic records and electronic
signatures have been approved under
OMB control number 0910–0303. The
collections of information pertaining to
the submissions of GDUFA III
commitment letter, meetings related to
generic drug development, and the
Generic Drug User Fee Program have
been approved under OMB control
number 0910–0727.
[FR Doc. 2025–11323 Filed 6–18–25; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by August 19, 2025.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
December 17, 2025. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
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
August 19, 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.
DATES:
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
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
26311
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–
2020–E–2185 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; EXEM FOAM.’’
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
E:\FR\FM\20JNN1.SGM
20JNN1
]]>Agencies
[Federal Register Volume 90, Number 117 (Friday, June 20, 2025)]
[Notices]
[Pages 26309-26311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-11323]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-3370]
Post-Warning Letter Meetings Under Generic Drug User Fee
Amendments; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
[[Page 26310]]
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Post-
Warning Letter Meetings Under GDUFA.'' This guidance provides
information on the implementation of the Post-Warning Letter Meeting
process for certain drug manufacturing facilities, a program
enhancement agreed upon by the Agency and industry as part of the
negotiations relating to the reauthorization of the Generic Drug User
Fee Amendments (GDUFA), as described in ``GDUFA Reauthorization
Performance Goals and Program Enhancements Fiscal Years 2023-2027''
(GDUFA III commitment letter). Specifically, this guidance describes
the process detailed in the GDUFA III commitment letter for how an
eligible facility may request a Post-Warning Letter Meeting with FDA
regarding the facility's ongoing remediation efforts to address current
good manufacturing practice (CGMP) deficiencies described in a warning
letter, how to prepare and submit a complete meeting package, and how
FDA intends to conduct the Post-Warning Letter Meeting.
DATES: The announcement of the guidance is published in the Federal
Register on June 20, 2025.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
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-2023-D-3370 for ``Post-Warning Letter Meetings Under GDUFA.''
Received comments 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 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Rebecca Frey-Cooper, Office of
Manufacturing Quality, Center for Drug Evaluation and Research (HFD-
003), Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002, 240-402-4127, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Post-Warning Letter Meetings Under GDUFA.'' This guidance
provides information on the implementation of the Post-Warning Letter
Meeting process, a program enhancement agreed upon by the Agency and
industry as part of the negotiations relating to the reauthorization of
GDUFA, as described in the GDUFA III commitment letter. Specifically,
this guidance describes the process in the GDUFA III commitment letter
for how an eligible facility may request a Post-Warning Letter Meeting
with FDA regarding the facility's ongoing remediation efforts to
address CGMP deficiencies described in a warning letter, how to prepare
and submit a complete meeting package, and how FDA intends to conduct
the Post-Warning Letter Meeting.
This guidance finalizes the draft guidance entitled ``Post-Warning
Letter Meetings Under GDUFA'' issued on September 5, 2023 (88 FR
60686). FDA considered comments received on the draft guidance as the
guidance was finalized. Though no significant changes were made, the
final guidance includes editorial changes made for clarity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current
[[Page 26311]]
thinking of FDA on ``Post-Warning Letter Meetings Under GDUFA.'' It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
FDA considered the applicability of Executive Order 14192, per
Office of Management and Budget (OMB) guidance in M-25-20, and finds
this action to be deregulatory in nature.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521). The collections of information in 21 CFR part 314 have been
approved under OMB control number 0910-0001. The collections of
information in 21 CFR parts 210 and 211 pertaining to CGMP has been
approved under OMB control number 0910-0139. The collections of
information in 21 CFR part 11 for electronic records and electronic
signatures have been approved under OMB control number 0910-0303. The
collections of information pertaining to the submissions of GDUFA III
commitment letter, meetings related to generic drug development, and
the Generic Drug User Fee Program have been approved under OMB control
number 0910-0727.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: June 13, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11323 Filed 6-18-25; 8:45 am]
BILLING CODE 4164-01-P
