Post-Warning Letter Meetings Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability, 60686-60688 [2023-19081]
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Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices
notice serves to allow an additional 30
days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
Healthcare Response and Prevention
Training Curriculum for Health
Departments—New—National Center
for Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
CDC funds Healthcare-Associated
Infection and Antibiotic Resistance
(HAI/AR) programs in 64 state, local
and territorial health departments.
Funding is awarded through the
Epidemiology and Laboratory
cooperative agreements (ELC). Funds
are intended to provide critical
resources to recipients in support of a
broad range of healthcare infection
prevention and control and
epidemiologic surveillance activities to
detect, monitor, mitigate, and prevent
the spread of HAI/AR in healthcare
settings. Recently, HAI/AR programs
have experienced an increase in
program size and scope through
COVID–19 supplemental funds. To
better support the growing programs,
CDC has developed high-priority
trainings requested by the health
department programs with the goal of
strengthening public health workforce
capacity to prevent and respond to HAI/
AR outbreaks in healthcare settings,
including preventing the spread of
SARS–CoV–2.
The proposed training evaluation will
be used to assess whether the CDCdeveloped trainings are reaching the
intended audience and achieving the
intended goal of strengthening public
health workforce capacity to prevent
and respond to HAI/AR outbreaks,
including COVID–19 at the individual
trainee and program level. CDC requests
OMB approval for an estimated 316
annual burden hours. There is no cost
to respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents
Form
name
Public Health Trainees ...................................
Public Health Trainees ...................................
Public Health Trainees ...................................
HAI/AR Program Leads .................................
Registration ...................................................
Pre-Test .........................................................
Post-test ........................................................
Public Health program impact of trainings ....
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2023–19066 Filed 9–1–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ddrumheller on DSK120RN23PROD with NOTICES1
Food and Drug Administration
[Docket No. FDA–2023–D–3370]
Post-Warning Letter Meetings Under
the Generic Drug User Fee Act; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
18:02 Sep 01, 2023
Jkt 259001
ACTION:
Number of
respondents
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘PostWarning Letter Meetings Under
GDUFA.’’ This draft 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 draft guidance
SUMMARY:
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600
600
600
64
Number of
responses
per
respondent
Average
burden per
response
(in hours)
2
2
2
1
5/60
5/60
5/60
15/60
describes the process detailed in the
GDUFA III commitment letter for how
an eligible facility may request a PostWarning Letter Meeting with FDA
regarding the facility’s ongoing
remediation efforts to 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.
Submit either electronic or
written comments on the draft guidance
by October 5, 2023 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
DATES:
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
E:\FR\FM\05SEN1.SGM
05SEN1
Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices
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’’).
ddrumheller on DSK120RN23PROD with NOTICES1
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
Meeting 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
VerDate Sep<11>2014
18:02 Sep 01, 2023
Jkt 259001
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://
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.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Post-Warning Letter Meetings under
GDUFA.’’ This draft guidance provides
information on the implementation of
the Post-Warning Letter Meeting
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
60687
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 ‘‘GDUFA Reauthorization
Performance Goals and Program
Enhancements Fiscal Years 2023–2027’’
(GDUFA III Commitment Letter).
Specifically, this draft 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
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.
The Generic Drug User Fee
Amendments of 2012 (GDUFA I)
amended the FD&C Act to authorize
FDA to assess and collect user fees to
provide FDA with additional resources
to help ensure patients have access to
quality, affordable, safe, and effective
generic drugs. GDUFA fee resources
bring greater predictability and
timeliness to the review of generic drug
applications. GDUFA has been
reauthorized every 5 years to continue
FDA’s ability to assess and collect
GDUFA fees, and this user fee program
has been reauthorized twice since
GDUFA I, most recently in the Generic
Drug User Fee Amendments of 2022. As
described in the GDUFA III
Commitment Letter applicable to this
latest reauthorization, FDA has agreed
to performance goals and program
enhancements regarding aspects of the
generic drug assessment program that
build on previous authorizations of
GDUFA. New enhancements to the
program are designed to maximize the
efficiency and utility of each assessment
cycle, with the intent of reducing the
number of assessment cycles for ANDAs
and facilitating timely access to generic
medicines for American patients.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current 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.
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
E:\FR\FM\05SEN1.SGM
05SEN1
60688
Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices
collections of information are subject to
review by the Office of Management and
Budget under the Paperwork Reduction
Act of 1995 (PRA) (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
current good manufacturing practice 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 draft 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: August 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–19081 Filed 9–1–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–3575]
Reauthorization of the Over-theCounter Monograph Drug User Fee
Program; Public Meeting; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, Agency, or we) is
announcing a public meeting to discuss
proposed recommendations for the
reauthorization of the Over-the-Counter
(OTC) Monograph Drug User Fee
Program (OMUFA) for fiscal years (FYs)
2026 through 2030. OMUFA authorizes
FDA to assess and collect user fees to
support OTC monograph drug activities.
The current legislative authority for
OMUFA expires September 30, 2025. At
that time, new legislation will be
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:02 Sep 01, 2023
Jkt 259001
required to reauthorize the OMUFA
program for future fiscal years. The
Federal Food, Drug, and Cosmetic Act
(FD&C Act) directs that FDA consult
with the public as part of the OMUFA
reauthorization process. FDA invites
public comment as the Agency begins
the process to reauthorize the program
for FYs 2026 through 2030.
DATES: The public meeting will be held
on September 28, 2023, from 9 a.m. to
5 p.m. Registration to attend the meeting
should be received by September 27,
2023. Either electronic or written
comments on this public meeting must
be submitted by October 27, 2023. See
the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: The public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, Rm. 1503, Silver
Spring, MD 20993. Entrance for the
public meeting participants (non-FDA
employees) is through Building 1 where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/about-fda/visitorinformation. Any changes to the public
meeting location and remote
information, as appropriate, will be
posted to https://www.fda.gov/industry/
fda-user-fee-programs/over-countermonograph-drug-user-fee-programomufa in advance of the meeting.
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 October 27, 2023.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is 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
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
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–N–3575 for ‘‘Reauthorization of
the Over-the-Counter Monograph Drug
User Fee Program; Public Meeting;
Request for Comments.’’ 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
E:\FR\FM\05SEN1.SGM
05SEN1
]]>Agencies
[Federal Register Volume 88, Number 170 (Tuesday, September 5, 2023)]
[Notices]
[Pages 60686-60688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19081]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-3370]
Post-Warning Letter Meetings Under the Generic Drug User Fee Act;
Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Post-
Warning Letter Meetings Under GDUFA.'' This draft 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 draft 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 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: Submit either electronic or written comments on the draft
guidance by October 5, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
[[Page 60687]]
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 Meeting 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.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Post-Warning Letter Meetings under GDUFA.'' This draft
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 ``GDUFA Reauthorization
Performance Goals and Program Enhancements Fiscal Years 2023-2027''
(GDUFA III Commitment Letter). Specifically, this draft 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 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.
The Generic Drug User Fee Amendments of 2012 (GDUFA I) amended the
FD&C Act to authorize FDA to assess and collect user fees to provide
FDA with additional resources to help ensure patients have access to
quality, affordable, safe, and effective generic drugs. GDUFA fee
resources bring greater predictability and timeliness to the review of
generic drug applications. GDUFA has been reauthorized every 5 years to
continue FDA's ability to assess and collect GDUFA fees, and this user
fee program has been reauthorized twice since GDUFA I, most recently in
the Generic Drug User Fee Amendments of 2022. As described in the GDUFA
III Commitment Letter applicable to this latest reauthorization, FDA
has agreed to performance goals and program enhancements regarding
aspects of the generic drug assessment program that build on previous
authorizations of GDUFA. New enhancements to the program are designed
to maximize the efficiency and utility of each assessment cycle, with
the intent of reducing the number of assessment cycles for ANDAs and
facilitating timely access to generic medicines for American patients.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current 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.
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
[[Page 60688]]
collections of information are subject to review by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 (PRA)
(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
current good manufacturing practice 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 draft 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: August 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19081 Filed 9-1-23; 8:45 am]
BILLING CODE 4164-01-P
