Quality Management Maturity Program for Drug Manufacturing Establishments; Establishment of a Public Docket; Request for Comments, 63587-63589 [2023-20015]
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Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Steven Fleischer, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0809,
Steven.Fleischer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft GFI #282 entitled ‘‘Informed
Consent Forms for Studies that Enroll
Client-Owned Companion Animals.’’ As
used in this guidance, informed consent
is a documented process by which an
owner or owner’s agent voluntarily
confirms the owner’s willingness to
allow their animal(s) to participate in a
particular study, after having been
informed of all aspects of the study that
may be relevant to the owner’s decision
to participate. A sponsor or investigator
should ensure the owner is provided
with adequate information and time to
allow for an informed decision about
voluntary participation in a clinical
investigation. This draft guidance
provides recommendations on ICFs
used for studies that enroll client-owned
companion animals (dogs, cats, and
horses). CVM recommends all studies
conducted with client-owned
companion animals use an ICF and be
conducted in accordance with GCP
guidelines.
This level 1 draft guidance is being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 The draft guidance, when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 ‘‘Informed Consent
Forms for Studies that Enroll ClientOwned Companion Animals.’’ 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.
ddrumheller on DSK120RN23PROD with NOTICES1
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 514 and
section 571 of the Federal Food, Drug,
and Cosmetic Act have been approved
under OMB control number 0910–0032.
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III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: September 11, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–19951 Filed 9–14–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–3721]
Quality Management Maturity Program
for Drug Manufacturing
Establishments; Establishment of a
Public Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing the establishment of a
docket to solicit comments that will
assist the Agency in developing a
Quality Management Maturity (QMM)
program for establishments
manufacturing human drugs, including
biological products, regulated by the
Center for Drug Evaluation and Research
(CDER).
DATES: Submit either electronic or
written comments on the notice by
December 14, 2023 to ensure that the
Agency considers your comment.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments may not be
considered. Electronic comments must
be submitted on or before December 14,
2023. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 14, 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.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
PO 00000
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63587
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–N–3721 for ‘‘Quality Management
Maturity Program for Drug
Manufacturing Establishments;
Establishment of a Public Docket;
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
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Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices
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.
FOR FURTHER INFORMATION CONTACT:
Djamila Harouaka, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4160,
Silver Spring, MD 20993–0002, 240–
402–0224, CDER-QMM@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
I. Background
Drug manufacturers can achieve
higher levels of QMM by successfully
integrating business and manufacturing
operations with quality practices and
technological advancements to optimize
manufacturing process performance and
product quality, enhance supply chain
reliability, and foster proactive
continual improvement. CDER is
developing a voluntary program to
promote QMM at drug manufacturing
establishments. The goals of this
program are: (1) to foster a strong quality
culture mindset; (2) recognize
establishments that have advanced
quality management practices and
acknowledge establishments that strive
to continually improve those practices;
(3) identify areas where quality
management practices can be enhanced
and provide suggestions for growth
opportunities; and (4) minimize risks to
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product availability to assure reliable
market supply.
The QMM assessment is designed to
appraise an establishment’s quality
culture mindset, behaviors, and
commitment to adopting best practices
to effectively meet the needs of patients
and consumers. QMM assessments
would not be used to evaluate
compliance with current good
manufacturing practice (CGMP).
QMM assessments would be
conducted by trained assessors, who
would engage directly with
establishments, either onsite or in a
hybrid (onsite/remote) environment, for
2 to 5 business days. The QMM
assessment will cover five practice
areas: (1) management commitment to
quality; (2) business continuity; (3)
advanced pharmaceutical quality
system; (4) technical excellence; and (5)
employee engagement and
empowerment. Within each practice
area, the assessors would explore key
elements to better understand an
establishment’s QMM. Examples of
elements covered under each practice
area could include: management review
and resource management (management
commitment to quality practice area),
supply planning and demand
forecasting (business continuity practice
area), data governance and process
optimization (technical excellence
practice area), effectiveness of the
corrective action and preventive action
process (advanced pharmaceutical
quality system practice area), and
rewards and recognition (employee
engagement practice area). Each
establishment’s responses, executed
practices, and behaviors would be
assessed using a standardized
assessment protocol and an objective
rubric, which is currently under
development, to help identify areas of
strength and potential areas with
opportunities for improvement.
At a November 2, 2022, meeting of the
Pharmaceutical Science and Clinical
Pharmacology Advisory Committee,
FDA sought to determine the support of
academic and industry experts for
CDER’s development of a QMM
program. By a vote of 9–0, the
committee affirmed that CDER should
establish a QMM program to incentivize
investments in mature quality
management practices . During
deliberations, committee members
advised the Agency to continue to seek
stakeholder input throughout the
program’s development. Further
information about the November 2022
Advisory Committee meeting, including
event materials, is available on FDA’s
website at https://www.fda.gov/
advisory-committees/advisory-
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Frm 00039
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committee-calendar/november-2-32022-pharmaceutical-science-andclinical-pharmacology-advisorycommittee-meeting. For further
information about QMM, relevant
research, and previously conducted
pilot programs, please see CDER’s QMM
web page at https://www.fda.gov/drugs/
pharmaceutical-quality-resources/cderquality-management-maturity. FDA has
verified the website addresses, as of the
date this document publishes in the
Federal Register, but websites are
subject to change over time.
II. Request for Comments
FDA is opening a docket to solicit
additional feedback from the public on
CDER’s planned, voluntary QMM
program. The public is invited to
provide detailed comments on all
aspects described in this notice. To
facilitate this input, FDA has developed
a list of questions. These questions are
not exhaustive, and FDA welcomes
other pertinent information the public
would like to share on this topic. In all
cases, FDA encourages the public to
provide the reasoning and specific basis
for any comments.
1. If you are a manufacturer, please
identify the types of drug(s) produced in
your establishment (e.g., active
pharmaceutical ingredients, innovator
drugs, innovator biologics, generics,
biosimilars, or OTC monograph drugs).
If you are not a manufacturer, please
specify whether you are a purchaser,
payor, pharmacy, healthcare provider,
patient, regulator, supplier, distributor,
contract service provider, or other
(please describe).
2. What advantages do you anticipate
that your sector (i.e., your organization
and others like yours) would gain from
CDER’s voluntary QMM program?
3. How would participation in a QMM
program benefit you or your specific
organization?
4. How would you use information
from a QMM assessment if it were
provided to your organization? For
example, if your organization acts as a
supplier or contract organization, would
you consider sharing information from a
QMM assessment with a potential
client? If your organization enters into
contracts with purchasers, would you
consider sharing information from a
QMM assessment with a purchaser? If
your organization is a purchaser, would
you consider requesting information
from a QMM assessment?
5. What, if any, unintended
consequences, roadblocks, or other
concerns do you anticipate with a
voluntary QMM program? What barriers
to participation do you anticipate?
Please explain. Which of these
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Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices
unintended consequences might be
unique to stakeholders like you? Why?
6. FDA anticipates that each
establishment would be provided with a
detailed report following their QMM
assessment. What would you want such
a report to contain?
7. With respect to the outcomes of a
QMM assessment, what are your
thoughts about making outcomes
public? Would your thoughts be
different if the outcomes were generally
qualitative (e.g., descriptive
information) versus quantitative (e.g., a
numerical rating)?
8. What other feedback would you
like the FDA to consider for a voluntary
QMM program?
III. References
The following references are on
display with the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; these are not available
electronically at https://
www.regulations.gov as these references
are copyright protected. Some may be
available at the website address, if
listed. FDA has verified the website
addresses, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
1. Maguire, J., A. Fisher, D. Harouaka, N.
Rakala, et al., 2023, ‘‘Lessons from
CDER’s Quality Management Maturity
Pilot Programs,’’ The AAPS Journal,
25(14), January 10, 2023, https://doi.org/
10.1208/s12248-022-00777-z.
2. Fellows, M., T. Friedli, Y. Li, J. Maguire,
et al., 2022, ‘‘Benchmarking the Quality
Practices of Global Pharmaceutical
Manufacturing to Advance Supply Chain
Resilience,’’ The AAPS Journal, 24(111),
October 20, 2022, https://doi.org/
10.1208/s12248-022-00761-7.
Dated: September 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–20015 Filed 9–14–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2019–N–4060]
Medical Devices With Indications
Associated With Weight Loss
Guidances; Draft Guidances for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
ACTION:
Notice of availability.
VerDate Sep<11>2014
17:05 Sep 14, 2023
Jkt 259001
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
Food and Drug Administration,
HHS.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of two draft
guidances entitled ‘‘Medical Devices
with Indications Associated with
Weight Loss—Clinical Study and
Benefit-Risk Considerations’’ and
‘‘Medical Devices with Indications
Associated with Weight Loss—NonClinical Recommendations.’’ These draft
guidance documents provide
recommendations regarding clinical
study design for devices with
indications for use associated with
weight loss, include discussion on how
FDA considers the benefit-risk analysis
to support such indications, and
provide recommendations for the nonclinical testing to support premarket
submissions for these medical devices.
These draft guidances are not final nor
are they for implementation at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by November 14, 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:
SUMMARY:
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
PO 00000
Frm 00040
Fmt 4703
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63589
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–
2019–N–4060 for ‘‘Medical Devices with
Indications Associated with Weight
Loss—Clinical Study and Benefit-Risk
Considerations’’ and ‘‘Medical Devices
with Indications Associated with
Weight Loss—Non-Clinical
Recommendations.’’ 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://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
E:\FR\FM\15SEN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Pages 63587-63589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20015]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3721]
Quality Management Maturity Program for Drug Manufacturing
Establishments; Establishment of a Public Docket; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of establishment of a public docket; request for
comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the establishment of a docket to solicit comments that will assist the
Agency in developing a Quality Management Maturity (QMM) program for
establishments manufacturing human drugs, including biological
products, regulated by the Center for Drug Evaluation and Research
(CDER).
DATES: Submit either electronic or written comments on the notice by
December 14, 2023 to ensure that the Agency considers your comment.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments may not be considered. Electronic comments must
be submitted on or before December 14, 2023. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 14, 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 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-3721 for ``Quality Management Maturity Program for Drug
Manufacturing Establishments; Establishment of a Public Docket; 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
[[Page 63588]]
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.
FOR FURTHER INFORMATION CONTACT: Djamila Harouaka, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4160, Silver Spring, MD 20993-0002, 240-
402-0224, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Drug manufacturers can achieve higher levels of QMM by successfully
integrating business and manufacturing operations with quality
practices and technological advancements to optimize manufacturing
process performance and product quality, enhance supply chain
reliability, and foster proactive continual improvement. CDER is
developing a voluntary program to promote QMM at drug manufacturing
establishments. The goals of this program are: (1) to foster a strong
quality culture mindset; (2) recognize establishments that have
advanced quality management practices and acknowledge establishments
that strive to continually improve those practices; (3) identify areas
where quality management practices can be enhanced and provide
suggestions for growth opportunities; and (4) minimize risks to product
availability to assure reliable market supply.
The QMM assessment is designed to appraise an establishment's
quality culture mindset, behaviors, and commitment to adopting best
practices to effectively meet the needs of patients and consumers. QMM
assessments would not be used to evaluate compliance with current good
manufacturing practice (CGMP).
QMM assessments would be conducted by trained assessors, who would
engage directly with establishments, either onsite or in a hybrid
(onsite/remote) environment, for 2 to 5 business days. The QMM
assessment will cover five practice areas: (1) management commitment to
quality; (2) business continuity; (3) advanced pharmaceutical quality
system; (4) technical excellence; and (5) employee engagement and
empowerment. Within each practice area, the assessors would explore key
elements to better understand an establishment's QMM. Examples of
elements covered under each practice area could include: management
review and resource management (management commitment to quality
practice area), supply planning and demand forecasting (business
continuity practice area), data governance and process optimization
(technical excellence practice area), effectiveness of the corrective
action and preventive action process (advanced pharmaceutical quality
system practice area), and rewards and recognition (employee engagement
practice area). Each establishment's responses, executed practices, and
behaviors would be assessed using a standardized assessment protocol
and an objective rubric, which is currently under development, to help
identify areas of strength and potential areas with opportunities for
improvement.
At a November 2, 2022, meeting of the Pharmaceutical Science and
Clinical Pharmacology Advisory Committee, FDA sought to determine the
support of academic and industry experts for CDER's development of a
QMM program. By a vote of 9-0, the committee affirmed that CDER should
establish a QMM program to incentivize investments in mature quality
management practices . During deliberations, committee members advised
the Agency to continue to seek stakeholder input throughout the
program's development. Further information about the November 2022
Advisory Committee meeting, including event materials, is available on
FDA's website at https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-2-3-2022-pharmaceutical-science-and-clinical-pharmacology-advisory-committee-meeting. For further
information about QMM, relevant research, and previously conducted
pilot programs, please see CDER's QMM web page at https://www.fda.gov/drugs/pharmaceutical-quality-resources/cder-quality-management-maturity. FDA has verified the website addresses, as of the date this
document publishes in the Federal Register, but websites are subject to
change over time.
II. Request for Comments
FDA is opening a docket to solicit additional feedback from the
public on CDER's planned, voluntary QMM program. The public is invited
to provide detailed comments on all aspects described in this notice.
To facilitate this input, FDA has developed a list of questions. These
questions are not exhaustive, and FDA welcomes other pertinent
information the public would like to share on this topic. In all cases,
FDA encourages the public to provide the reasoning and specific basis
for any comments.
1. If you are a manufacturer, please identify the types of drug(s)
produced in your establishment (e.g., active pharmaceutical
ingredients, innovator drugs, innovator biologics, generics,
biosimilars, or OTC monograph drugs). If you are not a manufacturer,
please specify whether you are a purchaser, payor, pharmacy, healthcare
provider, patient, regulator, supplier, distributor, contract service
provider, or other (please describe).
2. What advantages do you anticipate that your sector (i.e., your
organization and others like yours) would gain from CDER's voluntary
QMM program?
3. How would participation in a QMM program benefit you or your
specific organization?
4. How would you use information from a QMM assessment if it were
provided to your organization? For example, if your organization acts
as a supplier or contract organization, would you consider sharing
information from a QMM assessment with a potential client? If your
organization enters into contracts with purchasers, would you consider
sharing information from a QMM assessment with a purchaser? If your
organization is a purchaser, would you consider requesting information
from a QMM assessment?
5. What, if any, unintended consequences, roadblocks, or other
concerns do you anticipate with a voluntary QMM program? What barriers
to participation do you anticipate? Please explain. Which of these
[[Page 63589]]
unintended consequences might be unique to stakeholders like you? Why?
6. FDA anticipates that each establishment would be provided with a
detailed report following their QMM assessment. What would you want
such a report to contain?
7. With respect to the outcomes of a QMM assessment, what are your
thoughts about making outcomes public? Would your thoughts be different
if the outcomes were generally qualitative (e.g., descriptive
information) versus quantitative (e.g., a numerical rating)?
8. What other feedback would you like the FDA to consider for a
voluntary QMM program?
III. References
The following references are on display with the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; these are not
available electronically at https://www.regulations.gov as these
references are copyright protected. Some may be available at the
website address, if listed. FDA has verified the website addresses, as
of the date this document publishes in the Federal Register, but
websites are subject to change over time.
1. Maguire, J., A. Fisher, D. Harouaka, N. Rakala, et al., 2023,
``Lessons from CDER's Quality Management Maturity Pilot Programs,''
The AAPS Journal, 25(14), January 10, 2023, https://doi.org/10.1208/s12248-022-00777-z.
2. Fellows, M., T. Friedli, Y. Li, J. Maguire, et al., 2022,
``Benchmarking the Quality Practices of Global Pharmaceutical
Manufacturing to Advance Supply Chain Resilience,'' The AAPS
Journal, 24(111), October 20, 2022, https://doi.org/10.1208/s12248-022-00761-7.
Dated: September 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20015 Filed 9-14-23; 8:45 am]
BILLING CODE 4164-01-P
