[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]


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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.

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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

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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