Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program, 4950-4952 [2024-01423]
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4950
Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
Comments on the collection(s) of
information must be received by the
OMB desk officer by February 26, 2024.
ADDRESSES: Written 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.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
DATES:
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a currently
approved Information Collection; Title
of Information Collection: CMS Plan
Benefit Package (PBP) and Formulary
CY 2025; Use: Under the Medicare
Modernization Act (MMA), Medicare
Advantage (MA) and Prescription Drug
Plan (PDP) organizations are required to
submit plan benefit packages for all
Medicare beneficiaries residing in their
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SUPPLEMENTARY INFORMATION:
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17:22 Jan 24, 2024
Jkt 262001
service area. The plan benefit package
submission consists of the Plan Benefit
Package (PBP) software, formulary file,
and supporting documentation, as
necessary. MA and PDP organizations
use the PBP software to describe their
organization’s plan benefit packages,
including information on premiums,
cost sharing, authorization rules, and
supplemental benefits. They also
generate a formulary to describe their
list of drugs, including information on
prior authorization, step therapy,
tiering, and quantity limits.
CMS requires that MA and PDP
organizations submit a completed PBP
and formulary as part of the annual
bidding process. During this process,
organizations prepare their proposed
plan benefit packages for the upcoming
contract year and submit them to CMS
for review and approval. CMS uses this
data to review and approve the benefit
packages that the plans will offer to
Medicare beneficiaries. This allows
CMS to review the benefit packages in
a consistent way across all submitted
bids during with incredibly tight
timeframes. This data is also used to
populate data on Medicare Plan Finder,
which allows beneficiaries to access and
compare Medicare Advantage and
Prescription Drug plans. Form Number:
CMS–R–262 (OMB control number:
0938–0763); Frequency: Yearly;
Affected Public: Private Sector, Business
or other for-profits and Not-for-profit
institutions; Number of Respondents:
825; Total Annual Responses: 8,770;
Total Annual Hours: 55,782 (For policy
questions regarding this collection
contact Kristy Holtje at 410–786–2209.)
2. Type of Information Collection
Request: Revision of a currently
approved information collection; Title
of Information Collection: Satisfaction
of Nursing Homes, Hospitals, and
Outpatient Clinicians Working with the
CMS Network of Quality Improvement
and Innovation Contractors Program
(NQIIC); Use: The purpose of this
Information Collection Request (ICR) is
to collect data to inform the program
evaluation of the Centers for Medicare &
Medicaid Services (CMS) Quality
Innovation Network-Quality
Improvement Organization (QIN–QIO)
and Hospital Quality Improvement
Contractors (HQIC) programs under the
Network of Quality Improvement and
Innovation Contractors (NQIIC) contract
vehicle. This is a revision package. First,
we updated the Nursing Home and
Hospital Surveys to cover all the quality
improvement focus areas targeted by
NQIIC awardees, removed some but not
all COVID–19 Public Health Emergency
(PHE) related questions to reflect the
progress of Federal health program (e.g.,
PO 00000
Frm 00060
Fmt 4703
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Agency for Healthcare Research and
Quality Project Echo program was
officially ended in August 2021), and
made minor refinements based on the
first round of survey fielding. Second,
we added the Outpatient Clinician
Survey in the same revision package
since all three surveys are conducted
under the same NQIIC contract.
This revision package supports
evaluation of the technical assistance
provided by the QINQIO Program to
nursing homes and outpatient clinicians
in community settings, and Hospital
Quality Improvement Contractors
(HQIC) Program activities to support
hospitals. This ICR is part of a larger
evaluation of the overall impact of the
NQIIC Program. Form Number: CMS–
10769 (OMB control number: 0938–
1424); Frequency: Yearly; Affected
Public: State and Private Sector
(Business or other for-profits); Number
of Respondents: 1,900; Total Annual
Responses: 1,900; Total Annual Hours:
559. (For policy questions regarding this
collection, contact Jeff Mokry at 214–
767–4021.)
Dated: January 19, 2024.
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–01383 Filed 1–24–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–5706]
Voluntary Quality Management
Maturity Prototype Assessment
Protocol Evaluation Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for a limited
number of establishments to participate
in a voluntary Quality Management
Maturity Prototype Assessment Protocol
Evaluation Program involving the use of
a prototype assessment protocol to
evaluate quality management maturity
(QMM). The Center for Drug Evaluation
and Research (CDER) is implementing
this voluntary program for
manufacturers of CDER-regulated drug
products to gain experience with the
prototype assessment protocol and to
evaluate whether use of the protocol, as
designed, will enable a meaningful
assessment of the establishment’s
SUMMARY:
E:\FR\FM\25JAN1.SGM
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Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices
quality management practices while
providing useful feedback for the
establishment. This notice outlines the
types of establishments FDA is seeking
for participation and the process for
submitting a request to participate in the
program.
DATES: FDA intends to accept requests
to participate in the voluntary QMM
Prototype Assessment Protocol
Evaluation Program through March 25,
2024. See the ‘‘Participation’’ section of
this document for instructions on
submitting a request to participate and
the selection process.
FOR FURTHER INFORMATION CONTACT: For
questions about the voluntary QMM
Prototype Assessment Protocol
Evaluation Program: 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, CDERQMM@fda.hhs.gov.
To submit a request to participate in
the program: Conchetta Newton, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4144,
240–402–6551, CDER-QMM@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
QMM refers to the extent to which
drug manufacturing establishments
implement quality management
practices that prioritize patients, drive
continual improvement, and enhance
supply chain reliability through the
strategic integration of business
decisions and manufacturing operations
with quality practices and technological
advancements. CDER is in the process of
developing a voluntary program to
promote QMM at drug manufacturing
establishments, which would encourage
drug manufacturers to implement
quality management practices that go
beyond current good manufacturing
practice (CGMP) requirements.1
As part of the QMM program
initiative, CDER is developing a QMM
Assessment Tool (including both a
protocol and rubric) to evaluate how
effectively establishments monitor and
manage quality and quality systems.2 In
FY 2024, CDER intends to launch the
voluntary Quality Management Maturity
1 FDA has solicited comments to inform the
development of this program. See 88 FR 63587,
September 15, 2023.
2 For additional information, see CDER’s Quality
Management Maturity (QMM) Program: Practice
Areas and Prototype Assessment Protocol
Development (2023), available at https://
www.fda.gov/media/171705/download?attachment.
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17:22 Jan 24, 2024
Jkt 262001
Prototype Assessment Protocol
Evaluation Program to gain experience
with use of a prototype of the
assessment protocol to evaluate whether
use of the protocol, as currently
designed, will enable a meaningful
assessment of the establishment’s
quality management practices and
actionable feedback for the
establishment. The outcomes from this
prototype evaluation program will help
to inform the development of the QMM
Assessment Tool to be used in the
eventual QMM program. This notice
announces FDA’s intent to launch the
QMM Prototype Assessment Protocol
Evaluation Program, outlines the types
of establishments FDA is seeking for
participation, and describes the process
for submitting a request to participate in
the program.
Between October 2020 and March
2022, CDER conducted under contract
two pilot programs to assess the QMM
of drug manufacturing establishments.
The first pilot program evaluated the
maturity of seven domestic
manufacturers of finished dosage forms
for the U.S. market (Ref. 1). The second
pilot program evaluated the maturity of
eight foreign manufacturers of active
pharmaceutical ingredients (APIs) (Ref.
2). Each pilot program was conducted
by a different contractor. These pilot
programs provided valuable insights to
CDER for developing a protocol to
assess establishments’ QMM,
understanding assessor behaviors
during interviews of establishment
personnel, and gathering participant
feedback on assessment questions,
reports, and outcomes (Ref. 3).
Using findings from these two pilot
programs, a review of the quality
management maturity literature,
evaluations of existing external
programs assessing elements of quality
culture or pharmaceutical quality,
surveys of external stakeholders, and
feedback from partner offices and
centers within FDA, CDER has
developed a prototype assessment
protocol to evaluate an establishment’s
QMM. The prototype assessment
protocol includes a series of questions
in five practice areas: leadership,
business continuity, technical
excellence, advanced pharmaceutical
quality system, and employee
empowerment and engagement. Within
each practice area, the prototype
assessment protocol explores key
elements of the establishment’s QMM.
Examples of some topics that may be
covered under the practice areas
include: management review and
resource management (management
commitment to quality), supply
planning and demand forecasting
PO 00000
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Fmt 4703
Sfmt 4703
4951
(business continuity), corrective action
and preventive action process
(advanced pharmaceutical quality
system), data governance and process
optimization (technical excellence), and
rewards and recognition (employee
engagement and empowerment). CDER
will use the standardized prototype
assessment protocol to collect
information on an establishment’s
executed practices, behaviors, and
responses to specific questions, and will
evaluate this information using an
objective rubric to help identify areas of
strength and potential areas with
opportunities for improvement.
Prototype assessment protocols will
be conducted by trained assessors who
will engage directly with
establishments, either onsite or in a
hybrid (both virtual and onsite)
environment. Assessments are
anticipated to take up to five business
days and are distinct from FDA’s
regulatory inspections.
II. Participation
A. Establishment Characteristics
CDER will consider the following
establishment characteristics when
identifying potential participants for
this QMM Prototype Assessment
Protocol Evaluation Program:
• The potential participant is an
establishment as defined in 21 CFR
207.1 that registers with FDA under
section 510 (21 U.S.C. 360) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) and manufactures, prepares,
propagates, compounds, or processes
drugs, or APIs used in such drugs,
subject to approval or licensure under
section 505 (21 U.S.C. 355) of the FD&C
Act or section 351 of the Public Health
Service Act (42 U.S.C. 262), or that are
marketed pursuant to section 505G of
the FD&C Act without an approved
application under section 505 of the
FD&C Act (often referred to as over-thecounter (OTC) monograph drug
products).
• The establishment received at least
one human drug surveillance
inspection 3 in the prior 5 years.
• The current inspection
classification for the establishment at
the time of the request to participate is
No Action Indicated or Voluntary
Action Indicated.
• The establishment manufactures,
prepares, propagates, compounds, or
processes at least one CDER-regulated
drug (API or finished drug product) that
3 Inspections conducted by FDA or by Mutual
Recognition Agreement (MRA) partners and
classified by FDA would fulfill this criterion. See
Mutual Recognition Agreements (MRA) for more
information.
E:\FR\FM\25JAN1.SGM
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4952
Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices
is currently in commercial distribution
in the United States.
• The establishment is willing to
participate in an onsite or hybrid
assessment.
B. Requests To Participate
Drug product manufacturers that are
eligible and interested in participating
in the voluntary QMM Prototype
Assessment Protocol Evaluation
Program should submit a request
directly to Conchetta Newton (see FOR
FURTHER INFORMATION CONTACT). To be
considered for this program, a request
should include all the following
information: (1) a contact person (name
and email); (2) manufacturing
establishment address; (3) FDA
Establishment Identifier and Data
Universal Numbering System Numbers;
(4) a brief description of the business
operations (e.g., manufacturing, testing,
re/packaging, re/labeling, sterilizing,
storing, distributing, or salvaging)
conducted at the establishment; and (5)
confirmation that the establishment
features the characteristics discussed in
section II.A of this notice.
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C. Selection Process
FDA intends to select participants
that reasonably reflect the diversity of
the industry. FDA intends to notify each
establishment of FDA’s decision on
their request to participate in the
voluntary QMM Prototype Assessment
Protocol Evaluation Program within 90
days of receipt. FDA intends to select up
to nine volunteer participants for this
program.
D. FDA-Participant Interactions
FDA intends to notify selected
participants of their selection and
confirm participation. This notification
will include more information about
engagement with the Agency, including
an orientation and a pre-assessment
questionnaire to assist the establishment
in preparing for the assessment,
logistical information such as options
for dates and times to schedule the
assessment, and recommendations for
establishment personnel that should be
available during the assessment. Teams
of three assessors will conduct the
prototype assessment protocol over a
period that is expected to be up to five
business days. Each team will be
composed of CDER staff, or a
combination of CDER staff and
contractors. Following completion of
the assessment, each participating
establishment will receive a report
summarizing areas of strength and
growth opportunities. In addition,
approximately 6 months after the
assessment, FDA will followup with a
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17:22 Jan 24, 2024
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virtual meeting to get feedback on the
prototype assessment protocol, the
report, and any limitations encountered.
This will help the Agency evaluate use
of the protocol, including whether it
enables meaningful assessment of the
establishment’s quality management
practices and if feedback for the
establishment is actionable.
III. References
The following references marked with
an asterisk (*) are on display at 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; they also are available
electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff.
Although FDA verified the website
addresses in this document, please note
that websites are subject to change over
time.
* 1. Quality Management Maturity for
Finished Dosage Forms Pilot Program for
Domestic Drug Product Manufacturers;
Program Announcement,’’ 85 FR 65824,
October 16, 2020, https://www.federal
register.gov/d/2020-22976.
* 2. ‘‘Quality Management Maturity for
Active Pharmaceutical Ingredients Pilot
Program for Foreign Facilities; Program
Announcement,’’ 85 FR 65828, October 16,
2020, https://www.federalregister.gov/d/
2020-22977.
3. J. Maguire, A. Fisher, D. Harouaka, N.
Rakala, et al., 2023, ‘‘Lessons from CDER’s
Quality Management Maturity Pilot
Programs,’’ AAPS Journal, 25(14), January 10,
2023, https://doi.org/10.1208/s12248-02200777-z.
The Food and Drug
Administration (FDA or Agency) is
announcing the issuance of Emergency
Use Authorizations (EUAs) (the
Authorizations) for certain medical
devices related to Coronavirus Disease
2019 (COVID–19). FDA has issued the
Authorizations listed in this document
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act). These
Authorizations contain, among other
things, conditions on the emergency use
of the authorized products. The
Authorization follows the February 4,
2020, determination by the Secretary of
Health and Human Services (HHS), as
amended on March 15, 2023, that there
is a public health emergency, or a
significant potential for a public health
emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
U.S. citizens living abroad and that
involves the virus that causes COVID–
19, and the subsequent declarations on
February 4, 2020, March 2, 2020, and
March 24, 2020, that circumstances
exist justifying the authorization of
emergency use of in vitro diagnostics for
detection and/or diagnosis of the virus
that causes COVID–19, personal
respiratory protective devices, and
medical devices, including alternative
products used as medical devices,
respectively, subject to the terms of any
authorization issued under the FD&C
Act. These Authorizations, which
include an explanation of the reasons
for issuance, are listed in this document,
and can be accessed on FDA’s website
from the links indicated.
SUMMARY:
These Authorizations are
effective on their date of issuance.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Submit written requests for
single copies of an EUA to the Office of
Policy, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request or
include a fax number to which the
Authorization may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the Authorization.
Food and Drug Administration
FOR FURTHER INFORMATION CONTACT:
Dated: January 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01423 Filed 1–24–24; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2020–N–1584]
Authorization of Emergency Use of
Certain Medical Devices During
COVID–19; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00062
Fmt 4703
ADDRESSES:
Kim
Sapsford-Medintz, Office of Product
Evaluation and Quality, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3216,
Silver Spring, MD 20993–0002, 301–
796–0311 (this is not a toll-free
number).
SUPPLEMENTARY INFORMATION:
Sfmt 4703
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]]>Agencies
[Federal Register Volume 89, Number 17 (Thursday, January 25, 2024)]
[Notices]
[Pages 4950-4952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01423]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5706]
Voluntary Quality Management Maturity Prototype Assessment
Protocol Evaluation Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for a limited number of establishments to participate in
a voluntary Quality Management Maturity Prototype Assessment Protocol
Evaluation Program involving the use of a prototype assessment protocol
to evaluate quality management maturity (QMM). The Center for Drug
Evaluation and Research (CDER) is implementing this voluntary program
for manufacturers of CDER-regulated drug products to gain experience
with the prototype assessment protocol and to evaluate whether use of
the protocol, as designed, will enable a meaningful assessment of the
establishment's
[[Page 4951]]
quality management practices while providing useful feedback for the
establishment. This notice outlines the types of establishments FDA is
seeking for participation and the process for submitting a request to
participate in the program.
DATES: FDA intends to accept requests to participate in the voluntary
QMM Prototype Assessment Protocol Evaluation Program through March 25,
2024. See the ``Participation'' section of this document for
instructions on submitting a request to participate and the selection
process.
FOR FURTHER INFORMATION CONTACT: For questions about the voluntary QMM
Prototype Assessment Protocol Evaluation Program: 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].
To submit a request to participate in the program: Conchetta
Newton, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4144, 240-402-
6551, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
QMM refers to the extent to which drug manufacturing establishments
implement quality management practices that prioritize patients, drive
continual improvement, and enhance supply chain reliability through the
strategic integration of business decisions and manufacturing
operations with quality practices and technological advancements. CDER
is in the process of developing a voluntary program to promote QMM at
drug manufacturing establishments, which would encourage drug
manufacturers to implement quality management practices that go beyond
current good manufacturing practice (CGMP) requirements.\1\
---------------------------------------------------------------------------
\1\ FDA has solicited comments to inform the development of this
program. See 88 FR 63587, September 15, 2023.
---------------------------------------------------------------------------
As part of the QMM program initiative, CDER is developing a QMM
Assessment Tool (including both a protocol and rubric) to evaluate how
effectively establishments monitor and manage quality and quality
systems.\2\ In FY 2024, CDER intends to launch the voluntary Quality
Management Maturity Prototype Assessment Protocol Evaluation Program to
gain experience with use of a prototype of the assessment protocol to
evaluate whether use of the protocol, as currently designed, will
enable a meaningful assessment of the establishment's quality
management practices and actionable feedback for the establishment. The
outcomes from this prototype evaluation program will help to inform the
development of the QMM Assessment Tool to be used in the eventual QMM
program. This notice announces FDA's intent to launch the QMM Prototype
Assessment Protocol Evaluation Program, outlines the types of
establishments FDA is seeking for participation, and describes the
process for submitting a request to participate in the program.
---------------------------------------------------------------------------
\2\ For additional information, see CDER's Quality Management
Maturity (QMM) Program: Practice Areas and Prototype Assessment
Protocol Development (2023), available at https://www.fda.gov/media/171705/download?attachment.
---------------------------------------------------------------------------
Between October 2020 and March 2022, CDER conducted under contract
two pilot programs to assess the QMM of drug manufacturing
establishments. The first pilot program evaluated the maturity of seven
domestic manufacturers of finished dosage forms for the U.S. market
(Ref. 1). The second pilot program evaluated the maturity of eight
foreign manufacturers of active pharmaceutical ingredients (APIs) (Ref.
2). Each pilot program was conducted by a different contractor. These
pilot programs provided valuable insights to CDER for developing a
protocol to assess establishments' QMM, understanding assessor
behaviors during interviews of establishment personnel, and gathering
participant feedback on assessment questions, reports, and outcomes
(Ref. 3).
Using findings from these two pilot programs, a review of the
quality management maturity literature, evaluations of existing
external programs assessing elements of quality culture or
pharmaceutical quality, surveys of external stakeholders, and feedback
from partner offices and centers within FDA, CDER has developed a
prototype assessment protocol to evaluate an establishment's QMM. The
prototype assessment protocol includes a series of questions in five
practice areas: leadership, business continuity, technical excellence,
advanced pharmaceutical quality system, and employee empowerment and
engagement. Within each practice area, the prototype assessment
protocol explores key elements of the establishment's QMM. Examples of
some topics that may be covered under the practice areas include:
management review and resource management (management commitment to
quality), supply planning and demand forecasting (business continuity),
corrective action and preventive action process (advanced
pharmaceutical quality system), data governance and process
optimization (technical excellence), and rewards and recognition
(employee engagement and empowerment). CDER will use the standardized
prototype assessment protocol to collect information on an
establishment's executed practices, behaviors, and responses to
specific questions, and will evaluate this information using an
objective rubric to help identify areas of strength and potential areas
with opportunities for improvement.
Prototype assessment protocols will be conducted by trained
assessors who will engage directly with establishments, either onsite
or in a hybrid (both virtual and onsite) environment. Assessments are
anticipated to take up to five business days and are distinct from
FDA's regulatory inspections.
II. Participation
A. Establishment Characteristics
CDER will consider the following establishment characteristics when
identifying potential participants for this QMM Prototype Assessment
Protocol Evaluation Program:
The potential participant is an establishment as defined
in 21 CFR 207.1 that registers with FDA under section 510 (21 U.S.C.
360) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and
manufactures, prepares, propagates, compounds, or processes drugs, or
APIs used in such drugs, subject to approval or licensure under section
505 (21 U.S.C. 355) of the FD&C Act or section 351 of the Public Health
Service Act (42 U.S.C. 262), or that are marketed pursuant to section
505G of the FD&C Act without an approved application under section 505
of the FD&C Act (often referred to as over-the-counter (OTC) monograph
drug products).
The establishment received at least one human drug
surveillance inspection \3\ in the prior 5 years.
---------------------------------------------------------------------------
\3\ Inspections conducted by FDA or by Mutual Recognition
Agreement (MRA) partners and classified by FDA would fulfill this
criterion. See Mutual Recognition Agreements (MRA) for more
information.
---------------------------------------------------------------------------
The current inspection classification for the
establishment at the time of the request to participate is No Action
Indicated or Voluntary Action Indicated.
The establishment manufactures, prepares, propagates,
compounds, or processes at least one CDER-regulated drug (API or
finished drug product) that
[[Page 4952]]
is currently in commercial distribution in the United States.
The establishment is willing to participate in an onsite
or hybrid assessment.
B. Requests To Participate
Drug product manufacturers that are eligible and interested in
participating in the voluntary QMM Prototype Assessment Protocol
Evaluation Program should submit a request directly to Conchetta Newton
(see FOR FURTHER INFORMATION CONTACT). To be considered for this
program, a request should include all the following information: (1) a
contact person (name and email); (2) manufacturing establishment
address; (3) FDA Establishment Identifier and Data Universal Numbering
System Numbers; (4) a brief description of the business operations
(e.g., manufacturing, testing, re/packaging, re/labeling, sterilizing,
storing, distributing, or salvaging) conducted at the establishment;
and (5) confirmation that the establishment features the
characteristics discussed in section II.A of this notice.
C. Selection Process
FDA intends to select participants that reasonably reflect the
diversity of the industry. FDA intends to notify each establishment of
FDA's decision on their request to participate in the voluntary QMM
Prototype Assessment Protocol Evaluation Program within 90 days of
receipt. FDA intends to select up to nine volunteer participants for
this program.
D. FDA-Participant Interactions
FDA intends to notify selected participants of their selection and
confirm participation. This notification will include more information
about engagement with the Agency, including an orientation and a pre-
assessment questionnaire to assist the establishment in preparing for
the assessment, logistical information such as options for dates and
times to schedule the assessment, and recommendations for establishment
personnel that should be available during the assessment. Teams of
three assessors will conduct the prototype assessment protocol over a
period that is expected to be up to five business days. Each team will
be composed of CDER staff, or a combination of CDER staff and
contractors. Following completion of the assessment, each participating
establishment will receive a report summarizing areas of strength and
growth opportunities. In addition, approximately 6 months after the
assessment, FDA will followup with a virtual meeting to get feedback on
the prototype assessment protocol, the report, and any limitations
encountered. This will help the Agency evaluate use of the protocol,
including whether it enables meaningful assessment of the
establishment's quality management practices and if feedback for the
establishment is actionable.
III. References
The following references marked with an asterisk (*) are on display
at 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; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. Although FDA verified the website addresses
in this document, please note that websites are subject to change over
time.
* 1. Quality Management Maturity for Finished Dosage Forms Pilot
Program for Domestic Drug Product Manufacturers; Program
Announcement,'' 85 FR 65824, October 16, 2020, https://www.federalregister.gov/d/2020-22976.
* 2. ``Quality Management Maturity for Active Pharmaceutical
Ingredients Pilot Program for Foreign Facilities; Program
Announcement,'' 85 FR 65828, October 16, 2020, https://www.federalregister.gov/d/2020-22977.
3. J. Maguire, A. Fisher, D. Harouaka, N. Rakala, et al., 2023,
``Lessons from CDER's Quality Management Maturity Pilot Programs,''
AAPS Journal, 25(14), January 10, 2023, https://doi.org/10.1208/s12248-022-00777-z.
Dated: January 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01423 Filed 1-24-24; 8:45 am]
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