Statement of Organization, Functions, and Delegations of Authority

CourtFood And Drug Administration
Citation87 FR 89
Record Number2021-28386
Publication Date03 January 2022
89
Federal Register / Vol. 87, No. 1 / Monday, January 3, 2022 / Notices
E
XHIBIT
2—E
STIMATED
A
NNUALIZED
C
OST
B
URDEN
Number of
respondents Total
burden hours
Average
hourly
wage rate *
Total cost
burden
Total ................................................................................................................. 1,800 900 $44.31 $39,879
*Based upon the mean of the average wages for Life Scientists, All Other (19–1099), National Compensation Survey: Occupational Employ-
ment Statistics, May 2020 National Occupational Employment and Wage Estimates United States, U.S. Department of Labor, Bureau of Labor
Statistics. https://www.bls.gov/oes/current/oes_nat.htm#19-0000.
Request for Comments
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ’s health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: December 28, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–28441 Filed 12–30–21; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions,
and Delegations of Authority
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice.
SUMMARY
: The Food and Drug
Administration’s (FDA), Center for
Biologics Evaluation and Research
(CBER), Center for Drug Evaluation and
Research (CDER), Center for Devices and
Radiological Health (CDRH), and Center
for Tobacco Products (CTP) have
modified their organizational structures.
These new organizational structures
were approved by the Deputy Secretary
of Health and Human Services and
effective on November 24, 2021.
FOR FURTHER INFORMATION CONTACT
:
Yashika Rahaman, Director, Office of
Planning, Evaluation and Risk
Management, Office of Finance, Budget,
Acquisitions and Planning, FDA, 4041
Powder Mill Road, Beltsville, MD
20705–4304, 301–796–3843.
I. Introduction
Part D, Chapter D–B, (Food and Drug
Administration), the Statement of
Organization, Functions and
Delegations of Authority for the
Department of Health and Human
Services (35 FR 3685, February 25,
1970, 60 FR 56606, November 9, 1995,
64 FR 36361, July 6, 1999, 72 FR 50112,
August 30, 2007, 74 FR 41713, August
18, 2009, 76 FR 45270, July 28, 2011,
and 84 FR 22854, May 20, 2019) is
revised to reflect the Food and Drug
Administration’s reorganizations of
CBER, CDER’s Office of Medical Policy
(OMP), Office of Prescription Drug
Promotion (OPDP), CDRH’s Office of
Product Evaluation and Quality, and
CTP’s Office of Compliance and
Enforcement and Office of Science.
This reorganization will help to
enhance these organization’s ability to
advance FDA’s mission and streamline
operations and support functions.
The Center for Biologics Evaluation
and Research’s organizational changes
in the Office of the Center Director (OD),
the Office of Management, and the
Office of Communications, Outreach,
and Development refocus functions that
support CBER’s product offices to better
support the expected growth in those
offices. The OD’s functions are
streamlined into those that require
intensive engagement from the Center
Director and have no other natural
home. Several responsibilities are
realigned or consolidated to leverage
synergies with other functions.
Harnessing the power of real-world
evidence is a priority in the FDA
Priority Framework, the 21st Century
Cures Act, and the PDUFA commitment
letter. The changes proposed to CBER’s
Office of Biostatistics and Epidemiology
(OBE) position the center to advance
real-world evidence priorities for
biologics.
The 21st Century Cures Act
established the Regenerative Medicine
Advanced Therapy (RMAT) designation
program, in Office of Tissues and
Advanced Therapies (OTAT), and called
on FDA to work to advance standards
development for regenerative medicine
products in order to support the
development, evaluation, and review of
regenerative medicine products. The
RMAT program has generated
tremendous industry interest, and CBER
has granted 129 RMAT designations
since program inception in December
2016.
One of FDA’s key priorities is
leveraging innovation to advance public
health goals by continually improving
the product development process and
strengthening FDA’s gold standard.
CBER’s portfolio of products is currently
seeing an unprecedented level of
innovation and growth. These
innovations range from the development
of new pathogen inactivation
technology that has the potential to
drastically improve how FDA promotes
blood safety, the explosion in
submissions for gene therapies that have
the potential to transform patients’ lives,
innovations in approaches to managing
serious food allergies, and advances in
manufacturing technology for vaccines.
The changes proposed in two of CBER’s
product offices: OTAT and the Office of
Blood Research and Review (OBRR)
along with the crosscutting functions in
OBE and Office of Compliance and
Biologics Quality are intended to ensure
CBER’s regulatory structures and
processes are prepared to respond to
innovation and development in the
industry while upholding FDA’s
standards for safety and effectiveness for
biological products. Establishing the
Office of Regulatory Operations will
help CBER support continued efficiency
and effectiveness in CBER’s regulatory
processes and provide strategic
direction as the Center works to
modernize its supporting information
technology (IT) infrastructure.
The Center for Drug Evaluation and
Research’s OMP, Office of Prescription
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Drug Promotion (OPDP) establishes the
Division of Promotion Policy, Research,
and Operations (DPPRO). This
reorganization is critical to the FDA’s
ability to foster efficient oversight and
development of national prescription
drug promotion policy to enhance the
dissemination and communication of
high-quality drug information to
healthcare professionals, patients, and
consumers. The reorganization will also
provide enhanced support, oversight,
and direction to the OPDP’s social
science research program. This program
is critical in helping shape the direction
of OPDP’s new and evolving policy
initiatives through research studies
designed to evaluate the impact of
health communication and prescription
drug promotion directed toward
healthcare professionals and consumers.
The reorganization will provide
additional support and increased focus
on the regulatory counsel functions
necessary to develop sound and legally
supportable policy documents and
surveillance activities, particularly
given First Amendment jurisprudence
developments over the last few years.
The reorganization will also provide
enhanced operational support to all
OPDP functions, including policy
development and clearance, the
multimillion-dollar research program,
advisory comments to industry,
compliance actions, and internal FDA
review of approved labeling other
activities.
The Center for Devices and
Radiological Health’s Office of Product
Evaluation and Quality’s (OPEQ) retitles
the Office of In Vitro Diagnostics and
Radiological Health (OIR) as the Office
of Health Technology VII (OHT VII) and
establish an Office of Health Technology
VIII (OHT VIII) allowing the two offices
to have greater focus on In Vitro
Diagnostics (OHT VII) and
Mammography and Radiological Health
(OHT VIII). The OHT VII structure will
mirror the former OIR with the
exception of abolishing two divisions
(Division of Radiological Health and
Division of Mammography Quality
Standards). OHT VII will be solely
focused on in vitro diagnostics with
responsibility for regulating laboratory
and in-home diagnostic tests. In vitro
diagnostic devices allow for tests to be
completed using blood or tissue from
the human body. The results of these
tests are used to identify diseases and
other conditions. The devices allow for
individuals to monitor their health, and
they help to treat, cure, and prevent
diseases. Personnel utilizing the
precision medicine approach utilize in
vitro diagnostic devices in order to help
identify individuals who can improve
their health by undergoing specific
therapies or treatments. The
Mammography Quality Standards
program will move in tact with its entire
appropriated and User Fee budget to the
OHT VIII and will continue to serve as
the national focal point for the
implementation of the Mammography
Quality Standards Act.
The Center for Tobacco Products’
Office of Compliance and Enforcement
(OCE) establishes the Division of
External Programs and Resource
Management (DEPRM) and establishes
the Division of Product Compliance
(DPC). The CTP’s Office of Science (OS)
establishes the Division of Research and
Knowledge Integration (DRKI). These
reorganizations are critical to the FDA’s
ability to better utilize its resources in
an efficient and effective way to meet its
mission of promoting and protecting the
public health by ensuring industry
compliance with the requirements of the
law and respond to public health
emergencies. The reorganizations will
also result in increased support of
requirements of the Family Smoking
Prevention and Tobacco Control Act.
The Food and Drug Administration’s,
Center for Biologics Evaluation and
Research, Center for Drug Evaluation
and Research’s Office of Medical Policy,
the Center for Devices and Radiological
Health’s Office of Product Evaluation
and Quality, and the Center for Tobacco
Products’ Office of Compliance and
Enforcement and Office of Science has
been restructured as follows:
DCB. Organization. The Center for
Biologics Evaluation and Research is
headed by the Center Director, Center
for Biologics Evaluation and Research.
Center for Biologics Evaluation and
Research (DCB)
Office of the Center Director (DCBA)
Executive Operations Staff (DCBA1)
Regulations and Policy Staff (DCBA3)
Policy Staff (DCBA7)
Science Staff (DCBA8)
Office of Management (DCBB)
Division of Program Services (DCBBB)
Program Services Branch (DCBBB1)
Safety and Services Branch (DCBBB4)
Division of Scientific Advisors and
Consultants (DCBBC)
Division of Veterinary Services (DCBBD)
Division of Management Planning and
Analysis (DCBBE)
Capacity Planning and Management
Analysis Branch (DCBBE1)
Planning, Performance, and
Formulation Branch (DCBBE2)
Division of Acquisitions and Budget
Resources (DCBBF)
Acquisition Management Branch
(DCBBF1)
Budget Planning and Execution Branch
(DCBBF2)
Division of Human Capital (DCBBG)
Management Services Branch (DCBBG1)
Workforce Management Branch
(DCBBG2)
Office of Compliance and Biologics
Quality (DCBC)
Division of Case Management (DCBCA)
Blood and Tissue Compliance Branch
(DCBCA1)
Advertising and Promotional Labeling
Branch (DCBCA2)
Biological Drug and Device Compliance
Branch (DCBCA3)
Division of Inspections and Surveillance
(DCBCB)
Program Surveillance Branch (DCBCB1)
Bioresearch Monitoring Branch
(DCBCB2)
Division of Manufacturing and Product
Quality (DCBCC)
Product Release Branch (DCBCC1)
Manufacturing Review Branch 1
(DCBCC2)
Manufacturing Review Branch 2
(DCBCC3)
Applications Review Branch (DCBCC4)
Manufacturing Review Branch 3
(DCBCC5)
Division of Biological Standards and
Quality Control (DCBCD)
Laboratory of Analytical Chemistry and
Blood Related Products (DCBCD1)
Quality Assurance Branch (DCBCD2)
Laboratory of Microbiology, In-vivo
Testing and Standards (DCBCD3)
Laboratory of Analytical Chemistry
Branch (DCBCD4)
Laboratory of Biochemistry, Virology,
and Immunochemistry Branch
(DCBCD5)
Laboratory of Blood Related Products
Branch (DCBCD6)
Office of Biostatistics and
Pharmacovigilance (DCBD)
CBER Surveillance Program Staff
(DCBD1)
ABRA Staff (DCBD2)
Division of Biostatistics (DCBDA)
Vaccines Evaluation Branch (DCBDA1)
Therapeutics Evaluation Branch 1
(DCBDA2)
Device and Non-Clinical Evaluation
Branch (DCBDA3)
Therapeutics Evaluation Branch 2
(DCBDA4)
Division of Pharmacovigilance (DCBDB)
Pharmacovigilance Branch 1 (DCBDB1)
Pharmacovigilance Branch 2 (DCBDB2)
Pharmacovigilance Branch 3 (DCBDB3)
Office of Blood Research and Review
(DCBE)
Administrative Staff (DCBE1)
Division of Emerging and Transfusion
Transmitted Diseases (DCBEA)
Laboratory of Molecular Virology
(DCBEA1)
Laboratory of Parasitic and Emerging
Pathogens (DCBEA2)
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Product Review Branch (DCBEA4)
Division of Blood Components and
Devices (DCBEB)
Devices Review Branch (DCBEB2)
Laboratory of Biochemistry and
Vascular Biology (DCBEB5)
Laboratory of Cellular Hematology and
Vascular Biology Branch (DCBEB6)
Division of Clinical and Regulatory
Review (DCBEC)
Clinical Review Branch (DCBEC1)
Blood and Plasma Review Branch
(DCBEC2)
Regulatory Project Management Branch
(DCBEC3)
Office of Vaccine Research and Review
(DCBF)
Program Operations Staff (DCBF1)
Division of Bacterial, Parasitic, and
Allergenic Products (DCBFA)
Laboratory of Immunobiochemistry
(DCBFA1)
Laboratory of Respiratory and Special
Pathogens (DCBFA2)
Laboratory of Bacterial Polysaccharides
(DCBFA3)
Laboratory of Mucosal Pathogens and
Cellular Immunology (DCBFA4)
Division of Viral Products (DCBFB)
Laboratory of Pediatric and Respiratory
Viral Diseases (DCBFB1)
Laboratory of Hepatitis Viruses
(DCBFB2)
Laboratory of Retroviruses (DCBFB3)
Laboratory of DNA Viruses (DCBFB4)
Laboratory of Vector Borne Diseases
(DCBFB5)
Laboratory of Method Development
(DCBFB6)
Laboratory of Immunoregulation
(DCBFB7)
Division of Vaccines and Related
Products Applications (DCBFC)
CMC Review Branch 1 (DCBFC1)
CMC Review Branch 2 (DCBFC2)
CMC Review Branch 3 (DCBFC3)
Clinical Review Branch 1 (DCBFC4)
Clinical Review Branch 2 (DCBFC5)
Review Management Support Branch
(DCBFC6)
Office of Tissues and Advanced
Therapies (DCBG)
Division of Cellular and Gene Therapies
(DCBGA)
Cellular Therapies Branch (DCBGA1)
Gene Therapies Branch 1 (DCBGA2)
Gene Transfer and Immunogenicity
Branch (DCBGA3)
Tumor Vaccine and Biotechnology
Branch (DCBGA4)
Cellular and Tissue Therapy Branch
(DCBGA5)
Gene Therapies Branch 2 (DCBGA6)
Tissue Engineering Branch (DCBGA7)
Division of Clinical Evaluation and
Pharmacological/Toxicology (DCBGB)
General Medicine Branch 1 (DCBGB1)
Pharmacology/Toxicology Branch 1
(DCBGB2)
Oncology Branch (DCBGB3)
General Medicine Branch 2 (DCBGB4)
Pharmacology/Toxicology Branch 2
(DCBGB5)
Malignant Hematology Branch
(DCBGB6)
General Medicine Branch 3 (DCBGB7)
Benign Hematology Branch (DCBGB8)
Division of Human Tissues (DCBGC)
Division of Plasma Protein Therapeutics
(DCBGD)
Hemostasis Branch (DCBGD1)
Plasma Derivatives Branch (DCBGD2)
Division of Regulatory Project
Management (DCBGE)
Regulatory Project Management Branch
1 (DCBGE1)
Regulatory Project Management Branch
2 (DCBGE2)
Regulatory Project Management Branch
3 (DCBGE3)
Regulatory Project Management Branch
4 (DCBGE4)
Office of Communication, Outreach, and
Development (DCBH)
Division of Disclosure and Oversight
Management (DCBHA)
Congressional and Oversight Branch
(DCBHA1)
Access Litigation and Freedom of
Information Branch (DCBHA2)
Electronic Disclosure Branch (DCBHA3)
Division of Manufacturers Assistance
and Training (DCBHB)
Career Development and Directed
Training Branch (DCBHB1)
Manufacturers Assistance & Technical
Training Branch (DCBHB2)
Division of Communication and
Consumer Affairs (DCBHC)
Communication Technology Branch
(DCBHC1)
Consumer Affairs Branch (DCBHC2)
Office of Regulatory Operations (DCBI)
Division of Informatics and Information
Technology (DCBIA)
Data Standards Branch (DCBIA1)
Information Technology Branch
(DCBIA2)
Records Management Branch (DCBIA3)
Regulatory Information Branch
(DCBIA4)
Division of Regulatory Operations and
Programs (DCBIB)
Regulatory Affairs and Business
Operations Branch (DCBIB1)
Regulatory Programs Branch (DCBIB2)
DCDH. Organization. The Center for
Drug Evaluation and Research’s Office
of Medical Policy is headed by the
Director, Office of Medical Policy and
includes the following:
Office of Medical Policy (DCDH)
Office of Prescription Drug Promotion
(DCDHA)
Division of Advertising and Promotion
Review I (DCDHAA)
Division of Advertising and Promotion
Review II (DCDHAB)
Division of Promotion Policy, Research,
and Operations (DCDHAC)
Office of Medical Policy Initiatives
(DCDHB)
Division of Medical Policy Development
(DCDHBA)
Division of Medical Policy Programs
(DCDHBB)
Division of Clinical Trial Quality
(DCDHBC)
DCCF. Organization. The Center for
Devices and Radiological Health’s Office
of Product Evaluation and Quality is
headed by the Director, Office Product
Evaluation and Quality and includes the
follow:
Office of Product Evaluation and
Quality (DCCF)
Quality and Analytics Staff (DCCF1)
Clinical and Scientific Policy Staff
(DCCF2)
Strategic Initiatives Staff (DCCF3)
Regulation, Policy and Guidance Staff
(DCCF4)
Office of Regulatory Programs (DCCFA)
Division of Regulatory Programs I
(DCCFAA)
Division of Regulatory Programs II
(DCCFAB)
Division of Regulatory Programs III
(DCCFAC)
Division of Regulatory Programs IV
(DCCFAD)
Office of Clinical Evidence and Analysis
(DCCFB)
Division of Clinical Evidence and
Analysis I (DCCFBA)
Division of Clinical Evidence and
Analysis II (DCCFBB)
Office of Health Technology I (DCCFC)
Division of Health Technology I A
(DCCFCA)
Division of Health Technology I B
(DCCFCB)
Division of Health Technology I C
(DCCFCC)
Office of Health Technology II (DCCFD)
Division of Health Technology II A
(DCCFDA)
Division of Health Technology II B
(DCCFDB)
Division of Health Technology II C
(DCCFDC)
Office of Health Technology III (DCCFE)
Division of Health Technology III A
(DCCFEA)
Division of Health Technology III B
(DCCFEB)
Division of Health Technology III C
(DCCFEC)
Office of Health Technology IV (DCCFF)
Division of Health Technology IV A
(DCCFFA)
Division of Health Technology IV B
(DCCFFB)
Office of Health Technology V (DCCFG)
Division of Health Technology V A
(DCCFGA)
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Division of Health Technology V B
(DCCFGB)
Office of Health Technology VI (DCCFH)
Division of Health Technology VI A
(DCCFHA)
Division of Health Technology VI B
(DCCFHB)
Division of Health Technology VI C
(DCCFHC)
Office of Health Technology VII (DCCFI)
Division of Chemistry and Toxicology
(DCCFIA)
Division of Immunology and
Hematology (DCCFIB)
Division of Microbiology (DCCFIC)
Division of Program Management and
Operations (DCCFIE)
Division of Molecular Genetics and
Pathology (DCCFIG)
Office of Health Technology VIII
(DCCFJ)
Division of Health Technology VIII A
(DCCFJA)
Division of Health Technology VIII B
(DCCFJB)
Division of Health Technology VIII C
(DCCFJC)
DCFF. Organization. The Center for
tobacco Product’s Office of Compliance
and Enforcement is headed by the
Director, Office of Compliance and
Enforcement and includes the
following:
Division of Enforcement and
Manufacturing (DCFFA)
Division of Promotion, Advertising, and
Labeling (DCFFB)
Division of State Programs (DCFFC)
Division of Business Operations
(DCFFD)
Division of External Programs and
Resource Management (DCFFE)
Division of Product Compliance
(DCFFF)
DCFD. Organization. The Center for
tobacco Product’s Office of Science is
headed by the Director, Office of
Science and includes the following:
Division of Regulatory Project
Management (DCFDA)
Division of Regulatory Science
Informatics (DCFDB)
Division of Product Science (DCFDC)
Division of Individual Health Science
(DCFDD)
Division of Population Health Science
(DCFDE)
Division of Non-Clinical Sciences
(DCFDF)
Division of Research and Knowledge
Integration (DCFDG)
II. Delegations of Authority
Pending further delegation, directives,
or orders by the Commissioner of Food
and Drugs, all delegations and
redelegations of authority made to
officials and employees of affected
organizational components will
continue in them or their successors
pending further redelegations, provided
they are consistent with this
reorganization.
III. Electronic Access
This reorganization is reflected in
FDA’s Staff Manual Guide (SMG).
Persons interested in seeing the
complete Staff Manual Guide can find it
on FDA’s website at: https://
www.fda.gov/AboutFDA/
ReportsManualsForms/
StaffManualGuides/default.htm.
Authority: 44 U.S.C. 3101.
Dated: October 22, 2021.
Andrea Palm,
Deputy Secretary of Health and Human
Services.
[FR Doc. 2021–28386 Filed 12–30–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–1243]
Prospective Grant of an Exclusive
Patent License: A Diagnostic Tool
Based Upon Magnetic Resonance
Spectroscopy Pre-Processing and
Renormalization
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice.
SUMMARY
: The Food and Drug
Administration (FDA) is contemplating
the grant of an Exclusive Patent License
to practice the invention embodied in
the U.S. Patent listed in the
SUPPLEMENTARY INFORMATION
section of
this notice to Voxel Systems, LLC
located in Houston, Texas.
DATES
: Only written comments and/or
applications for a license that are
received by FDA’s Technology Transfer
Office on or before January 18, 2022,
will be considered.
ADDRESSES
: Inquiries and comments
relating to the contemplated Exclusive
Patent License should be directed to:
Ken Millburne, Food and Drug
Administration Technology Transfer
Office, Bldg. 1, Rm. 4213, Silver Spring,
MD 20993, 240–478–1662; email:
Kenneth.Millburne@fda.hhs.gov.
SUPPLEMENTARY INFORMATION
:
Intellectual Property
FDA Reference No.: E–2009–011/US–04:
‘‘System for Magnetic Resonance
Spectroscopy of Brain Tissue for
Pattern-Based Diagnostics’’
I. U.S. Non-Provisional Application
13/509,539, filed November 12, 2010
(FDA Reference No.: E–2009–011/US–
04).
II. U.S. Patent granted November 4,
2014: U.S. Patent 8,880,354 B2 (FDA
Reference No. E–2009–011/US–04).
The patent rights in this invention
have been assigned to the Government
of the United States of America.
The prospective exclusive license
territory may be worldwide and in fields
of use that may be limited to: (1) Any
and all in vivo use, application, or
developmental activity related to the
software, processing algorithm, and
Licensed Processes and Products; (2) all
human and animal diagnostics, in pre-
clinical, or clinical utilizations for any
and all maladies; (3) all human research
applications for expanded magnetic
resonance imaging (MRI) utilization,
application development, drug
development tools, molecular
compound characterization, algorithms,
and biomarker identification and
development; and (4) all animal or other
research applications and translational
studies for ultra high-field MRI
investigations, drug development,
metabolite, and biomarker
identification.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing. The prospective
exclusive license may be granted unless,
within 15 days from the date of this
published notice, FDA receives written
evidence and argument that establishes
that the grant of the license would not
be consistent with the requirements of
35 U.S.C. 209 and 37 CFR part 404.
In response to this notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a license
application, will not be treated
confidentially, and may be made
publicly available.
License applications submitted in
response to this notice will be presumed
to contain business confidential
information and any release of
information in these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
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