Notice2023-14701
Reorganization of the Office of Laboratory Science and Safety
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 12, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
CDC has modified its structure. This notice announces the reorganization of the Office of Laboratory Science and Safety and the establishment of the Center for Laboratory Systems and Response.
Full Text
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<title>Federal Register, Volume 88 Issue 132 (Wednesday, July 12, 2023)</title>
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[Federal Register Volume 88, Number 132 (Wednesday, July 12, 2023)]
[Notices]
[Pages 44306-44309]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-14701]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Reorganization of the Office of Laboratory Science and Safety
AGENCY: Centers for Disease Control and Prevention (CDC), the
Department of Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: CDC has modified its structure. This notice announces the
reorganization of the Office of Laboratory Science and Safety and the
establishment of the Center for Laboratory Systems and Response.
DATES: This reorganization was approved by the Director of CDC on June
28, 2023.
FOR FURTHER INFORMATION CONTACT: D'Artonya Graham, Office of the Chief
Operating Officer, Office of the Director, Centers for Disease Control
and Prevention, 1600 Clifton Road NE, MS TW-2, Atlanta, GA 30329;
Telephone 770-488-4401; Email: <a href="/cdn-cgi/l/email-protection#ccbea9a3beabbf8cafa8afe2aba3ba"><span class="__cf_email__" data-cfemail="f7859298859084b7949394d9909881">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Part C (Centers for Disease Control and
Prevention) of the Statement of Organization, Functions, and
Delegations of Authority of the Department of Health and Human Services
(45 FR 67772-76, dated October 14, 1980, and corrected at 45 FR 69296,
October 20, 1980, as amended most recently at 88 FR 9290-9291, dated
February 13, 2023) is amended to reflect the reorganization of the
Office of Laboratory Science and Safety. Immediate Office of the
Director, Centers for Disease Control and Prevention. Specifically, the
changes are as follows:
I. Under Part C, Section C-B, Organization and Functions, insert
the following:
<bullet> Office of the Laboratory Science and Safety (CAN)
<bullet> Office of the Director (CAN1)
<bullet> Office of Infectious Diseases Laboratory Quality (CAN12)
<bullet> Office of Laboratory Safety (CAN13)
<bullet> Office of Laboratory Science (CAN14)
<bullet> Center for Laboratory Systems and Response (CANB)
<bullet> Division of Laboratory Systems (CANBB)
<bullet> Office of the Director (CANBB1)
<bullet> National Laboratory Response Systems Branch (CANBBB)
<bullet> Quality and Safety Systems Branch (CANBBC)
<bullet> Training and Workforce Development Branch (CANBBD)
II. Under Part C, Section C-B, Organization and Functions, delete
the mission or functional statements for and replace with the
following:
Office of Laboratory Science and Safety (CAN). In carrying out its
mission, the Office of Laboratory Science and Safety: (1) provides
scientific, technical, and managerial expertise and leadership in the
development and enhancement of laboratory safety programs; (2) oversees
and monitors the development, implementation, and evaluation of the
laboratory safety and quality management programs across CDC; (3)
oversees the development and distribution of guidance and
interpretation of Clinical Laboratory Improvement Amendments (CLIA)
regulations for infectious disease laboratories and monitors and
ensures laboratory compliance; and (4) bridges and strengthens the
Nation's clinical and public health laboratory system by continually
improving quality and safety, informatics and data science, and
workforce competency.
Office of the Director (CAN1). (1) provides scientific, technical,
and managerial expertise and leadership in the development and
enhancement of laboratory science and safety programs; (2) oversees and
monitors the development, implementation, and evaluation of the
laboratory safety and quality management programs across CDC; (3)
provides the understanding of CLIA regulations and tools needed by the
infectious diseases laboratories to operate in compliance with
established requirements; (4) advises on policy, partnerships, and
issues management matters; (5) advises on matters related to internal
and external public health communications; (6) provides oversight to
ensure CDC compliance with regulations for select agents and toxins,
and the safe possession, use, and transfer of select agents and toxins;
(7) provides oversight to ensure CDC compliance with all applicable
laws, regulations, policies, and standards regarding the humane care
and use of laboratory animals at CDC; (8) serves as the Institutional
Official for purposes of compliance with the Public Health Service
Policy on Humane Care and Use of Laboratory Animals; (9) makes
appointments to the CDC Institutional Animal Care and Use Committees;
(10) leads responses to laboratory incidents and emergencies; (11)
guides the development of laboratory systems standards for quality and
safety; and (12) bridges and strengthens the Nation's clinical and
public health laboratory system by continually improving quality and
safety,
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informatics and data science, and workforce competency.
III. Under Part C, Section C-B, Organization and Functions, add the
following functional statements:
Office of Laboratory Science (CAN13). (1) provides high-level
coordination of policies and guidance for core laboratory training
programs in quality management, laboratory safety, and Food and Drug
Administration (FDA)-regulated diagnostic devices; (2) manages the
catalog of core laboratory quality, safety, and FDA-regulatory
compliance training courses; (3) provides expertise and consultation
for policy development and implementation of laboratory quality
management activities; and (4) provides regulatory expertise and
consultation to support policy development and compliance with FDA
regulations for in vitro diagnostic devices.
Office of Laboratory Safety (CAN14). (1) provides high-level
oversight and coordination of laboratory safety at all CDC campuses;
(2) develops and assesses the effectiveness of agency-level plans,
policies, manuals, and tools for implementation of laboratory safety
standards; (3) provides regulatory compliance for biological safety,
chemical safety, radiation safety, and the possession, use, and
transport of select agents and toxins; (4) provides expertise and
consultation for biological safety, chemical safety, and radiation
safety; and (5) provides expertise for CDC-wide compliance with all
applicable laws, regulations, policies, and standards regarding the
humane care and use of laboratory animals at CDC.
Center for Laboratory Systems and Response (CANB). The mission of
the Center for Laboratory Systems and Response (CLSR) is to collaborate
with the Nation's clinical and public health laboratory systems as well
as CDC's programmatic subject matter experts to ensure scientifically
advanced, timely, and efficient laboratory response and diagnostic
testing for infectious disease outbreaks, epidemics, and pandemics, and
to provide cross-cutting laboratory operation and systems support for
CDC's infectious disease laboratories. To carry out this mission, CLSR:
(1) arranges and manages the transfer of CDC diagnostic tests used in
national responses to public health and clinical laboratories,
including appropriate testing and biosafety guidance; (2) provides
cross-cutting laboratory products and services to support laboratory
activities of CDC programs; (3) advances the Nation's capacity to
electronically exchange clinical and public health laboratory testing
data through the use of standards and common infrastructure; (4)
develops and distributes state-of-the-art laboratory training and
development courses and tools to strengthen the clinical and public
health laboratory workforce; (5) supports the Nation's CLIA laboratory
quality program in collaboration with FDA and the Centers for Medicare
and Medicaid Services (CMS); (6) functions as the CDC lead for the
National Laboratory Response System and oversees CDC's role in the
national clinical and public health laboratory system before and during
infectious disease outbreaks, epidemics, and pandemics; (7) provides
scientific guidance, regulatory oversight, clearance review, and
coordination across CLSR to support, promote, and ensure scientific
quality and integrity of CLSR products and programs; (8) supports CLSR
program monitoring, evaluation and reporting efforts to ensure that
they advance both health equity and public health outcomes, and
reinforces the importance of robust public health evaluation across all
of CLSR's programs; (9) supports CLSR programs with strategy
development and implementation plans; (10) provides leadership and
guidance on policy issues, coordinates with agency and other government
organizations about CSLR activities, and helps to define and pursue
goals for policy formation and execution; and (11) provides
communication services, coordinates with communication professionals
about CLSR's activities, and facilitates partnerships across the
center.
Division of Laboratory Systems (CANBB). The mission of the Division
of Laboratory Systems (DLS) is to ensure the effectiveness of the
National Laboratory Response System and to improve public health,
patient outcomes, and health equity by advancing laboratory systems. To
carry out this mission, DLS: (1) functions as the CDC lead for the
National Laboratory Response System, and oversees CDC's role in this
system before and during infectious disease outbreaks, epidemics, and
pandemics; (2) advances the state of the national clinical laboratory
system's quality and safety, data exchange, preparedness and response
capacity, and workforce competency; (3) strengthens the capacity of the
Nation's public health and clinical laboratory system, including
diagnostic testing facilities, to prepare for and respond to infectious
disease outbreaks, epidemics, and pandemics; (4) engages, supports, and
bolsters the work of the Nation's public health and clinical laboratory
community; (5) engages and supports partners and professional
organizations in the clinical laboratory and diagnostic manufacturing
industries as well as across the U.S. Government; (6) collaborates with
CMS and FDA to implement the Federal CLIA program; (7) manages and
executes CDC's responsibilities for the Federal CLIA program; (8)
advances the Nation's capacity to electronically exchange clinical and
public health laboratory testing data through the use of standards and
common infrastructure; (9) develops and distributes state-of-the-art
laboratory training and development courses and tools to strengthen the
clinical and public health laboratory workforce; (10) fosters
collaborations and cross-cutting activities with other CDC components
and external organizations to support the mission, activities, and
operations of DLS; (11) provides stewardship of the agency's
cooperative agreement (CoAg) with the Association for Public Health
Laboratories (APHL) and other division procurement, grants, CoAgs,
materials management, interagency agreements, and extramural resources;
(12) addresses policy issues that affect or could affect the National
Laboratory Response System or other DLS programs and activities; (13)
provides communications, web support, social media presence, responses
to media requests, and promotion and outreach efforts to clinical and
public health laboratories on emergency response and testing through
the CDC's Laboratory Outreach and Communication System; and (14)
responds to requests from other CDC programs for technical assistance
relating to DLS capabilities.
Office of the Director (CANBB1). The DLS Office of the Director (1)
provides leadership and guidance on the development of strategic goals,
objectives, and milestones to advance the vision and mission of DLS and
CLSR, (2) develops administrative policies, processes, and operations
for the division; (3) ensures that health equity principles are applied
in all DLS activities; (4) works with the CSLR Office of the Director
(OD) to ensure that spending plans and budgets are executed and aligned
with the strategic priorities of the division; (5) works with the CSLR
OD to establish and maintain a diverse, equitable, inclusive, and
accessible workplace; (6) provides DLS communications resources,
including web support, writing and editing, social media presence, and
promotion and outreach efforts to clinical and public health
laboratories; (7) provides
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scientific guidance and resources, regulatory oversight, clearance
review, and coordination with DLS staff to support, promote, and ensure
scientific quality and integrity of DLS products and programs; (8)
manages the division's CoAgs, including the CDC APHL CoAg (OE20-2001)
and Enhancing U.S. Clinical Laboratory Workforce Capacity CoAg (OE22-
2202); (9) fosters existing and new partnerships with the clinical and
public health laboratory and testing community, other CDC programs,
Federal and state agencies, and professional organizations to further
DLS mission and goals; (10) liaises with CMS and FDA CLIA program
partners, CLIA-approved accreditation organizations and proficiency
testing programs, and other CDC programs and offices for CLIA-related
issues; and (11) analyzes and provides guidance on policy-related
issues that affect DLS and the broader public and clinical laboratory
community, and ensures that DLS activities, communications, and
materials are aligned with agency policy.
National Laboratory Response System Branch (CANBBB). The mission of
the National Laboratory Response System Branch (NLRSB) is to serve as
CDC's lead for the National Laboratory Response System and to oversee
CDC's role in this system before and during infectious disease
outbreaks, epidemics, and pandemics. To carry out its mission, NLRSB
(1) strengthens the Nation's diagnostic testing and reporting
capabilities and capacity, especially before and during public health
emergencies, through programs, partnerships, test deployment and
distribution, and electronic data exchange; (2) coordinates and
supports preparedness and response activities of public health
laboratories (PHLs) that are members of the Laboratory Response Network
(LRN) for biological threats; (3) develops and maintains partnerships
for expanded emergency diagnostic testing capacity to national
commercial and other clinical laboratories; (4) provides communication
to clinical and PHLs and laboratory partners on laboratory matters of
public health significance through the Laboratory Outreach
Communication System; (5) provides informatics solutions and technical
assistance to LRN member laboratories that share laboratory testing
data with CDC for surveillance and response; (6) promotes the
development and use of standards to advance the quality and semantic
interoperability of laboratory data; (7) oversees the development of
existing systems, new infrastructure, and tools and services for PHLs
to receive electronic test orders from and submit test results to
healthcare providers; (8) participates in and chairs interagency
workgroups or task forces for the rapid development and deployment of
emergency diagnostics, including the Tri-Agency Task Force for
Emergency Diagnostics; and (9) supports clinical, research, outbreak,
and other event response work by managing multiple aspects of the
Enterprise Laboratory Information Management system, providing a
centralized location for data storage, specimen management, testing,
and reporting and allowing for harmonized data transfer and enhanced
collaboration across CDC's laboratories.
Quality and Safety Systems Branch (CANBBC). The mission of the
Quality and Safety Systems Branch is to improve the quality and safety
of laboratory testing in clinical and public health settings across the
Nation. To carry out its mission, QSSB (1) collaborates across CDC and
engages broadly with external partners, including other Federal
agencies, state agencies and programs, and professional organizations;
(2) develops laboratory quality and safety standards, guidelines, and
recommendations in collaboration with partners; (3) promotes the
adoption of these products by clinical and public health laboratories;
(4) provides scientific and technical support for the national CLIA
program to ensure the quality and safety of clinical and public health
laboratory testing; (5) hosts and manages the Clinical Laboratory
Improvement Advisory Committee and its workgroups on behalf of a tri-
agency partnership among CDC, CMS, and FDA; (6) provides expertise in
the development and revision of CLIA technical standards and voluntary
guidelines for laboratory quality and safety; (7) provides quality and
safety subject matter expertise to the DLS Training and Workforce
Development Branch for the development of training courses for external
clinical and PHLs; (8) leads the Next Generation Sequencing Quality
Initiative to develop adaptive quality management systems that support
next generation sequencing workflows; (9) leads the implementation of
biorisk management system standards for the safety of laboratory and
testing professionals and their communities; (10) advances the
integration of laboratory expertise in healthcare systems to improve
the accuracy of diagnoses and to reduce diagnostic errors; (11)
develops, promotes, and implements data science approaches for improved
use of large and complex data sets in support of adherence to CLIA
standards; and (12) leverages data acquired from large health databases
to evaluate laboratory testing practices, capabilities, capacity, and
public health outcomes.
Training and Workforce Development Branch (CANBBD). The mission of
the Training and Development Branch (TWDB) is to strengthen laboratory
practice and systems through strategic, innovative training, and
leadership of initiatives to recruit, develop, and retain a diverse,
well-prepared laboratory workforce. To carry out its mission, TWDB (1)
develops, promotes, and disseminates laboratory capacity-building
resources that enhance the clinical laboratory community's ability to
combat emerging threats, learn evolving practices, and stay current
with the newest standards and technologies; (2) designs and
disseminates innovative training on laboratory core science, quality,
safety, informatics, and emergency preparedness for U.S. clinical and
public health laboratories and the testing community--including
eLearning, printable and video job aids, live webinars, Training of
Trainers programs, and virtual reality courses that build learners'
skills in a safe, simulated laboratory environment; (3) engages
clinical and public health laboratory professionals and point-of-care
testers and connects them to CDC and to each other to rapidly identify
and respond to urgent training needs and sustain a capacity-building
community; (4) develops just-in-time training for an integrated network
of domestic and international laboratories on how to respond to
biological and chemical threats and other high-priority public health
emergencies; (5) leverages expertise in instructional design,
multimedia production, evaluation, and project management to rapidly
identify and prioritize training needs, select the optimal format for a
given training goal, audience, and timeline, and efficiently develop
laboratory training that meets CDC Quality Training Standards and
Section 508 standards for learners with disabilities; (6) maintains a
free, publicly accessible learning management system tailored to the
needs of U.S. clinical laboratory professionals; (7) facilitates site-
specific training and increases U.S. clinical laboratories' capacity
sustain to their own workforce development programs; (8) develops
quality, safety, and regulatory affairs training informed by agency-
specific policies and guidelines and tailored to the needs of CDC
laboratory staff; (9) designs and delivers hands-on training at CDC's
laboratory
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training facilities; (10) provides leadership and support of the
laboratory workforce through sustainable initiatives that strengthen
recruitment, retention, management, and training; (11) increases
awareness of and access to laboratory education and training
opportunities among under-represented groups and communities to
increase diversity within the laboratory workforce and ultimately
advance health equity; (12) develops frameworks, models, and resources
that support competency-based laboratory training; and (13) evaluates
the efficiency and effectiveness of laboratory education, training and
workforce development programs to ensure the effective knowledge
transfer and skills attainment to improve laboratory practice.
V. Under Part C, Section C-B, Organization and Functions, the
following organizational unit is deleted in its entirety:
<bullet> Office of Laboratory Safety and Science (CPQ)
<bullet> Office of the Director (CPQ1)
<bullet> Office of Laboratory Science (CPQB)
<bullet> Office of Laboratory Science (CPQC)
<bullet> Division of Laboratory Science (CPNB)
<bullet> Office of the Director (CPNB1)
<bullet> Laboratory Services and Compliance Branch (CPNBB)
<bullet> Training and Workforce Development Branch (CPNBC)
<bullet> Quality and Safety Systems Branch (CPNBD)
<bullet> Informatics and Data Science Branch (CPNBE)
Delegations of Authority
All delegations and redelegations of authority made to officials
and employees of affected organizational components will continue in
them or their successors pending further redelegation, provided they
are consistent with this reorganization.
(Authority: 44 U.S.C. 3101)
Robin D. Bailey, Jr.,
Chief Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2023-14701 Filed 7-11-23; 8:45 am]
BILLING CODE 4163-18-P
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