[Federal Register Volume 88, Number 132 (Wednesday, July 12, 2023)]
[Notices]
[Pages 44306-44309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: [email protected].

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:

 Office of the Laboratory Science and Safety (CAN)
 Office of the Director (CAN1)
 Office of Infectious Diseases Laboratory Quality (CAN12)
 Office of Laboratory Safety (CAN13)
 Office of Laboratory Science (CAN14)
 Center for Laboratory Systems and Response (CANB)
 Division of Laboratory Systems (CANBB)
 Office of the Director (CANBB1)
 National Laboratory Response Systems Branch (CANBBB)
 Quality and Safety Systems Branch (CANBBC)
 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,

[[Page 44307]]

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

[[Page 44308]]

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:

 Office of Laboratory Safety and Science (CPQ)
 Office of the Director (CPQ1)
 Office of Laboratory Science (CPQB)
 Office of Laboratory Science (CPQC)
 Division of Laboratory Science (CPNB)
 Office of the Director (CPNB1)
 Laboratory Services and Compliance Branch (CPNBB)
 Training and Workforce Development Branch (CPNBC)
 Quality and Safety Systems Branch (CPNBD)
 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