[Federal Register Volume 89, Number 182 (Thursday, September 19, 2024)]
[Notices]
[Pages 76831-76836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21412]


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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 (OLSS). 
OLSS was retitled to the Office of Laboratory Systems and Response 
(OLSR) and additional organizational updates were approved.

DATES: This reorganization of OLSS was approved by the Director of CDC 
on September 13, 2024, and became effective September 13, 2024.

FOR FURTHER INFORMATION CONTACT: Victoria Olson, Centers for Disease 
Control and Prevention, 1600 Clifton Road NE, MS H24-2, Atlanta, GA 
30329. Telephone: 404-639-7466; 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 89 FR 68442-68443, dated 
August 26, 2024) is amended to reflect the reorganization of Office of 
Laboratory Science and Safety, Immediate Office of the Director, 
Centers for Disease Control and Prevention. Specifically, the changes 
are as follows:

[[Page 76832]]

    I. Under Part C, Section C-B, Organization and Functions, make the 
following changes:

 Retitle the Office of Laboratory Science and Safety to the 
Office of Laboratory Systems and Response (CAN)
 Update the mission statement of the Office of the Director 
(CAN1)
 Retitle the Office of Infectious Disease Laboratory Quality to 
the Office of Laboratory Quality and Safety (CAN12)
 Abolish the Office of Laboratory Science (CAN13)
 Abolish the Office of Laboratory Safety (CAN14)
 Abolish the Center for Laboratory Systems and Response (CANB)
 Abolish the Division of Laboratory Systems (CANBB)
 Abolish the Office of the Director (CANBB1)
 Abolish the National Laboratory Response System Branch 
(CANBBB)
 Abolish the Quality and Safety Systems Branch (CANBBC)
 Abolish the Training and Workforce Development Branch (CANBBD)
 Abolish the Division of Core Laboratory Services and Response 
(CRH)
 Abolish the Office of the Director (CRH1)
 Abolish the Advanced Diagnostics and Biotechnologies Branch 
(CRHB)
 Abolish the Comparative Medicine Branch (CRHC)
 Abolish the Preparedness, Response, and Outbreak Services 
Branch (CRHD)
 Abolish the Laboratory Products and Services Branch (CRHE)
 Establish the Division of Laboratory Systems (CANC)
 Establish the Office of the Director (CANC1)
 Establish the Laboratory Readiness and Informatics Branch 
(CANCB)
 Establish the Quality and Safety Systems Branch (CANCC)
 Establish the Training and Workforce Development Branch 
(CANCD)
 Establish the Division of Core Laboratory Services and 
Response (CAND)
 Establish the Office of the Director (CAND1)
 Establish the Biotechnology Core Facility Branch (CANDB)
 Establish the Comparative Medicine Branch (CANDC)
 Establish the Preparedness, Response, and Outbreak Services 
Branch (CANDD)
 Establish the Laboratory Products and Services Branch (CANDE)
    II. Under Part C, Section C-B, Organization and Functions, after 
the Office of Laboratory Science and Safety (CAN) delete and insert the 
following:
    Office of Laboratory Systems and Response (CAN). To carry out its 
mission, the Office of Laboratory Systems and Response (OLSR): (1) 
provides cross-cutting laboratory products, services, and systems 
(quality, safety, informatics, workforce, response readiness) support 
for CDC laboratories that conduct research, surveillance, and routine 
and emergency diagnostic testing, and develop diagnostic tests; (2) 
collaborates with the nation's laboratories (public health, clinical, 
industry, academic, and other government) to ensure scientifically 
advanced, timely, and efficient laboratory response and diagnostic 
testing; (3) provides scientific, technical, and managerial expertise 
and national leadership in the development and enhancement of 
laboratory quality, safety, informatics, and training and workforce 
development programs; (4) ensures regulatory compliance and monitors 
implementation and evaluation of the laboratory safety and quality 
management programs across CDC; (5) oversees the development and 
distribution of agency guidance on diagnostic testing and clinical 
laboratory operations and interpretation of laboratory regulations; and 
(6) bridges and strengthens the nation's clinical and public health 
laboratory system by continually improving quality and safety, response 
readiness, informatics and data science capability, and workforce 
competency.
    Office of the Director (CAN1). (1) serves as the home office of the 
Associate Director for Laboratory Science and Safety (ADLSS) who serves 
as the single point of laboratory accountability for all laboratory 
systems at the agency; (2) provides scientific, technical, and 
managerial expertise and leadership in the development and enhancement 
of laboratory systems (quality, safety, informatics, training and 
workforce development, and response readiness); (3) oversees and 
monitors the development, implementation, and evaluation of the 
laboratory safety and quality management programs across CDC; (4) 
provides expertise and consultation in interpreting and complying with 
regulations (e.g., Clinical Laboratory Improvement Amendments (CLIA), 
Food and Drug Administration (FDA)-regulated devices) and develops 
tools and systems needed by CDC laboratories to operate in compliance 
with established requirements; (5) 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; (6) 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; (7) ensures compliance with the Public 
Health Service (PHS) Policy on Humane Care and Use of Laboratory 
Animals; (8) makes appointments to the CDC Institutional Animal Care 
and Use Committees; (9) provides strategic direction and leadership in 
management of OLSR fiscal, workforce, information technology, and 
facilities resources and leads coordination and stewardship of 
procurement, grants, cooperative agreements, materials management, 
interagency agreements, and extramural resources; (10) ensures that 
spending plans (Office and Divisions) and budgets are executed and 
aligned with the strategic priorities of OLSR; (11) ensures that health 
equity principles are applied in all OLSR activities; (12) establishes 
and maintains a diverse, equitable, inclusive, and accessible workplace 
within all of OLSR; (13) provides scientific guidance, regulatory 
oversight, clearance review, and coordination across OLSR to support, 
promote, and ensure scientific quality and integrity of OLSR products 
and programs; (14) supports OLSR program monitoring, evaluation and 
reporting efforts to ensure that OLSR programs advance both health 
equity and public health outcomes, and reinforces the importance of 
robust public health evaluation across all of OLSR's programs; (15) 
supports OLSR programs with strategy development and implementation 
plans; (16) provides leadership and guidance on policy issues, 
coordinates with agency and other government organizations about OSLR 
activities, and helps to define and pursue goals for policy formation 
and execution; (17) provides communication services, coordinates with 
communication professionals about OLSR's activities, and facilitates 
partnerships across Centers/Institute/Offices (CIOs); (18) leads 
responses to laboratory incidents and emergencies; (19) bridges and 
strengthens the nation's clinical and public health laboratory system 
by continually improving quality and safety, response readiness, 
informatics and data science capability, and workforce competency; (20) 
serves as the lead for the laboratory and testing task force for all 
agency-wide public health responses; and (21) maintains CDC's 
laboratory and diagnostic testing relationships with interagency and 
public health partners.

[[Page 76833]]

    Office of Laboratory Quality and Safety (CAN12). (1) provides 
consultation, high-level oversight, and expertise for policy 
development and implementation of laboratory safety and quality 
management activities; (2) develops, selects, deploys, and implements 
agency-level plans, policies, manuals, and tools for laboratory quality 
and safety standards; (3) assesses effectiveness of agency-level 
laboratory quality and safety standards; (4) develops and distributes 
guidance and interpretation of the CLIA regulations for the CDC 
Infectious Disease (ID) laboratories; (5) provides data analysis, 
summary reports, and technical assistance for laboratory leadership; 
(6) ensures CDC laboratory compliance with all applicable laws, 
regulations, policies, and standards (e.g., possession, uses, and 
transport of select agents and toxins; CLIA regulations; Quality 
Management System Regulation (QMSR); laboratory waste and disposal 
policies; Quality Manual for Microbiological Laboratories (QMML); 
biological safety; chemical safety; radiation safety) through internal 
assessments, consultations and routine processes; (7) provides 
customer-driven services to support CDC laboratory operations (e.g., 
laboratory equipment certification, space decontamination, incident 
investigation, laboratory waste and disposal, facility design and 
renovation consultation, laboratory certification and decertification, 
and inventory management support); (8) 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; (9) serves as the home office for the CLIA Laboratory Director CDC 
Roybal campus ID laboratories; (10) provides regulatory expertise and 
consultation to support policy development and to support centers, 
institutes, and offices as they fulfill their responsibility to comply 
with FDA regulations for in vitro diagnostic devices; and (11) serves 
as the primary coordinating body for engagement with internal and 
external partners related to quality management systems, safety and 
regulatory compliance of domestic CDC laboratory research, surveillance 
and clinical testing.
    Division of Laboratory Systems (CANC). The mission of the Division 
of Laboratory Systems (DLS) is to ensure the effectiveness of the 
Laboratory Response Network 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 nation's 
Laboratory Response Network (LRN), and oversees CDC's role in this 
network 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 
Centers for Medicare and Medicaid Services (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 
CDC's as well as the nation's clinical and public health laboratory 
workforce; (10) manages the catalog of intramural core laboratory 
quality, safety, and regulatory compliance training courses; (11) 
fosters collaborations and cross-cutting activities with other CDC CIOs 
and external organizations to support the mission, activities, and 
operations of DLS; (12) provides stewardship of division procurement, 
materials management, interagency agreements, cooperative agreements, 
and extramural resources; (13) addresses policy issues that affect or 
could affect the National Laboratory Response System, other DLS 
programs and activities, and clinical and public health laboratory 
operations; (14) 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 (15) responds to requests from other CDC 
programs for technical assistance relating to DLS capabilities.
    Office of the Director (CANC1). 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 
OLSR, (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 OLSR 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 OLSR 
OD to establish and maintain a diverse, equitable, inclusive, and 
accessible workplace; (6) provides DLS communications resources, 
including web support, writing and editing services, social media 
presence, and promotion and outreach efforts to clinical and public 
health laboratories; (7) provides 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) 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; (9) 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 (10) 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.
    Laboratory Readiness and Informatics Branch (CANCB). The mission of 
the Laboratory Readiness and Informatics Branch (LRIB) is to serve as 
CDC's lead for implementing testing strategies in the LRN and 
commercial laboratories as well as to provide guidance and support to 
enhance laboratory data exchange before and during infectious disease 
outbreaks, epidemics, and pandemics. To carry out its mission, LRIB: 
(1) strengthens the nation's clinical testing and results reporting 
capabilities and capacity, especially before and during public health 
emergencies, through programs, partnerships, and by implementing 
strategies to improve electronic laboratory data exchange; (2) 
coordinates and supports preparedness and response activities of public 
health laboratories (PHLs) that are members of the LRN for biological 
threats; (3) develops and maintains partnerships for expanded emergency 
diagnostic testing

[[Page 76834]]

capacity to national commercial and other clinical laboratories; (4) 
provides communication to clinical and PHLs and laboratory partners on 
matters of public health significance through the Laboratory Outreach 
Communication System and the LRN; (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 Public Health Laboratories (PHLs) to receive electronic 
test orders from and submit test results to healthcare providers; and 
(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.
    Quality and Safety Systems Branch (CANCC). The mission of the 
Quality and Safety Systems Branch (QSSB) 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 Clinical Laboratory Improvement Amendments of 1988 program to 
ensure the quality and safety of clinical and public health laboratory 
testing; (5) hosts and manages the Clinical Laboratory Improvement 
Advisory Committee (CLIAC) 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 (CANCD). 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 CDC's and 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 CDC and the 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 testers 
in non-laboratory settings 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 CDC, 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 OneLab Rapid Education And Capacity-
building Hub (REACH), a free, publicly accessible learning management 
system tailored to the needs of CDC and U.S. clinical laboratory 
professionals; (7) facilitates site-specific training and increases CDC 
and U.S. clinical laboratories' capacity to sustain their own workforce 
development programs; (8) develops, delivers, and maintains a catalog 
of 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 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.
    Division of Core Laboratory Services and Response (CAND). The 
mission of the Division of Core Laboratory Services and Response 
(DCLSR) is to provide products, services, and specialized expertise to 
CDC programs in support of emergency response activities, laboratory 
research, and laboratory operations. To carry out its mission, DCLSR: 
(1) provides laboratory support to outbreak responses through sample 
accessioning, pre-clinical processing of diagnostic specimens, surge 
testing capacity, and long-term sample management, including the CDC 
Biorepository; (2) provides laboratory supplies, glassware, mammalian 
tissue cultures, microbiological media, special reagents, and other 
laboratory materials in support of research and service activities to 
laboratories and CDC investigators; (3) promotes animal welfare and 
improves the quality and integrity of animal-based research by engaging 
in independent and collaborative research, providing state-of-the-art 
training to researchers and partners, and offering a broad range of 
fully integrated professional veterinary services; (4) works with CDC 
pathogen specific programs and public health partners in test design 
and evaluation, including innovative and novel diagnostic tests and 
assays (molecular,

[[Page 76835]]

immunological, and sequence based) and new instrument platforms and 
technologies to detect emerging and known pathogens; (5) develops and 
implements applied research programs to expand and enhance the use of 
animal models necessary to support research and diagnostic programs and 
to improve breeding and husbandry procedures; (6) conducts applied 
research in cell biology and in the expansion of tissue culture 
technology as a research and diagnostic tool for infectious disease 
activities; (7) serves as an important entry point for emerging and 
advanced laboratory technologies, and a central core facility for high-
capacity or high-output instrumentation that can support multiple 
program activities; (8) provides services for laboratory investigators 
in DNA and peptide synthesis, genomic sequencing, bioinformatics, mass 
spectrometry, and proteomics; (9) obtains and distributes experimental 
and orphaned vaccines, drugs, antisera, antitoxins, and immune 
globulins; (10) manages and distributes the inventory, maintains the 
computerized system database, and provides general technical service 
support for the dispensing, lyophilizing, capping, and labeling of CDC 
reference reagents; (11) receives, triages, processes, and distributes 
samples to CDC laboratories for reference diagnostic testing, research 
studies, and epidemics, and reports diagnostic test results to 
submitting organizations; (12) manages all CDC exports and ensures 
compliance with regulations and serves as CDC liaison with the 
Department of Commerce for export-related issues; (13) produces and 
distributes specialized reagents and diagnostic products for research 
and development, surveillance, preparedness activities, outbreak and 
emergency response; (14) provides services and expertise in 
implementation of quality systems to support compliance with FDA 
regulations on production, distribution, and use of laboratory 
diagnostic reagents; (15) provides liaison activities, resources, and 
expertise for inquiries regarding multiple animal species relevant to 
zoonotic diseases; (16) provides a centralized activity for tracking 
requests for and distributing select agents to investigators outside of 
CDC in compliance with federal regulations; and (17) provides staffing 
and support for emergency responses at the program, division, center, 
and agency levels.
    Office of the Director (CAND1). (1) manages, directs, and 
coordinates the activities of DCLSR; (2) provides leadership and 
guidance on the development of strategic goals, objectives, and 
milestones to advance the vision and mission of DCLSR; (3) distributes 
investigational and licensed drugs and unique biologicals (antitoxins) 
to approved physicians for the treatment of rare, tropical, or 
exceptional diseases; (4) develops administrative policies, processes, 
and operations for the division; (5) ensures that health equity 
principles are applied in all DCLSR activities; (6) works to ensure 
that spending plans and budgets are executed and aligned with the 
strategic priorities of the division; (7) works with OLSR OD to 
establish and maintain a diverse, equitable, inclusive, and accessible 
workplace; (8) provides scientific, business, and policy oversight and 
guidance for all programs and activities housed in the division; and 
(9) works closely with other CIOs during outbreak investigations and on 
an ongoing basis, providing support, guidance, collaboration, and 
expertise.
    Biotechnology Core Facility Branch (CANDB). (1) serves a vital 
function at CDC, enabling rapid, high-quality and state-of-the-art 
sequencing services for infectious and biothreat agents, environmental, 
human, animal, and vector species in support of the agency's public 
health mission; (2) provides qualitative and quantitative proteomic 
analyses (identification of expressed proteins by mass spectrometry) 
and analysis of functionally relevant post-translational modifications 
of proteins; (3) provides mass spectrometry-based positive 
identification of bacteria and fungi; (4) provides synthetic 
oligonucleotide chemistry in support of development of rapid diagnostic 
tests and characterization of pathogens and their hosts; (5) provides 
synthetic peptide chemistry in support of studies of immune response 
and antigen-antibody interactions; (6) provides biotechnology seminars 
and methods evaluation; (7) works with CDC pathogen-specific programs 
in the evaluation of new instrument platforms and technologies to 
detect emerging and known pathogens and in the evaluation of existing 
and in the design of innovative and novel diagnostic tests and assays 
(sequence based); and (8) assesses and supports advanced analytical 
methodologies for the CDC scientific community.
    Comparative Medicine Branch (CANDC). (1) acquires and distributes 
laboratory animals for research; (2) provides appropriate housing, 
husbandry, and psychological enrichment for all research animals; (3) 
provides veterinary services, including clinical and surgical support, 
for the laboratory animals; (4) develops standard operating procedures 
for animal care and use in accordance with the policies established by 
Association for Assessment and Accreditation of Laboratory Animal Care 
(AAALAC) International, the Animal Welfare Act, The Guide for the Care 
& Use of Laboratory Animals, and the CDC International Animal Care & 
Use Committee; (5) conducts applied research to improve the care and 
use of animals in research and collaborates on research projects that 
use laboratory animals; (6) provides consultation and laboratory animal 
technology training to investigators, technical staff and animal care 
personnel; and (7) provides oversight, support and investigator 
training for the graphical animal information technology protocol 
development and animal tracking database.
    Preparedness, Response, and Outbreak Services Branch (CANDD). (1) 
provides centralized specimen management services for diagnostic, 
reference, and outbreak investigations; maintains a bank of biological 
specimens of epidemiological significance to CDC's research and 
diagnostic activities; manages and tracks systems of specimen 
collections; (2) receives, triages, processes, stores, and distributes 
specimens to CDC laboratories for reference diagnostic testing, 
research studies, and reports diagnostic and surveillance test results 
to submitting organizations; (3) provides extracted nucleic acids under 
a CLIA approved workflow that can be used for sequencing and molecular 
diagnostics; (4) maintains and manages the biological laboratory 
component of the LRN; (5) provides strategic guidance for LRN test 
development and reagent inventory operations; (6) provides technical 
input for assay development for federally managed environmental 
monitoring systems and guidelines developed through U.S. government 
collaborations for the validation and use of environmental detection 
devices; (7) develops LRN protocols for specimen handling and testing 
for bioterrorism agents; (8) produces and manages inventory of high-
quality reagents available to LRN laboratories and expedites shipping 
of products to support emergency response needs; (9) collaborates with 
CDC and external partners to assist in administering proficiency 
testing programs for critical agents for LRN member laboratories; (10) 
evaluates and validates advanced technology for the identification and 
characterization of agents of bioterrorism and other emerging 
infectious diseases; (11) works with

[[Page 76836]]

CDC pathogen-specific programs in the evaluation of existing and in the 
design of innovative and novel diagnostic tests and assays (molecular 
and immunological); (12) provides laboratory triage capability at CDC 
for unknown biological and chemical agents; (13) produces hybridomas, 
monoclonal, and polycolonal antibodies, and in vitro diagnostic 
products for diagnostic research purposes, proficiency testing, 
pandemic preparedness, outbreak response and surveillance activities; 
(14) collaborates with subject matter experts in regulatory compliant 
development, production, packaging, storing and distribution of 
Biosafety Level 2 (BSL2)/Biosafety Level 3 (BSL3) reagents, select 
agents, novel immuno- chemical reagents and reference diagnostic 
reagents; (15) provides dispensing, lyophilizing, label production, and 
device assembly services; (16) improves the process of bench-top 
development and in-house pilot scale production, providing immediate 
availability for distribution, preventing backorders, and streamlining 
commercialization; (17) operates the CDC Biorepository as a centralized 
resource to preserve CDC's valuable samples and provide ongoing support 
to CDC programs; (18) manages sample collections, along with associated 
information and data obtained from CDC's public health surveillance, 
research, and outbreak responses; (19) serves as the administrator that 
issues CDC's required standardized identifiers: the CDC Sample 
Identifier and CDC Unique Identified; and (20) provides consultation in 
all of the above technical services.
    Laboratory Products and Services Branch (CANDE). (1) maintains 
laboratory water treatment systems to ensure the quality of CDC reagent 
grade laboratory water; (2) produces, develops, evaluates, and 
distributes custom microbiological and cell culture media, buffers, 
chemical reagents, and cell cultures; (3) maintains CDC's Biological 
Reference Reagent Inventory and a serviceable inventory at the DCLSR 
Continuity of Operations storage facility; (4) packages infectious 
substances, clinical specimens, and other materials, ensuring 
compliance with shipping regulations; (5) manages all CDC exports and 
deemed exports ensuring compliance with regulations and serves as CDC 
liaison with Department of Commerce for export-related issues; (6) 
coordinates laboratory glassware and consumable stockroom operations; 
and (7) provides consultation in all of the above technical services.

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. 2024-21412 Filed 9-18-24; 8:45 am]
BILLING CODE 4163-18-P