Notice2024-21412
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
September 19, 2024
Effective
September 13, 2024
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 (OLSS). OLSS was retitled to the Office of Laboratory Systems and Response (OLSR) and additional organizational updates were approved.
Full Text
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<title>Federal Register, Volume 89 Issue 182 (Thursday, September 19, 2024)</title>
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[Federal Register Volume 89, Number 182 (Thursday, September 19, 2024)]
[Notices]
[Pages 76831-76836]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="/cdn-cgi/l/email-protection#1e71726d6d5e7d7a7d30797168"><span class="__cf_email__" data-cfemail="c5aaa9b6b685a6a1a6eba2aab3">[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 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:
<bullet> Retitle the Office of Laboratory Science and Safety to the
Office of Laboratory Systems and Response (CAN)
<bullet> Update the mission statement of the Office of the Director
(CAN1)
<bullet> Retitle the Office of Infectious Disease Laboratory Quality to
the Office of Laboratory Quality and Safety (CAN12)
<bullet> Abolish the Office of Laboratory Science (CAN13)
<bullet> Abolish the Office of Laboratory Safety (CAN14)
<bullet> Abolish the Center for Laboratory Systems and Response (CANB)
<bullet> Abolish the Division of Laboratory Systems (CANBB)
<bullet> Abolish the Office of the Director (CANBB1)
<bullet> Abolish the National Laboratory Response System Branch
(CANBBB)
<bullet> Abolish the Quality and Safety Systems Branch (CANBBC)
<bullet> Abolish the Training and Workforce Development Branch (CANBBD)
<bullet> Abolish the Division of Core Laboratory Services and Response
(CRH)
<bullet> Abolish the Office of the Director (CRH1)
<bullet> Abolish the Advanced Diagnostics and Biotechnologies Branch
(CRHB)
<bullet> Abolish the Comparative Medicine Branch (CRHC)
<bullet> Abolish the Preparedness, Response, and Outbreak Services
Branch (CRHD)
<bullet> Abolish the Laboratory Products and Services Branch (CRHE)
<bullet> Establish the Division of Laboratory Systems (CANC)
<bullet> Establish the Office of the Director (CANC1)
<bullet> Establish the Laboratory Readiness and Informatics Branch
(CANCB)
<bullet> Establish the Quality and Safety Systems Branch (CANCC)
<bullet> Establish the Training and Workforce Development Branch
(CANCD)
<bullet> Establish the Division of Core Laboratory Services and
Response (CAND)
<bullet> Establish the Office of the Director (CAND1)
<bullet> Establish the Biotechnology Core Facility Branch (CANDB)
<bullet> Establish the Comparative Medicine Branch (CANDC)
<bullet> Establish the Preparedness, Response, and Outbreak Services
Branch (CANDD)
<bullet> 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
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