Reorganization of the Office of Laboratory Science and Safety, 76831-76836 [2024-21412]
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Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices
uniformity and consistency in the
process.
B. Annual Reporting Burden
Respondents: 868.
Responses Per Respondent: 1.2.
Total Responses: 1,042.
Hours Per Response: 1.5.
Total Burden Hours: 1,563.
C. Public Comments
A 60-day notice published in the
Federal Register at 89 FR 55594 on July
5, 2024. No comments were received.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the Regulatory Secretariat Division
(MVCB), at GSARegSec@gsa.gov. Please
cite OMB Control No. 3090–0007,
Contractor Qualifications and Financial
Information, in all correspondence.
Jeffrey A. Koses,
Senior Procurement Executive, Office of
Acquisition Policy, Office of Governmentwide Policy.
[FR Doc. 2024–21405 Filed 9–18–24; 8:45 am]
BILLING CODE 6820–61–P
GENERAL SERVICES
ADMINISTRATION
[OMB Control No. 3090–0248; Docket No.
2024–0001; Sequence No. 10]
Information Collection; General
Services Administration Acquisition
Regulation; Electronic Data
Interchange (EDI) Information
Office of Acquisition Policy,
General Services Administration (GSA).
ACTION: Notice and request for public
comments.
AGENCY:
In accordance with the
Paperwork Reduction Act of 1995, and
the Office of Management and Budget
(OMB) regulations, GSA invites the
public to comment on a request to
review and approve an extension of a
previously approved information
collection requirement for a placement
of orders clause, and an ordering
information provision.
DATES: Submit comments on or before:
November 18, 2024.
ADDRESSES: Submit comments regarding
this burden estimate or any other aspect
of this collection of information,
including suggestions for reducing this
burden to https://www.regulations.gov.
Submit comments via the Federal
eRulemaking portal by searching for
Information Collection 3090–0248.
Select the link ‘‘Comment Now’’ that
corresponds with ‘‘Information
Collection 3090–0248, Electronic Data
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SUMMARY:
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Interchange (EDI) Information’’. Follow
the instructions on the screen. Please
include your name, company name (if
any), and ‘‘Information Collection 3090–
0248, Electronic Data Interchange (EDI)
Information’’ on your attached
document.
If your comment cannot be submitted
using https://www.regulations.gov, call
or email the points of contact in the FOR
FURTHER INFORMATION CONTACT section of
this document for alternate instructions.
Instructions: Comments received
generally will be posted without change
to https://www.regulations.gov, including
any personal and/or business
confidential information provided. To
confirm receipt of your comment(s),
please check www.regulations.gov,
approximately two-to-three days after
submission to verify posting.
FOR FURTHER INFORMATION CONTACT: Ms.
Vernita Misidor, Procurement Analyst,
GSA Acquisition Policy Division, by
phone at 202–357–9681 or by email at
vernita.misidor@gsa.gov.
SUPPLEMENTARY INFORMATION:
quality, utility, and clarity of the
information to be collected.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the Regulatory Secretariat Division by
calling 202–501–4755 or emailing
GSARegSec@gsa.gov. Please cite OMB
Control No. 3090–0248, Electronic Data
Interchange (EDI) Information, in all
correspondence.
A. Purpose
GSA has various mission
responsibilities related to the
acquisition and provision of the Federal
Acquisition Service’s (FAS’s) Special
Order Program items. These mission
responsibilities generate requirements
that are realized through the solicitation
and award of various types of FAS
contracts.
As such, the General Services
Administration Acquisition Regulation
(GSAR) 516.506 specifically directs
contracting officers to insert 552.216–
72, Placement of Orders, and 552.216–
73, Ordering Information, when the
contract authorizes FAS and other
activities to issue delivery or task
orders. This clause and provision
includes information reporting
requirements for Offerors to receive
electronic orders through computer-tocomputer Electronic Data Interchange
(EDI).
AGENCY:
B. Annual Reporting Burden
Respondents: 18,590.
Responses per Respondent: 1.
Annual Responses: 18,590.
Hours per Response: .50.
Total Burden Hours: 9,295.
C. Public Comments
Public comments are particularly
invited on: Whether this collection of
information is necessary and whether it
will have practical utility; whether our
estimate of the public burden of this
collection of information is accurate and
based on valid assumptions and
methodology; and ways to enhance the
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Jeffrey A. Koses,
Senior Procurement Executive, Office of
Acquisition Policy, Office of Governmentwide Policy.
[FR Doc. 2024–21406 Filed 9–18–24; 8:45 am]
BILLING CODE 6820–61–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Reorganization of the Office of
Laboratory Science and Safety
Centers for Disease Control and
Prevention (CDC), the Department of
Health and Human Services (HHS).
ACTION: Notice.
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: olss@cdc.gov.
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:
SUMMARY:
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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
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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
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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.
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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:
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(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
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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
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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
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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 capacitybuilding 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 capacitybuilding community; (4) develops justin-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
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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 underrepresented 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 stateof-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,
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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 highcapacity 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
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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 posttranslational 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 antigenantibody 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
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76835
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
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Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices
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 exportrelated issues; (6) coordinates laboratory
glassware and consumable stockroom
operations; and (7) provides
consultation in all of the above
technical services.
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Reorganization of the Office of Health
Equity
Centers for Disease Control and
Prevention (CDC), the Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
CDC has modified its
structure. This notice announces the
reorganization of the Office of Health
Equity (OHE). OHE abolished an office
and modified mission and function
statements.
SUMMARY:
This reorganization of OHE was
approved by the Director of CDC on
September 13, 2024, and became
effective September 13, 2024.
FOR FURTHER INFORMATION CONTACT: Kem
Williams, Centers for Disease Control
and Prevention, 1600 Clifton Road NE,
MS TW–3, Atlanta, GA 30329;
Telephone 404–639–7199; Email:
ohepolicy@cdc.gov.
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
Health Equity, 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, make the
following changes:
• Update the mission for the Office of
Health Equity (CAG)
DATES:
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• Update the mission for the Office of
the Director (CAG1)
• Abolish the Office of Equitable
Population Health (CAGB)
• Update the mission for the Office of
Minority Health (CAGC)
• Update the mission for the Office of
Health Equity (CAGD)
II. Under Part C, Section C–B,
Organization and Functions, within the
Office of Health Equity (CAG), delete
the mission or function statements for
and replace with the following:
Office of Health Equity (CAG). The
Office of Health Equity (OHE) is located
in the CDC Immediate Office of the
Director and serves as principal advisor
to the CDC Director on all health equity
matters domestic and global. In carrying
out its mission, OHE: (1) leads an
agency-wide health equity strategy that
includes crosscutting multi-year
initiatives that advance comprehensive,
well-defined, and measurable health
outcomes; (2) coordinates health equity
science including advancing the
surveillance of health equity indicators
and the science of achieving health
equity by consistently applying data
collection and analysis standards in
collaboration with the Office of Public
Health Data, Surveillance, and
Technology, as well as the Office of
Science; (3) coordinates programs,
practices, policies, and budget decisions
across the agency with a health equity
lens that includes a comprehensive
view of disparities (including race,
ethnicity, gender, sexual orientation,
rurality, disability) and health inequities
(e.g., social determinants of health); (4)
works in collaboration with CDC’s
Office of Communications to develop
and lead agency-wide communication
efforts aimed at increasing awareness,
transparency, language access, and
cultural responsiveness; disseminate
scientific and programmatic findings to
the public; and foster synergy amongst
CDC health equity initiatives; (5) shares
best practices, coordinates, collaborates,
and collectively advances health equity
standards and principles in science,
programs, and in communications with
the public and our partners; (6) leads
and supports a health equity approach
for emergency responses across the
agency that includes working with
partners to reach communities that are
underserved and subject to largely
preventable health disparities and
health-related needs; and (7) applies an
intersectionality lens to addressing
health disparities by working across
units within OHE and CIOs to increase
program efficacy closing gaps that
perpetuate disparities and inequities.
Office of the Director (CAG1). The
Office of the Director provides
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
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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
