[Federal Register Volume 82, Number 232 (Tuesday, December 5, 2017)]
[Notices]
[Pages 57457-57458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26148]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Statement of Organization, Functions, and Delegations of 
Authority

    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 81 FR 84583-84591, dated November 23, 2016) is 
amended to reflect the reorganization of the Center for Surveillance, 
Epidemiology and Laboratory Services, Office of Public Health 
Preparedness and Response, Centers for Disease Control and Prevention.
    Section C-B, Organization and Functions, is hereby amended as 
follows:
    Delete in its entirety the title for the Center for Surveillance, 
Epidemiology and Laboratory Service (CPN) and insert the following 
title which includes the Oxford comma: Center for Surveillance, 
Epidemiology, and Laboratory Service (CPN).
    Delete in its entirety the title and the mission and function 
statements for the Division of Laboratory Systems (CPNB) and insert the 
following:
    Division of Laboratory Systems (CPNB). The mission of the Division 
of Laboratory Systems (DLS) is to strengthen the nation's clinical and 
public health laboratory system by continually improving quality and 
safety, informatics and data science, and workforce competency.
    Office of the Director (CPNB1). (1) Provides leadership and 
guidance on development of strategic goals, objectives, and milestones 
to advance the vision and mission of the Division of Laboratory Systems 
(DLS), the Center for Surveillance Epidemiology and Laboratory Services 
(CSELS), and CDC; (2) ensures optimal planning and allocation of 
resources to achieve program objectives, conducts management and 
operations analyses, and oversees required reporting; (3) provides 
administrative management support, advice, and guidance to DLS 
regarding administrative policies, fiscal management, property 
management, human resources, and travel; (4) leads coordination and 
stewardship of DLS procurement, grants, cooperative agreements, 
materials management, interagency agreements, and extramural resources; 
(5) fosters collaborations and cross-cutting activities with other CDC 
components and external organizations to support the mission, 
activities, and operations of DLS; (6) enhances internal and external 
partnerships and partner/stakeholder communication; (7) provides 
leadership in evaluating and improving program performance, monitoring 
progress and accomplishments to ensure that programmatic goals are 
achieved with measurable impact; (8) manages issues, policy 
development, and tracks regulatory and legislative activities; (9) 
manages CDC Specimen Policy Board and the CDC/ATSDR Specimen Packaging, 
Inventory, and Repository (CASPIR) Advisory Committee; (10) 
collaborates with leadership of the Centers for Medicare & Medicaid 
Services (CMS) and the Food and Drug Administration (FDA) in 
advancement of the Clinical Laboratory Improvement Amendments (CLIA) 
program and oversees CDC responsibilities therein; (11) provides 
scientific oversight for DLS, performing scientific review and 
clearance for DLS publications, presentations, and reports; (12) 
provides DLS communications, Web support, responses to media requests, 
and communication outreach efforts; and (13) coordinates requests from 
other CDC programs for international technical assistance among DLS 
capabilities.
    Training and Workforce Development Branch (CPNBC). (1) Provides 
leadership and support of laboratory workforce through initiatives that 
strengthen recruitment, retention, management, and training; (2) 
supports the development, promotion, adoption, and implementation of 
competencies relevant to the laboratory workforce; (3) develops 
frameworks, models, and resources that support competency-based 
laboratory training, fellowships, and education; (4) engages agency and 
laboratory community experts to collaboratively assess and develop 
effective training products to maintain a competent, prepared, and 
sustainable national and global laboratory workforce; (5) designs and 
implements training pertaining to clinical and public health laboratory 
methodology, technology, quality and safety and practice for public 
health, clinical, CDC, and other federal agency laboratory 
professionals; and (6) evaluates the efficiency and effectiveness of 
public health laboratory education and training, including measuring 
the outcomes of all training to ensure the effective transfer of 
knowledge and skills to improved laboratory practice.
    Quality and Safety Systems Branch (CPNBD). (1) Develops, promotes, 
implements, and evaluates intervention strategies to improve quality 
and safety in clinical and public health laboratory systems; (2) 
provides scientific and technical support for the Clinical Laboratory 
Improvement Amendments (CLIA) program to assure the quality, including 
safety, of clinical and public health laboratory testing nationwide; 
(3) facilitates and conducts studies to provide scientific evidence and 
assess the impact of CLIA regulations and voluntary guidelines for 
laboratory quality and safety; (4) provides expertise and guidance in 
the development or revision of CLIA technical standards and voluntary 
guidelines for laboratory quality and safety, especially in light of 
new and evolving laboratory technology and practices; (5) develops, 
disseminates, promotes, and evaluates the impact of educational 
materials to support the understanding of and compliance with CLIA 
regulations and voluntary quality and safety guidelines; (6) 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; (7) provides information to the laboratory medicine and 
public health communities, as well as policy makers, regarding the 
interpretation and application of the CLIA technical standards and 
other issues of laboratory quality and safety; (8) provides technical 
assistance in the review of laboratory accreditation and state 
licensure programs, and CLIA-approved proficiency testing programs; (9) 
facilitates and supports collaborations with federal partners and other 
stakeholders (including other CDC programs upon request) for the 
exchange of information about

[[Page 57458]]

laboratory quality and safety practices, research, standards, and 
guidelines, and coordinates clinical and public health laboratory 
improvement efforts among all; (10) provides safety and quality subject 
matter expertise to the Training and Workforce Development Branch for 
the development of training courses for internal CDC laboratories and 
external clinical and public health laboratories; (11) provides advice 
and oversight of safety and quality measures, controls, practices and 
documents to ensure compliance of DLS laboratory areas with CDC 
policies, regulations, and guidelines for laboratory quality and safety 
(e.g., Roybal campus--Building 18 Training Laboratory and Lawrenceville 
campus laboratories); (12) provides scientific and technical support 
and guidance for CDC initiatives, programs, committees, work groups, 
and task forces involving use, handling, shipping, import/export, 
transport or storage of biological specimens and their support 
materials; (13) provides safety and quality-related content expertise 
for the development of the Laboratory Leadership Service (LLS) Fellows 
curriculum and serve as course instructors for LLS training classes 
(and to other laboratory-related workforce efforts as may be requested 
by other programs); and (14) serves as quality and safety advisors and 
liaisons to other CDC programs and offices involving clinical 
laboratory activities upon request.
    Informatics and Data Science Branch (CPNBE). (1) Supports the CDC 
Specimen Policy Board and OADLSS in the development of CDC specimen 
management and collection policies, and oversees implementation of 
those policies at CASPIR in collaboration with the CASPIR Advisory 
Committee; (2) develops, promotes, implements, and evaluates data 
science approaches for improved research of large and complex data sets 
in support of CLIA standards and laboratory practice; (3) maintains and 
leverages data acquired from national laboratory systems and other 
large health databases to evaluate laboratory testing events, 
capabilities, capacity, and public health outcomes; (4) develops 
solutions to strengthen the management of laboratory test service 
capability and capacity data, biorepositories, access to materials for 
standardizing laboratory testing, as well as support laboratory 
preparedness and workforce development activities; (5) develops and 
implements solutions, often with external partners and collaborators, 
to strengthen clinical and public health laboratory information 
systems, reporting of laboratory results between diagnostic facilities 
and healthcare providers, electronic reporting of laboratory 
information to electronic health records, and general preparedness of 
the laboratory system to respond to public health emergencies; (6) 
develops and implements computer-based decision support tools and 
mobile applications that help to inform better laboratory-related 
decision-making by healthcare providers; and (7) collaborates with 
other CDC programs to develop and promote informatics solutions for 
improving laboratory management, practice, and preparedness.

Sherri A. Berger,
Chief Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2017-26148 Filed 12-4-17; 8:45 am]
 BILLING CODE 4160-18-P