82 FR 57457 - Statement of Organization, Functions, and Delegations of Authority
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 82, Issue 232 (December 5, 2017)
Centers for Disease Control and Prevention
Federal Register Volume 82, Issue 232 (December 5, 2017)
| Page Range | 57457-57458 | |
| FR Document | 2017-26148 |
[Federal Register Volume 82, Number 232 (Tuesday, December 5, 2017)] [Notices] [Pages 57457-57458] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26148] ----------------------------------------------------------------------- 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
![Federal Register / Vol. 82, No. 232 / Tuesday, December 5, 2017 / Notices 57457
immunization practices and policies in development of strategic goals, based laboratory training, fellowships,
the U.S and internationally; (7) provides objectives, and milestones to advance and education; (4) engages agency and
and supports public health training; (8) the vision and mission of the Division laboratory community experts to
responds to and assists internal and of Laboratory Systems (DLS), the Center collaboratively assess and develop
external partners on other public health for Surveillance Epidemiology and effective training products to maintain a
problems of national and international Laboratory Services (CSELS), and CDC; competent, prepared, and sustainable
significance, as needed; (9) serves as the (2) ensures optimal planning and national and global laboratory
National Reference Laboratory (rotavirus allocation of resources to achieve workforce; (5) designs and implements
and norovirus) and other agents of viral program objectives, conducts training pertaining to clinical and
gastroenteritis; and (10) serves as the management and operations analyses, public health laboratory methodology,
WHO Global Reference Center for and oversees required reporting; (3) technology, quality and safety and
Rotavirus and other agents of viral provides administrative management practice for public health, clinical, CDC,
gastroenteritis. support, advice, and guidance to DLS and other federal agency laboratory
regarding administrative policies, fiscal professionals; and (6) evaluates the
Sherri Berger,
management, property management, efficiency and effectiveness of public
Chief Operating Officer, Centers for Disease
human resources, and travel; (4) leads health laboratory education and
Control and Prevention.
coordination and stewardship of DLS training, including measuring the
[FR Doc. 2017–26150 Filed 12–4–17; 8:45 am]
procurement, grants, cooperative outcomes of all training to ensure the
BILLING CODE 4160–18–P
agreements, materials management, effective transfer of knowledge and
interagency agreements, and extramural skills to improved laboratory practice.
resources; (5) fosters collaborations and Quality and Safety Systems Branch
DEPARTMENT OF HEALTH AND
cross-cutting activities with other CDC (CPNBD). (1) Develops, promotes,
HUMAN SERVICES
components and external organizations implements, and evaluates intervention
Centers for Disease Control and to support the mission, activities, and strategies to improve quality and safety
Prevention operations of DLS; (6) enhances internal in clinical and public health laboratory
and external partnerships and partner/ systems; (2) provides scientific and
Statement of Organization, Functions, stakeholder communication; (7) technical support for the Clinical
and Delegations of Authority provides leadership in evaluating and Laboratory Improvement Amendments
improving program performance, (CLIA) program to assure the quality,
Part C (Centers for Disease Control monitoring progress and
and Prevention) of the Statement of including safety, of clinical and public
accomplishments to ensure that health laboratory testing nationwide; (3)
Organization, Functions, and programmatic goals are achieved with
Delegations of Authority of the facilitates and conducts studies to
measurable impact; (8) manages issues, provide scientific evidence and assess
Department of Health and Human policy development, and tracks
Services (45 FR 67772–76, dated the impact of CLIA regulations and
regulatory and legislative activities; (9) voluntary guidelines for laboratory
October 14, 1980, and corrected at 45 FR manages CDC Specimen Policy Board
69296, October 20, 1980, as amended quality and safety; (4) provides expertise
and the CDC/ATSDR Specimen and guidance in the development or
most recently at 81 FR 84583–84591, Packaging, Inventory, and Repository
dated November 23, 2016) is amended revision of CLIA technical standards
(CASPIR) Advisory Committee; (10) and voluntary guidelines for laboratory
to reflect the reorganization of the collaborates with leadership of the
Center for Surveillance, Epidemiology quality and safety, especially in light of
Centers for Medicare & Medicaid new and evolving laboratory technology
and Laboratory Services, Office of Services (CMS) and the Food and Drug
Public Health Preparedness and and practices; (5) develops,
Administration (FDA) in advancement disseminates, promotes, and evaluates
Response, Centers for Disease Control of the Clinical Laboratory Improvement
and Prevention. the impact of educational materials to
Amendments (CLIA) program and support the understanding of and
Section C–B, Organization and
oversees CDC responsibilities therein; compliance with CLIA regulations and
Functions, is hereby amended as
(11) provides scientific oversight for voluntary quality and safety guidelines;
follows:
Delete in its entirety the title for the DLS, performing scientific review and (6) hosts and manages the Clinical
Center for Surveillance, Epidemiology clearance for DLS publications, Laboratory Improvement Advisory
and Laboratory Service (CPN) and insert presentations, and reports; (12) provides Committee (CLIAC) and its workgroups
the following title which includes the DLS communications, Web support, on behalf of a tri-agency partnership
Oxford comma: Center for Surveillance, responses to media requests, and among CDC, CMS, and FDA; (7)
Epidemiology, and Laboratory Service communication outreach efforts; and provides information to the laboratory
(CPN). (13) coordinates requests from other medicine and public health
Delete in its entirety the title and the CDC programs for international communities, as well as policy makers,
mission and function statements for the technical assistance among DLS regarding the interpretation and
Division of Laboratory Systems (CPNB) capabilities. application of the CLIA technical
and insert the following: Training and Workforce Development standards and other issues of laboratory
Division of Laboratory Systems Branch (CPNBC). (1) Provides quality and safety; (8) provides
(CPNB). The mission of the Division of leadership and support of laboratory technical assistance in the review of
workforce through initiatives that laboratory accreditation and state
sradovich on DSK3GMQ082PROD with NOTICES
Laboratory Systems (DLS) is to
strengthen the nation’s clinical and strengthen recruitment, retention, licensure programs, and CLIA-approved
public health laboratory system by management, and training; (2) supports proficiency testing programs; (9)
continually improving quality and the development, promotion, adoption, facilitates and supports collaborations
safety, informatics and data science, and and implementation of competencies with federal partners and other
workforce competency. relevant to the laboratory workforce; (3) stakeholders (including other CDC
Office of the Director (CPNB1). (1) develops frameworks, models, and programs upon request) for the
Provides leadership and guidance on resources that support competency- exchange of information about
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![57458 Federal Register / Vol. 82, No. 232 / Tuesday, December 5, 2017 / Notices
laboratory quality and safety practices, between diagnostic facilities and FOR FURTHER INFORMATION CONTACT:
research, standards, and guidelines, and healthcare providers, electronic Omar Valverde at omar.valverde@
coordinates clinical and public health reporting of laboratory information to acl.hhs.gov or (202) 795–7460.
laboratory improvement efforts among electronic health records, and general SUPPLEMENTARY INFORMATION: Under the
all; (10) provides safety and quality preparedness of the laboratory system to PRA (44 U.S.C. 3501–3520), Federal
subject matter expertise to the Training respond to public health emergencies; agencies must obtain approval from the
and Workforce Development Branch for (6) develops and implements computer- Office of Management and Budget
the development of training courses for based decision support tools and mobile (OMB) for each collection of
internal CDC laboratories and external applications that help to inform better information they conduct or sponsor.
clinical and public health laboratories; laboratory-related decision-making by ‘‘Collection of information’’ is defined
(11) provides advice and oversight of healthcare providers; and (7) in 44 U.S.C. 3502(3) and 5 CFR
safety and quality measures, controls, collaborates with other CDC programs to 1320.3(c) and includes agency requests
practices and documents to ensure develop and promote informatics or requirements that members of the
compliance of DLS laboratory areas with solutions for improving laboratory public submit reports, keep records, or
CDC policies, regulations, and management, practice, and provide information to a third party.
guidelines for laboratory quality and preparedness. Section 3506(c)(2)(A) of the PRA (44
safety (e.g., Roybal campus—Building Sherri A. Berger, U.S.C. 3506(c)(2)(A)) requires Federal
18 Training Laboratory and Chief Operating Officer, Centers for Disease agencies to provide a 60-day notice in
Lawrenceville campus laboratories); (12) Control and Prevention. the Federal Register concerning each
provides scientific and technical [FR Doc. 2017–26148 Filed 12–4–17; 8:45 am] proposed collection of information,
support and guidance for CDC including each proposed extension or
BILLING CODE 4160–18–P
initiatives, programs, committees, work update of an existing collection of
groups, and task forces involving use, information, before submitting the
handling, shipping, import/export, DEPARTMENT OF HEALTH AND collection to OMB for approval. The
transport or storage of biological HUMAN SERVICES proposed collection of information
specimens and their support materials; represents new information requested
(13) provides safety and quality-related Administration for Community Living from aging/disability networks to fulfill
content expertise for the development of requirements regarding the provision of
the Laboratory Leadership Service (LLS) Agency Information Collection services and overall performance of ACL
Fellows curriculum and serve as course Activities; Proposed Collection; Public legal assistance programs.
instructors for LLS training classes (and Comments Request; New Data To comply with the above
to other laboratory-related workforce Collection; National Center on Law and requirement, ACL is publishing a notice
efforts as may be requested by other Elder Rights (NCLER) regarding the proposed collection of
programs); and (14) serves as quality AGENCY: Administration for Community information set forth in this document.
and safety advisors and liaisons to other Living, HHS. ACL contracts with a national legal
CDC programs and offices involving ACTION: Notice. assistance resource center, the National
clinical laboratory activities upon Center on Law and Elder Rights, to
request. SUMMARY: The Administration for provide the required services. Through
Informatics and Data Science Branch Community Living (ACL) is announcing the contract, ACL provides aging,
(CPNBE). (1) Supports the CDC an opportunity for the public to disability, and related legal
Specimen Policy Board and OADLSS in comment on ACL’s intention to collect professionals with training and complex
the development of CDC specimen information from legal and aging/ case consultations and support for
management and collection policies, disability service professionals. Under demonstration projects regarding
and oversees implementation of those the Paperwork Reduction Act of 1995 contractually identified priority legal
policies at CASPIR in collaboration with (the PRA), Federal agencies are required topics.
the CASPIR Advisory Committee; (2) to publish a notice in the Federal The purpose of the information
develops, promotes, implements, and Register concerning each proposed requested is for ACL to ensure that the
evaluates data science approaches for collection of Information and to allow resource center creates and prioritizes
improved research of large and complex 60 days for public comment in response the training, case consultations and
data sets in support of CLIA standards on the proposed action. This notice technical assistance resources it was
and laboratory practice; (3) maintains solicits comments on proposed contracted to provide and to ensure that
and leverages data acquired from information collection requirements the center targets the contractually
national laboratory systems and other relating to ACL funded training, case designated aging network practitioners
large health databases to evaluate consultation, and technical assistance about the priority subject matters. This
laboratory testing events, capabilities, for aging/disability networks assisting approach enables ACL to make data-
capacity, and public health outcomes; older adults in social or economic need informed decisions about the
(4) develops solutions to strengthen the facing legal issues. deployment of its resource center assets.
management of laboratory test service DATES: Submit written or electronic These data are necessary for ACL to
capability and capacity data, comments on the collection of evaluate contractual compliance with
biorepositories, access to materials for information by February 5, 2018. established performance indicators.
standardizing laboratory testing, as well ADDRESSES: Submit electronic These metrics include quantifiable
sradovich on DSK3GMQ082PROD with NOTICES
as support laboratory preparedness and comments on the collection of increases in uptake by stakeholders of
workforce development activities; (5) information to Omar Valverde at training, case consultation and technical
develops and implements solutions, omar.valverde@acl.hhs.gov. Submit assistance, and measures of satisfaction
often with external partners and written comments on the collection of with and perceived benefit from these
collaborators, to strengthen clinical and information by mail to Omar Valverde, services. For example, the metrics
public health laboratory information Administration for Community Living, measure successful problem resolution
systems, reporting of laboratory results Washington, DC 20201. as a result of the services provided,
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Document Created: 2017-12-04 23:45:19
Document Modified: 2017-12-04 23:45:19
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 82 FR 57457 |
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