81 FR 66282 - Statement of Organization, Functions, and Delegations of Authority

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 187 (September 27, 2016)

[Federal Register Volume 81, Number 187 (Tuesday, September 27, 2016)]
[Notices]
[Pages 66282-66284]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-23213]


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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 54091-54094, dated August 15, 2016) is 
amended to reflect the reorganization of the Division of Healthcare 
Quality and Promotion, National Center for Emerging and Zoonotic 
Infectious Diseases, Office of Infectious Diseases, Centers for Disease 
Control and Prevention.
    Section C-B, Organization and Functions, is hereby amended as 
follows:
    Delete and replace the title and the mission and function 
statements for the Division of Healthcare Quality and Promotion (CVLD) 
and insert the following:
    Division of Healthcare Quality Promotion (CVLD). Protects patients 
and healthcare personnel, and promotes safety, quality, and value in 
both national and international healthcare delivery systems. In 
carrying out its mission, Division of Healthcare Quality Promotion 
(DHQP): (1) Measures, validates, interprets, and responds to data 
relevant to healthcare-associated infections (HAI); antimicrobial use 
and resistant infections, sepsis, adverse drug events, blood, organ and 
tissue safety, immunization safety, and other related adverse events or 
medical errors in healthcare affecting patients and healthcare 
personnel; (2) investigates and responds to emerging infections, 
antimicrobial resistance, and related adverse events among patients and 
healthcare personnel; (3) develops and maintains the National 
Healthcare Safety Network (NHSN), a tool for monitoring healthcare-
associated infections, antimicrobial use and resistance, measuring 
healthcare outcomes and processes, and monitoring healthcare worker 
vaccination and selected health measures in healthcare facilities; (4) 
assesses local, regional, national scope and burden of infections 
caused by resistant-bacteria in the U.S. through surveillance and 
special studies, review of national healthcare data sets, and 
laboratory surveillance programs; (5) conducts epidemiologic, and basic 
and applied laboratory research to identify new strategies to monitor 
and prevent infections/antimicrobial resistance, and related adverse 
events or medical errors, especially those associated with medical or 
surgical procedures, indwelling medical devices, contaminated products, 
dialysis, healthcare environment, and water; (6) collaborates with 
academic and public health partners to design, develop, and evaluate 
new approaches to monitoring infections and the efficacy of 
interventions for preventing infections, improving antibiotic use, and 
reducing antimicrobial resistance, and related adverse events or 
medical errors; (7) develops and disseminates evidence-based guidelines 
and recommendations to prevent and control HAI, antimicrobial 
resistance (AR), and related adverse events or medical errors; (8) 
collaborates with Federal, state, and local public health and private 
partners to promote nationwide implementation of CDC guidelines and 
other evidence-based interventions to prevent HAI, antimicrobial 
resistance, and related adverse events or medical errors among patients 
and healthcare personnel; (9) evaluates the impact of evidence-based 
recommendations and interventions across the spectrum of healthcare 
delivery sites; (10) serves as the Designated Federal Official for the 
Healthcare Infection Control Practices Advisory Committee (HICPAC); 
(11) serves as the National Reference Laboratory for the identification 
and antimicrobial susceptibility testing of staphylococci, anaerobic 
bacteria, non-tuberculous mycobacterial, and those gram-negative 
bacilli causing healthcare-associated infections; (12) serves as the 
technical reference laboratory for detection and characterization of 
other pathogens related to healthcare, and for characterizing the 
contribution of the healthcare environment to HAI and antimicrobial 
resistant infections; (13) serves as a global resource for HAI, 
antimicrobial resistance, and device-associated HAI; (14) coordinates 
guidance and research related to infection control across CDC and with 
national and international partners; (15) monitors vaccine safety and 
conducts research to evaluate the safety of available and new vaccines; 
(16) trains EIS Officers and other trainees; (17) coordinates 
antimicrobial resistance activities at CDC; (18) works in a national 
leadership capacity with public and private organizations to enhance 
antimicrobial resistance prevention and control, surveillance and 
response, and applied research; (19) coordinates blood, organ, and 
other tissue safety at CDC; and (20) provides expertise and assistance 
to HHS, other Federal agencies, and global partners on efforts and 
activities related to safe healthcare.
    Office of the Director (CVLD1). (1) Manages, directs, and 
coordinates the activities of DHQP; (2) provides leadership and 
guidance on policy impacting patient and healthcare safety; (3) leads 
targeted patient safety communication campaigns coordinated with 
release of CDC surveillance data, infection control guidelines, 
research publications, and prevention tools; (4) fosters strategic 
partnerships with clinical professional organizations to advance 
implementation of CDC's recommendations and best clinical practices; 
(5) leads communication/media outreach to include social media 
platforms and CDC's patient and healthcare safety Web sites; (6) works 
with Federal agencies, international organizations, and other partners 
on activities related to safe healthcare; (7) coordinates state and 
local activities to monitor and prevent HAI and antimicrobial 
resistance; (8) coordinates activities related to infection control in 
healthcare and related settings including, guideline development and 
maintenance, interim guidance development, training, consultation, and 
international activities across DHQP, CDC, and with national and 
international partners; (9) coordinates DHQP activities and 
collaborates with the CDC EOC for emergency response to emerging 
infections in healthcare; (10) coordinates DHQP activities and 
collaborates with other CIOs and Federal agencies to prepare healthcare 
to respond to emerging threats; (11) oversees the quality of DHQP 
research activities and identifies research gaps; (12) leads CDC's 
activities on blood, organ, and other tissue safety; (13) represents 
CDC on the Advisory Committee on Blood Safety and Availability, and the 
Advisory Committee on Organ Transplantation; (14) works with other 
Federal agencies, state governments, and other public and private 
organizations to enhance blood, organ, and other tissue safety through 
coordination of investigation, prevention, response, surveillance,

[[Page 66283]]

applied research, health communication, and public policy; (15) 
provides leadership and guidance for program planning and development, 
program management, and operations; (16) provides DHQP-wide 
administrative and program services, and coordinates or ensures 
coordination with the appropriate CIOs and CDC staff offices on 
administrative and program matters including, budget formulation and 
execution, and human resource management; (17) oversees the 
coordination of Federal and state programs and new initiatives to 
prevent HAI and antimicrobial resistance; (18) interprets general 
program and administrative policy directives for implications on 
management and execution of DHQP's programs; (19) serves as lead, 
primary contact, and liaison with relevant CDC Staff Offices on all 
matters pertaining to DHQP's procurement needs and activities; (20) 
provides management and coordination for DHQP-occupied space and 
facilities including laboratory space and facilities; (21) provides 
oversight and management of the distribution, accountability, and 
maintenance of CDC property and equipment including laboratory property 
and equipment; (22) provides program and administrative support for 
HICPAC; and (23) advises the Director, NCEZID, on science, policy and 
communication matters concerning DHQP activities.
    Antimicrobial Resistance Coordination and Strategy Unit (CVLD13). 
(1) Oversees the coordination of AR activities at CDC to meet national 
goals; (2) represents CDC in interagency activities on AR including the 
President's Advisory Committee for Combatting Antibiotic Resistant 
Bacteria (PAC-CARB); (3) coordinates with other agencies, state 
governments, medical societies, and other public and private 
organizations to enhance AR prevention and control, surveillance and 
response, and applied research; (4) represents CDC at the Transatlantic 
Task Force on Antimicrobial Resistance; (5) oversees CDC AR budget to 
implement AR activities as part of the Federal Action Plan to Combat 
Antibiotic Resistant Bacteria; (6) coordinates policies and 
communications associated to CDC-wide programs related to AR; (7) 
ensures coordination with appropriate CIOs and CDC staff offices on AR 
program matters, including budget formulation and execution; (8) 
provides updates and reports about CDC AR activities and progress to 
the CDC Director, HHS, and the White House; and (9) oversees 
coordination of CDC collaborations and new Federal initiatives to 
detect, respond and prevent antimicrobial resistance.
    International Infection Control Activity (CVLD14). (1) Leads, in 
collaboration with the appropriate CIO and CDC components, global 
health activities related to the prevention of HAI, antimicrobial 
resistance, and related adverse events or medical errors; (2) 
coordinates international efforts to establish and improve infection 
prevention and control policies, programs, and coordination; (3) 
assists countries to improve infection prevention and control capacity 
toward prevention and control of HAI disease outbreaks and device-
associated HAIs; (4) collaborates with ministries of health, CDC 
country offices, and implementing partners, to develop country-specific 
national policies and action plans to reduce the global burden of 
antimicrobial resistance associated with healthcare delivery; and (5) 
provides technical assistance to partners in building antimicrobial 
resistance laboratory capacity and surveillance systems.
    Clinical and Environmental Microbiology Branch (CVLDB). (1) Leads 
national laboratory characterization of HAI-related threats in 
partnership with state and regional laboratories; (2) provides 
comprehensive laboratory support and expertise for investigations of 
recognized and emerging pathogens in healthcare settings, such as 
methicillin-resistant S. aureus, carbapenem-resistant 
Enterobacteriaceae (CRE), and Clostridium difficile; (3) provides 
laboratory response to outbreaks and emerging threats associated with 
infections/antimicrobial resistance and related adverse events 
throughout the healthcare delivery system; (4) develops methods to 
assess contamination of environmental surfaces; (5) investigates novel 
and emerging mechanisms of antimicrobial resistance among targeted 
pathogens found in healthcare settings; (6) conducts research in 
collaboration with partners to develop new, accurate methods of 
detecting antimicrobial resistance in bacteria and to improve reporting 
of antimicrobial susceptibility test results to physicians to improve 
antimicrobial use; (7) conducts laboratory research to identify new 
strategies to prevent infections/antimicrobial resistance, related 
adverse events, and medical errors, especially those associated with 
invasive medical devices, contaminated products, dialysis, and water; 
(8) maintains capacity to evaluate commercial microbial identification, 
antimicrobial susceptibility testing systems and products, and 
facilitates their improvement to provide accurate patient test results; 
(9) investigates the role of biofilms, particularly those detected in 
indwelling medical devices and medical water systems, in medicine and 
public health, and identifies novel methods to eliminate colonization 
and biofilm formation on foreign bodies; (10) investigates the role of 
microbiome in the prevention of infections and antimicrobial 
resistance; (11) investigates the role of the water distribution 
systems in healthcare facilities in order to understand and prevent 
transmission of healthcare-associated infections due to water; and (12) 
provides expertise, research opportunities, training, and laboratory 
support for investigations of infections and related adverse events to 
other CDC CIOs and to our partners in areas related to quality clinical 
microbiology laboratory practices, investigation of emerging pathogens, 
and environmental microbiology.
    Prevention and Response Branch (CVLDC). Across the healthcare 
continuum, including acute, long-term, ambulatory, and chronic care 
settings: (1) Develops, promotes, and monitors implementation of 
evidence-based recommendations, standards, policies, strategies and 
related educational materials to prevent and control HAI, and related 
adverse events, and healthcare personnel safety events associated with 
antibiotic resistance, device, and procedure associated infections, 
poor adherence to quality standards and safety, and emerging infectious 
diseases; (2) develops, promotes, and monitors implementation of and 
adherence to evidence-based recommendations, standards and related 
educational materials, policies and strategies to increase adherence to 
appropriate antimicrobial use and stewardship; (3) uses data from the 
National Healthcare Safety Network (NHSN) and other sources to target 
and improve the prevention and control healthcare-associated infections 
and antimicrobial resistance in the U.S. in specific regions, settings 
and institutions; (4) supports local, state, and national efforts to 
prevent HAI, antimicrobial resistance, and related adverse events by 
providing leadership and consultative services, including monitoring 
adherence to CDC-recommended practices; (5) provide leadership and 
epidemiologic support for the investigation, monitoring, and control of 
both recognized and emerging healthcare pathogens, including 
antimicrobial resistant bacteria; (6) leads response and control of 
outbreaks and emerging threats involving HAI and

[[Page 66284]]

related adverse events, contaminated medical products and devices, and 
adverse drug events; (7) communicates the results of response 
activities with Federal and state agencies, healthcare providers, and 
the public, with recommendations to prevent similar adverse events in 
the future; and (8) provides leadership and expert consultation, 
guidance, and technical support to and collaborates with other CDC CIOs 
and divisions, other HHS Operating Divisions, and extramural domestic 
partners, on the epidemiology, prevention, and control of HAI, AR, and 
related adverse events; (9) implements state activities to prevent HAI 
and AR across healthcare; and (10) leads CDC activities to promote 
antimicrobial stewardship in all healthcare settings.
    Surveillance Branch (CVLDD). (1) Monitors and evaluates on the 
national level the extent, distribution, and impact of HAI, 
antimicrobial use and resistance, adverse drug events, healthcare 
worker safety events, and adherence to clinical processes and 
intervention programs designed to prevent or control adverse exposures 
or outcomes in healthcare; (2) provides services, including leadership, 
consultation, and analysis support, for statistical methods and 
analysis to investigators in the branch, division, and other 
organizations responsible for surveillance, research studies, and 
prevention and control of HAI and other healthcare-associated adverse 
events; (3) works with the Centers for Medicare and Medicaid Services 
and other partners to develop new metrics and support maintenance of 
National Quality Forum-approved metrics; (4) collaborates with public 
and private sector partners to further standardize, integrate, and 
streamline systems by which healthcare organizations collect, manage, 
analyze, report, and respond to data on clinical guideline adherence, 
HAI, including transmission of multi-drug resistant organisms, and 
other HAI; (5) coordinates, further develops, enables wider use, and 
maintains NHSN to obtain scientifically valid clinical performance 
indices that promote healthcare quality and value at the facility, 
state, and national levels; (6) develops and implements new NHSN 
modules and provides enrollment and user support for NHSN; (7) improves 
surveillance systems by utilizing new technology; (8) generates and 
provides NHSN surveillance reports and analyses, which include 
collaborative analytic projects with partners; and (9) leads CDC's 
national adverse drug events surveillance activities and seeks to 
translate population-based surveillance data into evidence-based 
policies and targeted, innovative and collaborative interventions.
    Immunization Safety Office (CVLDE). Assesses the safety of new and 
currently available vaccines received by children, adolescents and 
adults using a variety of strategies: (1) Conducts ongoing surveillance 
for the timely detection of possible adverse events following 
immunization (AEFI) in collaboration with the Food and Drug 
Administration (FDA), through coordination and management of the 
Vaccine Adverse Event Reporting System, the national reporting system 
that acts as an early-warning system to detect health conditions that 
may be associated with immunization; (2) coordinates, further develops, 
maintains and directs activities of the Vaccine Safety Datalink (VSD), 
a collaborative effort with integrated healthcare organizations, to 
conduct surveillance and investigate possible AEFI to assess causality 
and determine risk factors; (3) conducts epidemiologic research on 
causality of AEFI using the VSD and other data sources, and provides 
national estimates of incidence of AEFI and background rates of health 
conditions; (4) leads the nation in developing biostatistical methods 
for research of AEFI using large linked databases and other data 
sources, and shares methods for use by other Agencies and public and 
private entities; (5) conducts clinical research to identify causes of 
adverse events after immunization, specific populations susceptible to 
specific adverse events, and prevention strategies through the Clinical 
Immunization Safety Assessment network, a national network of medical 
research centers, and other efforts; (6) applies findings from 
epidemiologic and clinical studies to develop strategies for prevention 
of AEFI; (7) provides global consultation and leadership for the 
development, use, and interpretation of vaccine safety surveillance 
systems, and for the development of shared definitions of specific 
health outcomes through participation in the Brighton Collaboration and 
other international organizations; (8) provides data for action to HHS, 
the Advisory Committee on Immunization Practices, the FDA's Vaccine and 
Related Biological Products Advisory Committee, Health Resources and 
Services Administration's Advisory Commission on Childhood Vaccines, 
and collaborators around the globe including the WHO Global Advisory 
Committee on Vaccine Safety; and (9) provides timely, accurate 
communication and education to partners and the public on vaccine 
safety concerns.
    Epidemiology Research and Innovations Branch (CVLDG). (1) 
Identifies and evaluates the efficacy of interventions to prevent HAI 
and related adverse events or medical errors across the spectrum of 
healthcare delivery sites including acute and long-term inpatient care, 
dialysis, and ambulatory settings; (2) identifies gaps in HAI-related 
knowledge, and conducts prevention research through the Prevention 
Epicenters cooperative agreements program and Safety and Healthcare 
Epidemiology Prevention Research Development research contracts; (3) 
conducts and supports research and evaluates impact of public health 
practices to prevent HAI, antimicrobial resistance, and related adverse 
events; (4) improves methods and enables wider use of clinical 
performance measurements by healthcare facilities and public health 
entities for specific interventions and prevention strategies designed 
to safeguard patients and healthcare workers from risk exposures and 
adverse outcomes through collaborations with extramural partners; (5) 
conducts applied research to identify and develop innovative methods to 
detect and monitor HAI and antimicrobial resistance; (6) conducts 
special studies to identify key risk factors for and provides national 
estimates of targeted, healthcare-associated adverse events, 
antimicrobial use and resistance patterns, and the extent to which 
prevention and control safeguards are in use to protect at-risk 
patients across the spectrum of healthcare delivery sites; (7) develops 
new ways to assess the impact of HAI prevention programs; (8) conducts 
analysis of the return on investment and costs related to prevention 
efforts and impact of HAI prevention programs; and (9) works with the 
Emerging Infections Program (EIP) and other partners to identify 
emerging issues.

Sherri Berger,
Chief Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2016-23213 Filed 9-26-16; 8:45 am]
 BILLING CODE 4160-18-P