81_FR_66469 81 FR 66282 - Statement of Organization, Functions, and Delegations of Authority

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)

Page Range66282-66284
FR Document2016-23213

Federal Register, Volume 81 Issue 187 (Tuesday, 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]


-----------------------------------------------------------------------

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



                                                    66282                     Federal Register / Vol. 81, No. 187 / Tuesday, September 27, 2016 / Notices

                                                    coordination with overall OSSAM goals                   monitoring healthcare worker                          research to evaluate the safety of
                                                    and objectives.                                         vaccination and selected health                       available and new vaccines; (16) trains
                                                                                                            measures in healthcare facilities; (4)                EIS Officers and other trainees; (17)
                                                    Sherri Berger,
                                                                                                            assesses local, regional, national scope              coordinates antimicrobial resistance
                                                    Chief Operating Officer, Centers for Disease
                                                                                                            and burden of infections caused by                    activities at CDC; (18) works in a
                                                    Control and Prevention.
                                                                                                            resistant-bacteria in the U.S. through                national leadership capacity with public
                                                    [FR Doc. 2016–23252 Filed 9–26–16; 8:45 am]
                                                                                                            surveillance and special studies, review              and private organizations to enhance
                                                    BILLING CODE 4160–18–P
                                                                                                            of national healthcare data sets, and                 antimicrobial resistance prevention and
                                                                                                            laboratory surveillance programs; (5)                 control, surveillance and response, and
                                                    DEPARTMENT OF HEALTH AND                                conducts epidemiologic, and basic and                 applied research; (19) coordinates
                                                    HUMAN SERVICES                                          applied laboratory research to identify               blood, organ, and other tissue safety at
                                                                                                            new strategies to monitor and prevent                 CDC; and (20) provides expertise and
                                                    Centers for Disease Control and                         infections/antimicrobial resistance, and              assistance to HHS, other Federal
                                                    Prevention                                              related adverse events or medical errors,             agencies, and global partners on efforts
                                                                                                            especially those associated with medical              and activities related to safe healthcare.
                                                    Statement of Organization, Functions,                   or surgical procedures, indwelling                       Office of the Director (CVLD1). (1)
                                                    and Delegations of Authority                            medical devices, contaminated                         Manages, directs, and coordinates the
                                                      Part C (Centers for Disease Control                   products, dialysis, healthcare                        activities of DHQP; (2) provides
                                                    and Prevention) of the Statement of                     environment, and water; (6) collaborates              leadership and guidance on policy
                                                    Organization, Functions, and                            with academic and public health                       impacting patient and healthcare safety;
                                                    Delegations of Authority of the                         partners to design, develop, and                      (3) leads targeted patient safety
                                                    Department of Health and Human                          evaluate new approaches to monitoring                 communication campaigns coordinated
                                                    Services (45 FR 67772–76, dated                         infections and the efficacy of                        with release of CDC surveillance data,
                                                    October 14, 1980, and corrected at 45 FR                interventions for preventing infections,              infection control guidelines, research
                                                    69296, October 20, 1980, as amended                     improving antibiotic use, and reducing                publications, and prevention tools; (4)
                                                    most recently at 81 FR 54091–54094,                     antimicrobial resistance, and related                 fosters strategic partnerships with
                                                    dated August 15, 2016) is amended to                    adverse events or medical errors; (7)                 clinical professional organizations to
                                                    reflect the reorganization of the Division              develops and disseminates evidence-                   advance implementation of CDC’s
                                                    of Healthcare Quality and Promotion,                    based guidelines and recommendations                  recommendations and best clinical
                                                    National Center for Emerging and                        to prevent and control HAI,                           practices; (5) leads communication/
                                                    Zoonotic Infectious Diseases, Office of                 antimicrobial resistance (AR), and                    media outreach to include social media
                                                    Infectious Diseases, Centers for Disease                related adverse events or medical errors;             platforms and CDC’s patient and
                                                    Control and Prevention.                                 (8) collaborates with Federal, state, and             healthcare safety Web sites; (6) works
                                                      Section C–B, Organization and                         local public health and private partners              with Federal agencies, international
                                                    Functions, is hereby amended as                         to promote nationwide implementation                  organizations, and other partners on
                                                    follows:                                                of CDC guidelines and other evidence-                 activities related to safe healthcare; (7)
                                                      Delete and replace the title and the                  based interventions to prevent HAI,                   coordinates state and local activities to
                                                    mission and function statements for the                 antimicrobial resistance, and related                 monitor and prevent HAI and
                                                    Division of Healthcare Quality and                      adverse events or medical errors among                antimicrobial resistance; (8) coordinates
                                                    Promotion (CVLD) and insert the                         patients and healthcare personnel; (9)                activities related to infection control in
                                                    following:                                              evaluates the impact of evidence-based                healthcare and related settings
                                                      Division of Healthcare Quality                        recommendations and interventions                     including, guideline development and
                                                    Promotion (CVLD). Protects patients and                 across the spectrum of healthcare                     maintenance, interim guidance
                                                    healthcare personnel, and promotes                      delivery sites; (10) serves as the                    development, training, consultation,
                                                    safety, quality, and value in both                      Designated Federal Official for the                   and international activities across
                                                    national and international healthcare                   Healthcare Infection Control Practices                DHQP, CDC, and with national and
                                                    delivery systems. In carrying out its                   Advisory Committee (HICPAC); (11)                     international partners; (9) coordinates
                                                    mission, Division of Healthcare Quality                 serves as the National Reference                      DHQP activities and collaborates with
                                                    Promotion (DHQP): (1) Measures,                         Laboratory for the identification and                 the CDC EOC for emergency response to
                                                    validates, interprets, and responds to                  antimicrobial susceptibility testing of               emerging infections in healthcare; (10)
                                                    data relevant to healthcare-associated                  staphylococci, anaerobic bacteria, non-               coordinates DHQP activities and
                                                    infections (HAI); antimicrobial use and                 tuberculous mycobacterial, and those                  collaborates with other CIOs and
                                                    resistant infections, sepsis, adverse drug              gram-negative bacilli causing                         Federal agencies to prepare healthcare
                                                    events, blood, organ and tissue safety,                 healthcare-associated infections; (12)                to respond to emerging threats; (11)
                                                    immunization safety, and other related                  serves as the technical reference                     oversees the quality of DHQP research
                                                    adverse events or medical errors in                     laboratory for detection and                          activities and identifies research gaps;
                                                    healthcare affecting patients and                       characterization of other pathogens                   (12) leads CDC’s activities on blood,
                                                    healthcare personnel; (2) investigates                  related to healthcare, and for                        organ, and other tissue safety; (13)
                                                    and responds to emerging infections,                    characterizing the contribution of the                represents CDC on the Advisory
                                                    antimicrobial resistance, and related                   healthcare environment to HAI and                     Committee on Blood Safety and
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    adverse events among patients and                       antimicrobial resistant infections; (13)              Availability, and the Advisory
                                                    healthcare personnel; (3) develops and                  serves as a global resource for HAI,                  Committee on Organ Transplantation;
                                                    maintains the National Healthcare                       antimicrobial resistance, and device-                 (14) works with other Federal agencies,
                                                    Safety Network (NHSN), a tool for                       associated HAI; (14) coordinates                      state governments, and other public and
                                                    monitoring healthcare-associated                        guidance and research related to                      private organizations to enhance blood,
                                                    infections, antimicrobial use and                       infection control across CDC and with                 organ, and other tissue safety through
                                                    resistance, measuring healthcare                        national and international partners; (15)             coordination of investigation,
                                                    outcomes and processes, and                             monitors vaccine safety and conducts                  prevention, response, surveillance,


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                                                                              Federal Register / Vol. 81, No. 187 / Tuesday, September 27, 2016 / Notices                                            66283

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


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                                                    66284                     Federal Register / Vol. 81, No. 187 / Tuesday, September 27, 2016 / Notices

                                                    related adverse events, contaminated                    surveillance data into evidence-based                 partners and the public on vaccine
                                                    medical products and devices, and                       policies and targeted, innovative and                 safety concerns.
                                                    adverse drug events; (7) communicates                   collaborative interventions.                            Epidemiology Research and
                                                    the results of response activities with                                                                       Innovations Branch (CVLDG). (1)
                                                                                                               Immunization Safety Office (CVLDE).
                                                    Federal and state agencies, healthcare                                                                        Identifies and evaluates the efficacy of
                                                                                                            Assesses the safety of new and currently
                                                    providers, and the public, with                                                                               interventions to prevent HAI and related
                                                                                                            available vaccines received by children,
                                                    recommendations to prevent similar                                                                            adverse events or medical errors across
                                                                                                            adolescents and adults using a variety of             the spectrum of healthcare delivery sites
                                                    adverse events in the future; and (8)                   strategies: (1) Conducts ongoing
                                                    provides leadership and expert                                                                                including acute and long-term inpatient
                                                                                                            surveillance for the timely detection of              care, dialysis, and ambulatory settings;
                                                    consultation, guidance, and technical
                                                                                                            possible adverse events following                     (2) identifies gaps in HAI-related
                                                    support to and collaborates with other
                                                                                                            immunization (AEFI) in collaboration                  knowledge, and conducts prevention
                                                    CDC CIOs and divisions, other HHS
                                                                                                            with the Food and Drug Administration                 research through the Prevention
                                                    Operating Divisions, and extramural
                                                                                                            (FDA), through coordination and                       Epicenters cooperative agreements
                                                    domestic partners, on the epidemiology,
                                                    prevention, and control of HAI, AR, and                 management of the Vaccine Adverse                     program and Safety and Healthcare
                                                    related adverse events; (9) implements                  Event Reporting System, the national                  Epidemiology Prevention Research
                                                    state activities to prevent HAI and AR                  reporting system that acts as an early-               Development research contracts; (3)
                                                    across healthcare; and (10) leads CDC                   warning system to detect health                       conducts and supports research and
                                                    activities to promote antimicrobial                     conditions that may be associated with                evaluates impact of public health
                                                    stewardship in all healthcare settings.                 immunization; (2) coordinates, further                practices to prevent HAI, antimicrobial
                                                                                                            develops, maintains and directs                       resistance, and related adverse events;
                                                      Surveillance Branch (CVLDD). (1)
                                                                                                            activities of the Vaccine Safety Datalink             (4) improves methods and enables wider
                                                    Monitors and evaluates on the national
                                                                                                            (VSD), a collaborative effort with                    use of clinical performance
                                                    level the extent, distribution, and
                                                                                                            integrated healthcare organizations, to               measurements by healthcare facilities
                                                    impact of HAI, antimicrobial use and
                                                                                                            conduct surveillance and investigate                  and public health entities for specific
                                                    resistance, adverse drug events,
                                                                                                            possible AEFI to assess causality and                 interventions and prevention strategies
                                                    healthcare worker safety events, and                                                                          designed to safeguard patients and
                                                    adherence to clinical processes and                     determine risk factors; (3) conducts
                                                                                                            epidemiologic research on causality of                healthcare workers from risk exposures
                                                    intervention programs designed to                                                                             and adverse outcomes through
                                                    prevent or control adverse exposures or                 AEFI using the VSD and other data
                                                                                                            sources, and provides national estimates              collaborations with extramural partners;
                                                    outcomes in healthcare; (2) provides                                                                          (5) conducts applied research to identify
                                                    services, including leadership,                         of incidence of AEFI and background
                                                                                                            rates of health conditions; (4) leads the             and develop innovative methods to
                                                    consultation, and analysis support, for                                                                       detect and monitor HAI and
                                                    statistical methods and analysis to                     nation in developing biostatistical
                                                                                                            methods for research of AEFI using large              antimicrobial resistance; (6) conducts
                                                    investigators in the branch, division,                                                                        special studies to identify key risk
                                                    and other organizations responsible for                 linked databases and other data sources,
                                                                                                            and shares methods for use by other                   factors for and provides national
                                                    surveillance, research studies, and                                                                           estimates of targeted, healthcare-
                                                    prevention and control of HAI and other                 Agencies and public and private
                                                                                                            entities; (5) conducts clinical research to           associated adverse events, antimicrobial
                                                    healthcare-associated adverse events; (3)                                                                     use and resistance patterns, and the
                                                    works with the Centers for Medicare                     identify causes of adverse events after
                                                                                                            immunization, specific populations                    extent to which prevention and control
                                                    and Medicaid Services and other                                                                               safeguards are in use to protect at-risk
                                                    partners to develop new metrics and                     susceptible to specific adverse events,
                                                                                                            and prevention strategies through the                 patients across the spectrum of
                                                    support maintenance of National                                                                               healthcare delivery sites; (7) develops
                                                    Quality Forum-approved metrics; (4)                     Clinical Immunization Safety
                                                                                                            Assessment network, a national network                new ways to assess the impact of HAI
                                                    collaborates with public and private                                                                          prevention programs; (8) conducts
                                                    sector partners to further standardize,                 of medical research centers, and other
                                                                                                            efforts; (6) applies findings from                    analysis of the return on investment and
                                                    integrate, and streamline systems by                                                                          costs related to prevention efforts and
                                                    which healthcare organizations collect,                 epidemiologic and clinical studies to
                                                                                                            develop strategies for prevention of                  impact of HAI prevention programs; and
                                                    manage, analyze, report, and respond to                                                                       (9) works with the Emerging Infections
                                                    data on clinical guideline adherence,                   AEFI; (7) provides global consultation
                                                                                                            and leadership for the development,                   Program (EIP) and other partners to
                                                    HAI, including transmission of multi-                                                                         identify emerging issues.
                                                    drug resistant organisms, and other HAI;                use, and interpretation of vaccine safety
                                                    (5) coordinates, further develops,                      surveillance systems, and for the                     Sherri Berger,
                                                    enables wider use, and maintains NHSN                   development of shared definitions of                  Chief Operating Officer, Centers for Disease
                                                    to obtain scientifically valid clinical                 specific health outcomes through                      Control and Prevention.
                                                    performance indices that promote                        participation in the Brighton                         [FR Doc. 2016–23213 Filed 9–26–16; 8:45 am]
                                                    healthcare quality and value at the                     Collaboration and other international                 BILLING CODE 4160–18–P
                                                    facility, state, and national levels; (6)               organizations; (8) provides data for
                                                    develops and implements new NHSN                        action to HHS, the Advisory Committee
                                                    modules and provides enrollment and                     on Immunization Practices, the FDA’s                  DEPARTMENT OF HEALTH AND
                                                    user support for NHSN; (7) improves                     Vaccine and Related Biological Products               HUMAN SERVICES
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                                                    surveillance systems by utilizing new                   Advisory Committee, Health Resources
                                                    technology; (8) generates and provides                  and Services Administration’s Advisory                Centers for Disease Control and
                                                    NHSN surveillance reports and                           Commission on Childhood Vaccines,                     Prevention
                                                    analyses, which include collaborative                   and collaborators around the globe
                                                                                                                                                                  Statement of Organization, Functions,
                                                    analytic projects with partners; and (9)                including the WHO Global Advisory
                                                                                                                                                                  and Delegations of Authority
                                                    leads CDC’s national adverse drug                       Committee on Vaccine Safety; and (9)
                                                    events surveillance activities and seeks                provides timely, accurate                               Part C (Centers for Disease Control
                                                    to translate population-based                           communication and education to                        and Prevention) of the Statement of


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Document Created: 2016-09-27 01:18:52
Document Modified: 2016-09-27 01:18:52
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation81 FR 66282 

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