Statement of Organization, Functions, and Delegations of Authority, 21760-21763 [2014-08551]
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21760
Federal Register / Vol. 79, No. 74 / Thursday, April 17, 2014 / Notices
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Time and Date: 12:00 p.m.–4:00 p.m. EST,
May 22, 2014 (Closed).
Place: This meeting will be held via
teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters For Discussion: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘Motor Vehicle Injury
Prevention: Evaluation of Increased
Nighttime Enforcement of Seatbelt Use, FOA
CE14–003’’.
Contact Person For More Information: Jane
Suen, Dr.P.H., M.S., Scientific Review
Officer, CDC, 4770 Buford Highway NE.,
Mailstop F–63, Atlanta, Georgia 30341–3724,
Telephone (770) 488–4281.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
Environmental Diseases (CVLB), insert
the following:
Food Safety Office (CVLB13). (1)
Provides leadership in preventing and
controlling foodborne illness by
coordinating related activities within
CDC and with other local, state, federal,
and international organizations; (2)
directs the activities related to
development of long-term NCEZID, OID,
and CDC strategies, policies, and
budgets for foodborne disease
prevention activities; (3) allocates and
tracks interagency resources within CDC
for foodborne disease surveillance,
outbreak response, applied research,
education and training; (4) administers
and tracks resources for foodborne
disease prevention and control activities
of state and local health departments
and other organizations; (5) represents
NCEZID and CDC programs and
prevention policies in meetings with
governmental, non-governmental,
private, and international organizations;
(6) reviews, prepares, and coordinates
congressional testimony and briefing
documents related to foodborne
diseases, and analyzes programmatic
and policy implications of legislative
proposals; and (7) provides direction
and administrative support to the World
Health Organization (WHO)
Collaborating Center for Foodborne
Disease Surveillance.
BILLING CODE 4163–18–P
Dated: April 7, 2014.
Sherri A. Berger,
MSPH Chief Operating Officer, Centers for
Disease Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2014–08593 Filed 4–16–14; 8:45 am]
[FR Doc. 2014–08761 Filed 4–16–14; 8:45 am]
BILLING CODE 4160–18–M
Centers for Disease Control and
Prevention
TKELLEY on DSK3SPTVN1PROD with NOTICES
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 79 FR 15593–19954,
dated March 20, 2014) is amended to
reflect the reorganization of the Food
Safety Office, National Center for
Emerging and Zoonotic Infectious
Diseases.
Delete in its entirety the title and
function statements for the Food Safety
Office (CVL12), Office of the Director
(CVL1).
After the mission statement for the
Division of Foodborne, Waterborne and
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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 79 FR 15593–15594,
dated March 20, 2014) is amended to
reflect the reorganization of the Division
of Healthcare Quality Promotion,
National Center for Emerging and
Zoonotic Infectious Diseases, Centers for
Disease Control and Prevention.
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Section C–B, Organization and
Functions, is hereby amended as
follows:
Delete in its entirety the title and the
mission and function statements for the
Division of Healthcare Quality
Promotion (CVLD) and insert the
following:
Division of Healthcare Quality
Promotion (CVLD). The mission of the
Division of Healthcare Quality
Promotion (DHQP) is to protect patients;
protect healthcare personnel; and
promote safety, quality, and value in
both national and international
healthcare delivery systems. In carrying
out its mission, DHQP: (1) Measures,
validates, interprets, and responds to
data relevant to healthcare-associated
infections (HAI); antimicrobial use and
resistance; 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 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, 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, 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
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,
and related adverse events or medical
errors; (8) promotes the nationwide
implementation of CDC guidelines and
other evidence-based interventions to
prevent HAI, antimicrobial resistance,
and related adverse events or medical
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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, nontuberculous 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; (13)
coordinates guidance and research
related to infection control across the
agency and with national and
international partners; (14) monitors
vaccine safety and conducts research to
evaluate the safety of available and new
vaccines; (15) trains Epidemic
Intelligence Service Officers and other
trainees; (16) coordinates antimicrobial
resistance activities at CDC; (17) works
in a national leadership capacity with
public and private organizations to
enhance antimicrobial resistance
prevention and control, surveillance
and response, and applied research; (18)
coordinates blood, organ, and other
tissue safety at CDC; and (19) provides
expertise and assistance to HHS and
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 the DHQP; (2) provides
leadership and guidance on policy and
communications/media; (3) works with
Federal agencies, international
organizations, and other partners on
activities related to safe healthcare; (4)
coordinates state and local activities to
monitor and prevent HAI; (5)
coordinates, in collaboration with the
appropriate CIO and CDC components,
global health activities relating to the
prevention of healthcare-associated
infections/antimicrobial resistance, and
related adverse events or medical errors;
(6) coordinates activities, guidance,
emergency response, and research
related to infection control in healthcare
settings across the agency and with
national and international partners; (7)
oversees the coordination of
antimicrobial resistance activities at
CDC; (8) represents CDC as co-chair of
the Federal Interagency Task Force on
Antimicrobial Resistance; (9)
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coordinates with other agencies, state
governments, medical societies, and
other public and private organizations
to enhance antimicrobial resistance
prevention and control, surveillance
and response, and applied research; (10)
leads CDC’s activities on blood, organ,
and other tissue safety; (11) represents
CDC on the Advisory Committee on
Blood Safety and Availability and the
Advisory Committee on Organ
Transplantation; (12) 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,
applied research, health
communication, and public policy; and
(13) advises the Director, NCEZID, on
science, policy and communication
matters concerning DHQP activities.
Program Implementation and
Integration Activity (CVLD13). (1)
Provides leadership and guidance for
program planning and development,
program management, and operations;
(2) 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; (3) oversees the
coordination of Federal and state
programs and new initiatives to prevent
HAI; (4) interprets general program and
administrative policy directives for
implications on management and
execution of DHQP’s programs; (5)
serves as lead and primary contact and
liaison with relevant CDC staff offices
on all matters pertaining to DHQP’s
procurement needs and activities; (6)
provides management and coordination
for DHQP-occupied space and facilities
including laboratory space and
facilities; (7) provides oversight and
management of the distribution,
accountability, and maintenance of CDC
property and equipment including
laboratory property and equipment; and
(8) provides program and administrative
support for HICPAC.
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 bacterial
agents in healthcare settings; (3)
provides laboratory response to
outbreaks and emerging threats
associated with infections/antimicrobial
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21761
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 and
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 the water
distribution systems in healthcare
facilities in order to understand and
prevent transmission of healthcareassociated infections due to water; and
(11) provides expertise, research
opportunities, training, and laboratory
support for investigations of infections
and related adverse events to other CDC
National Centers 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, adverse drug
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
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materials, policies and strategies to
increase adherence to Appropriate
Antimicrobial Use and Stewardship; (3)
uses data from the NHSN and other
sources to target and improve the
prevention and control healthcareassociated infections in the U.S. in
specific regions, settings and
institutions; (4) supports local, state,
and national efforts to prevent HAT and
related adverse events by providing
leadership and consultative services,
including monitoring adherence to CDCrecommended practices and policies; (5)
provide leadership and epidemiologic
support for the investigation,
monitoring, and control of both
recognized and emerging healthcare
pathogens, including antimicrobial
resistant forms; (6) leads and
coordinates rapid response to assess and
control outbreaks and emerging threats
involving HAI and related adverse
events, microbially-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; (8)
provides leadership and expert
consultation, guidance, and technical
support to and collaborates with other
CDC Operating Divisions (OPDIV)
Centers and Divisions, other HHS
OPDIVs, and extramural domestic and
international partners, on the
epidemiology and prevention and
control of HAI and related adverse
events, adverse drug events, and
healthcare personnel safety events; and
(9) develops implementation strategies
to utilize innovative evidence-based
methods for preventing and controlling
HAI and related adverse events, adverse
drug events, and healthcare personnel
safety events to recommendations to
allow broad, effective implementation
and more rapid improvement in the
standard of care.
Surveillance Branch (CVLDD). (1)
Monitors and evaluates on the national
level the extent distribution, and impact
of healthcare-associated infections,
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 HAT and
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other healthcare-associated adverse
events; (3) works with Centers for
Medicare & Medicaid Services and other
partners to develop new metrics and
support maintenance of NQF-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)
development and implementation of
new NHSN modules and provides
enrollment and user support for NHSN;
(7) improve system 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).
(1) Assesses the safety of new and
currently available vaccines received by
children, adolescents and adults using a
variety of strategies; (2) conducts
ongoing surveillance for the timely
detection of possible adverse events
following immunization (AEFI) in
collaboration with the Food and Drug
Administration, through coordination
and management of the Vaccine
Adverse Event Reporting System, the
national spontaneous reporting system
that acts as an early-warning system to
detect health conditions that may be
associated with immunization; (3)
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; (4)
conducts epidemiologic research on
causality of AEFI using the VSD and
other data sources, provide national
estimates of incidence of AEFI and
background rates of health conditions;
(5) 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; (6) conducts clinical
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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; (7)
applies findings from epidemiologic and
clinical studies to develop strategies for
prevention of AEFI; (8) 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; (9) provides data for
action to HHS, the Advisory Committee
on Immunization Practices, the Food
Drug Administration’s Vaccine and
Related Biological Products Advisory
Committee, HRSA’s Advisory
Commission on Childhood Vaccines,
and collaborators around the globe
including the World Health
Organization Global Advisory
Committee on Vaccine Safety; and (10)
provides timely, accurate
communication and education to
partners and the public on vaccine
safety concerns.
Epidemiology Research and
Innovations Branch (CVLDG). (1)
Develops 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 longterm inpatient
care, dialysis, and ambulatory settings;
(2) conducts and supports research and
evaluates impact of public health
practices to prevent HAIs and related
adverse events and monitors progress in
reaching national prevention goals; (3)
identifies gaps in HAI-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 factor
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
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prevention efforts and impact of HAI
prevention programs; and (9) works
with the Emerging Infections Program
and other partners to identify emerging
issues.
Dated: April 7, 2014.
Sherri A. Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2014–08551 Filed 4–16–14; 8:45 am]
BILLING CODE 4160–18–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–5506–N4]
Medicare Program; Comprehensive
ESRD Care Initiative; Extension of the
Submission Deadlines for the Letters
of Intent and Applications
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Reopening of the application
period.
AGENCY:
This notice reopens the
application period and provides
information on new dates for the
submission of the Comprehensive ESRD
Care initiative letters of intent and
application. The letter of intent
submission date for End-stage Renal
Disease Seamless Care Organizations
(ESCOs) that include a dialysis facility
from a large dialysis organization (LDO)
is June 23, 2014, and the submission
deadline for the LDO application is June
23, 2014. The letter of intent submission
date for ESCOs that include a non-LDO
facility is September 15, 2014, and the
submission deadline for the non-LDO
application is September 15, 2014.
DATES: Letter of Intent Submission
Deadline: Interested large dialysis
organizations (LDOs) must submit a
non-binding letter of intent on or before
June 23, 2014, and interested non-large
dialysis organizations (non-LDOs) must
submit a non-binding letter of intent on
or before September 15, 2014, by an
online form at: https://
innovationgov.force.com/cec.
Application Submission Deadline:
Interested LDO applicants must submit
an application on or before June 23,
2014, and interested non-LDO
applicants must submit an application
on or before September 15, 2014, by an
online form at: https://
innovationgov.force.com/rfa.
An updated Request for Applications
which includes the new submission
deadlines and additional updates is
TKELLEY on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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17:28 Apr 16, 2014
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available on the Innovation Center Web
site at: https://innovation.cms.gov/
initiatives/comprehensive-ESRD-care.
FOR FURTHER INFORMATION CONTACT:
Alefiyah Mesiwala, (410) 786–2224 or
ESRD-CMMI@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Center for Medicare and
Medicaid Innovation (Innovation
Center) is interested in identifying
models designed to improve care for
beneficiaries with end-stage renal
disease (ESRD). To promote seamless
and integrated care for beneficiaries
with ESRD, we are developing a
comprehensive care delivery model to
emphasize coordination of a full-range
of clinical and non-clinical services
across providers, suppliers, and settings.
Through the Comprehensive ESRD Care
Model, we seek to identify ways to
improve the coordination and quality of
care for this population, while lowering
total per-capita expenditures to the
Medicare program. We anticipate that
the Comprehensive ESRD Care Model
would result in improved health
outcomes for beneficiaries with ESRD
regarding the functional status, quality
of life, and overall well-being, as well as
increased beneficiary and caregiver
engagement, and lower costs to
Medicare through improved care
coordination.
On February 6, 2013, we published a
notice in the Federal Register
announcing a request for applications
from organizations to participate in the
testing of the Comprehensive ESRD Care
Model, for a period beginning in 2013
and ending in 2016, with a possible
extension into subsequent years. In that
notice, we stated that organizations
interested in applying to participate in
the testing of the Comprehensive ESRD
Care Model must submit a non-binding
letter of intent by March 15, 2013, and
an application by May 1, 2013.
Several stakeholders requested
additional time to prepare their
applications and form partnerships.
Therefore, the Innovation Center
extended the deadlines relating to the
Comprehensive ESRD Care initiative.
On July 17, 2013, we published a notice
in the Federal Register announcing an
extension of deadlines. The new
deadlines were July 19, 2013 for the
Letter of Intent and August 1, 2013 for
the application. On August 9, 2013, we
published an additional notice in the
Federal Register announcing an
extension of deadlines. The notice
reopened the Letters of Intent
submission period and extended the
deadlines for submission of both the
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21763
Letters of Intent and the Applications to
August 30, 2013.
II. Provisions of the Notice
Since the publication of the August 9,
2013 notice, we have made several
revisions to the design of the
Comprehensive ESRD Care initiative.
Therefore, for the Comprehensive ESRD
Care Initiative, the Innovation Center is
reopening the Letters of Intent
submission period and extending the
deadlines for submission of both the
Letters of Intent and the Applications.
The new deadline for submission of the
letter of intent is June 23, 2014 for LDO
applicants and September 15, 2014 for
non-LDO applicants; and the new
deadline for submission of the
application is June 23, 2014, for LDO
applicants and September 15, 2014 for
non-LDO applicants.
In the DATES section of this notice, we
are including the new submissions
deadlines. For additional information
on the Comprehensive ESRD Care
Model, and how to apply, we refer the
reader to click on the Request for
Applications located on the Innovation
Center Web site at: https://
innovation.cms.gov/initiatives/
comprehensive-ESRD-care.
Dated: April 11, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2014–08758 Filed 4–15–14; 11:15 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: OCSE–157 Child Support
Enforcement Program Annual Data
Report.
OMB No.: 0970–0177.
Description: The information obtained
from this form will be used to: (1)
Report Child Support Enforcement
activities to the Congress as required by
law; (2) calculate incentive measures
performance and performance
indicators utilized in the program; and
(3) assist the Office of Child Support
Enforcement (OCSE) in monitoring and
evaluating State Child Support
programs.
OCSE is proposing minor updates to
the OCSE–157 report instructions to
update submission procedures.
Respondents will no longer have the
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Agencies
[Federal Register Volume 79, Number 74 (Thursday, April 17, 2014)]
[Notices]
[Pages 21760-21763]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08551]
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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 79 FR 15593-15594, dated March 20, 2014) is
amended to reflect the reorganization of the Division of Healthcare
Quality Promotion, National Center for Emerging and Zoonotic Infectious
Diseases, Centers for Disease Control and Prevention.
Section C-B, Organization and Functions, is hereby amended as
follows:
Delete in its entirety the title and the mission and function
statements for the Division of Healthcare Quality Promotion (CVLD) and
insert the following:
Division of Healthcare Quality Promotion (CVLD). The mission of the
Division of Healthcare Quality Promotion (DHQP) is to protect patients;
protect healthcare personnel; and promote safety, quality, and value in
both national and international healthcare delivery systems. In
carrying out its mission, DHQP: (1) Measures, validates, interprets,
and responds to data relevant to healthcare-associated infections
(HAI); antimicrobial use and resistance; 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 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, 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, 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 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,
and related adverse events or medical errors; (8) promotes the
nationwide implementation of CDC guidelines and other evidence-based
interventions to prevent HAI, antimicrobial resistance, and related
adverse events or medical
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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; (13) coordinates guidance and research
related to infection control across the agency and with national and
international partners; (14) monitors vaccine safety and conducts
research to evaluate the safety of available and new vaccines; (15)
trains Epidemic Intelligence Service Officers and other trainees; (16)
coordinates antimicrobial resistance activities at CDC; (17) works in a
national leadership capacity with public and private organizations to
enhance antimicrobial resistance prevention and control, surveillance
and response, and applied research; (18) coordinates blood, organ, and
other tissue safety at CDC; and (19) provides expertise and assistance
to HHS and 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 the DHQP; (2) provides leadership and
guidance on policy and communications/media; (3) works with Federal
agencies, international organizations, and other partners on activities
related to safe healthcare; (4) coordinates state and local activities
to monitor and prevent HAI; (5) coordinates, in collaboration with the
appropriate CIO and CDC components, global health activities relating
to the prevention of healthcare-associated infections/antimicrobial
resistance, and related adverse events or medical errors; (6)
coordinates activities, guidance, emergency response, and research
related to infection control in healthcare settings across the agency
and with national and international partners; (7) oversees the
coordination of antimicrobial resistance activities at CDC; (8)
represents CDC as co-chair of the Federal Interagency Task Force on
Antimicrobial Resistance; (9) coordinates with other agencies, state
governments, medical societies, and other public and private
organizations to enhance antimicrobial resistance prevention and
control, surveillance and response, and applied research; (10) leads
CDC's activities on blood, organ, and other tissue safety; (11)
represents CDC on the Advisory Committee on Blood Safety and
Availability and the Advisory Committee on Organ Transplantation; (12)
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, applied research, health communication, and public
policy; and (13) advises the Director, NCEZID, on science, policy and
communication matters concerning DHQP activities.
Program Implementation and Integration Activity (CVLD13). (1)
Provides leadership and guidance for program planning and development,
program management, and operations; (2) 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; (3) oversees the coordination
of Federal and state programs and new initiatives to prevent HAI; (4)
interprets general program and administrative policy directives for
implications on management and execution of DHQP's programs; (5) serves
as lead and primary contact and liaison with relevant CDC staff offices
on all matters pertaining to DHQP's procurement needs and activities;
(6) provides management and coordination for DHQP-occupied space and
facilities including laboratory space and facilities; (7) provides
oversight and management of the distribution, accountability, and
maintenance of CDC property and equipment including laboratory property
and equipment; and (8) provides program and administrative support for
HICPAC.
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 bacterial agents in healthcare settings; (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
and 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
the water distribution systems in healthcare facilities in order to
understand and prevent transmission of healthcare-associated infections
due to water; and (11) provides expertise, research opportunities,
training, and laboratory support for investigations of infections and
related adverse events to other CDC National Centers 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, adverse drug 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
[[Page 21762]]
materials, policies and strategies to increase adherence to Appropriate
Antimicrobial Use and Stewardship; (3) uses data from the NHSN and
other sources to target and improve the prevention and control
healthcare-associated infections in the U.S. in specific regions,
settings and institutions; (4) supports local, state, and national
efforts to prevent HAT and related adverse events by providing
leadership and consultative services, including monitoring adherence to
CDC-recommended practices and policies; (5) provide leadership and
epidemiologic support for the investigation, monitoring, and control of
both recognized and emerging healthcare pathogens, including
antimicrobial resistant forms; (6) leads and coordinates rapid response
to assess and control outbreaks and emerging threats involving HAI and
related adverse events, microbially-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; (8) provides leadership and expert
consultation, guidance, and technical support to and collaborates with
other CDC Operating Divisions (OPDIV) Centers and Divisions, other HHS
OPDIVs, and extramural domestic and international partners, on the
epidemiology and prevention and control of HAI and related adverse
events, adverse drug events, and healthcare personnel safety events;
and (9) develops implementation strategies to utilize innovative
evidence-based methods for preventing and controlling HAI and related
adverse events, adverse drug events, and healthcare personnel safety
events to recommendations to allow broad, effective implementation and
more rapid improvement in the standard of care.
Surveillance Branch (CVLDD). (1) Monitors and evaluates on the
national level the extent distribution, and impact of healthcare-
associated infections, 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 HAT and other
healthcare-associated adverse events; (3) works with Centers for
Medicare & Medicaid Services and other partners to develop new metrics
and support maintenance of NQF-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) development and
implementation of new NHSN modules and provides enrollment and user
support for NHSN; (7) improve system 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). (1) Assesses the safety of new
and currently available vaccines received by children, adolescents and
adults using a variety of strategies; (2) conducts ongoing surveillance
for the timely detection of possible adverse events following
immunization (AEFI) in collaboration with the Food and Drug
Administration, through coordination and management of the Vaccine
Adverse Event Reporting System, the national spontaneous reporting
system that acts as an early-warning system to detect health conditions
that may be associated with immunization; (3) 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; (4) conducts epidemiologic
research on causality of AEFI using the VSD and other data sources,
provide national estimates of incidence of AEFI and background rates of
health conditions; (5) 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; (6) 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; (7) applies findings from
epidemiologic and clinical studies to develop strategies for prevention
of AEFI; (8) 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; (9) provides data for action to HHS,
the Advisory Committee on Immunization Practices, the Food Drug
Administration's Vaccine and Related Biological Products Advisory
Committee, HRSA's Advisory Commission on Childhood Vaccines, and
collaborators around the globe including the World Health Organization
Global Advisory Committee on Vaccine Safety; and (10) provides timely,
accurate communication and education to partners and the public on
vaccine safety concerns.
Epidemiology Research and Innovations Branch (CVLDG). (1) Develops
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 longterm inpatient care, dialysis,
and ambulatory settings; (2) conducts and supports research and
evaluates impact of public health practices to prevent HAIs and related
adverse events and monitors progress in reaching national prevention
goals; (3) identifies gaps in HAI-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 factor 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
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prevention efforts and impact of HAI prevention programs; and (9) works
with the Emerging Infections Program and other partners to identify
emerging issues.
Dated: April 7, 2014.
Sherri A. Berger,
Chief Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2014-08551 Filed 4-16-14; 8:45 am]
BILLING CODE 4160-18-M