9578 Federal Register / Vol. 66, No. 27 / Thursday, February 8, 2001 / Notices

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 66 FR 1363–1364, dated

January 8, 2001) is amended to retitle

and revise the functional statement of

the Hospital Infections Program (HIP),

National Center for Infectious Diseases

(NCID).

Section C–B, Organization and

Functions, is hereby amended as

follows:

Delete in its entirety the titles and

functional statements for the Hospital

Infections Program (CRM) and insert the

following:

Division of Healthcare Quality

Promotion (CRM). Protects patients,

protects healthcare personnel, and

promotes safety, quality, and value in

the healthcare delivery system by

providing national leadership for (1)

Measuring, validating, interpreting, and

responding to data relevant to

healthcare outcomes, healthcareassociated infections/antimicrobial

resistance, related adverse events, and

medical errors among patients and

healthcare personnel; (2) investigating

and responding to outbreaks and

emerging infections and related adverse

events among patients, healthcare

providers, or associated with the

healthcare environment; (3) detecting,

evaluating, monitoring, and responding

to emerging antimicrobial resistant

pathogens and infections; (4) creating

and evaluating the efficacy of new

interventions designed to prevent

infections/antimicrobial resistance,

related adverse events, and medical

errors; (5) promoting clinical

microbiology laboratory quality; (6)

promoting water quality in healthcare

settings; (7) identifying effective

interventions that prevent healthcareassociated infections/antimicrobial

resistance, related adverse events, and

medical errors among patients and

healthcare personnel; (8) promoting the

nationwide implementation of these

interventions; and (9) evaluating the

impact of their implementation across

the spectrum of healthcare delivery

sites.

Office of the Director (CRM1). (1)

Manages, directs, and coordinates the

activities of the Division of Healthcare

Quality Promotion (DHQP); (2) provides

leadership and guidance on policy,

program planning and development,

program management, and operations;

(3) provides DHQP-wide administrative

and program services and coordinates or

ensures coordination with the

appropriate National Center for

Infectious Diseases (NCID) and Centers

for Disease Control and Prevention

(CDC) staff offices on administrative and

program matters; (4) provides liaison

with other governmental agencies,

international organizations, and other

outside groups; (5) coordinates, in

collaboration with the appropriate NCID

and CDC components, global health

activities relating to the prevention of

healthcare-associated infections/

antimicrobial resistance, related adverse

events, and medical errors; (6) manages

the division local area network (LAN)

and coordinates the evolving LAN

design with the Information Resources

Management Office and the NCID LAN

administrator; (7) provides hardware

and software support to DHQP

personnel in response to the changing

information technology environment;

and (8) advises the Director, NCID, on

policy matters concerning DHQP

activities.

Epidemiology and Laboratory Branch

(CRM2). (1) Coordinates rapid and

effective epidemiologic and laboratory

response to outbreaks and emerging

threats associated with infections/

antimicrobial resistance and related

adverse events throughout the

healthcare delivery system; (2) provides

comprehensive laboratory support and

expertise (including consultation;

organism recovery and identification;

microbiologic, toxin, chemical, and

molecular assays; and strain typing) for

investigations of recognized and

emerging bacterial agents (including

those resistant to available

antimicrobials) in healthcare settings;

(3) implements surveillance and

response systems to detect emerging

threats, including those related to agents

of bioterrorism, among patients and

healthcare personnel; (4) investigates

novel and emerging mechanisms of

antimicrobial resistance among targeted

pathogens found in healthcare settings;

(5) conducts epidemiologic and basic

and applied laboratory research to

identify new strategies to prevent

infections/antimicrobial resistance,

related adverse events, and medical

errors, especially those associated with

indwelling medical devices,

contaminated products, dialysis, and

water; (6) evaluates the accuracy of

commercial microbial identification and

susceptibility testing systems and

products through research and

facilitates their improvement; (7)

provides leadership in reducing

microbiology laboratory errors that

affect patient outcomes by evaluating

laboratory proficiency and promoting

laboratory quality improvements; (8)

investigates the role of biofilms,

particularly those detected in

indwelling medical devices and medical

water systems, in medicine and public

health; and (9) in collaboration with

other CDC Centers, Institutes, and

Offices (CIOs) and partners, provides

expertise (e.g. environmental sampling,

microbial assays, environmental

engineering, disinfection strategies),

research opportunities, and laboratory

support for investigations of

environmental sources of infections and

related adverse events, including those

related to bioterrorism.

Epidemiology Section (CRM22). (1)

Coordinates and ensures rapid and

effective response to requests from state

and local health departments and

healthcare organizations for assistance

with investigations of outbreaks and

emerging threats associated with

infections, antimicrobial resistance, and

related adverse events throughout the

healthcare delivery system; (2) provides

comprehensive epidemiologic support

(including detection systems,

consultation, field investigation, risk

factor evaluation, and control strategies)

for investigations of recognized and

emerging bacterial pathogens (including

those resistant to available

antimicrobials) in healthcare settings

and potential bioterrorism events; (3)

evaluates the relationship between

bacterial strain characteristics and

epidemiologic characteristics of

pathogens associated with healthcare

infections/antimicrobial resistance; and

(4) develops and evaluates the efficacy

of interventions designed to prevent

healthcare-associated infections/

antimicrobial resistance, related adverse

events, and medical errors across the

spectrum of healthcare delivery sites.

Diagnostic Microbiology Section

(CRM23). (1) Provides laboratory

support and expertise for outbreak

investigations and special studies of

aerobic and anaerobic bacteria causing

healthcare-associated infections; (2)

evaluates the relationship between

bacterial strain characteristics and

epidemiologic characteristics of

pathogens; (3) provides reference

diagnostic services for identification

and classification of the

Micrococcaceae, many

Enterobacteriaceae, and all anaerobic

Federal Register / Vol. 66, No. 27 / Thursday, February 8, 2001 / Notices 9579

bacteria; (4) develops, evaluates, and

improves novel or existing laboratory

methods for identifying and

characterizing bacteria causing healthassociated infections; (5) evaluates in

vitro reagents and products that show

public health promise in improving the

identification and characterization of

bacterial pathogens; (6) conducts

biochemical, immunochemical, and

genetic studies of bacterial pathogens to

determine marker systems useful for

epidemiologic purposes such as

determining pathogenicity, or virulence;

(7) provides reference diagnostic

activities for detection of staphylococcal

toxins in isolates obtained from clinical

specimens and environmental sources,

including those that may be associated

with bioterrorism events; (8) serves as

the World Health Organization (WHO)

National Klebsiella Center; (9) manages

the bacteriology laboratory component

of the College of American Pathologists

(CAP) proficiency testing program for

NCID/CDC; and (10) provides leadership

in laboratory quality improvement

practices directed toward reducing

laboratory errors that affect healthcare

outcomes.

Environmental and Applied

Microbiology Section (CRM24). (1)

Provides laboratory support and

expertise for epidemic evaluations,

consultation, and field investigations of

healthcare-associated infections

involving medical devices, therapeutic

or diagnostic products and devices,

environmental reservoirs of

microorganisms/pathogens, or issues

involving water quality; (2) investigates

and defines environmental factors

associated with healthcare-associated

infections/antimicrobial resistance and

related adverse events that affect

healthcare outcomes; (3) conducts basic

and applied laboratory research to

identify new strategies to prevent

infections/antimicrobial resistance,

related adverse events, and medical

errors, especially those associated with

indwelling medical devices,

contaminated products, dialysis, and

water; (4) investigates and defines the

role of biofilms and develops and

evaluates methods to control them in

water distribution systems and on

indwelling medical devices; (5)

develops and evaluates reliable methods

to detect and quantify bacterial

endotoxin, bioterrorism agents

associated with institutional outbreaks,

and dialysis-associated diseases; (6)

develops and evaluates reliable methods

and protocols for the disinfection and

sterilization of medical devices,

formites, potable water, recreational

water, and water associated with

healthcare-associated infections/

antimicrobial resistance, in

collaboration with other NCID divisions,

the Environmental Protection Agency

(FDA), and the Food and Drug

Administration (FDA); (7) provides

laboratory and field capability in

environmental microbiology, and

collaborates with other NCID

organizations in epidemic

investigations, evaluation of

bioterrorism events, and field studies

requiring expertise in environmental

microbiology; (8) serves as the NCID/

CDC lead for information,

recommendations, and technical

support concerning environmental

sterilization, disinfection, and disposal/

handling of medical waste; and (9)

serves as the NCID/CDC lead for

information, recommendations, and

technical support concerning dialysisassociated infections and related

adverse events, sterilization and

disinfection strategies, water quality,

and bacterial endotoxins.

Anti-infectives Investigation Section

(CRM25). (1) Provides laboratory

support for investigations of

antimicrobial-resistant infections

conducted by DHQP Epidemic

Intelligence Service (EIS) officers and

staff; (2) provides reference

antimicrobial susceptibility testing

services to state health departments,

healthcare organizations, and other

laboratories; (3) evaluates and reports on

the accuracy of commercial

antimicrobial susceptibility testing

methods; (4) develops and evaluates

new methods for detecting bacterial

resistance to antimicrobial agents, in

collaboration with the National

Committee for Clinical Laboratory

Standards; (5) improves the proficiency

of microbiology laboratories by

providing quality control and

proficiency testing organisms to clinical

laboratories in the United States and

throughout the world in cooperation

with state health departments, Emory

University Rollins School of Public

Health, and the WHO; (6) serves as a

WHO Collaborating Center on Global

Antimicrobial Resistance Monitoring in

Bacteria; (7) collaborates with state

health departments to perform surveys

of antimicrobial susceptibility testing

procedures in clinical laboratories; (8)

investigates the molecular basis of

antimicrobial resistance in bacteria

through DNA hybridization studies,

DNA sequence analysis, iso-electric

focusing, and other analytical methods;

and (9) provides bacterial strain typing

services to evaluate dissemination of

resistant organisms.

Prevention and Evaluation Branch

(CRM3). (1) Supports local, state,

national, and international efforts to

prevent healthcare-associated

infections/antimicrobial resistance,

related adverse events, and medical

errors using evidence-based

recommendations and state-of-the art

informatics and health communications

strategies that enhance rapid and

reliable information exchange; (2)

develops and demonstrates the

effectiveness of health communications,

guidelines, recommendations, and other

interventions to prevent healthcareassociated infections/antimicrobial

resistance, related adverse events, and

medical errors across the spectrum of

healthcare delivery sites; (3) promotes

the implementation of effective

guidelines, recommendations, and other

interventions to prevent healthcareassociated infections/antimicrobial

resistance, related adverse events, and

medical errors; (4) evaluates the impact

of implementation of effective

guidelines, recommendations, and other

interventions on healthcare-associated

infections/antimicrobial resistance,

related adverse events, and medical

errors; (5) provides consultation,

guidance, and technical support to

domestic and international partners on

the prevention of healthcare-associated

infections/antimicrobial resistance,

related adverse events, and medical

errors; and (6) develops and

disseminates training tools and other

strategies that enhance local capacity to

protect patients and healthcare

personnel and to promote quality

healthcare.

Interventions and Evaluation Section

(CRM32). (1) Collaborates with partners

to promote healthcare safety, quality,

and value across the spectrum of

healthcare delivery sites; (2) coordinates

the development of and disseminates

evidence-based guidelines and

recommendations to prevent and

control healthcare-associated infections/

antimicrobial resistance, related adverse

events, and medical errors; (3) evaluates

the effectiveness of interventions to

prevent healthcare-associated

infections/antimicrobial resistance,

related adverse events, and medical

errors; (4) promotes the implementation

and evaluates the impact of guidelines,

recommendations, performance

measurement systems, best practices,

and other strategies to prevent

healthcare-associated infections/

antimicrobial resistance, related adverse

events, and medical errors; (5) develops,

implements, and evaluates the

effectiveness and impact of

interventions to prevent transmission of

healthcare-associated human

immunodeficiency virus (HIV) and

9580 Federal Register / Vol. 66, No. 27 / Thursday, February 8, 2001 / Notices

other bloodborne pathogen infections;

and (6) develops, implements, and

evaluates the effectiveness and impact

of interventions to prevent the

dissemination of infections endemic in

the community (e.g., as tuberculosis and

influenza) in healthcare settings.

Health Communications Section

(CRM33). (1) With input from DHQP

branches, NCID/CDC Centers, Institutes

and Offices (CIO’s), partners and

stakeholders, develops, implements,

and evaluates the effectiveness of the

DHQP health communications strategic

plan to (a) deliver effective messages to

target audiences that protect patients,

protect healthcare personnel, and

promote quality healthcare and (b)

inform patients, partners, the public,

decision makers, and other constituents

about these issues; (2) coordinates

provision of DHQP technical support

and consultation to partners and

constituents on the prevention of

healthcare-associated infections/

antimicrobial resistance, related adverse

events, and medical errors; (3) develops

and tests health communication

materials in a variety of media,

including but not limited to electronic

and print; (4) develops and implements

a real-time communication network for

the delivery of information to

intramural and extramural partners and

stakeholders; (5) disseminates

information to medical, technical,

scientific, and lay audiences and news

media about healthcare-associated

infections/antimicrobial resistance,

adverse events, and medical errors; (6)

develops, coordinates, and maintains

DHQP website; (7) develops and tests

material, technologies, and strategies for

training programs to prevent and control

healthcare-associated infections/

antimicrobial resistance, related adverse

events, and medical errors; (8) develops

and implements national health

communication campaigns to promote

the prevention and control of

healthcare-associated infections/

antimicrobial resistance, related adverse

events, and medical errors; (9) evaluates

the effectiveness of DHQP’s health

communication strategies to determine

the impact and contribution to

prevention and control of healthcareassociated infections/antimicrobial

resistance, related adverse events, and

medical; and (10) oversees DHQP’s

scientific and editorial clearance

process for all print and non-print

materials and ensures adherence to and

consistency with CDC’s scientific and

editorial policies and clearance

processes.

Healthcare Outcomes Branch (CRM4).

(1) Evaluates the impact of healthcareassociated infections/antimicrobial

resistance, related adverse events, and

medical errors on healthcare outcomes

and costs in order to establish priorities

for DHQP intervention programs; (2)

improves methods to measure

healthcare outcomes, performance, and

cost-effectiveness of intervention

strategies; (3) improves systems by

which health organizations collect,

manage, analyze, report, and respond to

data on healthcare outcomes,

healthcare-associated adverse events,

and medical errors; (4) implements and

coordinates the National Healthcare

Safety Network (NHSN) (a

representative sample of healthcare

organizations that report data on

targeted healthcare-associated adverse

events and medical errors) to obtain

locally relevant and scientifically valid

benchmarks and performance

measurements that promote healthcare

quality and value; (5) provides national

estimates of targeted adverse events and

medical errors among selected

populations of patients across the

spectrum of healthcare delivery sites;

and (6) provides national estimates of

targeted occupational illnesses and

injuries among healthcare workers

across the spectrum of healthcare

delivery sites.

Quality Research Section (CRM42). (1)

Evaluates the impact of healthcareassociated infections/antimicrobial

resistance, related adverse events, and

medical errors on patient outcomes,

healthcare costs, and resource

utilization; (2) develops scientifically

valid and locally relevant methods of

risk adjustment for interpreting and

comparing performance measures and

healthcare outcomes and costs among

targeted populations; (3) develops

analytic methods to provide reliable

national estimates of the frequency and

impact of targeted adverse health events

among patients and healthcare

personnel; and (4) develops analytic

methods to evaluate the relationship

among healthcare structure, processes of

care, and healthcare outcomes.

Performance Measurement Section

(CRM43). (1) with collaborating

partners, establishes, maintains, and

expands the NHSN to collect, report,

monitor, interpret, and disseminate data

relevant to healthcare safety, quality,

and value; (2) with collaborating

partners, develops and validates

standard definitions of monitored

healthcare events in targeted

populations and healthcare settings.

These events may include medical

device-associated infections/adverse

events/errors, drug-associated adverse

events/errors, antimicrobial use/misuse,

blood product-associated infections/

adverse events/errors, procedureassociated infections/adverse events/

errors, laboratory-associated adverse

events/errors, vaccine-preventable and

antimicrobial-resistant infections, and

occupational exposures and infections;

(3) develops, implements, and validates

protocols for reporting monitored health

events in targeted populations and

healthcare settings; (4) develops analytic

tools to create performance measures

and other locally relevant data to

enhance quality promotion activities; (5)

collaborates with NCID, other CDC

CIOs, and other information system

partners to ensure that the NHSN and

related information systems adhere to

relevant standards and emerging

architecture for integrated surveillance

and information management; (6)

coorindates translation of NHSN

functional specifications and CDC

standards to software developers and

maintains ongoing communication with

developers as the system evolves; (7)

coordinates NHSN data management,

data warehousing, and analysis systems;

(8) develops information system

capacity and transfer protocols to

acquire data from various existing

databases and sources to provide

national estimates of monitored adverse

health events among patients and

healthcare personnel; (9) develops,

updates, and disseminates public use

de-identified data sets relevant to

healthcare outcomes, infections and

other adverse events, and medical

errors; (10) investigates novel strategies

for data acquisition and electronic

reporting of adverse event and relevant

data from healthcare organization

information systems; and (11) identifies

novel strategies for electronic detection,

automated reporting, and interpretation

of healthcare-associated infections/

antimicrobial resistance, related adverse

health events, and medical errors.

Dated: January 30, 2001.

Jeffrey P. Koplan,

Director.

[FR Doc. 01–3221 Filed 2–7–01; 8:45 am]

BILLING CODE 4160–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0051]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Adverse Event

Pilot Program for Medical Devices and

Blood Products

AGENCY: Food and Drug Administration,

HHS.