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73024 Federal Register / Vol. 72, No.

246 / Wednesday, December 26, 2007 / Notices

ESTIMATED ANNUALIZED BURDEN HOURS


Number of Average hours
Number of
Form responses per per
respondents respondent response

Referral/Consent to Contact Form (Patient) ................................................................................ 507 1 12/60


CATI Detailed Telephone Interview ............................................................................................. 395 1 42/60
Health Care Utilization/Sense of Community (for adult) ............................................................. 196 1 20/60
Health Care Utilization (for parent of adolescent) ....................................................................... 50 1 20/60
Economic Impact (adult) .............................................................................................................. 196 1 20/60
Spielberger State-Trait Anxiety Inventory (for adult subjects) .................................................... 196 1 20/60
Personality Diagnostic Questionnaire (PDQ–4+) (for adults) ...................................................... 196 1 42/60
Childhood Trauma Questionnaire (for adult subjects) ................................................................ 196 1 25/60
Traumatic Life Events Questionnaire (for adult subjects) ........................................................... 196 1 20/60
Life Experiences Survey (for adult subjects) ............................................................................... 196 1 20/60
Adolescent Subject Fatigue Questionnaire ................................................................................. 50 1 8/60
Adolescent Health Questionnaire ................................................................................................ 50 1 20/60
Symptoms Inventory .................................................................................................................... 246 1 12/60
Medical Outcomes Study Short Form 36 .................................................................................... 246 1 20/60
Multi-dimensional Fatigue Inventory ............................................................................................ 246 1 12/60
Zung Self-Rating Depression Scale ............................................................................................ 246 1 20/60
Illness Perception Questionnaire ................................................................................................. 246 1 20/60
Davidson Trauma Scale .............................................................................................................. 246 1 12/60
Ironson-Woods Spirituality/Religiousness Index ......................................................................... 246 1 8/60
Illness Management Questionnaire ............................................................................................. 246 1 20/60
Ways of Coping Questionnaire .................................................................................................... 246 1 33/60
Social Support Questionnaire ...................................................................................................... 246 1 20/60

Dated: December 14, 2007. Division of Healthcare Quality antimicrobial resistance, and related
Maryam I. Daneshvar, Promotion (CVKD). The mission of the adverse events or medical errors among
Acting Reports Clearance Officer, Centers for Division of Healthcare Quality patients and healthcare personnel;
Disease Control and Prevention. Promotion (DHQP) is to protect patients; evaluates the impact of these
[FR Doc. E7–24933 Filed 12–21–07; 8:45 am] protect healthcare personnel; and recommendations and interventions
BILLING CODE 4163–18–P promote safety, quality, and value in across the spectrum of healthcare
both national and international delivery sites; (6) develops, implements,
healthcare delivery systems. In carrying and evaluates the effectiveness and
DEPARTMENT OF HEALTH AND out its mission, DHQP: (1) Measures, impact of interventions to prevent
HUMAN SERVICES validates, interprets, and responds to transmission of healthcare-associated
data relevant to healthcare processes human immunodeficiency virus (HIV)
Centers for Disease Control and and outcomes, healthcare-associated and other bloodborne pathogen
Prevention infections, antimicrobial resistance, infections; (7) develops and evaluates
Statement of Organization, Functions, adverse drug events, and other related diagnostic instruments and novel
and Delegations of Authority adverse events or medical errors in laboratory tests to detect and
healthcare affecting patients and characterize antimicrobial-resistant
Part C (Centers for Disease Control healthcare personnel; (2) investigates bacterial pathogens and the infections
and Prevention) of the Statement of and responds to emerging infections and that they cause; (8) promotes high
Organization, Functions, and related adverse events among patients standards of water quality in healthcare
Delegations of Authority of the and healthcare providers, or others settings and tests and assures the water
Department of Health and Human associated with the healthcare quality for CCID laboratories; (9)
Services (45 FR 67772–76, dated environment; (3) collaborates with conducts epidemiologic, and basic and
October 14, 1980, and corrected at 45 FR academic and public health partners to applied laboratory research to identify
69296, October 20, 1980, as amended design, develop, and evaluate the new strategies to prevent infections/
most recently at 72 FR 67308, dated efficacy of interventions for preventing antimicrobial resistance, and related
November 28, 2007) is amended to infections and reducing antimicrobial adverse events or medical errors,
reflect the reorganization of the Division resistance, and related adverse events or especially those associated with medical
of Healthcare Quality Promotion, medical errors; (4) develops and or surgical procedures, indwelling
National Center for Preparedness, disseminates evidence-based guidelines medical devices, contaminated
Detection and Control of Infectious and recommendations to prevent and products, dialysis, and water; (10)
Diseases, Coordinating Center for control healthcare-associated infections/ establishes evidence-based data for
Infectious Diseases, Centers for Disease antimicrobial resistance, and related bioterrorism preparedness, and building
Control and Prevention. adverse events or medical errors; (5) and site remediation by performing
Section C–B, Organization and promotes the nationwide laboratory research on surface sampling,
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Functions, is hereby amended as implementation of Healthcare Infection detection of bacterial bioterrorist agents
follows: Delete in their entirety the Control Practices Advisory Committee by non-culture methods, and rapid
functional statements for the Division of (HICPAC) recommendations and other detection of antimicrobial resistance in
Healthcare Quality Promotion (CVKD), evidence-based interventions to prevent category A and B bacterial bioterrorist
and insert the following: healthcare-associated infections, agents; (11) serves as the National

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Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Notices 73025

Reference Laboratory for the (4) provides liaison with other contamination of environmental
identification and antimicrobial governmental agencies, international surfaces with bacterial agents of
susceptibility testing of staphylococci, organizations, and other outside groups; bioterrorism, the effectiveness of various
anaerobic bacteria, and those gram- (5) coordinates, in collaboration with water treatment strategies to control the
negative bacilli causing healthcare- the appropriate NC and CDC intentional introduction of agents of
associated infections; (12) develops and components, global health activities bioterrorism into municipal water
maintains the National Healthcare relating to the prevention of healthcare- systems, and develops molecular
Safety Network (NHSN), a tool for associated infections/antimicrobial methods for rapid assessment of
monitoring healthcare-associated resistance, and related adverse events or antimicrobial resistance in agents of
infections, for measuring healthcare medical errors; (6) coordinates bioterrorism; (4) investigates novel and
outcomes and processes, and for activities, guidance, and research emerging mechanisms of antimicrobial
monitoring healthcare worker related to infection control across the resistance among targeted pathogens
vaccination and selected health agency and with national and found in healthcare settings; (5) detects
measures in healthcare facilities; (13) international partners; (7) works with the toxins/virulence factors of bacteria
continually assesses rates of infections other federal agencies, state causing healthcare-associated infections
caused by resistant-bacteria in the U.S. governments, medical societies, and to understand their transmission and
through active surveillance, review of other public and private organizations pathogenicity; (6) conducts research in
national healthcare data sets, and to promote collaboration and to collaboration with partners to develop
laboratory surveillance programs; (14) integrate healthcare preparedness in new, accurate methods of detecting
promotes the integration of the federal/state/local public health antimicrobial resistance in bacteria and
healthcare delivery system in federal/ preparedness planning; (8) develops and to improve reporting of antimicrobial
state/local public health preparedness conducts healthcare preparedness susceptibility testing results to
planning; (15) coordinates activities, exercises and drills; (9) leads and staffs physicians to improve antimicrobial
guidance, and research related to the Healthcare Delivery and the use; (7) conducts laboratory research to
infection control across the agency and Infection Control/Clinical Care identify new strategies to prevent
with national and international functional seats in the CDC Director’s infections/antimicrobial resistance,
partners; (16) collaborates with other Emergency Operations Center; (10) related adverse events, and medical
CDC National Centers (NC) and partners coordinates antimicrobial resistance errors, especially those associated with
to assure quality clinical microbiology activities at CDC and represents CDC as invasive medical devices, contaminated
laboratory practices through proficiency co-chair of the federal Interagency Task products, dialysis, and water; (8)
testing, educational programs, and Force on Antimicrobial Resistance; (11) evaluates commercial microbial
training of personnel; (17) trains works with other agencies, state identification and antimicrobial
Epidemic Intelligence Service Officers governments, medical societies, and susceptibility testing systems and
and other trainees; (18) coordinates other public and private organizations products and facilitates their
antimicrobial resistance activities at to enhance antimicrobial resistance improvement to provide accurate
CDC; (19) represents CDC as co-chair of prevention and control, surveillance patient test results; (9) provides
the federal Interagency Task Force on and response, and applied research; (12) leadership in reducing microbiology
Antimicrobial Resistance; (20) works in coordinates blood, organ, and other laboratory errors that affect patient
a national leadership capacity with tissue safety at CDC and represents CDC outcomes by evaluating laboratory
public and private organizations to on the Advisory Committee on Blood proficiency and promoting laboratory
enhance antimicrobial resistance Safety and Availability and the quality improvements; (10) investigates
prevention and control, surveillance Advisory Committee on Organ the role of biofilms, particularly those
and response, and applied research; (21) Transplantation; (13) works with other detected in indwelling medical devices
coordinates blood, organ, and other federal agencies, state governments, and and medical water systems, in medicine
tissue safety at CDC; (22) represents other public and private organizations and public health, and identifies novel
CDC on the Advisory Committee on to enhance blood, organ, and other methods to eliminate colonization and
Blood Safety and Availability and the tissue safety through coordination of biofilm formation on foreign bodies; (11)
Advisory Committee on Organ investigation, prevention, response, investigates the role of the water
Transplantation; and (23) works in a surveillance, applied research, health distribution systems in healthcare
national leadership capacity with other communication, and public policy; (14) facilities in order to understand and
public and private organizations to provides program and administrative prevent waterborne healthcare-
enhance blood, organ, and other tissue support for HICPAC; and (15) advises associated infections; (12) provides
safety through coordination of the Director, NCPDCID, on policy expertise, research opportunity,
investigation, prevention, response, matters concerning DHQP activities. training, and laboratory support for
surveillance, applied research, health Clinical and Environmental investigations of infections and related
communication, and public policy. Microbiology Branch (CVKDB). (1) adverse events to those in other CDC
Office of the Director (CVDK1). (1) Collaborates with the Prevention and NCs and to our partners in areas related
Manages, directs, and coordinates the Response Branch to provide laboratory to quality clinical microbiology
activities of the DHQP: (2) provides response to outbreaks and emerging laboratory practices, investigation of
leadership and guidance on policy, threats associated with infections/ emerging pathogens, environmental
communications/media, program antimicrobial resistance and related microbiology and bioterrorism
planning and development, program adverse events throughout the preparedness.
management, and operations; (3) healthcare delivery system; (2) provides Prevention and Response Branch
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provides DHQP-wide administrative comprehensive laboratory support and (CVKDC). (1) Coordinates rapid and
and program services and coordinates or expertise for investigations of effective epidemiologic response to
ensures coordination with the recognized and emerging bacterial strategically selected outbreaks and
appropriate NC’s and CDC staff offices agents in healthcare settings; (3) emerging threats caused by healthcare-
on administrative and program matters; develops methods to assess associated infections, related adverse

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73026 Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Notices

healthcare events, related infections in adverse events due to infections provide national estimates of targeted
the community, and antimicrobial associated with indwelling medical occupational illnesses and injuries
resistance; communicates the results devices, contaminated products, among healthcare workers and the
and findings of response activities with dialysis, and water. extent to which preventive safeguards
federal and state agencies in order to Surveillance Branch (CVKDD). (1) are in use across the spectrum of
alert healthcare providers and educate Monitors and evaluates on the national healthcare delivery sites.
the public to prevent similar adverse level the extent, distribution, and Dated: December 13, 2007.
events in the future; (2) strategically impact of healthcare-associated William H. Gimson,
supports local, state, national, and infections, antimicrobial use and Chief Operating Officer, Centers for Disease
international efforts to prevent resistance, adverse drug events, Control and Prevention.
healthcare-associated infections, related healthcare worker safety events, and [FR Doc. 07–6130 Filed 12–21–07; 8:45 am]
infections in the community, adherence to clinical processes and BILLING CODE 4160–18–M
antimicrobial resistance, and related intervention programs designed to
adverse events or medical errors using prevent or control adverse exposures or
evidence-based recommendations and outcomes in healthcare; (2) provides DEPARTMENT OF HEALTH AND
effective health communications leadership and consultative services for HUMAN SERVICES
strategies that enhance rapid and statistical methods and analysis to
reliable information dissemination and investigators in the Branch, Division, Administration for Children and
exchange; (3) develops and/or evaluates and other organizations responsible for Families
the effectiveness of both experimental surveillance, research studies, and
and applied interventions to prevent prevention and control of healthcare- Submission for OMB Review;
healthcare-associated infections, related associated infections and other Comment Request
infections in the community, healthcare-associated adverse events; (3) Title: National Survey of Child and
antimicrobial resistance, blood-borne improves methods and enables wider Adolescent Well-Being-Second Cohort
virus transmission, and related adverse use of clinical performance (NSCAW II).
events or medical errors across the measurements by healthcare facilities OMB No.: 0970–0202.
spectrum of healthcare delivery sites; (4) and public health entities for specific Description: The Department of
provides epidemiology support to interventions and prevention strategies Health and Human Services (HHS)
laboratory branch for investigation and designed to safeguard patients and intends to collect data on a new sample
study of both recognized and emerging healthcare workers from risk exposures of children and families for the National
bacterial healthcare pathogens and and adverse outcomes through Survey of Child and Adolescent Well-
related community pathogens, including collaborations with extramural partners; Being (NSCAW). The NSCAW was
antimicrobial resistant forms of these (4) collaborates with public and private authorized under Section 427 of the
pathogens; (5) develops, promotes, and sector partners to further standardize, Personal Responsibility and Work
monitors implementation of guidelines/ integrate, and streamline systems by Opportunities Reconciliation Act of
recommendations, and other proven which healthcare organizations collect, 1996. The original survey began in
interventions to prevent healthcare- manage, analyze, report, and respond to November 1999 with a national sample
associated infections, related infections data on clinical guideline adherence, of 5,501 children, ages 0–14, who had
in the community, blood-borne virus healthcare-associated infections, been the subject of investigation by
transmission, antimicrobial resistance, including transmission of multi-drug- Child Protective Services during the
medical errors, and occupational resistant organisms and other baseline data collection period, which
infections/exposures among healthcare healthcare-associated adverse events; (5) extended from November 1999 through
personnel; (6) develops and/or evaluates coordinates, further develops, enables April 2000. Direct assessments and
the effectiveness of both experimental wider use, and maintains the NHSN, (a interviews were conducted with the
and applied interventions to promote web-based system for healthcare children themselves, their primary
healthcare worker safety; (7) develops, facilities throughout the U.S. to collect caregivers, their caseworkers, and, for
promotes, and monitors implementation and analyze their own data and share school-aged children, their teachers;
of interventions to prevent transmission data with DHQP and other organizations agency directors also were interviewed
of healthcare-associated HIV infections on healthcare-associated adverse events at baseline. Follow-up data collections
and conducts case investigations of and process-of-care measures) to obtain were conducted 12 months, 18 months,
occupational HIV infections; (8) scientifically valid clinical performance and 36 months post-baseline, and a fifth
conducts research, including applied indices and benchmarks that promote data collection is currently under way.
epidemiologic and clinical, to prevent healthcare quality and value at the The NSCAW is the only source of
healthcare-associated infections and facility, state, and national levels; (6) nationally representative, firsthand
antimicrobial resistant infections; (9) conducts applied research to identify information about the functioning and
provides expert consultation, guidance, and develop innovative methods to well-being, service needs, and service
and technical support to other branches detect and monitor healthcare- utilization of children and families who
in the division, across the agency, to associated infections and antimicrobial come to the attention of the child
domestic and international partners, resistance; (7) conducts special studies welfare system. Information is collected
and the U.S. public on the epidemiology and provides national estimates of about children’s cognitive, social,
and prevention of healthcare-associated targeted, healthcare-associated adverse emotional, behavioral, and adaptive
infections, related community events, antimicrobial use and resistance functioning, as well as family and
infections, antimicrobial resistance, and patterns, and the extent to which community factors that are likely to
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exposures/injuries among healthcare prevention and control safeguards are in influence their functioning. Family
personnel; and (10) provides use to protect at-risk patients across the service needs and service utilization
epidemiology support to clinical and spectrum of healthcare delivery sites; also are addressed in the data collection.
environmental microbiology branch to and (8) uses NHSN and other data The current data collection plan calls
identify new strategies to prevent sources to conduct special studies and for selecting a new cohort of 5,700

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