Att B Published 60d FRN

43828

Federal Register / Vol. 77, No. 144 / Thursday, July 26, 2012 / Notices

NICEATM and ICCVAM are
organizing the workshop in
collaboration with partner organizations
in the International Cooperation on
Alternative Test Methods (ICATM): the
European Union Reference Laboratory
for Alternatives to Animal Testing
(EURL ECVAM), the Japanese Center for
the Validation of Alternative Methods,
the Korean Center for the Validation of
Alternative Methods, and Health
Canada. Cosponsors include EURL
ECVAM, the Animal Health Institute,
the International Alliance for Biological
Standardization, and the USDA Center
for Veterinary Biologics.

of the NIEHS under NICEATM.
NICEATM administers ICCVAM,
provides scientific and operational
support for ICCVAM-related activities,
and conducts independent validation
studies to assess the usefulness and
limitations of new, revised, and
alternative test methods and strategies.
NICEATM and ICCVAM welcome the
public nomination of new, revised, and
alternative test methods and strategies
applicable to the needs of U.S. Federal
agencies. Additional information about
ICCVAM and NICEATM can be found
on the NICEATM–ICCVAM Web site
(http://iccvam.niehs.nih.gov).

Preliminary Workshop Agenda and
Registration
Registration information, draft
agenda, and additional meeting
information are available on the
NICEATM–ICCVAM Web site (http://
iccvam.niehs.nih.gov/meetings/
LeptoVaccWksp-2012/
LeptoVaccWksp.htm) and upon request
from NICEATM (see FOR FURTHER
INFORMATION CONTACT).

References

TKELLEY on DSK3SPTVN1PROD with NOTICES

Call for Abstract Submissions
NICEATM and ICCVAM invite the
submission of abstracts for scientific
posters to be displayed during this
workshop. Guidelines for the
submission of abstracts are available at
http://iccvam.niehs.nih.gov/meetings/
LeptoVaccWksp-2012/LeptoWkspAbstractSubmit-508.pdf. Abstracts must
be submitted by email to
[email protected]. The deadline
for abstract submission is August 13,
2012. The corresponding author will be
notified regarding the abstract’s
acceptance within 7 working days of the
submission deadline. Guidelines for
poster presentations will be sent to the
corresponding authors with notification
of acceptances.
Background Information on NICEATM
and ICCVAM
ICCVAM is an interagency committee
composed of representatives from 15
Federal regulatory and research agencies
that require, use, generate, or
disseminate toxicological and safety
testing information. ICCVAM conducts
technical evaluations of new, revised,
and alternative safety testing methods
and integrated testing strategies with
regulatory applicability and promotes
the scientific validation and regulatory
acceptance of testing methods that more
accurately assess the safety and hazards
of chemicals and products and that
reduce, refine, or replace animal use.
The ICCVAM Authorization Act of 2000
(42 U.S.C. 285l–3) established ICCVAM
as a permanent interagency committee

VerDate Mar<15>2010

16:42 Jul 25, 2012

Jkt 226001

Kulpa-Eddy J. 2012. Successful
Development and Validation of an In Vitro
Replacement Assay for Leptospira Vaccine
Potency Tests. In: Proceedings of an
International Scientific Workshop on Potency
Testing of Veterinary Vaccines for Animals:
The Way from In Vivo to In Vitro; Langen,
Germany; 1–3 December 2010 (Jungba¨ck, C,
ed.). Basel: Karger.
USDA. 2009a. SAM 624: Supplemental
Assay Method for In Vitro Potency Testing of
Leptospira interrogans Serovar pomona
Bacterins. Washington, DC:USDA Animal
and Plant Health Inspection Service.
Available: http://www.aphis.usda.gov/
animal_health/vet_biologics/
vb_sams_600_series.shtml.
USDA. 2009b. SAM 625: Supplemental
Assay Method for In Vitro Potency Testing of
Leptospira interrogans Serovar canicola
Bacterins. Washington, DC:USDA Animal
and Plant Health Inspection Service.
Available: http://www.aphis.usda.gov/
animal_health/vet_biologics/
vb_sams_600_series.shtml.
USDA. 2009c. SAM 627: Supplemental
Assay Method for In Vitro Potency Testing of
Leptospira interrogans Serovar
icterohaemorrhagiaea Bacterins. Washington,
DC:USDA Animal and Plant Health
Inspection Service. Available: http://
www.aphis.usda.gov/animal_health/
vet_biologics/vb_sams_600_series.shtml.
USDA. 2011. SAM 626: Supplemental
Assay Method for In Vitro Potency Testing of
Leptospira kirschneri serogroup
grippotyphosa Bacterins. Washington,
DC:USDA Animal and Plant Health
Inspection Service. Available: http://
www.aphis.usda.gov/animal_health/
vet_biologics/vb_sams_600_series.shtml.
Stokes WS, Kulpa-Eddy J, McFarland R.
2011. The International Workshop on
Alternative Methods to Reduce, Refine, and
Replace the Use of Animals in Vaccine
Potency and Safety Testing: introduction and
summary. In: International Workshop on
Alternative Methods to Reduce, Refine, and
Replace the Use of Animals in Vaccine
Potency and Safety Testing: State of the
Science and Future Directions (Kulpa-Eddy J,
McFarland R, Stokes WS, eds). Procedia
Vaccinol 5: 1–15.

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Dated: July 19, 2012.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2012–18294 Filed 7–25–12; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-12–0666]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 and
send comments to Kimberly S. Lane,
CDC Reports Clearance Officer, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to [email protected].
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
National Healthcare Safety Network
(NHSN) (OMB No. 0920–0666), exp. 01/
31/2015—Revision—National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The National Healthcare Safety
Network (NHSN) is a system designed to
accumulate, exchange, and integrate
relevant information and resources
among private and public stakeholders
to support local and national efforts to

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Federal Register / Vol. 77, No. 144 / Thursday, July 26, 2012 / Notices
protect patients and promote healthcare
safety. Specifically, the data is used to
determine the magnitude of various
healthcare-associated adverse events
and trends in the rates of these events
among patients and healthcare workers
with similar risks. The data will be used
to detect changes in the epidemiology of
adverse events resulting from new and
current medical therapies and changing
risks. The NHSN consists of four
components: Patient Safety, Healthcare
Personnel Safety, Biovigilance, and
Long-Term Care Facility (LTCF). In
general, the data reported under the
Patient Safety Component protocols are
used to (1) determine the magnitude of
the healthcare-associated adverse events
under study, trends in the rates of
events, in the distribution of pathogens,
and in the adherence to prevention
practices, and (2) to detect changes in
the epidemiology of adverse events
resulting from new medical therapies
and changing patient risks.
Additionally, reported data will be used
to describe the epidemiology of
antimicrobial use and resistance and to
understand the relationship of
antimicrobial therapy to this growing
problem. Under the Healthcare
Personnel Safety Component protocols,
data on events, both positive and
adverse, are used to determine (1) the
magnitude of adverse events in

package to clarify and/or update
surveillance definitions. Six forms have
been removed for the purposes of
simplification from the Healthcare
Personnel Safety Component of the
package due to changes within NHSN
reporting of healthcare personnel
influenza vaccination. Old functionality
of individual level vaccination reporting
will be removed from NHSN. CMS
Inpatient Quality Reporting (IQR)
requirements designate that all acute
care facilities will report healthcare
personnel vaccination counts at the
summary level for the 2012–2013 flu
season.
The previously approved NSHN
package included 54 individual
collection forms; the current revision
request removes six forms for a total of
48 forms. The reporting burden will
decrease by 415,523 hours, for a total of
3,562,653 hours.
Healthcare institutions that
participate in NHSN report their data to
CDC using a web browser based
technology for data entry and data
management. Data are collected by
trained surveillance personnel using
written standardized protocols.
Participating institutions must have a
computer capable of supporting an
Internet service provider (ISP) and
access to an ISP. There is no cost to
respondents other than their time.

healthcare personnel and (2)
compliance with immunization and
sharps injuries safety guidelines. Under
the Biovigilance Component, data on
adverse reactions and incidents
associated with blood transfusions are
used to provide national estimates of
adverse reactions and incidents. The
Long-Term Care Facility (LTCF)
Component is used to more specifically
and appropriately capture data from the
residents of skilled nursing facilities.
Surveillance methods and definitions
for this component specifically address
the nuances of LTCF residents.
This revision submission includes
major revisions to the Patient Safety
Component—Outpatient Dialysis Center
Practices Survey (Form 57.104) in an
effort to provide further clarification to
those collecting the information.
Additionally, some of the changes have
been made to improve surveillance data
available for the outpatient dialysis
population. Due to the CMS End Stage
Renal Disease (ESRD) Quality
Improvement Program (QIP) reporting
requirements, over 5,700 dialysis
facilities have already enrolled or will
enroll into NHSN to report data in 2012.
Form 57.104 is completed by each
facility upon enrollment into NHSN and
then every January thereafter.
Furthermore, minor revisions have
been made to 28 other forms within the

ESTIMATE OF ANNUALIZED BURDEN HOURS
Form number and name
57.100: NHSN Registration Form .....
57.101: Facility Contact Information
57.103: Patient Safety Component—
Annual Hospital Survey.
57.104: Patient Safety Component—
Outpatient Dialysis Center Practices Survey.
57.105: Group Contact Information ..
57.106: Patient Safety Monthly Reporting Plan.
57.108: Primary Bloodstream Infection (BSI).
57.109: Dialysis Event ......................
57.111: Pneumonia (PNEU) .............

TKELLEY on DSK3SPTVN1PROD with NOTICES

57.112: Ventilator-Associated Event
57.114: Urinary Tract Infection (UTI)
57.116: Denominators for Neonatal
Intensive Care Unit (NICU).
57.117: Denominators for Specialty
Care Area (SCA)/Oncology (ONC).
57.118: Denominators for Intensive
Care Unit (ICU)/Other locations
(not NICU or SCA).
57.119: Denominator for Outpatient
Dialysis.

VerDate Mar<15>2010

16:42 Jul 25, 2012

Number of
respondents

Type of respondents
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).

Number of
responses per
respondent

Avg. Burden
per response
(in hours)

Total burden
(in hours)

(Infection

2,000

1

5/60

167

(Infection

2,000

1

10/60

333

(Infection

6,000

1

30/60

3,000

(Infection

5,700

1

1.5

8,550

Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Staff RN ............................................
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Infection Preventionist ......................
Staff RN ............................................

6,000

1

5/60

500

10,000

12

35/60

70,000

6,000

36

35/60

126,000

5,700
6,000

60
72

16/60
32/60

91,200
230,400

6,000

144

25/60

360,000

6,000
6,000

27
9

32/60
3

86,400
162,000

Staff RN ............................................

6,000

9

5

270,000

Staff RN ............................................

6,000

18

5

540,000

Staff RN ............................................

5,700

12

6/60

6,840

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Federal Register / Vol. 77, No. 144 / Thursday, July 26, 2012 / Notices
ESTIMATE OF ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent

Avg. Burden
per response
(in hours)

Total burden
(in hours)

Type of respondents

57.120: Surgical Site Infection (SSI)

Registered
Nurse
(Infection
Preventionist).
Staff RN ............................................
Laboratory Technician ......................

6,000

36

32/60

115,200

6,000
6,000

540
12

5/60
5/60

270,000
6,000

Pharmacy Technician .......................

6,000

12

5/60

6,000

Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).

(Infection

1,000

100

5/60

8,333

(Infection

6,000

72

32/60

230,400

(Infection

6,000

24

10/60

24,000

Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).

(Infection

6,000

240

15/60

360,000

(Infection

6,000

5

14

420,000

(Infection

2,000

5

2

20,000

(Infection

2,000

250

10/60

83,333

(Infection

250

1

45/60

188

(Infection

250

8

15/60

500

(Infection

250

12

5/60

250

Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Occupational Health RN/Specialist ..

250

9

30/60

1,125

250

12

5/60

250

250

12

3

9,000

250

12

5/60

250

400

1

30/60

200

1,000

1

25/60

417

100

1

8

800

Occupational Health RN/Specialist ..

100

9

10/60

150

Occupational Health RN/Specialist ..

100

200

20/60

6,667

Occupational Health RN/Specialist ..

100

50

1

5,000

Occupational Health RN/Specialist ..

100

30

15/60

750

Laboratory Technician ......................

100

50

15/60

1,250

Occupational Health RN/Specialist ..

600

50

10/60

5,000

Medical/Clinical
nologist.
Medical/Clinical
nologist.
Medical/Clinical
nologist.
Medical/Clinical
nologist.
Medical/Clinical
nologist.

57.121: Denominator for Procedure
57.123: Antimicrobial Use and Resistance (AUR)-Microbiology Data
Electronic Upload Specification
Tables.
57.124: Antimicrobial Use and Resistance (AUR)-Pharmacy Data
Electronic Upload Specification
Tables.
57.125: Central Line Insertion Practices Adherence Monitoring.
57.126: MDRO or CDI Infection
Form.
57.127: MDRO and CDI Prevention
Process and Outcome Measures
Monthly Monitoring.
57.128: Laboratory-identified MDRO
or CDI Event.
57.130: Vaccination Monthly Monitoring Form–Summary Method.
57.131: Vaccination Monthly Monitoring Form–Patient-Level Method.
57.133: Patient Vaccination ..............
57.137: Long-Term Care Facility
Component—Annual Facility Survey.
57.138: Laboratory-identified MDRO
or CDI Event for LTCF.
57.139: MDRO and CDI Prevention
Process Measures Monthly Monitoring for LTCF.
57.140: Urinary Tract Infection (UTI)
for LTCF.
57.141: Monthly Reporting Plan for
LTCF.
57.142: Denominators for LTCF Locations.
57.143: Prevention Process Measures Monthly Monitoring for LTCF.
57.150: LTAC Annual Survey ...........
57.151: Rehab Annual Survey ..........

TKELLEY on DSK3SPTVN1PROD with NOTICES

Number of
respondents

Form number and name

57.200: Healthcare Personnel Safety
Component Annual Facility Survey.
57.203: Healthcare Personnel Safety
Monthly Reporting Plan.
57.204: Healthcare Worker Demographic Data.
57.205: Exposure to Blood/Body
Fluids.
57.206: Healthcare Worker Prophylaxis/Treatment.
57.207: Follow-Up Laboratory Testing.
57.210: Healthcare Worker Prophylaxis/Treatment-Influenza.
57.300: Hemovigilance Module Annual Survey.
57.301:
Hemovigilance
Module
Monthly Reporting Plan.
57.302:
Hemovigilance
Module
Monthly Incident Summary.
57.303:
Hemovigilance
Module
Monthly Reporting Denominators.
57.304: Hemovigilance Adverse Reaction.

VerDate Mar<15>2010

16:42 Jul 25, 2012

Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).

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Laboratory

Tech-

500

1

2

1,000

Laboratory

Tech-

500

12

2/60

200

Laboratory

Tech-

500

12

2

12,000

Laboratory

Tech-

500

12

30/60

3,000

Laboratory

Tech-

500

120

10/60

10,000

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Federal Register / Vol. 77, No. 144 / Thursday, July 26, 2012 / Notices
ESTIMATE OF ANNUALIZED BURDEN HOURS—Continued
Form number and name
57.305: Hemovigilance Incident ........
Total Est Annual Burden Hours

Medical/Clinical
nologist.

72

10/60

6,000

...........................................................

........................

........................

........................

3,562,653

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 77 FR 27070–27071,
dated May 8, 2012) is amended to
reorganize the Human Capital and
Resources Management Office, Office of
the Chief Operating Officer, Centers for
Disease Control and Prevention.
Section C–B, Organization and
Functions, is hereby amended as
follows:
Delete in its entirety the titles and
functional statements for the Human
Capital and Resources Management
Office (CAJQ) and insert the following:
Human Capital and Resources
Management Office (CAJ0). (1) Provides
leadership, policy formation, oversight,
guidance, service, and advisory support
and assistance to the Centers for Disease
Control and Prevention (CDC) and the
Agency for Toxic Substances and
Disease Registry (ATSDR); (2)
collaborates as appropriate, with the
CDC Office of the Director (OD),
Centers/Institute/Offices (CI0s),
domestic and international agencies and
organizations; and provides a focus for
short- and long-term planning within
the Human Capital and Resource
Management Office (HCRM0); (3)
develops and administers human capital
and human resource management

16:42 Jul 25, 2012

Total burden
(in hours)

500

[FR Doc. 2012–17987 Filed 7–25–12; 8:45 am]

VerDate Mar<15>2010

Avg. Burden
per response
(in hours)

Tech-

Dated: July 3, 2012.
Kimberly S. Lane,
Deputy Director, Office of Scientific Integrity,
Office of the Associate Director for Science,
Office of the Director, Centers for Disease
Control and Prevention.

Jkt 226001

Laboratory

Number of
responses per
respondent

Number of
respondents

Type of respondents

policies; (4) serves as the business
steward for all CDC developed human
capital and human resources
management systems and applications;
(5) develops, maintains, and supports
information systems to conduct
personnel activities and provide timely
information and analyses of personnel
and staffing to management and
employees; (6) conducts and
coordinates human resources
management for civil service and
Commissioned Corps personnel; (7)
manages the administration of
fellowship programs; (8) conducts
recruitment, special emphasis, staffing,
position classification, position
management, pay and leave
administration, work-life programs,
performance management, employee
training and development, and
employee and labor relations programs;
(9) maintains personnel records and
reports, and processes personnel actions
and documents; (10) administers the
federal life and health insurance
programs; (11) administers employee
recognition, suggestion, and incentive
awards programs; (12) furnishes advice
and assistance in the processing of
workers compensation claims; (13)
interprets standards of conduct
regulations, reviewing financial
disclosure reports, and offer ethics
training and counseling services to CDC
employees; (14) maintains liaison with
the Department of Health and Human
Services (HHS) and the Office of
Personnel Management (OPM) on
human resources management, policy,
compliance and execution of the Human
Capital Assessment and Accountability
Framework (HCAAF); (15) conducts
organizational assessments to determine
compliance with human capital
policies, guidance, regulatory and
statutory requirements of federal human
capital and resource management
programs and initiatives; (16) plans,
directs, and manages CDC-wide training
programs, monitors compliance with
mandatory training requirements, and
maximizes economies of scale through
systematic planning and valuation of
agency-wide training initiatives to assist
employees in achieving required
competencies; (17) assists in the

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definition and analysis of training needs
and develops and evaluates
instructional products designed to meet
those needs; (18) develops, designs, and
implements a comprehensive leadership
and career management program for all
occupational series throughout CDC;
(19) provides technical assistance in
organizational development, career
management, employee development,
and training; (20) collaborates and
works with partners, internally and
externally, to develop workforce goals
and a strategic vision for the public
health workforce; and (21) provides
support for succession planning,
forecasting services, and environmental
scanning to ascertain both current and
future public health workforce needs.
Office of the Director (CAJQ1). (1)
Provides leadership and overall
direction for HCRMO; (2) develops goals
and objectives, and provides leadership,
policy formation, oversight, and
guidance in program planning and
development; (3) plans, coordinates,
and develops strategic plans for
HCRMO; (4) develops and administers
human capital and human resource
management policies and procedures;
(5) coordinates all program reviews; (6)
reviews, prepares, coordinates, and
develops proposed legislation,
Congressional testimony, and briefing
materials; (7) establishes performance
metrics and coordinates quarterly
reviews to ascertain status on meeting of
the metrics; (8) coordinates budget
formulation, negotiation, and execution
of financial resources; (9) identifies
relevant scanning/benchmarking on
workforce and career development
processes, services and products; (10)
provides leadership and guidance on
new developments and national trends
for public health workforce; (11)
establishes and oversees policies
governing human capital and human
resources management, and works
collaboratively within CDC and other
components in planning, developing
and implementing policies; (12)
develops strategic plans for information
technology and information systems
required to support human capital and
human resources management
information requirements; (13) serves as

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