Attachment E - 60 Day Federal Register Notice

Federal Register / Vol. 72, No. 143 / Thursday, July 26, 2007 / Notices
relevant to this determination shall
include but will not be limited to:
(i) The existence of separate
personnel, management, and
governance;
(ii) The existence of separate
accounts, accounting records, and
timekeeping records;
(iii) The degree of separation from
facilities, equipment and supplies used
by the affiliated organization to conduct
restricted activities, and the extent of
such restricted activities by the affiliate;
(iv) The extent to which signs and
other forms of identification which
distinguish the Recipient from the
affiliated organization are present, and
signs and materials that could be
associated with the affiliated
organization or restricted activities are
absent; and
(v) The extent to which HHS, the U.S.
Government and the project name are
protected from public association with
the affiliated organization and its
restricted activities in materials such as
publications, conference and press or
public statements.
EFFECTIVE DATE: This guidance is
effective on the final date of publication.
Dated: July 23, 2007.
William R. Steiger,
Director.
[FR Doc. 07–3658 Filed 7–23–07; 11:59 am]
BILLING CODE 4150–38–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–07–0666]

rwilkins on PROD1PC63 with NOTICES

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 404–639–5960 and
send comments to Maryam I. Daneshvar,
CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an e-mail to
[email protected].
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance

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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 Control No. 0920–
0666)—Revision—National Center for
Preparedness, Detection, and Control of
Infectious Diseases (NCPDCID), 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
protect patients and to 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.
Healthcare institutions that
participate in NHSN voluntarily report
their data to CDC using a web browserbased technology for data entry and data
management. Data are collected by
trained surveillance personnel using
written standardized protocols. This
application to OMB includes a
significant increase in the number of
burden hours to the previously
approved data collection. The increase
is due to inclusion of new forms and an
increased number of respondents.
NHSN was first approved by OMB in
2005 and CDC proposes to revise this
data collection by adding new modules
to the NHSN as well as modifying
currently approved forms. Four new
forms are proposed: (1) Healthcare
Worker Influenza Vaccination form; (2)
Healthcare Worker Influenza Antiviral
Medication Administration form; (3)
Pre-season survey on Influenza
Vaccination Programs for Healthcare
Workers; and (4) Post-season Survey on
Influenza Vaccination Programs for

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Healthcare Workers. The purpose of
these new forms is to help participating
healthcare institutions and CDC to: (1)
Monitor influenza vaccination coverage
among healthcare personnel at
individual facilities and to provide
aggregate coverage estimates for all
participating facilities; (2) monitor
progress towards attaining the Healthy
People 2010 goal of 60% vaccination
coverage among healthcare personnel;
(3) monitor influenza vaccination
coverage by ward/unit of the facility or
occupational group so that areas or
groups with low vaccination rates can
be targeted for interventions; (4) monitor
adverse reactions related to receipt of
the vaccine or receipt of antiviral
medications; and (5) assess the
characteristics of influenza vaccination
programs pre- and post-influenza season
to identify practices associated with
high immunization rates. The total
estimated annual burden for these forms
is 13,800 hours.
CDC is proposing to add an additional
form, Central Line Insertion Practices
Monitoring Form, to the Patient Safety
Component Device Associated Module.
This new form will enable participating
facilities and CDC to (1) monitor central
line insertion practices in individual
patient care units and facilities and
provide aggregate data for all
participating facilities (facilities have
the option of recording inserter-specific
adherence data); (2) link gaps in
recommended practice with the clinical
outcome both in individual facilities
and for all participating facilities; (3)
facilitate quality improvement by
identifying specific gaps in adherence to
recommended prevention practices,
thereby helping to target intervention
strategies for reducing central line
infection rates. The total estimated
annual burden for this form is 12,500
hours.
CDC proposes to add the Multi-Drug
Resistant Organism (MDRO) Prevention
Process Monitoring Module to the
Patient Safety Component. This module
consists of four forms: (1) MDRO
Prevention Process Monitoring Form; (2)
MDRO Infection Event Form; (3)
Laboratory-identified MDRO Event
Form; and (4) Laboratory-identified
MDRO Event Summary Form. The
purpose of these forms is to: (1) Monitor
processes and practices in individual
patient care units and facilities and to
provide aggregate adherence data for all
participating facilities; (2) link gaps in
recommended practice with the clinical
outcome (i.e., MDRO infection) both in
individual facilities and for all
participating facilities; (3) facilitate
quality improvement by identifying
specific gaps in adherence to

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Federal Register / Vol. 72, No. 143 / Thursday, July 26, 2007 / Notices

recommended prevention practices,
thereby helping to target intervention
strategies for reducing MDRO infection
rates. The total estimated annual burden
for these forms is 244,500 hours.
The fourth new proposed collection to
the NHSN is the High Risk Inpatient
Influenza Vaccination Module. This
module consists of four forms: (1)
Influenza High Risk Inpatient Influenza
Vaccine Summary Form—Method A; (2)
Influenza High Risk Inpatient Influenza
Vaccine Summary Form—Numerator
Data Form Method B; (3) Influenza High
Risk Inpatient Influenza Vaccine
Summary Form—Method B; and (4)
Influenza High Risk Inpatient Influenza
Vaccine—Denominator Form Method B.
The purpose of these forms is to: (1)
Monitor influenza vaccination practices
for high risk patients and provide
aggregate data in regard to the number
of high risk patients receiving

on all of the types of facilities that
utilize the NHSN. The total estimated
annual burden for this form is 38 hours.
Finally, CDC also proposes to make
minor edits and modifications to
currently approved forms.
CDC is also adding an increased
number of participating healthcare
institutions from a wide spectrum of
settings. Part of this increase in burden
hours is due to the passage of legislation
in many states requiring mandatory
reporting of healthcare-associated
infections. Some states plan to use or
are using NHSN as their data collection
system to meet this mandate.
Participating institutions must have a
computer capable of supporting an
Internet service provider (ISP) and
access to an ISP. The only other cost to
respondents is their time to complete
the appropriate forms.

vaccination, those already vaccinated,
and those who decline due to medical
contraindications or other reasons; and
(2) to identify reasons that high risk
patients are not receiving influenza
vaccination. The total estimated annual
burden of these forms is 161,250 hours.
CDC is also proposing to open
enrollment to any healthcare facility;
therefore this submission includes a
registration form (Registration Form) to
collect necessary registration
information. The total estimated annual
burden for this form is 125 hours.
A Long Term Acute Care Hospital
(LTACH) survey form is included in this
submission. This survey will allow long
term acute care hospitals and CDC to
collect information on LTACH
characteristics, infection control
practices, and microbiology laboratory
practices. This data will provide CDC
with more comprehensive information

ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
respondents

rwilkins on PROD1PC63 with NOTICES

Form

Facility Contact Information .............................................................................
Patient Safety Component Hospital Survey ....................................................
Agreement to Participate and Consent ...........................................................
Group Contact Information ..............................................................................
Patient Safety Monthly Reporting Plan ............................................................
Healthcare Personnel Safety Reporting Plan ..................................................
Primary Bloodstream Infection (BSI) ...............................................................
Pneumonia (PNEU)—also includes Any Patient Pneumonia Flow Diagram
and Infant and Children Pneumonia Flow Diagram .....................................
Urinary Tract Infection (UTI) ............................................................................
Surgical Site Infection (SSI) ............................................................................
Dialysis (DI) .....................................................................................................
Antimicrobial Use and Resistance (AUR)—Microbiology Laboratory Data .....
Antimicrobial Use and Resistance—Pharmacy Data ......................................
Denominators for Intensive Care Unit (ICU)/Other locations (Not NICU or
SCA) .............................................................................................................
Denominators for Specialty Care Area (SCA) .................................................
Denominators for Neonatal Intensive Care Unit (NICU) .................................
Denominator for Procedure .............................................................................
Denominator for Outpatient Dialysis ................................................................
Patient Safety Component—Outpatient Dialysis Center Practices Survey .....
List of Blood Isolates .......................................................................................
Manual Categorization of Positive Blood Cultures ..........................................
Exposures to Blood/Body Fluids .....................................................................
Healthcare Personnel Post-exposure Prophylaxis ..........................................
Healthcare Personnel Demographic Data .......................................................
Healthcare Personnel Vaccination History ......................................................
Annual Facility Survey .....................................................................................
Implementation of Engineering Controls .........................................................
Healthcare Worker Survey ..............................................................................
Healthcare Personnel Influenza Vaccination Form .........................................
Healthcare Personnel Influenza Antiviral Medication Administration Form ....
Pre-season Survey on Influenza Vaccination Programs for Healthcare
Workers ........................................................................................................
Post-Season Survey on Influenza Vaccination Programs for Healthcare
Workers ........................................................................................................
Central Line Insertion Practices Adherence Monitoring Form (CLIP) .............
Laboratory Testing ...........................................................................................
MDRO Prevention Process and Outcome Measures Monthly Monitoring
Form .............................................................................................................
MDRO Infection Event Form ...........................................................................
Laboratory Identified MDRO Event Form (LIME) ............................................
Registration Form ............................................................................................

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Average
number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
hours

1,500
1,500
1,500
1,500
1,500
150
1,500

1
1
1
1
9
9
36

10/60
30/60
15/60
5/60
35/60
10/60
30/60

250
750
375
125
7,875
225
27,000

1,500
1,500
1,500
80
1,500
1,500

72
27
27
90
45
36

30/60
30/60
30/60
15/60
3
2

54,000
20,250
20,250
1,800
202,500
108,000

1,500
1,500
1,500
1,500
80
80
1,500
1,500
150
150
150
150
150
150
150
150
150

18
9
9
540
9
1
1
1
50
10
200
300
1
1
100
500
50

5
5
4
8/60
5/60
1
1
1
1
15/60
20/60
10/60
8
30/60
10/60
10/60
10/60

135,000
67,500
54,000
108,000
60
80
1,500
1,500
7,500
375
10,000
7,500
1,200
75
2,500
12,500
1,250

150

1

10/60

25

150
1,500
150

1
100
100

10/60
5/60
15/60

25
12,500
3,750

1,500
1,500
1,500
1,500

24
72
240
1

10/60
30/60
30/60
5/60

6,000
54,000
180,000
125

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Federal Register / Vol. 72, No. 143 / Thursday, July 26, 2007 / Notices
ESTIMATE OF ANNUALIZED BURDEN HOURS—Continued
Average
burden per
response
(in hours)

Total burden
hours

High Risk Inpatient Influenza Vaccine—Summary Form Method A ...............
High Risk Inpatient Influenza Vaccine-Numerator Data Form Method B .......
High Risk Inpatient Influenza Vaccine—Summary Form Method B ...............
High Risk Inpatient Influenza Vaccine—Denominator Data Form Method B
Laboratory Identified MDRO Event—Summary Form .....................................
Long-term Acute Care Hospital Survey ...........................................................

1,500
500
500
500
1,500
75

5
250
5
250
3
1

16
10/60
4
5/60
1
30/60

120,000
20,833
10,000
10,417
4,500
38

Total ..........................................................................................................

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

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

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

1,276,153

Dated: July 19, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–14432 Filed 7–25–07; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–07–0106]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

rwilkins on PROD1PC63 with NOTICES

Average
number of
responses per
respondent

Number of
respondents

Form

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 404–639–5960 and
send comments to Maryam I. Daneshvar,
CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an e-mail 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

VerDate Aug<31>2005

17:41 Jul 25, 2007

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be received within 60 days of this
notice.
Proposed Project
Preventive Health and Health Services
Block Grant, Annual Application and
Reports—Revision—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
In 1994, OMB approved the collection
of information provided in the grant
applications and annual reports for the
Preventive Health and Health Services
Block Grant (OMB #0920–0106). This
approval expires on October 31, 2008.
* * * CDC is requesting OMB clearance
for this legislatively mandated
information collection until January 31,
2011. The request is to approve the
development and adherence to Healthy
People 2010, the Nation’s Health
Objectives which was released the
Spring of 2000. The PHHS block grant
is mandated according to section 1904
to adhere to the Healthy People
framework, therefore, the current
application and report format was
restructured to coincide with 2010.
This information collected through
the applications from the official State
health agencies is required from section
1905 of the Public Health Service Act.
The information collected from the
annual reports is required by section
1906. * * * The data collection tool is
being moved from software that is
installed to each user’s desktop to a
web-based system. The following
changes will be incorporated into the
web-based system: (1) Applications are
referred to as Work Plans, (2) Grantees
are asked to submit Work Plans within
recommended page ranges based on the
amount of funding with the objective of
reducing the number of pages submitted
per grantee, (3) Review functions have
been added to the Work Plan, Success
Stories, and Annual Report sections, (4)
The rationale that was used by the
Preventive Health and Health Services

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Block Grant (PHHSBG) Advisory
Committee to prioritize use of PHHSBG
funds is identified via check boxes
versus a free form text field, (5)
Information is captured relative to the
percent of time dedicated to the
PHHSBG by the Block Grant
Coordinator and other Full Time
Equivalents (FTEs) that are paid for in
whole or in part with Block Grant
dollars, (6) Grantees select the Evidence
Based Guideline or Best Practice that is
used as the basis for interventions from
a pre-defined list, (7) Grantees select the
CDC Goals that are being addressed with
Block Grant Funds from a pre-defined
list and identify the location wherein
the funds are being applied, (8)
Information items are broken down into
discrete fields, for example, specific
begin and end dates are entered for
objectives and activities, and the
components for a SMART (Specific
Measurable Achievable, Realistic and
Time based) objective are entered
individually versus via free form text
fields, (9) Grantees select a percent from
a pre-defined list in the Annual Report
section to identify the extent to which
objectives and activities have been
accomplished. Written detail is
provided only for those items that are
‘exceptions’ to projected outcomes, (10)
A Compliance Review section has been
added to provide grantees with general
information regarding the Compliance
Review process and specific information
that pertains to past reviews of their
state/territory/tribe.
The total burden hours is estimated at
3355 hours, a reduction of 915 hours
below the previous data collection
estimate (4270). The number of hours is
equal to 61 grantees × 25 hours (1525
hrs) for completion of the application
and 61 grantees × 30 hours (1830 hrs)
for completion of the annual report.
Respondent burden is based upon
experience with the Grant Application
and Reporting system that is used to
complete applications and annual
reports.

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