Attachment S--Federal Register Notice

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Number of
respondents

Data collection

Number of
responses per
respondent

Hours per
response

Total burden
hours

Screening Questionnaire .................................................................................
In-Person Focus Groups EHR Users only ......................................................
Virtual Focus Groups EHR Users only ............................................................
Virtual Focus Groups EHR Non-users only .....................................................

300
40
29
20

1
1
1
1

12/60
2
2
1.5

60
80
58
30

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

389

na

na

228

Exhibit 2. Estimated Annualized Cost
Burden
Number of
respondents

Data collection

Total burden
hours

Average hourly wage rate*

Total cost
burden

Screening Questionnaire .................................................................................
In-Person Focus Groups EHR Users only ......................................................
Virtual Focus Groups EHR Users only ............................................................
Virtual Focus Groups EHR Non-users only .....................................................

300
40
29
20

60
80
58
30

73.66
73.66
73.66
73.66

$4,420
5,893
4,272
2,210

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

389

228

na

$16,795

*Hourly wage rate is the weighted average of hourly rates of the types of professionals who will complete the screening questionnaire and participate in the focus groups. The weighted average includes the following occupational codes and wage rates: 29–1065 (Pediatricians, General),
$78.67; 29–1069 (Physicians and Surgeons, all others), $97.35; 29–1021 (Dentists, General), $76.61; 29–1111 (Registered Nurses, includes
Certified Nurse Midwives), $32.35; 29–1071 (Physician Assistants), $41.86. Source: ‘‘National Compensation Survey: Occupational Wages in the
United States 2009,’’ U.S. Department of Labor, Bureau of Labor Statistics.

Estimated Annual Costs to the Federal
Government

for conducting this research. The total
cost is estimated to be $424,493.

Exhibit 3. Estimated Total and
Annualized Cost

Exhibit 3 shows the estimated total
and annualized cost to the government

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Cost component

Total cost

Annualized
cost

Project Development .......................................................................................................................................................
Data Collection Activities .................................................................................................................................................
Data Processing and Analysis .........................................................................................................................................
Publication of Results ......................................................................................................................................................
Project Management ........................................................................................................................................................
Overhead .........................................................................................................................................................................

$79,313
99,464
49,732
38,415
37,601
119,968

$39,657
49,732
24,866
19,208
18,801
59,984

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

$424,493

$212,247

Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ healthcare
research and healthcare information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) 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 upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.

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Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: May 20, 2011.
Carolyn M. Clancy,
Director.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities; Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

[FR Doc. 2011–13740 Filed 6–2–11; 8:45 am]
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This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project: ‘‘Using
Nursing Home Antibiograms to Improve
Antibiotic Prescribing and Delivery.’’ In
accordance with the Paperwork

SUMMARY:

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Reduction Act, 44 U.S.C. 3501–3521,
AHRQ invites the public to comment on
this proposed information collection.
This proposed information collection
was previously published in the Federal
Register on March 25th, 2011 and
allowed 60 days for public comment. No
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment.
DATES: Comments on this notice must be
received by July 5, 2011.
ADDRESSES: Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by
e-mail at
OIRA_submission@omb.eop.gov
(attention: AHRQ’s desk officer).
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:

Proposed Project

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Using Nursing Home Antibiograms to
Improve Antibiotic Prescribing and
Delivery
Overuse and inappropriate use of
antibiotics, particularly broad-spectrum
antibiotics, is recognized as a serious
problem in nursing homes (NHs). The
adverse consequences of inappropriate
prescribing practices including drug
reactions/interactions, secondary
complications, and the emergence of
multi-drug resistant organisms, have
become more common. For example, in
one point-prevalence survey of 117 NH
residents, 43 percent were culturepositive for one or more antimicrobialresistant pathogens, including
methicillin-resistant staphylococcus
aureas (24 percent), extended-spectrum
+-lactamase-producing klebsiella
pneumoniae (18 percent) or Escherichia
coli (15 percent), and vancomycinresistant enterococci. Inappropriate
overprescribing and overuse of broadspectrum antibiotics, when narrower
spectrum drugs would suffice, are
believed to be important contributors to
this problem.
Physicians typically begin antibiotics
for suspected infections in NH residents
without waiting for bacteriology
laboratory culture results. If there is a
clinical failure (e.g., patient does not
improve), the physician may request a
bacteriology laboratory test, but will

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often try a second antibiotic without
waiting for culture confirmation. If a NH
resident is deteriorating, many NHs do
not try a second antibiotic but will
instead transfer the patient to a hospital
emergency department (ED). In the ED,
physicians must make quick decisions
about whether to continue the first
antibiotic prescribed in the NH or start
another, again often without culture
results.
NH patients are transferred to EDs for
all sorts of medical reasons, including
but not limited to infections. When NH
patients arrive at an ED, physicians may
identify a urinary tract, respiratory, or
other infection that was not the primary
reason for the ED visit. Thus, patients
may not leave the NH with a suspected
bacterial infection or taking any
antibiotics, but an infection is suspected
in the ED and the first antibiotic is
prescribed there.
As a result of the above complexities,
NHs are increasingly recognized as
reservoirs of antibiotic-resistant
bacteria. Antibiograms aggregate
information for an entire institution
over a period of several months or a
year. They display the organisms
present in clinical specimens sent for
laboratory testing, and the susceptibility
of each organisms to an array of
antibiotics. Antibiograms are routinely
prepared by hospital laboratories but are
not routine in the NH setting. The
culmination of this project will be a NH
Antibiogram toolkit so that NHs can
create facility-specific antibiograms that
are cost-effective and helpful to
physicians who must make antibiotic
prescription decisions without
bacteriology laboratory test results, for
patients in NHs, and for patients who
are transferred from the NH to the ED.
Outcomes of interest for antibiograms
include reduced reliance on broadspectrum antibiotics as initial therapy,
and fewer clinical failures of antibiotics
that are first prescribed. The
development of a toolkit will be the first
step in this process; future studies are
required to test the toolkit and,
subsequently, the effectiveness of NH
antibiograms.
The objectives of the study are to:
1. Develop a standardized method for
determining antibiotic susceptibility
patterns and developing NH-specific
antibiograms;
2. Extract preliminary data from NH
facilities of various sizes and types to
guide the development of the draft
toolkit; and
3. Develop a draft toolkit to guide a
wide variety of sizes and types of NHs
in developing and sharing antibiogram
information with prescribing providers

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(i.e., physicians and physician
extenders) and EDs.
Three NHs and one ED will
participate in this study, which will be
conducted in two phases. The first
phase will include one small NH and
one ED and is intended to test the data
collection instruments and to draft the
initial toolkit, including the creation of
a NH specific antibiogram. The second
phase will expand the study by adding
two larger NHs, while retaining the
same NH and ED as in the first phase
and is intended to further test the data
collection instruments and refine the
draft toolkit. Each phase will use the
same methods and data collections.
This study is being conducted by the
Agency for Healthcare Research and
Quality through its contractors, Abt
Associates and the Brigham and
Women’s Hospital ED, pursuant to the
Agency for Healthcare Research and
Quality’s statutory authority to conduct
and support research on healthcare and
on systems for the delivery of such care,
including activities with respect to the
quality, effectiveness, efficiency,
appropriateness and value of healthcare
services and with respect to quality
measurement and improvement. 42
U.S.C. 299a(a)(1) and (2).
Method of Collection
The following data collection
activities will be implemented to
achieve the objectives of this project:
(1) Medical Records Extraction.
Medical record data related to antibiotic
use will be extracted by the research
team at the three participating NHs and
one ED. The team will extract the
necessary data from the infection
control log and request access to
additional records (e.g., medication log
and/or patient medical record) as
needed to collect relevant data. Two
months of retrospective NH and ED
medical records will be reviewed prior
to the implementation period, on a
monthly basis during implementation,
and for one month post-implementation.
In the ED medical records will be
extracted for only those NH residents
who have been transferred to the ED
from one of the participating NHs. The
pre-implementation data will be
compared to the data collected during
implementation and postimplementation to see if the use of the
antibiogram report had an effect on
antibiotic use at the participating
facilities. It is unlikely, but possible,
that NH staff may be asked to assist the
research team with this task in the two
larger, Expansion Phase Two sites;
however, ED staff will not. Medical
record extraction during Phase One will

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occur prior to OMB clearance and will
be limited to 9 or fewer records.
(2) Provider Pre-Implementation and
Post-Implementation Questionnaires.
These questionnaires will be completed
by providers at both the NHs and ED
one month prior to implementation and
again in the final month of
implementation. NH and ED questions
differ somewhat, as do pre- and postimplementation surveys. In addition to
basic background questions such as the
providers’ title, type of residency and
length of practice, questions related to
their use and opinion of antibiograms
are included. The post-implementation
questionnaire contains three additional
questions related to the use of
antibiograms as well as a series of
vignettes administered before and after
the presentation of an antibiogram
report. These questionnaires will assess
change in the providers’ use and
opinion of antibiograms.
(3) Nurse Pre/Post-Implementation
Questionnaire. This questionnaire will
be administered one month prior to
implementation and again in the final
month of implementation. In addition to
basic background questions such as the
nurses’ title, position at the NH and
length of employment, questions related
to their use and opinion of antibiograms
are included. The same set of questions
are asked at each time period. This
questionnaire will measure any change

in the nurses’ use and opinion of
antibiograms.
(4) NH Leadership PostImplementation Questionnaire. This
questionnaire will be completed by the
NH administrator or the director of
nursing in the final month of the
implementation. In addition to basic
background questions such as their title,
position at the NH and length of
employment, questions are asked about
the impact the antibiograms had in
terms of antibiotic use, the cost
associated with their use and whether
they intend to continue using them once
the study has been completed.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in this
research. Although medical records
extraction using the NH and ED Data
Extraction Tools will occur at the NHs
and ED, the potential information
collection burden will be limited to staff
at each of the Expansion Phase 2 NHs.
Medical record data extraction will
occur monthly for 7 months at the two
Expansion Phase Two NHs and may
require 15 minutes assistance from the
NH staff.
The NH Provider Pre-Implementation
Questionnaire will be completed by 10
providers at each of the two Expansion
Phase Two NHs and will take about 10

minutes to complete. The NH Provider
Post-Implementation Questionnaire will
be completed by three providers in the
Initial Phase One NH and 10 providers
at each of the two Expansion Phase Two
NHs (23 total or an average of 7.67
providers per NH as shown in Exhibit
1) and takes 15 minutes to complete.
The ED Provider Post-Implementation
Questionnaire will be completed by 30
providers in the ED and requires 15
minutes to complete. The Nurse Pre/
Post Implementation Questionnaire will
be completed pre-implementation by
approximately 25 nurses at each of the
two Expansion Phase Two NHs and
again post-implementation by 25 nurses
at each of the 3 participating NHs (125
total or an average of 41.67 nurses per
NH as shown in Exhibit 1). The Nurse
Pre/Post-Implementation Questionnaire
is estimated to take 5 minutes to
complete. The NH Leadership PostImplementation Questionnaire will be
completed by one NH administrator or
director of nursing at each of the three
participating NHs and will require 10
minutes to complete. The total
annualized burden hours are estimated
to be 32 hours.
Exhibit 2 shows the estimated annual
cost burden to the respondent, based on
their time to participate in this research.
The annual cost burden is estimated to
be $1,921.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
facility

Number of
facilities

Form name
Medical Records Extraction ...........................................................................
NH Provider Pre-Implementation Questionnaire ...........................................
NH Provider Post-Implementation Questionnaire ..........................................
ED Physician Post-implementation Questionnaire ........................................
Nurse Pre/Post Implementation Questionnaire .............................................
NH Leadership Post-Implementation Questionnaire .....................................

2
2
3
1
3
3

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

14

7
10
7.67
30
41.67
1
n/a

Hours per
resonse

Total burden
hours

15/60
10/60
15/60
15/60
5/60
10/60

4
3
6
8
10
1

n/a

32

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
facilities

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Form name

Total burden
hours

Average
hourly wage
rate*

Total cost
burden

Medical Records Extraction .............................................................................
NH Provider Pre-Implementation Questionnaire .............................................
NH Provider Post-Implementation Questionnaire ............................................
ED Physician Post-implementation Questionnaire ..........................................
Nurse Pre/Post Implementation Questionnaire ...............................................
NH Leadership Post-Implementation Questionnaire .......................................

2
2
3
1
5
3

4
3
6
8
10
1

$31.99
83.59
83.59
83.59
31.99
51.45

$128
251
502
669
320
51

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

14

32

n/a

1,921

*Based upon the mean of the average wages, National Occupational Employment and Wage Estimates, U.S. Department of Labor, Bureau of
Labor Statistics. May 2009. Hourly mean wage for registered nurse ($31.99), physician ($83.59), and NH administrator ($51.45).

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Federal Register / Vol. 76, No. 107 / Friday, June 3, 2011 / Notices

Estimated Annual Costs to the Federal
Government

research. The total budget for this two
year study is $458,812.

Exhibit 3 shows the total and
annualized cost for conducting this

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST
Cost component

Annualized cost

Project Administration ..................................................................................................................................
Initial Antibiogram Development and Implementation .................................................................................
Expansion of Antibiogram Development and Implementation ....................................................................
Toolkit—Development and Refinement .......................................................................................................
Evaluation ....................................................................................................................................................
Final Report and Dissemination ..................................................................................................................

$60,511
47,618
36,948
92,688
153,978
67,071

$30,256
23,809
18,474
46,344
76,989
33,536

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

458,812

229,406

Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ healthcare
research and healthcare information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) 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 upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: May 20, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–13742 Filed 6–2–11; 8:45 am]
BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
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[30Day–11–0106]

Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of

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information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
Preventive Health and Health Services
Block Grant (OMB No. 0920–0106, exp.
8/31/2011)—Revision—National Center
for Chronic Disease Prevention and
Health Promotion (NCDDPHP), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
The Preventive Health and Health
Services Block Grant program provides
awardees with their primary source of
flexible funding for health promotion
and disease prevention programs. Sixtyone awardees (50 states, the District of
Columbia, two American Indian Tribes,
and eight U.S. territories) currently
receive block grants from CDC in order
to address locally-defined public health
needs in innovative ways. Block Grants
allow awardees to prioritize the use of
funds to fill funding gaps in programs
that deal with the leading causes of
death and disability. Block Grants also
improve awardees’ ability to respond
rapidly to emerging health issues.
CDC currently collects standardized
application and performance
information from each awardee through
a web-based system called the Block
Grant Management Information System
(BGMIS). As required by the authorizing
legislation for the Block Grant program,
the BGMIS collects information by the

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areas described in Healthy People
National Health Objectives, and
improves adherence to its goals. The
BGMIS requires awardees to enter their
objectives in SMART (Specific,
Measurable, Achievable, Realistic, and
Time-based) format, and to use evidence
based guidelines and best practices as
the basis for public health programs and
interventions. Finally, the BGMIS
information collection includes a
Compliance Review section, which
provides feedback to each awardee
pertaining to its past reviews.
Information will be collected from
awardees twice per year, once for the
annual Work Plan, and once for the
Annual Report. CDC will continue to
use the information collected from
Block Grant awardees to provide
oversight and direction to recipients and
to inform CDC management, decision
makers, and the general public about
PHHS Block Grant allocations,
activities, and outcomes. There are no
changes to the information being
collected during the period of this
Revision request, however, there are
expected reductions in the estimated
burden per response for both the Work
Plan and the Annual Report. These
reductions are due to changes in the
BGMIS, which has been modified to
allow pre-population of some fields.
Respondents will only need to update
information already entered into the
system, thus improving the efficiency of
reporting and reducing the burden per
response. In addition, the guidance
documents for both information
collections are being revised to improve
their usability.
All information is collected
electronically. There are no costs to
respondents other than their time. The
estimated annualized burden hours are
2,135.

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