Attachment K -- Federal Register Notice

38104

Federal Register / Vol. 75, No. 126 / Thursday, July 1, 2010 / Notices

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day–10–0816]

Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
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
Youth Knowledge, Attitudes, and
Feedback to Inform Choose Respect
Implementation formerly known as
Youth Advice and Feedback to Inform
Choose Respect Implementation (OMB
no. 0920–0816 exp. 6/30/2012)—
Revision—National Center for Injury
Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).

Background and Brief Description
This is a revision for a currently
approved collection, OMB# 0920–0816.
This revision seeks approval to ask
knowledge and attitude questions at
several of the focus groups, and it seeks
an adjustment in the ages of the youths
(currently ages 11 through 14 to ages 11
through 18).
Over a three-year period, NCIPC seeks
to understand youths’ (ages 11 through
18) knowledge and attitudes regarding
healthy and unhealthy relationships,
and obtain their feedback regarding:
Message development/placement,
creative executions, appropriate
partners, and other similar issues. This
data collected will provide for ongoing
implementation and evaluation of the
Choose Respect campaign, which is an
initiative intended to promote youth
awareness of and participation in
healthy dating relationships.
Communication research indicates that
campaign planning implementation
must employ a consumer-oriented
approach to ensure that program
messages/materials, and their
placement, can successfully gain the
attention of and resonate with the
intended audience. NCIPC proposes
conducting further planning,
implementation, and evaluation
research that enlists the involvement
and support of youths.
This proposed information collection
will enlist geographically, culturally/

racially/ethnically, and socioeconomically diverse groups of young
people to complete: (1) Ten-minute
online surveys, with 200 respondents,
up to four times per year; and (2) up to
36 in-person focus groups, with up to
eight participants each (or more smaller
discussion groups with fewer people per
group), twice per year (288 × 2). Online
surveys will reduce the potential burden
for young people as Web-based formats
are convenient and consistent with the
way they communicate and spend their
leisure time.
Online surveys—Each Web-based
survey will involve a different group of
tweens/teens. The burden table shows
time to screen parents and youth, as
well as the actual time to complete the
survey (rows 4–6).
In-person focus groups—First and
second focus groups will involve
different groups of young people. The
focus groups will be segmented by age,
gender, and race/ethnicity. Other
variables for segmentation may include,
but not be limited to, geography and
language. Two youth contacts will be
needed to successfully recruit one focus
group participant, and two parent
contacts will be needed to successfully
recruit one online survey participant
(i.e., 400 participants screened to obtain
200 successful participants).
There are no costs to respondents
other than their time. The total
estimated burden hours are 1354.

ESTIMATED ANNUALIZED BURDEN HOURS
Data
collection
type

Type of respondents

Youths ages 11 to 18 and parents of boys
and girls, ages 11 to 18.
Youths ages 11 to 18 .....................................
Youths ages 11 to 18 .....................................
Parents of boys and girls, ages 11 to 18 .......
Youths ages 11 to 18 .....................................
Youths ages 11 to 18 .....................................

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Dated: June 25, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–16045 Filed 6–30–10; 8:45 am]
BILLING CODE 4163–18–P

Number of
respondents

Focus Group Screening Instrument for Youth
and Script for Obtaining Verbal Consent
from Parent.
Focus Group Survey ......................................
Focus Group Moderator’s Guide (participation in focus group).
Online Survey E-mail Invitation AND Online
Survey Screening Instrument for Parents.
Online Survey Screening Instrument for
Youth.
Online Survey .................................................

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.

AGENCY:

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Number of
responses
per
respondent

Average
burden per
response
(in hours)

576

2

5/60

288
288

2
2

5/60
1.5

400

4

5/60

400

4

3/60

200

4

10/60

ACTION:

Notice.

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:
‘‘Standardizing Antibiotic Use in LongTerm Care Settings (SAUL) Study.’’ In
accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,

SUMMARY:

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Federal Register / Vol. 75, No. 126 / Thursday, July 1, 2010 / Notices

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AHRQ invites the public to comment on
this proposed information collection.
This proposed information collection
was previously published in the Federal
Register on May 3rd, 2010 and allowed
60 days for public comment. One
comment was 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 August 2, 2010.
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 email 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
Standardizing Antibiotic Use in LongTerm Care Settings (SAUL) Study
Inappropriate antibiotic prescribing
practices by primary care clinicians
caring for residents in long-term care
(LTC) communities is becoming a major
public health concern as it is a risk
factor for morbidity and mortality
among LTC residents. Antibiotics are
among the most commonly prescribed
pharmaceuticals in LTC settings, yet
reports indicate that a high proportion
of antibiotic prescriptions are
inappropriate. The adverse
consequences of inappropriate
prescribing practices are serious and
include drug reactions/interactions,
secondary complications, and the
emergence of multi-drug resistant
organisms.
In an effort to reduce antibiotic
overprescribing, Loeb and colleagues
developed minimum criteria for the
initiation of antibiotics in LTC setting
(Loeb, M., et al. 2001). The criteria have
been tested in several studies, but their
implementation and tests of validity
have been limited. In particular, though
Loeb and colleagues developed distinct
minimum criteria for several types of
infection (skin and soft-tissue,
respiratory, urinary tract, and
unexplained fever), a rigorous
evaluation has been conducted only for
urinary tract infections.
Twelve nursing homes (NH) will
participate in this project; six NHs will
be recruited to serve as treatment sites

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and six to serve as control sites. Once
a nursing home community has been
selected and randomly assigned to the
treatment or control group, a facility
recruitment letter will be sent to the
facility Administrator. The letter will
include a description of the study and
inform the Administrator that the
project manager will be calling in the
near future to further discuss the project
and answers any questions that he/she
might have regarding the program.
The objectives of the study are to:
1. Implement a quality improvement
(QI) intervention program to optimize
antibiotic prescribing practices;
2. Evaluate the effect of the QI
intervention on antibiotic prescribing
practices including validation of the
Loeb minimum criteria; and
3. Develop and execute a
dissemination plan to ensure wide
dissemination of the findings and
recommendations for improving
antibiotic prescribing behaviors in LTC
settings.
To address the first study objective,
the research team will conduct a sixmonth QI intervention program in the
six treatment sites to improve antibiotic
prescribing practices. The intervention
incorporates investigative evidence
including the Loeb algorithms. QI
program procedures are documented in
the draft intervention manual, including
the Loeb algorithms. The protocol
recognizes that not all factors will need
attention in all instances, as (for
example) some NHs may already be
vigilant to advance directive
completion. The QI program is intended
for facilities to self-implement and
monitor with guidance provided from
the research team upon request.
In order to validate the Loeb Criteria
and to test the efficacy of the QI
intervention, recruited facilities will be
matched in pairs with respect to
bedsize, profit status and location
(urban, suburban, rural) and within each
pair, one facility will be randomized to
each study arm (treatment and control).
This study is being conducted by
AHRQ through its contractors, Abt
Associates and the University of North
Carolina, pursuant to AHRQ’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 and trainings will be

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38105

implemented to achieve the first two
objectives of this project:
(1) Pre-implementation semistructured interviews will be conducted
separately with physicians, facility
administrators and with the director of
nursing (DON) or nurse educators (see
Attachment D for each type of preimplementation interview) from the six
treatment sites. The purpose of these
interviews is to generate ideas on how
best to implement the new procedures
and what approaches work best across
facilities. Related risk factors and
remedial strategies also will be
identified. These interviews will take
place during the three month baseline
period and feedback will be used to
modify the intervention materials as
appropriate.
(2) Administrator interviews will be
conducted at the time of facility
enrollment to collect facility-level data
in order to describe the sample and to
explore linkages to prescribing
practices. General facility-level
descriptors including size (number of
beds), profit status, location (urban,
suburban, rural), and staffing levels
(number of full and part-time registered
nurses, licensed practical nurses, and
nurse aides) will be collected.
Additionally, simple summary (facilitylevel) information regarding resident
demographics will be collected (e.g. age,
gender, race/ethnicity, proportion longstay vs. post-acute/rehab). Facility data
will be collected through interviews
with the Administrator at all twelve
facilities.
(3) Train-the-trainer training will be
conducted during the baseline period
(prior to the implementation of the
intervention). Research staff will present
information about the Antibiotic Use QI
and Monitoring Program at one, twohour in-person meeting held at each
treatment site. The research team will
work with physicians (the physician
champion at each facility; a physician
champion is an expert that provides
education, champions a cause or
product, or gives support to staff around
the diffusion and implementation of
clinical practice guidelines, protocols,
or research evidence), administrators,
directors of nursing and nurse educators
using a train-the-trainer model to offer
guidance on educating intervention site
staff on how to implement the
Antibiotic Use QI Program that is based
on the Loeb criteria. Intervention and
training materials include those
products and strategies used in other
successful projects (e.g., written Loeb
algorithms).
(4) Train-the-nurses training will be
conducted by the nurse educator at each
of the six treatment sites following the

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Federal Register / Vol. 75, No. 126 / Thursday, July 1, 2010 / Notices

train-the-trainer training. The nurse
educator will introduce the facility
nurses to the Antibiotic Use QI and
Monitoring Program materials and train
them on the use of the Loeb minimum
criteria. This training will be offered
two times at regularly scheduled inservice meetings; however each nurse
will be required to attend only one
session.
(5) Train-the-physicians training will
be conducted by the physician
champion at each of the six treatment
sites following the train-the-trainer
training. The project team will be
present to address any questions
regarding the study. The physician
champion will introduce the facility
physicians to the Antibiotic Use QI and
Monitoring Program materials and
discuss with them the use of the Loeb
minimum criteria. An average of five
physicians at each facility will be
individually contacted by the physician
champion to discuss the use of the Loeb
criteria. Each physician will have
received a letter with the study
description and the Loeb criteria prior
to contact by the physician champion.
(6) Medical record reviews (MMR)
will be conducted by research staff to
collect primary outcome data to
determine antibiotic prescribing.
Primary outcomes will be obtained by
monthly chart review for a period of
nine months: three months preceding
the initiation of the QI intervention (for
which the charts of all residents will be
abstracted), and each month for six
months following the inception of the
program (for which the charts of all
residents will be abstracted, regardless
of whether or not they are discharged
from the setting or die) at all 12 facilities
(treatment and control) by trained
research staff from current (not archival)

records. Since this data collection will
not impose a burden on the facility staff
OMB clearance is not required.
(7) Final semi-structured interviews
with QI team members including
physicians, facility administrators, and
other key facility staff will be conducted
at the completion of the intervention to
determine their perceptions regarding
facilitators and barriers to successful
program implementation.
(8) Nurse survey will be administered
to nurses in all twelve facilities in the
month prior to program
implementation, and again in the final
month of implementation. The purpose
of this survey is to collect secondary
outcome data regarding the antibiotic
prescribing decision-making process
and to collect basic information about
each nurse, such as their title, type of
degree and years worked in a LTC
facility.
(9) Physician survey will be
administered in all twelve facilities in
the month prior to program
implementation, and again in the final
month of implementation. Similar to the
nurse survey, the purpose of this survey
is to collect secondary outcome data
regarding the antibiotic prescribing
decision-making process and to collect
basic information about each physician.
In response to the third study
objective, AHRQ will draw upon its
extensive experience of successfully
disseminating information through
varying strategies. To assist in designing
a plan that has ‘‘real world’’ impact,
AHRQ’s Dissemination Planning Tool
will be utilized.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in this

research. Pre-implementation semistructured interviews will be conducted
with 3 staff members from each of the
6 intervention sites and will last about
1 hour. The administrator interviews
will be completed with one
administrator from each of the 12
participating NHs and will require 15
minutes. Train-the-trainer training will
include 4 persons from each of the 6
intervention sites and will last 2 hours.
Train-the-nurses training will be
conducted with 24 nurses from each of
the intervention sites; the number of
responses per NH is 26 since the nurse
trainer is an employee of the NH and
will conduct the training twice, with
about 12 nurses in each training. The
nurse training will last about 1 hour.
Train-the-physician training will be
conducted with 5 physicians from each
of the 6 intervention sites; the number
of responses per NH is 6 since the
physician trainer is affiliated with the
NH. The physician training will last
about 30 minutes.
Final semi-structured interviews will
include 4 QI team members from each
of the 6 intervention sites, at the
completion of the intervention, and will
last one hour. The nurse survey will be
administered twice to 24 nurses from
each of the 12 participating NHs and
will take about 15 minutes to complete.
The physician survey will be
administered twice to 5 physicians from
each of the 12 facilities and requires 15
minutes to complete. The total
annualized burden hours are estimated
to be 441 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 $25,204.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
nursing homes

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Form name

Number of
responses
per nursing
home

Hours per
response

Total burden
hours

Pre-implementation semi-structured interviews ...............................................
Administrator Interviews ..................................................................................
Train-the-trainer training ..................................................................................
Train-the-nurses training ..................................................................................
Train-the-physicians training ............................................................................
Final Semi-Structured Interview .......................................................................
Nurse survey ....................................................................................................
Physician survey ..............................................................................................

6
12
6
6
6
6
12
12

3
1
4
26
6
4
48
10

1
15/60
2
1
30/60
1
15/60
15/60

18
3
48
156
18
24
144
30

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

66

na

na

441

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Federal Register / Vol. 75, No. 126 / Thursday, July 1, 2010 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
nursing homes

Form name

Total burden
hours

Average
hourly wage
rate*

Total cost
burden

Pre-implementation semi-structured interviews ...............................................
Administrator Interviews ..................................................................................
Train-the-trainer training ..................................................................................
Train-the-nurses training ..................................................................................
Train-the-physicians training ............................................................................
Final Semi-Structured Interview .......................................................................
Nurse survey ....................................................................................................
Physician survey ..............................................................................................

6
12
6
6
6
6
12
12

18
3
48
156
18
24
144
30

**51.68
***46.59
31.31
77.64
31.31
77.64
***46.59
46.10

$930
140
1,503
12,112
564
1,863
6,709
1,383

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

66

441

n/a

25,204

* Based upon the mean of the average wages, National Occupational Employment and Wage Estimates, U.S. Department of Labor, Bureau of
Labor Statistics. May 2008.
** Average wages for one registered nurse ($31.31), one physician ($77.64), and one Administrator ($46.10).
*** Average wages for two registered nurse ($31.31), one physician ($77.64), and one Administrator ($46.10).

Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the total and
annualized cost for conducting this
research. The total budget for this three
year study is $999,976. The
administration task includes costs
associated with the initial kick-off
conference call with AHRQ and

monthly progress reports and ongoing
conference calls. The research plan task
includes costs to finalize the research
plan; conduct the literature search;
prepare and submit the IRB applications
and OMB package; recruit facilities;
collect baseline and monthly data from
medical record reviews and conduct
pre- and post-intervention provider
interviews; implement the intervention;

and write the final report on the
explanatory model. The dissemination
costs include the writing of a
dissemination plan and two
manuscripts for publication as well as
presentations at two national
conferences. The final report costs
include the writing of a draft and final
report.

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST
Cost component

Annualized
cost

Administration ..........................................................................................................................................................
Research Plan .........................................................................................................................................................
Dissemination Plan ..................................................................................................................................................
Final Report .............................................................................................................................................................
Overhead .................................................................................................................................................................

$24,474
591,788
63,397
46,501
273,816

$8,158
197,263
21,132
15,500
91,272

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

999,976

333,325

Request for Comments

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Total

In accordance with the above-cited
Paperwork Reduction Act legislation,
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: June 22, 2010.
Carolyn M. Clancy,
Director.

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. 2010–15796 Filed 6–30–10; 8:45 am]
BILLING CODE 4160–90–M

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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:
‘‘Assessing the Impact of the National
Implementation of TeamSTEPPS Master
Training Program.’’ In accordance with
the Paperwork Reduction Act, 44 U.S.C.
3501–3520, AHRQ invites the public to

SUMMARY:

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