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

Type of respondents 

Data 

collection 

type 

Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Youths ages 11 to 18 and parents of boys 

and girls, ages 11 to 18.

Focus Group Screening Instrument for Youth 

and Script for Obtaining Verbal Consent 

from Parent.

576 2 5/60 

Youths ages 11 to 18 ..................................... Focus Group Survey ...................................... 288 2 5/60 

Youths ages 11 to 18 ..................................... Focus Group Moderator’s Guide (participation in focus group).288 2 1.5 

Parents of boys and girls, ages 11 to 18 ....... Online Survey E-mail Invitation AND Online 

Survey Screening Instrument for Parents.

400 4 5/60 

Youths ages 11 to 18 ..................................... Online Survey Screening Instrument for 

Youth.

400 4 3/60 

Youths ages 11 to 18 ..................................... Online Survey ................................................. 200 4 10/60 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: 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, 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 126 / Thursday, July 1, 2010 / Notices 38105 

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 

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 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES
38106 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

Form name Number of 

nursing homes 

Number of 

responses 

per nursing 

home 

Hours per 

response 

Total burden 

hours 

Pre-implementation semi-structured interviews ............................................... 6 3 1 18 

Administrator Interviews .................................................................................. 12 1 15/60 3 

Train-the-trainer training .................................................................................. 6 4 2 48 

Train-the-nurses training .................................................................................. 6 26 1 156 

Train-the-physicians training ............................................................................ 6 6 30/60 18 

Final Semi-Structured Interview ....................................................................... 6 4 1 24 

Nurse survey .................................................................................................... 12 48 15/60 144

Physician survey .............................................................................................. 12 10 15/60 30 

Total .......................................................................................................... 66 na na 441 


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Federal Register / Vol. 75, No. 126 / Thursday, July 1, 2010 / Notices 38107 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

nursing homes 

Total burden 

hours 

Average 

hourly wage 

rate* 

Total cost 

burden 

Pre-implementation semi-structured interviews ............................................... 6 18 **51.68 $930 

Administrator Interviews .................................................................................. 12 3 ***46.59 140 

Train-the-trainer training .................................................................................. 6 48 31.31 1,503 

Train-the-nurses training .................................................................................. 6 156 77.64 12,112 

Train-the-physicians training ............................................................................ 6 18 31.31 564 

Final Semi-Structured Interview ....................................................................... 6 24 77.64 1,863 

Nurse survey .................................................................................................... 12 144 ***46.59 6,709 

Physician survey .............................................................................................. 12 30 46.10 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 Total Annualized 

cost 

Administration .......................................................................................................................................................... $24,474 $8,158 

Research Plan ......................................................................................................................................................... 591,788 197,263 

Dissemination Plan .................................................................................................................................................. 63,397 21,132 

Final Report ............................................................................................................................................................. 46,501 15,500 

Overhead ................................................................................................................................................................. 273,816 91,272 

Total .................................................................................................................................................................. 999,976 333,325 

Request for Comments 

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. 

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. 

[FR Doc. 2010–15796 Filed 6–30–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: 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 


jlentini on DSKJ8SOYB1PROD with NOTICES