23266 Federal Register / Vol. 75, No. 84 / Monday, May 3, 2010 / Notices 

actual interview; and Estimated Total 

Annual Burden Hours Requested: 

83.64.The annualized cost to 

respondents is estimated at: $1505.52 

(based on $18 per hour). There are no 

Capital Costs to report. There are no 

Operating or Maintenance Costs to 

report. 

Table 1: Estimate of Requested Burden 

Hours and Dollar Value of Burden 

Hours 

TABLE A.12–1 ESTIMATES OF HOUR BURDEN

Type of respondents No. of respondents 

Estimated number of responses 

per respondent 

Average burden 

hours per response 

Estimated total 

annual burden 

hours requested 

Donors initially contacted ............................................................... 408 1 .08 32 .6 

PDI Donors .................................................................................... *60 1 0.5 30 

Deferred Donors ............................................................................ *30 1 0.5 15 

Accepted Donors ........................................................................... *12 1 0.5 6 

Total ........................................................................................ 408 ............................ ............................ 83 .64 

*These respondents are a subgroup of total 408 donors who will be initially contacted to participate in the study. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) Ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

Ways to minimize the burden of the 

collection of information on those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact Dr. 

George Nemo, Project Officer, NHLBI, 

Two Rockledge Center, Suite 361, 6700 

Rockledge Drive, Bethesda, MD 20892, 

or call non-toll-free number 301–435– 

0075, or e-mail your request, including 

your address to nemog@nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: April 26, 2010. 

George Nemo, 

Project Officer, NHLBI, National Institutes of 

Health. 

[FR Doc. 2010–10283 Filed 4–30–10; 8:45 am] 

BILLING CODE 4140–01–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, 

AHRQ invites the public to comment on 

this proposed information collection. 

DATES: Comments on this notice must be 

received by July 2, 2010. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@AHRQ.hhs.gov. 

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 longterm 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 


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Federal Register / Vol. 75, No. 84 / Monday, May 3, 2010 / Notices 23267 

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 

train-the-trainer training. The nurse 

educator will introduce the facility 

nurses to the Antibiotic Use Ql 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 


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23268 Federal Register / Vol. 75, No. 84 / Monday, May 3, 2010 / Notices 

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 n/a n/a 441 

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. 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 75, No. 84 / Monday, May 3, 2010 / Notices 23269 

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 tile 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: April 22, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–10197 Filed 4–30–10; 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 

comment on this proposed information 

collection. 

DATES: Comments on this notice must 

he received by July 2, 2010. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@AHRQ.hhs.gov. 

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 

Assessing the Impact of the National 

Implementation of TeamSTEPPS Master 

Training Program 

As part of their effort to fulfill their 

mission goals, AHRQ, in collaboration 

with the Department of Defense’s (DoD) 

Tricare Management Activity (TMA), 

developed TeamSTEPPS® (aka Team 

Strategies and Tools for Enhancing 

Performance and Patient Safety) to 

provide an evidence-based suite of tools 

and strategies for training teamworkbased patient safety to health care 

professionals. In 2007, AHRQ and DoD 

coordinated the national 

implementation of the TeamSTEPPS 

program. The main objective of this 

program is to improve patient safety by 

training a select group of stakeholders 

such as Quality Improvement 

Organization (QIO) personnel, High 

Reliability Organization (HRO) staff and 

healthcare system staff in various 

teamwork, communication, and patient 

safety concepts, tools, and techniques 

and ultimately helping to build a 

national infrastructure for supporting 

teamwork-based patient safety efforts in 

healthcare organizations and at the state 

level. The implementation includes the 

training of Master Trainers in various 

health care systems capable of 

stimulating the utilization and adoption 

of TeamSTEPPS in their health care 

delivery systems, providing technical 

assistance and consultation on 

implementing TeamSTEPPS, and 

developing various channels of learning 

(e.g., user networks, various educational 

venues) for continuation support and 

improvement of teamwork in 

healthcare. During this effort, AHRQ has 

trained a corps of 2400 participants to 

serve as the Master Trainer 

infrastructure supporting national 

adoption of TeamSTEPPS. Participants 

in training become Master Trainers in 

TeamSTEPPS and are afforded the 

opportunity to observe the tools and 

strategies provided in the program in 

action. In addition to developing a corps 

of Master Trainers, AHRQ has also 

developed a series of support 

mechanisms for this effort including a 

data collection Web tool, a 

TeamSTEPPS call support center, and a 

monthly consortium to address any 

challenges encountered by 

implementers of TeamSTEPPS. 

To understand the extent to which 

this infrastructure of patient safety 

knowledge and skills has been created, 

AHRQ will conduct an evaluation of the 

National Implementation of 

TeamSTEPPS Master Training program. 

The goals of this evaluation are to 

examine the extent to which training 

participants have been able to: 

(1) Implement the TeamSTEPPS 

products, concepts, tools, and 

techniques in their home organizations 

and, 

(2) the extent to which participants 

have spread that training, knowledge, 

and skills to their organizations, local 

areas, regions, and states. 

This study is being conducted by 

AHRQ through its contractor, American 

Institutes for Research (AIR), 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, 


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