Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Notices 69677 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued 

Form name Number of 

respondents 

Total burden 

hours 

Average hourly wage rate* Total cost 

burden 

Total .......................................................................................................... 977 1,190 n/a 27,316 

* Based upon the mean of the wages for 11–9111 Medical & Health Services Manager ($43.74), 29–000 Healthcare Practitioner and Technical 

Occupations ($33.51), 43–6011 Executive Secretaries and Administrative Assistants ($21.16) and 00–0000 All Occupations ($20.90), May 2009 

National Occupational Employment and Wage Estimates. United States, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ http:// 

www.bls.gov/oes/current/oes_nat.htm#b29–0000. 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 below breaks down the costs 

related to this study. Since this study 

will span two years, the costs have been 

annualized over a two year period. The 

total annualized cost is estimated to be 

$536,396.50. 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

Cost component Total cost Annualized cost 

Guide Development ............................................................................................................................................... $526,214 $263,107 

Data Collection Activities ....................................................................................................................................... 310,006 155,003 

Data Processing and Analysis ............................................................................................................................... 110,620 55,310 

Project Management .............................................................................................................................................. 20,270 10,135 

Overhead ............................................................................................................................................................... 105,683 52,842 

Total ................................................................................................................................................................ 1,072,793 536,396 .50 

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: November 1, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–28368 Filed 11–12–10; 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: 

‘‘Standardizing Antibiotic Use in Longterm Care Settings.’’ 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 January 14, 2011. 

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 

This project seeks to contribute to 

AHRQ’s mission by optimizing 

antibiotic prescribing practices in 

nursing homes. Nursing homes serve as 

one of our most fertile breeding grounds 

for antibiotic-resistant strains of 

bacteria. Nursing home residents, with 

their combination of the effects of 

normal aging and multiple chronic 

diseases, have relatively high rates of 

infection. With high rates of respiratory, 

urinary, skin, and other infection comes 

a very high rate of antibiotic use that 

gives rise to Methicillin-resistant 

Staphylococcus aureus (MRSA), 

Vancomycin-resistant Enterococci 

(VRE), fluoroquinolone-resistant strains 

of a variety of bacteria, and multi-drug 

resistant organisms (MDROs). 

Inappropriate antibiotic prescribing 

practices by primary care clinicians 

caring for residents in long-term care 

(LTC) communities is becoming a major 

public health concern. Antibiotics are 

among the most commonly prescribed 

pharmaceuticals in LTC settings, yet 

reports indicate that a high proportion 

of antibiotic prescriptions are 

inappropriate. 

In an effort to reduce antibiotic 

overprescribing, Loeb and colleagues 


srobinson on DSKHWCL6B1PROD with NOTICES
69678 Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Notices 

developed minimum criteria for the 

initiation of antibiotics in LTC setting. 

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 softtissue, respiratory, urinary tract, and 

unexplained fever), a rigorous 

evaluation has been conducted only for 

urinary tract infections. 

This project will assess an approach 

to using the Loeb criteria that requires 

minimal changes in facility procedures 

and, therefore, is likely to be widely 

adopted by nursing homes. The 

intervention makes use of a 

Communication and Order Form (COF), 

which has been designed by the 

researchers and will be used by the 

nurses and physicians to guide their 

decisionmaking about whether to order 

an antibiotic for a specific resident 

experiencing a specific infection. 

Twelve nursing homes will participate 

in this project with eight assigned to the 

intervention and four serving as 

controls. The eight intervention sites 

will be divided into two groups of four 

sites each, with one group receiving an 

additional follow-up training 2 months 

after the intervention. 

The objectives of the study are to: 

1. Implement a quality improvement 

(01) intervention program to optimize 

antibiotic prescribing practices; 

2. Evaluate the effect of the 01 

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. 

This study is being conducted by 

AHRQ through its contractor, the 

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, 

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. Loeb criteria communication and 

Order Form—This form will be 

completed by staff in the eight 

intervention nursing homes to 

determine if the Loeb criteria have been 

met. The COF provides a logical 

decision model for determining the 

need for an antibiotic. Facility staff will 

complete the paper form and the data 

from the forms will be entered into a 

database by the project researchers. 

Based on a preliminary review of the 

infection logs at 4 nursing homes, we 

estimate that staff nurses will complete 

an average of 17 COFs per month per 

nursing home at the 8 nursing homes 

that will use the COF during the 6- 

month intervention period. 

2. Medical record reviews (MMR)—To 

be conducted by research staff to collect 

outcome data to determine antibiotic 

prescribing practices and their effects 

and to assess the resident’s health and 

functional status, which are potentially 

important control variables. Outcome 

and control variables will be obtained 

by monthly chart review and review of 

the Nursing Home Minimum Data Set 

(MDS) for a period of nine months: three 

months preceding the initiation of the 

01 intervention (for which the charts of 

all eligible residents will be abstracted 

for a 3-month period at one time), and 

every other month during a 6-month 

period following the inception of the 

intervention (for which the charts of all 

eligible residents will be abstracted for 

the preceding two months. AHRQ’s 

contractor will conduct the data 

abstraction at all 12 facilities (treatment 

and control). Since this data collection 

will not impose a burden on the facility 

staff, OMB clearance is not required. 

3. Staff training—Prior to 

implementation, the staff 

(administrators, nurses, and physicians) 

at all eight intervention sites will be 

trained in the proper use of the Loeb 

Criteria COF. Staff at four of the 

intervention sites will be trained a 

second time 2 months after the initial 

training. We estimate that an average of 

24 nurses and 2 physicians will be 

trained at each nursing home. 

4. Pre-implementation semistructured interview—The purpose of 

this interview is to gain an 

understanding of: (1) How the staff and 

the department(s) and/or wider facility 

perceive quality improvement, in 

general; (2) the amount of experience 

the site has in QI and its processes for 

handling infections; (3) why the facility 

decided to adopt the Loeb Criteria COF; 

and (4) the facility’s goals for the Loeb 

Criteria COF implementation. Four staff 

members will be interviewed at each 

nursing home: two champions (likely 

the administrator, director of nursing, 

and/or the assistant director of nursing), 

one line nurse, and one staff physician. 

Questions vary by respondent type. 

5. Post-training semi-structured 

interview—The purpose of this 

interview is to measure the staff’s: (1) 

Perceived adequacy of the training; (2) 

their reactions to the training; and (3) 

their plans for implementation. The 

same four persons at each nursing home 

who were interviewed for the preimplementation semi-structured 

interviews will participate in this 

interview. Questions vary by respondent 

type. 

6. Post-implementation semistructured interview—The purpose of 

this interview is to identify: (1) 

Facilitators and barriers to 

implementation; (2) how barriers were 

overcome; (3) what barriers remain; (4) 

perceived impacts of the Loeb Criteria 

COF on the use of antibiotics within the 

facility; and (5) the facility’s view on the 

business case for Loeb Criteria COF. The 

same four persons at each nursing home 

who participated in the previous semistructured interviews will participate in 

this interview. Questions do not vary by 

respondent type. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the nursing 

homes’ time to participate in this 

project. All of the data collections and 

training in Exhibit 1 pertain only to the 

eight intervention nursing homes. The 

Loeb Criteria COF will be completed 

approximately 17 times a month for 6 

months (102 total) by staff at each 

nursing home and will require about 5 

minutes to complete. Staff training will 

be attended by all nursing and medical 

staff members at each nursing home (an 

average of 24 nurses and two physicians 

per facility) and will last 1 hour. All 

eight intervention facilities will receive 

training once at the start of the 

intervention and four of the eight 

facilities will receive a second training 

one month later to see if reinforcement 

results in improved performance. The 

pre-implementation, post training and 

post-implementation semi-structured 

interviews will be completed by the 

same four staff members at each nursing 

home consisting of two champions 

(likely the administrator, director of 

nursing, and/or the assistant director of 

nursing), one line nurse, and one staff 

physician. Each interview will be 

scheduled for 1 hour. The total annual 

burden is estimated to be 476 hours. 

Exhibit 2 shows the estimated annual 

cost burden associated with the 

respondents’ time to participate in this 

project. The total annual cost burden is 

estimated to be $17,508. 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Notices 69679 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

nursing homes 

Number of responses per 

nursing home 

Hours per 

response 

Total burden 

hours 

Loeb Criteria COF Staff training ...................................................................... 8 102 5/60 68 

Initial Training .................................................................................................. 8 26 1 208 

Re-training ....................................................................................................... 4 26 1 104 

Pre-implementation semi-structured interview ................................................. 8 4 1 32 

Post training semi-structured interview ............................................................ 8 4 1 32 

Post-implementation semi-structured interview ............................................... 8 4 1 32 

Total .......................................................................................................... 44 na na 476 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

nursing homes 

Total burden 

hours 

Average hourly wage rate* Total burden 

Loeb Criteria COF Staff training ...................................................................... 8 68 $33 $2,244 

Initial Training .................................................................................................. 8 208 36 7,488 

Re-training ....................................................................................................... 8 104 36 3,744 

Pre-implementation semi-structured interview ................................................. 8 32 42 1,344 

Post training semi-structured interview ............................................................ 8 32 42 1,344 

Post-implementation semi-structured interview ............................................... 8 32 42 1,344 

Total .......................................................................................................... 44 476 na 17,508

* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States May 2009, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ $33 is the average wage for nurses who will complete the COF. $36 is the weighted average 

wage of 24 nurses at $33 per hour and 2 physicians at $70 per hour who will be trained. $42 is the weighted average wage of 3 nurses and administrators at $33 per hour and 1 physician at $70 per hour who will be interviewed. 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the estimated total 

and annual cost to the government for 

funding this project. Although data 

collection will require less than one 

year, the entire project will span 2 years. 

The total cost of this research is 

estimated to be $999,554. 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

Cost component Total cost Annualized 

cost 

Project Development ............................................................................................................................................... $103,498 $51,749 

Data Collection Activities ......................................................................................................................................... 361,178 180,589 

Data Processing and Analysis ................................................................................................................................. 193,830 96,915 

Publication of Results .............................................................................................................................................. 48,497 24,249 

Project Management ................................................................................................................................................ 65,334 32,667 

Overhead ................................................................................................................................................................. 227,217 113,609 

Total .................................................................................................................................................................. $999,554 $499,777 

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: November 4, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–28367 Filed 11–12–10; 8:45 am] 

BILLING CODE 4160–90–M 


srobinson on DSKHWCL6B1PROD with NOTICES