### 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 E STIMATES OF 

### H OUR 

### B URDEN

Type of respondents No. of respondents Estimated number of responses per respondent Average burdenhours 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 careclinicians 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


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

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 (seeAttachment 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 QIand 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 offeredtwo 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


### 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 thisresearch. 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.



### E XHIBIT 

### 1—E STIMATED 

### A NNUALIZED 

### B URDEN 

### H OURS

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



### E XHIBIT 

### 2—E STIMATED 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, Burea u 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.


### 23269 Federal Register / Vol. 75, No. 84 / Monday, May 3, 2010 / Notices

E XHIBIT 

### 3—E STIMATED 

### T OTAL AND 

### A NNUALIZED 

### C OST

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 toolsand 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,