### 4700 Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Notices

**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.

This proposed information collection was previously published in the Federal Register on November 15th, 2010 and allowed 60 days for public comment. No comments were 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 February 25, 2011.

**ADDRESSES :**  Written comments should be submitted to: AHRQ’s OMB Desk Officer by fax at (202) 395–6974(attention: AHRQs 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

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 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 forseveral 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 decision-making 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 (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.

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 9 months: Three months preceding the initiation of the QI 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


### 4701 Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Notices

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 COP 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 homewho 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 COP on the use of antibiotics within the facility; and (5) the facility’s view on the business case for Loeb Criteria COP. The same four persons at each nursing home who participated in the previous semi-structured 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 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.



### 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

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



### E XHIBIT 

### 2—E STIMATED 

### A NNUALIZED 

### C OST 

### B URDEN

Form name Number of nursing homes Total burden hours Average hourly wage rate * Total cost burden

Loeb Criteria COF ........................................................................................... 8 68 $33 $2,244 Staff training ..................................................................................................... Initial Training .................................................................................................. 8 208 36 7,488 Re-training ....................................................................................................... 4 104 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 averagewage 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.


### 4702 Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Notices

E XHIBIT 

### 3—E STIMATED 

### TOTAL AND 

### A NNUALIZED 

### C OST

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: January 11, 2011. Carolyn M. Clancy,

Director.
[FR Doc. 2011–1540 Filed 1–25–11; 8:45 am]

**BILLING CODE 4160–90–M**

**DEPARTMENT OF HEALTH AND HUMAN SERVICES** 

**Centers for Disease Control and Prevention** 

**Disease, Disability, and Injury Prevention and Control Special**  **Emphasis Panel (SEP): Member Conflict Review, Program**  **Announcement (PA) 07–318, Initial Review** 

In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting:

Time and Date: 1 p.m.–3 p.m., March 9, 2011 (Closed).

Place: National Institute for Occupational Safety and Health (NIOSH), CDC, 1095 Willowdale Road, Morgantown, West Virginia 26506, telephone: (304) 285–6143.

Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463.

Matters to be Discussed: The meeting will include the initial review, discussion, and evaluation of ‘‘Member Conflict Review, PA

07–318. ’’

Contact Person for More Information: M. Chris Langub, PhD, Scientific Review Officer, Office of Extramural Programs, National Institute for Occupational Safety and Health, CDC, 1600 Clifton Road, NE., Mailstop E74, Atlanta, Georgia 30333; Telephone: (404)

498–2543.

The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention, and the Agency for Toxic Substances and Disease Registry.

Dated: January 17, 2011. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and
Prevention.

[FR Doc. 2011–1615 Filed 1–25–11; 8:45 am]

**BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND**  **HUMAN SERVICES**

**Centers for Disease Control and Prevention** 

**Disease, Disability, and Injury Prevention and Control Special**  **Emphasis Panel (SEP): Cooperative Agreement Program for the National**  **Academic Centers of Excellence in Youth Violence Prevention (U01),**  **Funding Opportunity Announcement (FOA) CE10–004, Initial Review** 

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announce the following meeting of the aforementioned meeting:

Times and Dates: 8 a.m.–5 p.m., February 17, 2011 (Closed). 8 a.m.–5 p.m., February 18, 2011 (Closed). Place: Atlanta Marriot Marquis Hotel, 265 Peachtree Center Avenue, Atlanta, Georgia 30303, Telephone: (404) 521–0000.

Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5, U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Section 10(d) of Public Law

92–463.

Matters To Be Discussed: The meeting will include the review, discussion, and evaluation of applications received in response to ‘‘Cooperative Agreement Program for the National Academic Centers of Excellence in Youth Violence Prevention (U01), FOA CE10–004, initial review’’

.

Agenda items are subject to change as priorities dictate.

Contact Person for More Information: J. Felix Rogers, PhD, M.P.H., Extramural Research Program Office, National Center for Injury Prevention and Control, CDC, 4770 Buford Highway, NE., Mailstop F–63, Atlanta, Georgia 30341, Telephone: (770)

488–4334.

The Director, Management Analysis and Services Office has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.