### 14370 Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Notices

EARLY 

### T ERMINATIONS 

### G RANTED 

### F EBRUARY 

### 1, 2012 THRU 

### F EBRUARY 

### 29, 2012—Continued

20120505 ......................................................... G Alfred E. Mann MannKind Corporation; Alfred E. Mann.

**02/14/2012**

20120477 ......................................................... G GTCR Fund IX/A, L.P.; Universal American Corp.; GTCR Fund IX/A, L.P. 20120496 ......................................................... G Amgen Inc.; Micromet, Inc.; Amgen Inc. 20120498 ......................................................... G The Weir Group PLC; Starr L. Pitzer and Christine H. Pitzer; The Weir Group PLC.

**02/15/2012**

20120501 ......................................................... G KEMET Corporation; Denham Commodity Partners IV LP; KEMET Co rporation. 20120506 ......................................................... G Redtop Holdings Limited; Intermediate Capital Group plc; Redtop Holdings Limited.

**02/16/2012**

20111164 ......................................................... G Apple Inc.; Rockstar Bidco, L.P.; Apple Inc. 20111389 ......................................................... G Microsoft Corporation; Rockstar Bidco, LP; Microsoft Corporation. 20111423 ......................................................... G Research In Motion Limited; Rockstar Bidco, LP; Research In Motion Limited.

**02/17/2012**

20111146 ......................................................... G Apple Inc.; CPTN Holdings LLC; Apple Inc. 20120508 ......................................................... G Medical Properties Trust, Inc.; FFC Partners II, L.P.; Medical Properties Trust, Inc. 20120510 ......................................................... G GS Engineering & Construction Corporation; Inmobiliaria Espacio, S.A.; GS Engineering & Construction Corporation. 20120513 ......................................................... G Archipelago Holdings; CDC Corporation; Archipelago Holdings.20120516 ......................................................... G Gores Capital Partners HI, L.P.; The Pep Boys-Manny, Moe & Jack; Gores Capital Partners III, L.P.

**02/23/2012**

20120338 ......................................................... G TE Connectivity Ltd.; Wendel SA; TE Connectivity Ltd. 20120469 ......................................................... G Raymond James Financial, Inc.; Regions Financial Corp.; Raymond James Financial, Inc. 20120519 ......................................................... G Molibdenos y Metales S.A.; Molycorp, Inc.; Molibdenos y Metales S.A.

**02/24/2012**

20120502 ......................................................... G CVS Caremark Corporation; Health Net, Inc.; CVS Caremark Corporation. 20120522 ......................................................... G Innovative Interfaces Holdings Ltd.; Gerald M. Kline; Innovative Interfaces Holdings Ltd. 20120523 ......................................................... G KRG Capital Fund IV. L.P.; Frontenac VIII Limited Partnership; KRG Capital Fund IV. L.P. 20120524 ......................................................... G Roger S. Penske; Roger S. Penske; Roger S. Penske. 20120529 ......................................................... G Fidelity National Financial. Inc.; O’Charley’s Inc.; Fidelity National Financial, Inc.

**02/27/2012**

20120536 ......................................................... G Oracle Corporation; Taleo Corporation; Oracle Corporation.

**FOR FURTHER INFORMATION CONTACT :**  Renee Chapman, Contact Representative, or Theresa Kingsberry, Legal Assistant, Federal Trade Commission, Premerger Notification Office, Bureau of Competition, Room H– 303, Washington, DC 20580, (202) 326–

3100.

By Direction of the Commission. Donald S. Clark, Secretary.
[FR Doc. 2012–5606 Filed 3–8–12; 8:45 a.m.]

**BILLING CODE 6750–01–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: ‘‘Workflow Assessment for Health IT Toolkit Evaluation.’’

In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501–3521, AHRQ invites the public to comment on this proposed information collection.

**DATES :**  Comments on this notice must be received by May 8, 2012.

**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 email at doris.lefkowitz@AHRQ.hhs.gov.

**SUPPLEMENTARY INFORMATION :** 


### 14371 Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Notices

Proposed Project Workflow Assessment for Health IT Toolkit Evaluation

AHRQ is a lead Federal agency in developing and disseminating evidence and evidence-based tools on how health IT can improve health care quality, safety, efficiency, and effectiveness. Understanding clinical work practices and how they will be affected by practice innovations such as implementing health IT has become a central focus of health IT research. While much of the attention of health IT research and development had been directed at the technical issues of building and deploying health IT systems, there is growing consensus that deployment of health IT has often had disappointing results, and while technical challenges remain, there is a need for greater attention to sociotechnical issues and the problems of modeling workflow.

The implementation of health IT in practice is costly in time and effort and less is known about these issues in small- and medium-sized practices where the impact of improved or disrupted workflows may have especially significant consequences because of limited resources. Practices would derive great benefit from effective tools for assessing workflow during many types of health IT implementation, such as creating disease registries, collecting quality measures, using patient portals, or implementing a new electronic health record system. To that end, in 2008, AHRQ funded the development of the Workflow Assessment for Health IT toolkit (Workflow toolkit). Through this toolkit, end users should obtain a better understanding of the impact of health IT on workflow in ambulatory care for each of the following stages of health IT implementation: (1) Determining system requirements, (2) selecting a vendor, (3) preparing for implementation, or (4) using the system post implementation. They should also be able to effectively utilize the publicly available workflow tools and methods before, during, and after health IT implementation while recognizing commonly encountered issues in health IT implementation. In the current project AFIRQ is conducting an evaluation to ensure that the newly developed Workflow toolkit is useful to small- and medium-sized ambulatory care clinic managers, clinicians, and staff.

The evaluation will consist of field assessments of use of the Workflow toolkit in 18 small- and medium-sized practices and gathering feedback from two Health IT Regional Extension Centers (RECs) who are providing support to some of these practices. The evaluation will address the issues of system validation as classically defined in software engineering: determining whether the software or system actually meets the requirements of the user to perform the relevant tasks. The evaluation will answer the following questions:

• Are results correct? Are individual tools included in the Workflow toolkit accurate? Does workflow assessment with the Workflow toolkit provide accurate information the practice can act upon?

• Does knowledge change? Does user knowledge and capacity change? Does user knowledge of workflow in their own practice change?

• Do decisions change? Do user decisions about workflow assessment change? Do user decisions about health information technology (health IT) implementation change?

• Do outcomes change? Are changes in workflow favorable? Are changes in clinical practices favorable? Are changes to the practice favorable? Are changes for patients favorable?

To answer these questions the proposed evaluation will be conducted to examine usefulness of the Workflow toolkit in small- and medium-sized practices. The evaluation will be conducted with 18 practices affiliated with one of two Practice-based Research Networks (PBRNs) in Oregon and Wisconsin, and with the Health IT Regional Extension Centers (RECs) in those States. Participants will be recruited who agree to use the Workflow toolkit in their specific health IT project for a minimum of 10 weeks. This will provide an opportunity to observe use of the Workflow toolkit amongst its intended end users, who are best positioned to provide critical feedback to improve the functionality of the Workflow toolkit.

This study is being conducted by AHRQ through its contractors, the Oregon Rural Practice-based Research Network (ORPRN) and the Wisconsin Research & Education Network (WREN), pursuant to AHRQ’s statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness, and value of health care services and with respect to health care technologies, facilities, and equipment. 42 U.S.C. 299a(a)(1) and (5). Method of Collection To achieve the goals of this project the following data collections will be implemented:

(1) Pre-Workflow Toolkit Interview: these will consist of semi-structured interviews with practice staff and with three specialists from each Health IT Regional Extension Center. These interviews are designed to examine the knowledge, attitudes, and barriers to and facilitators of workflow assessment for implementation of health IT. Respondents will be asked to define workflow, to rate its importance to the practice or REC and to health IT implementation, to describe factors motivating use of the Workflow toolkit, to describe previous experience with assessing or redesigning workflow, and to describe previous experience with health IT implementation and the effect of this implementation on work processes in their practice (practices) or for their clients (RECs).

(2) Observations: Participating practices will form small teams (Clinic Study Teams) who will use the Workflow toolkit. A member of the project staff will join each Clinic Study Team or the three specialists at each of the two RECs, as participant-observer and will meet with the team at times to be determined by the teams, but at least every two weeks after the Pre-Workflow Toolkit Interview for at least four visits. During these visits project staff will participate in and keep field notes regarding the practice’s or REC’s workflow assessment activities.

(3) Usage Logs: As part of their workflow assessment process, Clinic Study Teams, and REC staff, will be asked to meet weekly. For weekly meetings at which a project staff member is not present, Clinic Study Teams and REC staff will keep a record of workflow assessment activities including use of the workflowassessment toolkit, recording in a freeform journal the purpose and results of the activity as well as issues that arose in the process.

(4) Post-Workflow Toolkit Interview: This final interview will consist of individual semi-structured interviews of practice staff and three specialists from each Health IT Regional ExtensionCenter. These interviews will (a) reexamine their knowledge and attitudes about workflow assessment; (b) revisit the barriers to and facilitators of workflow assessment; (c) discuss changes that have taken place as a result of the process; (d) explore outcomes in terms of: (d.1) for practices, the perceived impacts on clinicians, the practice staff, the practice, and the


### 14372 Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Notices

patients; and (d.2) for RECs, technician confidence in guiding affiliated clinics in understanding workflow; and finally (e) assess the overall impressions about the usefulness of the Workflow toolkit as well as any suggested changes.

The outcome of the evaluation will be a report including recommendations for enhancing and improving the Workflow toolkit. The report will provide results about the perceived usefulness of the Workflow toolkit. Results will be produced separately for practices and RECs as well as for both user groups as a whole. The report will also include specific suggestions on how to revise Workflow toolkit to make it more useful to its intended audiences. Estimated Annual Respondent Burden

Exhibit 1 shows the estimated annual burden hours for each respondent’s time to participate in this evaluation. The Pre-Workflow interview will be completed by a total of up to 248 persons (about 12 per practice) and requires one hour. Up to four observations will be conducted for up to 248 persons and they are each estimated to take two hours. Ten usage logs will be completed by a total of up to 248 persons (one per week of study activity) and completion of a single usage log should take no longer than 15 minutes. The Post-Workflow interview will be completed by a total of up to 248 persons and requires one hour.

The total annual burden is estimated to be 3,100 hours or 155 hours per practice or Regional Extension Center.

Exhibit 2 shows the estimated annual cost burden associated with the organizations’ time to participate in this research. The total annual burden is estimated to be $96,100.



### E XHIBIT 

### 1—E STIMATED 

### A NNUALIZED 

### B URDEN 

### H OURS

Data collection Number of respondents Number of respoonses per respondent Hours per response Total burden hours

Pre-Workflow Toolkit Interview ........................................................................ 248 1 1 248 Observations .................................................................................................... 248 4 2 1,984 Usage Logs ...................................................................................................... 248 10 15/60 62 0 Post-Workflow Toolkit Interview ....................................................................... 248 1 1 248

Total .......................................................................................................... 992 NA NA 3,100



### E XHIBIT 

### 2—E STIMATED 

### A NNUALIZED 

### C OST 

### B URDEN

Data collection Number of respondents Total burden hours Average hourly wage rate* Total cost burden

Pre-Workflow Toolkit Interview ........................................................................ 248 248 $31.00 $7,688 Observations .................................................................................................... 248 1,984 31.0061,504 Usage Logs ...................................................................................................... 248 620 31.00 1 9,220 Post-Workflow Toolkit Interview ....................................................................... 248 248 31.00 7,688

Total .......................................................................................................... 992 147 NA 96,100
* The hourly wage for the participants across the four data collections (pre-workflow toolkit interviews, observations, usage logs, and postworkflow toolkit interview) is based upon a weighted mean of the average hourly wages for Family and General Practitioners (1.5; $87.84 per hour); office managers (1.0; $35.18 per hour); front office staff (1.0; $15.15 per hour); medical assistants or nurses (2.5; $24.36 per hour); nurse care managers (0.5; $33.57); social workers (0.1; $24.44 per hour); health educators (0.1; $25.12 per hour); information technology specialists(0.25; $23.43 per hour); quality improvement directors (0.25; 25.12 per hour); and technical staff (1.0; $33.14 per hour) for Oregon and Wisconsin from the U.S. Department of Labor, Bureau of Labor Statistics, May 2010 National Occupational Employment and Wage Estimates for the United States, Occupational Employment Statistics (OES), Washington, DC (Feb. 2009), http://bls.GOV/oes/2010/may/www.bls.GOVOessrcst.htm (accessed November, 2011).

Estimated Annual Costs to the Federal Government

The estimated total cost to the Federal Government for this project is $793,456 over a 27-month period from September 23, 2011 to December 22, 2013. The estimated average annual cost is $352,646. Exhibit 3 provides a breakdown of the estimated total and average annual costs by category.



### E XHIBIT 

### 3—E STIMATED 

### TOTAL AND 

### A NNUAL 

### C OST

### * TO THE 

### F EDERAL 

### G OVERNMENT

Cost component Total cost Annualized cost

Project Management and Coordination Activities .................................................................................

.. $96,449 $42,866 Develop Research and Recruitment Plans ......................................................................................... .... 78,383 34,837 Compliance with PRA ............................................................................................................ .................. 12,267 5,452 Obtaining IRB approval ......................................................................................................... .................. 10,254 4,557 Develop Data Analysis Plan ..................................................................................................... ............... 18,246 8,109 Conduct Evaluation ............................................................................................................. ..................... 534,401 237,512 Data analysis and Final Report .................................................................................................

.............. 23,554 10,468 Ensure 508-compliant deliverables .............................................................................................. ........... 19,902 8,845 Total .......................................................................................................................... ........................ 793,456 352,646

* Costs are fully loaded including overhead and G&A.


### 14373 Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Notices

Request for Comments

In accordance with the Paperwork Reduction Act, 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: February 29, 2012. Carolyn M. Clancy,

Director.
[FR Doc. 2012–5574 Filed 3–8–12; 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: ‘‘Demonstration of a Health Literacy Universal Precautions Toolkit.’’ In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501–3521, AHRQ invites the public to comment on this proposed information collection.

**DATES :**  Comments on this notice must be received by May 8, 2012.

**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 email at doris.lefkowitz@AHRQ.hhs.gov.

**SUPPLEMENTARY INFORMATION :**  Proposed Project Demonstration of Health Literacy Universal Precautions Toolkit

A goal of Healthy People 2020 is to increase Americans’ health literacy, defined as, ‘‘the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.’’ The effects of limited literacy are numerous and serious, including medication errors resulting from patients’ inability to read labels; underuse of preventive measures suchas Pap smears and vaccines; poor selfmanagement of conditions such as asthma and diabetes; and higher rates of hospitalization and longer hospital stays.

According to the 2003 National Assessment of Adult Literacy (NAAL), more than one-third of Americans—77 million people—have limited health literacy. Although some adults are more likely than others to have difficulty understanding and acting upon health information ( e.g., minority Americans, elderly), providers cannot tell by looking which patients have limited health literacy. Experts recommend that providers assume all patients may have difficulty understanding health-related information. Known as adopting ‘‘health literacy universal precautions,’’ providers create an environment in which all patients benefit from clear communication.

AHRQ contracted with the University of North Carolina at Chapel Hill to develop the Health Literacy Universal Precautions Toolkit to help primary care practices ensure that systems are in place to promote better understanding of health-related information by all patients. As part of Toolkit development, testing of a ‘‘prototype Toolkit’’ was conducted in eightprimary care practices over an eightweek period. Testing provided important information about implementation and resulted in refinement of the Toolkit, which AHRQ made publically available in Spring 2010. At this time, the Toolkit includes 20 tools to prepare practices for health literacy-related quality improvement activities and to guide them in improving their performance related to four domains: (1) Improving spoken communication with patients, (2) improving written communication withpatients, (3) enhancing patient selfmanagement and empowerment, and (4) linking patients to supportive systems in the community.

The tools included in the Health Literacy Universal Precautions Toolkit are listed below:

Tools To Start on the Path to Improvement

Tool 1: Form a Team Tool 2: Assess Your Practice Tool 3: Raise Awareness Tools To Improve Spoken Communication Tool 4: Tips for Communicating Clearly Tool 5: The Teach-Back Method Tool 6: Follow up with Patients Tool 7: Telephone Considerations Tool 8: Brown Bag Medication Review Tool 9: How to Address Language

Differences Tool 10: Culture and Other

Considerations Tools To Improve Written Communication Tool 11: Design Easy-to-Read Material Tool 12: Use Health Education Material

Effectively Tool 13: Welcome Patients: Helpful

Attitude, Signs, and More Tools To Improve Self-Management and

Empowerment Tool 14: Encourage Questions Tool 15: Make Action Plans Tool 16: Improve Medication Adherence

and Accuracy Tool 17: Get Patient Feedback Tools to Improve Supportive Systems

Tool 18: Link Patients to Non-Medical

Support Tool 19: Medication Resources Tool 20: Use Health and Literacy

Resources in the Community AHRQ will now conduct a demonstration of the Health Literacy Universal Precautions Toolkit. The purpose of this demonstration project is to explore whether the Toolkit helps motivated practices to make changes intended to improve communication with and support for patients of all literacy levels. Twelve primary care practices will be recruited to implement at least four tools from the Health Literacy Universal Precautions Toolkit. The project team will provide participating practices with limited technical assistance throughout the implementation period. Data regarding the assistance provided will contribute