11540 Federal Register / Vol. 75, No. 47 / Thursday, March 11, 2010 / Notices 

TRANSACTION GRANTED EARLY TERMINATION—Continued 

ET Date Trans. No. 

ET 

req. 

status 

Party name 

G Initiate Systems, Inc. 

25–FEB–10 .............................................................. 20100406 G Samsung Electronics Co., Ltd. 

G Samsung Digital Imaging Co., Ltd. 

G Samsung Digital Imaging Co., Ltd. 

20100412 G GTCR Fund IX/A, L.P. 

G ATI Holdings, Inc. 

G ATI Holdings, Inc. 

20100418 G PepsiCo, Inc. 

G PepsiAmericas, Inc. 

G PepsiAmericas, Inc. 

20100419 G PepsiCo, Inc. 

G The Pepsi Bottling Group, Inc. 

G The Pepsi Bottling Group, Inc. 

26–FEB–10 .............................................................. 20100420 G S.A.C. Private Equity Investors, L.P. 

G Spheris Holding II, Inc. a debtor-in-possession 

G Spheris Leasing LLC 

G Spheris Canada Inc. 

G Spheris Holding II, Inc., a debtor-in-possession 

G Spheris Operations LLC 

G Vianeta Communications 

FOR FURTHER INFORMATION CONTACT: 

Sandra M. Peay, Contact Representative 

Or Renee Hallman, Contact 

Representative, 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. 2010–5172 Filed 3–10–10; 8:45 am] 

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: 

‘‘Development and Evaluation of 

AIIRQ’s Quality Indicators Improvement 

Toolkit.’’ 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 December 31st, 2009 and 

allowed 60 days for public comment. 

One comment was 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 April 12, 2010. 

ADDRESSES: Written comments should 

be submitted to: AHRQ’s OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQ’s desk officer) or by 

e-mail 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 

Development and Evaluation of AHRQ’s 

Quality Indicators Improvement Toolkit 

An important part of AHRQ’s mission 

is to disseminate information and tools 

that can support improvement in quality 

and safety in the U.S. health care 

community. See 42 U.S.C. 299(b)(1)(F); 

299a(a)(1) and (2). This proposed 

information collection supports that 

part of AHRQ’s mission by developing 

and evaluating a toolkit that will enable 

hospitals to effectively use AHRQ’s 

Quality Indicators (QIs). 

AHRQ has developed sets of QIs that 

can be used by the Agency and others 

to document quality and safety 

conditions at U.S. hospitals. Two sets of 

QIs will be used in this proposed 

toolkit: the Inpatient Quality Indicators 

(IQIs) and the Patient Safety Indicators 

(PSIs). The IQIs contain measures of 

volume, mortality, and utilization for 

common medical conditions and major 

surgical procedures. The PSIs are a set 

of measures to screen for potentially 

preventable adverse events that patients 

may experience during hospitalization. 

These QIs have been previously 

developed and evaluated by AHRQ, and 

are in use at a number of hospitals 

throughout the country. The QIs and 

supportive documentation on how to 

work with them are posted on AHRQ’s 

Web site at http:// 

www.qualityindicators.ahrg.gov. Many 

of the QIs have been endorsed by the 

National Quality Forum through its 

consensus review process. 

Values for each QI can be estimated 

for a given hospital by applying 

computations in SAS programs 

developed by AHRQ to the hospital’s 

pre-existing inpatient encounter data. 

To identify potential areas for 

improving the quality and safety of the 

care that a hospital provides, the 

hospital can use these data to examine 

its current performance on each QI 

measure, changes in its performance 

over time, and how its performance 

compares to that of other hospitals. 

However, despite the availability of the 

QIs as tools to help hospitals assess 

their performance, many U.S. hospitals 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 47 / Thursday, March 11, 2010 / Notices 11541 

have limited experience with the use of 

such measurement tools, or in using 

quality improvement methods to 

improve their performance as assessed 

by these measures. 

An alpha version of the Quality 

Indicators Improvement Toolkit will be 

developed, which then will be field 

tested by six hospitals. During the field 

test, the proposed evaluation will assess 

the usability of the Toolkit for hospitals, 

and it will examine their experiences in 

implementing interventions to improve 

their performance on the AHRQ QIs, as 

well as effects on trends in the 

hospitals’ AHRQ QI values. Using 

results from the evaluation, the alpha 

Toolkit will be revised to yield a final 

Toolkit that will be effective in 

supporting hospitals’ quality 

improvement efforts. 

The development and evaluation of 

the Quality Indicators Improvement 

Toolkit will be conducted by AHRQ’s 

contractor, the RAND Corporation, 

under contract number 

HHSA290200600017I. RAND has 

subcontracted with the University 

HealthSystem Consortium (UHC) to 

partner in the development of the 

Toolkit and field testing of it with 

hospitals as they use the Toolkit in 

carrying out initiatives designed to 

improve performance on the QIs. 

Method of Collection 

Case study research methods will be 

used for this qualitative study. The 

following four data collection 

instruments will be used in the 

evaluation: 

(1) Pre/post-test interview protocol— 

Consisting of both open- and closedended questions will be administered 

prior to implementation of the Toolkit 

and again post implementation. The 

purpose of this data collection is to 

obtain data on the steps the hospitals 

took to implement actions to improve 

performance on the QIs; their plans for 

making process changes; and their 

experiences in achieving changes and 

perceptions regarding lessons learned 

that could be shared with other 

hospitals. 

(2) Update protocol—Consisting of 

both open- and closed-ended questions 

will be administered three times during 

the study (quarterly during the 

implementation year). The purpose of 

this data collection is to capture 

longitudinal data regarding hospitals’ 

progress in implementing changes, 

successes and challenges, and plans for 

subsequent actions. These data will 

include descriptive information on 

changes over time in the hospitals’ 

implementation actions and how they 

are using the Toolkit, as well as 

experiential information on the 

perceptions of participants regarding the 

improvement implementation process 

and its effects. It also ensures the 

collection of information close to 

pertinent events, which avoids the 

recall bias associated with retrospective 

reporting of experiences. 

(3) Usability testing protocol—Also 

consisting of both open and closed 

ended questions will be administered 

once at the end of the evaluation period. 

The purpose of this data collection is to 

gather information from the hospitals on 

how they used each tool in the Toolkit, 

the ease of use of each tool, which tools 

were most helpful, suggested changes to 

improve each tool, and suggestions for 

other tools to add to the Toolkit. This 

information will be used in the 

revisions of the Toolkit following the 

end of the field test. 

(4) AHRQ QI data collection tool— 

Used to collect the IQI and PSI measures 

calculated by the hospitals both prior to 

implementation of the Toolkit and again 

post implementation. The purpose of 

this data collection is to determine if the 

hospitals’ implementation actions, 

including use of the toolkit, had a 

measurable impact on the QI measures. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

respondents’ time to participate in this 

information collection. Three protocols 

will be used to collect data from 

respondents in interviews that will take 

one hour each. The pre/post-test 

interview protocol will be administered 

twice—at the beginning and end of the 

field-test year. The pre- test interviews 

will be performed as one-hour group 

interviews conducted with the six 

hospitals’ implementation teams at the 

start of the year. At the end of the year, 

post-test interviews will be performed 

as one-hour group interviews with three 

of the hospitals and during site visits 

with the other three hospitals. At each 

site visit, data will be collected through 

one-hour interviews with the hospital’s 

implementation team as well as through 

other group interviews performed 

separately with each of the key 

stakeholder groups—physicians, nurses, 

clerks, and others. The additional data 

from the stakeholder groups will allow 

triangulation of variations in 

perceptions and experiences among 

different groups, of which the 

implementation teams might not be 

aware. 

The quarterly update protocol will be 

administered quarterly to 2 hospital 

staff members from each hospital during 

the year (in months 3, 6, and 9). The 

usability testing protocol will be 

administered to 4 staff members once at 

the end of the evaluation period. The 

AHRQ QI data collection tool will be 

used both pre- and post-implementation 

to collect the QI measures. The total 

burden is estimated to be 360 hours. 

Exhibit 2 shows the estimated 

annualized cost burden associated with 

the respondents’ time to participate in 

the evaluation. The total cost burden is 

estimated to be $9,886. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

hospitals 

Number of 

responses per 

hospital 

Hours per 

response 

Total burden 

hours 

Pre/Post-Test Interview Protocol ..................................................................... 6 26 1 156 

Quarterly Update Protocol ............................................................................... 6 6 1 36 

Usability Testing Protocol ................................................................................ 6 4 1 24 

AHRQ QI Data Collection Tool ........................................................................ 6 2 *12 144 

Total .......................................................................................................... 24 NA NA 360 

* Includes time to program and run the computer programs necessary to produce the measures. 


jlentini on DSKJ8SOYB1PROD with NOTICES
11542 Federal Register / Vol. 75, No. 47 / Thursday, March 11, 2010 / Notices 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN FOR HOSPITALS

Form name Number of 

hospitals 

Total burden 

hours 

Average 

hourly wage 

rate* 

Total cost 

burden 

Pre/Post-Interview Protocol ............................................................................. 6 156 $27.46 $4,284 

Quarterly Update Protocol ............................................................................... 6 36 27.46 989 

Usability Testing Protocol ................................................................................ 6 24 27.46 659 

AHRQ QI Data Collection Tool ........................................................................ 6 144 27.46 3,954 

Total .......................................................................................................... 24 360 NA 9,886 

* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States, March 2009, ‘‘U.S. 

Department of Labor, Bureau of Labor Statistics.’’ Used as an overall average wage rate across the various types of staff involved in the quality 

improvements. 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the estimated total 

and annualized cost of this project to 

the government. The estimated total cost 

for the evaluation work is $209,827 over 

the two-year year project, with an 

annualized total cost of $104,914. These 

costs were developed based on 

estimates of staff days required, to 

which administrative expenses are 

applied, and based on airfare, hotel, and 

per diem costs for staff travel for the site 

visits at the end of the evaluation. 

EXHIBIT 3—ESTIMATED COST OF THE EVALUATION

Cost component Total cost Annualized 

cost 

Protocol Development ............................................................................................................................................. $40,278 $20,139 

Data Collection Activities ......................................................................................................................................... 91,104 45,552 

Data Analysis ........................................................................................................................................................... 45,252 22,626 

Publication of Results .............................................................................................................................................. 24,370 12,185 

Travel for Site Visits ................................................................................................................................................ 8,823 4,412 

Total .................................................................................................................................................................. 209,827 104,914 

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: February 24, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–4948 Filed 3–10–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0121] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Mammography 

Quality Standards Act Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the estimated reporting and 

recordkeeping burden associated with 

the Mammography Quality Standards 

Act requirements. 

DATES: Submit written or electronic 

comments on the collection of 

information by May 10, 2010. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes agency requests or 

requirements that members of the public 


jlentini on DSKJ8SOYB1PROD with NOTICES