Attachment B -- 30 Day Federal Register Notice

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TRANSACTION GRANTED EARLY TERMINATION—Continued
ET Date

25–FEB–10 ..............................................................

20100406
20100412
20100418
20100419

26–FEB–10 ..............................................................

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.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request

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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.

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Initiate Systems, Inc.
Samsung Electronics Co., Ltd.
Samsung Digital Imaging Co., Ltd.
Samsung Digital Imaging Co., Ltd.
GTCR Fund IX/A, L.P.
ATI Holdings, Inc.
ATI Holdings, Inc.
PepsiCo, Inc.
PepsiAmericas, Inc.
PepsiAmericas, Inc.
PepsiCo, Inc.
The Pepsi Bottling Group, Inc.
The Pepsi Bottling Group, Inc.
S.A.C. Private Equity Investors, L.P.
Spheris Holding II, Inc. a debtor-in-possession
Spheris Leasing LLC
Spheris Canada Inc.
Spheris Holding II, Inc., a debtor-in-possession
Spheris Operations LLC
Vianeta Communications

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.

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
[email protected]
(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.

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ADDRESSES:

[FR Doc. 2010–5172 Filed 3–10–10; 8:45 am]

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FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at
[email protected].
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

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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

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

Estimated Annual Respondent Burden

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.

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
Number of
hospitals

Form name

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Pre/Post-Test Interview Protocol .....................................................................
Quarterly Update Protocol ...............................................................................
Usability Testing Protocol ................................................................................
AHRQ QI Data Collection Tool ........................................................................
Total ..........................................................................................................

Number of
responses per
hospital

6
6
6
6
24

26
6
4
2
NA

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

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Hours per
response
1
1
1
*12
NA

Total burden
hours
156
36
24
144
360

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Federal Register / Vol. 75, No. 47 / Thursday, March 11, 2010 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN FOR HOSPITALS
Number of
hospitals

Form name
Pre/Post-Interview Protocol .............................................................................
Quarterly Update Protocol ...............................................................................
Usability Testing Protocol ................................................................................
AHRQ QI Data Collection Tool ........................................................................
Total ..........................................................................................................

Total burden
hours

6
6
6
6
24

156
36
24
144
360

Average
hourly wage
rate*
$27.46
27.46
27.46
27.46
NA

Total cost
burden
$4,284
989
659
3,954
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

Protocol Development .............................................................................................................................................
Data Collection Activities .........................................................................................................................................
Data Analysis ...........................................................................................................................................................
Publication of Results ..............................................................................................................................................
Travel for Site Visits ................................................................................................................................................
Total ..................................................................................................................................................................

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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.

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Dated: February 24, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–4948 Filed 3–10–10; 8:45 am]
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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

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$40,278
91,104
45,252
24,370
8,823
209,827

Annualized
cost
$20,139
45,552
22,626
12,185
4,412
104,914

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, [email protected].
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

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