Attachment H -- 30 Day FRN

Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices

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TRANSACTION GRANTED EARLY TERMINATION—Continued
ET date

Trans. No.

20100659
20100662
20100663
20100677
20100678

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. 2010–13725 Filed 6–8–10; 8:45 am]
BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute for Occupational
Safety and Health; Designation of a
Class of Employees for Addition to the
Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services (HHS).
ACTION: Notice.
AGENCY:

HHS gives notice of a
decision to designate a class of
employees from the Canoga Avenue
Facility, Los Angeles County, California,
as an addition to the Special Exposure
Cohort (SEC) under the Energy
Employees Occupational Illness
Compensation Program Act of 2000. On
May 14, 2010, the Secretary of HHS
designated the following class of
employees as an addition to the SEC:

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All employees of the Department of
Energy, its predecessor agencies, and its
contractors and subcontractors who worked
at the Canoga Avenue Facility, Los Angeles
County, California, from January 1, 1955
through December 31, 1960 for a number of

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Party name
Thoratec Corporation.
International Technidyne Corporation.
Theodore J. Leonsis.
Washington Sports & Equipment Limited Partnership.
Washington Sports & Equipment Limited Partnership.
Oak Hill Capital Partners III, L.P.
Wellspring Capital Partners III, L.P.
Dave & Buster’s Holdings, Inc.
Iconix Brand Group, Inc.
The Edward W. Scripps Trust.
Character Licensing, LLC.
Thomas H. Lee Equity Fund VI, L.P.
Sterling Financial Corporation.
Sterling Financial Corporation.
Thomas H. Lee Parallel Fund VI, L.P.
Sterling Financial Corporation.
Sterling Financial Corporation.

work days aggregating at least 250 work days,
occurring either solely under this
employment or in combination with work
days within the parameters established for
one or more other classes of employees in the
Special Exposure Cohort.

This designation will become
effective June 13, 2010, unless Congress
provides otherwise prior to the effective
date. After this effective date, HHS will
publish a notice in the Federal Register
reporting the addition of this class to the
SEC or the result of any provision by
Congress regarding the decision by HHS
to add the class to the SEC.
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Interim Director,
Division of Compensation Analysis and
Support, National Institute for
Occupational Safety and Health
(NIOSH), 4676 Columbia Parkway, MS
C–46, Cincinnati, OH 45226, Telephone
877–222–7570. Information requests can
also be submitted by e-mail to
DCAS@CDC.GOV.
John Howard,
Director, National Institute for Occupational
Safety and Health.

SUMMARY:

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[FR Doc. 2010–13795 Filed 6–8–10; 8:45 am]
BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

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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:
‘‘Spreading Techniques To Radically
Reduce Antibiotic Resistant Bacteria
(Methicillin Resistant Staphylococcus
aureus, or MRSA).’’ 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 25th, 2009 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.

SUMMARY:

Comments on this notice must be
received by July 9, 2010.

DATES:

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

ADDRESSES:

FOR FURTHER INFORMATION CONTACT:

Dons Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:

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Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices

original Indianapolis hospital systems
and an additional 3 hospital systems
Spreading Techniques To Radically
beyond Indianapolis;
Reduce Antibiotic Resistant Bacteria
(2) Identify and monitor healthcare
(Methicillin Resistant Staphylococcus
associated community onset (HACO)
aureus, or MRSA)
MRSA cases and controls who receive
Healthcare Acquired Infections (HAIs) care in participating hospitals and
caused almost 100,000 deaths among
affiliated settings, identify strategies to
the 2.1 million people who acquired
reduce HACO MRSA and demonstrate
infections while hospitalized in 2000,
reduction of HACO MRSA;
and HAI rates have risen relentlessly
(3) Assess the relative effectiveness of
since then. Alarmingly, 70% of HAIs are various antibiotics in abatement or
due to bacteria that are resistant to
eradication of MRSA carriage in
commonly used antibiotics, with
hospital patients;
Methicillin Resistant Staphylococcus
(4) Evaluate the effectiveness of the
aureus (MRSA) being the most rapidly
tested implementation strategies and
growing, and among the most virulent,
innovations by applying information
pathogens. Resistance is increasing
technology to enable consistent
rapidly in all types of hospitals (Huang
collection, sharing, analysis and
2007). Despite evidence that routinely
reporting of data;
applied, simple interventions do work,
(5) Disseminate findings and promote
most hospitals have failed to make
outreach to target audiences and other
notable progress in reducing MRSA
stakeholders.
infections. Hospitals in some European
While many secondary data are
countries and select U.S. hospitals,
available for this study, Aims 1 and 2
however, have succeeded with
involve primary data collection. Use of
impressive results.
the intervention bundle requires that
Sites that have already achieved
opinion leaders and front line workers
dramatic decreases in their MRSA
be equipped with techniques used in
infection rates have done so by
the reorganization of healthcare delivery
implementing precautions to prevent
to improve health outcomes (Singhal
transmission, using system redesign
and Greiner, 2007; IHI, 2005). These
approaches. Further, many hospitals
techniques will assist in identifying
have successfully instituted isolation
goals, implementing the interventions to
procedures for patients suspected to be
meet local needs and measuring and
MRSA carriers. In doing so, these
feeding back progress on key processes
hospitals have followed the broadly
and outcomes to staff and others.
disseminated guidelines for hand
The study also incorporates an
hygiene and contact isolation
additional informatics surveillance
precautions. This study is a follow up
system to allow participating hospitals
to a recent study implemented in 6
to more efficiently communicate, share
hospital systems in the Indianapolis
and track MRSA infections. This system
metropolitan area that used a ‘‘MRSA
will save infection control and
intervention bundle’’ composed of active clinicians’ time-for example, by
surveillance screening, contact isolation electronically identifying patients with
precautions, and increased hand
a known history of drug-resistant
hygiene. Preliminary data from that
infections when they first contact a new
initial study suggest a 60% decrease in
institution.
MRSA rates in participating intensive
This study is being conducted by
care units (ICUs) (Doebbeling, B.
AHRQ through its contractor, Indiana
Redesigning Hospital Care for Quality
University and the Regenstrief Institute,
and Efficiency Applications of Positive
pursuant to AHRQ’s statutory authority
Deviance and Lean in Reducing MRSA.
to conduct and support research on
Presentation at AHRQ Annual Meeting,
healthcare and on systems for the
Rockville, MD. Sept 2009).
delivery of such care, including
This project, a case study, will utilize activities with respect to the quality,
the same guidelines and precautions
effectiveness, efficiency,
that were applied in the original study,
appropriateness and value of healthcare
and will add an innovative feature that
services and with respect to quality
will use electronic medical record
measurement and improvement. 42
systems to improve identifying,
U.S.C. 299a(a)(1) and (2).
communicating and tracking MRSA
Method of Collection
infections among healthcare systems.
To achieve the aims of this project the
More specifically, this study has five
following data collections will be
aims:
(1) Further test the ‘‘MRSA
implemented:
• Electronic medical record data on
intervention bundle’’ from the original
MRSA infections and screening rates
Indianapolis MRSA study, and test the
intervention in additional units in the 4 will be collected from an existing and

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Proposed Project

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unique healthcare information exchange
(Indiana Network for Patient Care or
INPC) in the Indianapolis area, and the
CDC’s National Healthcare Safety
Network (Aims 1–5). This data will be
used to calculate the rate of MRSA
Nosocomial Bloodstream Infections
among individuals admitted to the
project units at all seven participating
hospitals. Screening rates for MRSA at
time of admission and at discharge or
transfer will also be collected on project
units. This data will be used to evaluate
the impact of the intervention on
infection rates within the participating
hospital units.
• Observational data on hand
washing will be collected for at least
three hours each week per hospital
(Aims 1, 2, and 4). Observations will be
conducted in 10-minute blocks per
patient selected. In total, 18
observations per hospital will be
conducted each week. Hand hygiene
rates will be based on observing the
number of opportunities for hand
hygiene and the number of actual times
completing hand hygiene. Hand hygiene
opportunities include when a provider
enters a patient room, moves from a
contaminated site to a clean site, helps
with an invasive procedure, or leaves a
patient room.
• Social Network Analysis (SNA)
Questionnaire, will be administered
twice, pretest and posttest, to about 75
healthcare workers with direct patient
care on project units (Aims 1, 4, and 5).
The purpose of this questionnaire is to
reveal the communicative patterns of
complex groups and teams in order to
identify: (1) The strength and frequency
of the connections between members,
(2) the level of knowledge members
have concerning the structure of the
network, and (3) the evaluation by
members concerning the overall success
of the network.
• Culture Questionnaire will also be
administered twice, pretest and posttest,
to about 75 healthcare workers with
direct patient care (Aims 1, 4, and 5).
The purpose of this questionnaire is to
understand the cultural beliefs,
attitudes, and knowledge of the hospital
staff.
• Implementation Assessment
Interviews of key informants will be
conducted with about 4 individuals on
the implementation team at each
hospital and will be conducted
quarterly (Aims 1, 4, and 5). This will
allow the project team to understand
and monitor how the intervention is
proceeding on project units. By
monitoring progress, the barriers and
facilitators that could affect the project
implementation can be identified.

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Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices
• Patient Healthcare Use
Questionnaire will be mailed to a
sample of patients from the 7
participating hospitals (Aims 2 and 4).
The purpose of this survey is to identify
risk factors for developing healthcare
associated community onset (HACO)
MRSA infections during a 12-month
period after discharge from a healthcare
facility.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours associated
with the hospital’s time to participate in
this research. Electronic medical record
data will be collected weekly from 7
participating hospitals, however only
two of these hospitals will use their staff

to perform this data collection. Over the
course of the project electronic medical
record data will be extracted 52 times
and each data extraction will take about
10 hours. Observational data will be
collected 18 times each week from all
participating hospitals, however only 3
hospitals will use their staff to perform
the observations. The project will
require 52 weeks of observations per
hospital and will last 10 minutes per
observation.
Both the social network analysis
questionnaire and the culture
questionnaire will be administered
twice, pretest and posttest, to about 75
personnel at each of the 7 hospitals. The
social network analysis questionnaire
will take about 15 minutes to complete

while the culture questionnaire will
take 30 minutes. The implementation
assessment questionnaire will be
administered quarterly to 3 key
informants at each hospital and will
take about one hour.
The patient healthcare use
questionnaire will be completed by 200
patients sampled from the 7
participating hospitals. Each patient
will respond once which will require
about 15 minutes. The total annualized
burden hours for all the associated data
collections are estimated to be 2,458.
Exhibit 2 shows the estimated
annualized cost burden associated with
the respondents’ time to participate in
this research. The total annual cost
burden is estimated to be $77,387.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
hospitals

Form name

Number of responses per
hospital

Hours per
response

Total burden
hours

Electronic Medical Record Data Collection .....................................................
Observational Data Collection .........................................................................
Social Network Analysis Questionnaire ...........................................................
Culture Questionnaire ......................................................................................
Implementation Assessment Interviews ..........................................................
Patient Healthcare Use Questionnaire ............................................................

2
3
7
7
7
200

52
936
150
150
16
1

10
10/60
15/60
30/60
1
15/60

1,040
468
263
525
112
50

Total ..........................................................................................................

226

na

na

2,458

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
hospitals

Form name

Total burden
hours

Average hourly wage rate *

Total cost
burden

Electronic Medical Record Data Collection .....................................................
Observational Data Collection .........................................................................
Social Network Analysis Questionnaire ...........................................................
Culture Questionnaire ......................................................................................
Implementation Assessment Interviews ..........................................................
Patient Healthcare Use Questionnaire ............................................................

2
3
7
7
7
200

1040
468
263
525
112
50

$30.03
20.98
38.28
38.28
45.33
21.90

$31,231
9,819
10,068
20,097
5,077
1,095

Total ..........................................................................................................

226

2,458

na

77,387

* Based upon the mean of the average wages for Nursing Care Providers ($30.03), Primary Care Physicians ($84.97), Allied Health Providers
($20.98), Administrators, Chief Executives ($76.23) and All Workers ($21.90); National Compensation Survey: Occupational wages in the United
States May 2008, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’

Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the total and
annualized cost of this project to the

Federal Government over a two-year
period. The total cost of this project is
$1.8 million which includes $785,000
for project development, $70,000 for
data collection activities, $235,000 for

data analysis, $125,000 for publication
of the results, $170,000 for project
management and $415,000 for overhead
costs.

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

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Cost component

Total cost

Project Development ...............................................................................................................................................
Data Collection Activities .........................................................................................................................................
Data Processing and Analysis .................................................................................................................................
Publication of Results ..............................................................................................................................................
Project Management ................................................................................................................................................
Overhead .................................................................................................................................................................

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$785,000
70,000
235,000
125,000
170,000
415,000

Annualized
cost
$262,000
35,000
78,000
125,000
57,000
138,000

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Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued
Cost component

Total cost

Total ..................................................................................................................................................................

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: May 28, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–13728 Filed 6–8–10; 8:45 am]
BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration

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[Docket No. FDA–2010–N–0019]

Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; General Licensing
Provisions: Biologics License
Application, Changes to an Approved
Application, Labeling, Revocation and
Suspension, Postmarketing Studies
Status Reports, and Forms FDA 356h
and 2567
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is announcing

SUMMARY:

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that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 9,
2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0338. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; General Licensing
Provisions: Biologics License
Application, Changes to an Approved
Application, Labeling, Revocation and
Suspension, Postmarketing Studies
Status Reports, and Forms FDA 356h
and 2567 (OMB Control Number 0910–
0338)—Extension
Under Section 351 of the Public
Health Services Act (the PHS Act) (42
U.S.C. 262), manufacturers of biological
products must submit a license
application for FDA review and
approval before marketing a biological
product in interstate commerce.
Licenses may be issued only upon
showing that the establishment and the
products for which a license is desired
meets standards prescribed in
regulations designed to ensure the
continued safety, purity, and potency of
such products. All such licenses are
issued, suspended, and revoked as

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1,800,000

Annualized
cost
900,000

prescribed by regulations in part 601 (21
CFR Part 601).
Section 130(a) of the Food and Drug
Administration Modernization Act
(Public Law 105–115) amended the
Federal Food, Drug, and Cosmetic Act
(the act) by adding a new provision
(section 506B of the act (21 U.S.C.
356b)) requiring reports of
postmarketing studies for approved
human drugs and licensed biological
products. Section 506B of the act
provides FDA with additional authority
to monitor the progress of postmarketing
studies that applicants have made a
commitment to conduct and requires
the agency to make publicly available
information that pertains to the status of
these studies. Under section 506B(a) of
the act, applicants that have committed
to conduct a postmarketing study for an
approved human drug or licensed
biological product must submit to FDA
a status report of the progress of the
study or the reasons for the failure of the
applicant to conduct the study. This
report must be submitted within 1 year
after the U.S. approval of the
application and then annually until the
study is completed or terminated.
A summary of additional collection of
information requirements follows.
Section 601.2(a) requires a
manufacturer of a biological product to
submit an application on forms
prescribed for such purposes with
accompanying data and information,
including certain labeling information,
to FDA for approval to market a product
in interstate commerce. The container
and package labeling requirements are
provided under §§ 610.60 through
610.65. The estimate for these
regulations is included in the estimate
under § 601.2(a) in table 1 of this
document.
Section 601.5(a) requires a
manufacturer to submit to FDA notice of
its intention to discontinue manufacture
of a product or all products. Section
601.6(a) requires the manufacturer to
notify selling agents and distributors
upon suspension of its license, and
provide FDA of such notification.
Section 601.12 (a)(2) requires,
generally, that the holder of an
approved BLA must assess the effects of
a manufacturing change before
distributing a biological product made
with the change. Section 601.12(a)(4)
requires, generally, that the applicant

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