Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices 32783 

TRANSACTION GRANTED EARLY TERMINATION—Continued 

ET date Trans. No. ET req 

status Party name 

G Thoratec Corporation. 

G International Technidyne Corporation. 

20100659 G Theodore J. Leonsis. 

G Washington Sports & Equipment Limited Partnership. 

G Washington Sports & Equipment Limited Partnership. 

20100662 G Oak Hill Capital Partners III, L.P. 

G Wellspring Capital Partners III, L.P. 

G Dave & Buster’s Holdings, Inc. 

20100663 G Iconix Brand Group, Inc. 

G The Edward W. Scripps Trust. 

G Character Licensing, LLC. 

20100677 G Thomas H. Lee Equity Fund VI, L.P. 

G Sterling Financial Corporation. 

G Sterling Financial Corporation. 

20100678 G Thomas H. Lee Parallel Fund VI, L.P. 

G Sterling Financial Corporation. 

G Sterling Financial Corporation. 

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 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Department of Health and 

Human Services (HHS). 

ACTION: Notice. 

SUMMARY: 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: 

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 

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. 

[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: 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: 

‘‘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. 

DATES: Comments on this notice must be 

received by July 9, 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 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: 

Dons Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

e-mail at 

doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 


erowe on DSK5CLS3C1PROD with NOTICES
32784 Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices 

Proposed Project 

Spreading Techniques To Radically 

Reduce Antibiotic Resistant Bacteria 

(Methicillin Resistant Staphylococcus 

aureus, or MRSA) 

Healthcare Acquired Infections (HAIs) 

caused almost 100,000 deaths among 

the 2.1 million people who acquired 

infections while hospitalized in 2000, 

and HAI rates have risen relentlessly 

since then. Alarmingly, 70% of HAIs are 

due to bacteria that are resistant to 

commonly used antibiotics, with 

Methicillin Resistant Staphylococcus 

aureus (MRSA) being the most rapidly 

growing, and among the most virulent, 

pathogens. Resistance is increasing 

rapidly in all types of hospitals (Huang 

2007). Despite evidence that routinely 

applied, simple interventions do work, 

most hospitals have failed to make 

notable progress in reducing MRSA 

infections. Hospitals in some European 

countries and select U.S. hospitals, 

however, have succeeded with 

impressive results. 

Sites that have already achieved 

dramatic decreases in their MRSA 

infection rates have done so by 

implementing precautions to prevent 

transmission, using system redesign 

approaches. Further, many hospitals 

have successfully instituted isolation 

procedures for patients suspected to be 

MRSA carriers. In doing so, these 

hospitals have followed the broadly 

disseminated guidelines for hand 

hygiene and contact isolation 

precautions. This study is a follow up 

to a recent study implemented in 6 

hospital systems in the Indianapolis 

metropolitan area that used a ‘‘MRSA 

intervention bundle’’ composed of active 

surveillance screening, contact isolation 

precautions, and increased hand 

hygiene. Preliminary data from that 

initial study suggest a 60% decrease in 

MRSA rates in participating intensive 

care units (ICUs) (Doebbeling, B. 

Redesigning Hospital Care for Quality 

and Efficiency Applications of Positive 

Deviance and Lean in Reducing MRSA. 

Presentation at AHRQ Annual Meeting, 

Rockville, MD. Sept 2009). 

This project, a case study, will utilize 

the same guidelines and precautions 

that were applied in the original study, 

and will add an innovative feature that 

will use electronic medical record 

systems to improve identifying, 

communicating and tracking MRSA 

infections among healthcare systems. 

More specifically, this study has five 

aims: 

(1) Further test the ‘‘MRSA 

intervention bundle’’ from the original 

Indianapolis MRSA study, and test the 

intervention in additional units in the 4 

original Indianapolis hospital systems 

and an additional 3 hospital systems 

beyond Indianapolis; 

(2) Identify and monitor healthcare 

associated community onset (HACO) 

MRSA cases and controls who receive 

care in participating hospitals and 

affiliated settings, identify strategies to 

reduce HACO MRSA and demonstrate 

reduction of HACO MRSA; 

(3) Assess the relative effectiveness of 

various antibiotics in abatement or 

eradication of MRSA carriage in 

hospital patients; 

(4) Evaluate the effectiveness of the 

tested implementation strategies and 

innovations by applying information 

technology to enable consistent 

collection, sharing, analysis and 

reporting of data; 

(5) Disseminate findings and promote 

outreach to target audiences and other 

stakeholders. 

While many secondary data are 

available for this study, Aims 1 and 2 

involve primary data collection. Use of 

the intervention bundle requires that 

opinion leaders and front line workers 

be equipped with techniques used in 

the reorganization of healthcare delivery 

to improve health outcomes (Singhal 

and Greiner, 2007; IHI, 2005). These 

techniques will assist in identifying 

goals, implementing the interventions to 

meet local needs and measuring and 

feeding back progress on key processes 

and outcomes to staff and others. 

The study also incorporates an 

additional informatics surveillance 

system to allow participating hospitals 

to more efficiently communicate, share 

and track MRSA infections. This system 

will save infection control and 

clinicians’ time-for example, by 

electronically identifying patients with 

a known history of drug-resistant 

infections when they first contact a new 

institution. 

This study is being conducted by 

AHRQ through its contractor, Indiana 

University and the Regenstrief Institute, 

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 

To achieve the aims of this project the 

following data collections will be 

implemented: 

• Electronic medical record data on 

MRSA infections and screening rates 

will be collected from an existing and 

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 32785 

• 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

Form name Number of 

hospitals 

Number of responses per 

hospital 

Hours per 

response 

Total burden 

hours 

Electronic Medical Record Data Collection ..................................................... 2 52 10 1,040 

Observational Data Collection ......................................................................... 3 936 10/60 468 

Social Network Analysis Questionnaire ........................................................... 7 150 15/60 263 

Culture Questionnaire ...................................................................................... 7 150 30/60 525 

Implementation Assessment Interviews .......................................................... 7 16 1 112 

Patient Healthcare Use Questionnaire ............................................................ 200 1 15/60 50 

Total .......................................................................................................... 226 na na 2,458 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

hospitals 

Total burden 

hours 

Average hourly wage rate *Total cost 

burden 

Electronic Medical Record Data Collection ..................................................... 2 1040 $30.03 $31,231 

Observational Data Collection ......................................................................... 3 468 20.98 9,819 

Social Network Analysis Questionnaire ........................................................... 7 263 38.28 10,068 

Culture Questionnaire ...................................................................................... 7 525 38.28 20,097 

Implementation Assessment Interviews .......................................................... 7 112 45.33 5,077 

Patient Healthcare Use Questionnaire ............................................................ 200 50 21.90 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

Cost component Total cost Annualized 

cost 

Project Development ............................................................................................................................................... $785,000 $262,000 

Data Collection Activities ......................................................................................................................................... 70,000 35,000 

Data Processing and Analysis ................................................................................................................................. 235,000 78,000 

Publication of Results .............................................................................................................................................. 125,000 125,000 

Project Management ................................................................................................................................................ 170,000 57,000 

Overhead ................................................................................................................................................................. 415,000 138,000 


erowe on DSK5CLS3C1PROD with NOTICES
32786 Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued 

Cost component Total cost Annualized 

cost 

Total .................................................................................................................................................................. 1,800,000 900,000 

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 

[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. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

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 

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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