76736 Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Notices 

ET Date Trans No. ET req. 

status Party name 

G B&H Contracting, L.P. 

G RHMB Capital, LLC. 

20110168 G Blackstone Capital Partners (Cayman) V–NQ L.P. 

G Mark Buster. 

G RHMB Capital, LLC. 

G B&H Contracting, L.P. 

G SCS Materials, L.P. 

G RK Hall Construction Limited. 

G Hall Materials, LTD. 

17–NOV–10 ........................................................................... 20101200 G Laboratory Corporation of America Holdings. 

G Genzyme Corporation. 

G Genzyme Genetic Counseling, LLC. 

20110151 G General Electric Company. 

G Clarient, Inc. 

G Clarient, Inc. 

18–NOV–10 ........................................................................... 20110159 G Carlyle Partners V, L.P. 

G Syniverse Holdings, Inc. 

G Syniverse Holdings, Inc. 

20110160 G Lion Capital Fund III (USD), L.P. 

G Bumble Bee Foods, L.P. 

G Stinson Seafood (2001), Inc. 

20110164 G Athene Group Ltd. 

G Royal Bank of Canada. 

G Liberty Life Insurance Company. 

FOR FURTHER INFORMATION CONTACT: 

Sandra M. Peay, Contact Representative, 

or Renee Chapman, 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. 2010–30806 Filed 12–8–10; 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: 

‘‘Improving Patient Safety System 

Implementation for Patients with 

Limited English Proficiency.’’ In 

accordance with the Paperwork 

Reduction Act, 44 U.S.C. 3501–3520, 

AHRQ invites the public to comment on 

this proposed information collection. 

DATES: Comments on this notice must be 

received by February 7, 2011. 

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 

e-mail at 

doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Improving Patient Safety System 

Implementation for Patients with 

Limited English Proficiency 

According to the 2009 American 

Community Survey (U.S. Census 

Bureau), approximately 57 million 

people 20% of the U.S. population— 

speak a language other than English at 

home. Of that number, approximately 

24 million (8.6% of the U.S. population) 

are defined as having Limited English 

Proficiency (LEP), meaning that they 

report speaking English less than ‘‘very 

well’’. Recent research suggests that 

adverse events affect LEP patients more 

severely than they affect Englishspeaking patients. In addition to 

linguistic barriers, LEP patients often 

face cultural barriers to care and low 

health literacy as well. 

AHRQ proposes to develop a new 

training program to improve patient 

safety system implementation for 

patients with limited English 

proficiency. The new training program 

is designed as a continuing education 

module within the TeamSTEPPS 

system. TeamSTEPPS is an evidencebased framework to optimize team 

performance across the healthcare 

delivery system with the goal of 

improving patient safety. This system 

has been successfully implemented in 

numerous hospitals across the United 

States. The TeamSTEPPS curriculum is 

an easy-to-use comprehensive 

multimedia kit that includes modules in 

text and presentation format, video 

vignettes to illustrate key concepts, and 

workshop materials, including a 

supporting CD and DVD, on change 

management, coaching, and 

implementation. Portions of the training 

module may also be useful for hospitals 

that have not implemented 

TeamSTEPPS. The new training module 

will show how TeamSTEPPS principles 

can be better implemented to improve 

the safety of patients with LEP. 

AHRQ proposes to field-test this 

module by conducting case studies of its 

implementation in three hospitals. The 

primary goals of this field test are to 

identify needed changes in the training 

module content or format to increase the 

feasibility of implementation and 

improve module outcomes including 

audience response, learning, adoption of 

recommended team behaviors, and 

improved outcomes for LEP patients. 

Patient outcome measures for this 

project include the patient’s access to an 

interpreter and how well they 


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Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Notices 76737 

understood instructions from the 

hospital staff. 

This study is being conducted by 

AHRQ through its contractor, Abt 

Associates Inc., 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 goals of this project the 

following activities will be 

implemented: 

(1) Readiness Assessment Survey of 

whether a hospital has the right policies 

in place to implement the training 

module. The readiness assessment will 

be completed by the key contact person 

(hospital champion) at each site. The 

assessment may be completed in 

consultation with other members of a 

‘‘change team’’ that the hospital 

champion may form to support the 

initiative. 

(2) Pre-work for Master-Training, 

including a survey, process map 

exercise, and a request to locate the 

hospital’s or organization’s policy on 

accessing language services. The prework will be completed by one of the 

hospital staff persons selected to be a 

Master-Trainer at each site. 

(3) Master Training session in which 

two staff members from each of three 

participating hospitals will learn how to 

teach the training module. The 

TeamSTEPPS system requires at least 

two trainers for each hospital because 

its implementation is a team endeavor. 

Trainers will be selected either by the 

hospital champion, or by the ‘‘change 

team’’ formed by the hospital champion 

to support the intervention. Trainers 

will be selected from among natural 

leaders working within the hospital unit 

where the training will take place. 

Ideally the team will include a provider 

(e.g., doctor, nurse) and an interpreter. 

Hospital staff selected to attend the 

training will be required to travel to 

Boston for the training session. 

(4) Staff Training session using the 

training module developed for this 

project. Training participants will be 

drawn from the interprofessional care 

team in one or more hospital units (e.g., 

ob/gyn, surgery, etc.). This team may 

include nurses, physicians, technicians, 

front desk staff, and interpreters. Since 

the training teaches team behaviors, the 

entire interprofessional care team in a 

given hospital unit will be asked to 

attend the training session together. The 

training will be conducted onsite by the 

hospital staff members who attended the 

Master Training. 

(5) Training Participant Satisfaction 

Survey to assess trainee satisfaction 

with, and perceived adequacy of, the 

training module. This questionnaire will 

be administered at the end of the 

training module. 

(6) Learning Outcomes Survey to 

assess staff knowledge about the best 

way to handle situations with LEP 

patients. To measure the change in staff 

knowledge resulting from the training 

module this questionnaire will be 

administered both before and after the 

training. 

(7) Pre-training Behavior Survey to 

assess trainee behavior change resulting 

from the training. The behavior 

measured by this survey is the hospital 

staffs’ use of interpreters when 

interacting with LEP patients. To 

measure the change in staff behavior 

resulting from the training module, 

questions from this survey are repeated 

in the post-training behavior survey. 

Interpreters are exempt from this 

questionnaire because the questions 

relate to interpreter use. 

(8) Post-Training Behavior Survey to 

assess trainee use of interpreters when 

interacting with LEP patients (repeated 

from the Pre-Training Behavior Survey) 

and questions to assess the use of team 

communication tools demonstrated 

during the training. 

(9) Patient Outcome Survey to 

measure change in patient 

communication and safety outcomes 

resulting from the training. This 

survey’s target audience is all patients 

identified as LEP. The purpose of this 

survey is to measure intermediate 

outcomes related to LEP patients’ access 

to language services, comprehension, 

and satisfaction with services. 

(10) Semi-Structured Follow-Up 

Interview to assess hospitals’ 

experiences implementing the training 

module. This semi-structured 

interview’s target audience consists of 

up to two master-trainers or change 

team members in each hospital where 

the training module is implemented. 

These interviews will be conducted 3 

times at the 2-week, 6-week and 10- 

week mark after the training. 

(11) Semi-Structured Site Visit 

Interview to assess the hospitals’ 

experiences implementing the training 

module. This semi-structured 

interview’s target audience consists of 

up to 6 persons who may include 

master-trainers, change team members, 

frontline staff members, or other persons 

designated by the ‘‘hospital champion’’ 

as persons who might provide insight 

into module implementation and 

outcomes. These interviews will be 

conducted 3 months after the training. 

Estimated Annual Respondent Burden 

Exhibit 1 presents estimates of the 

reporting burden hours for this one-year 

data collection process. Time estimates 

are based on experience with similar 

instruments used with comparable 

respondents. The Readiness Assessment 

Survey will be completed by the key 

contact/project champion at each of the 

3 participating hospitals and will take 

about 5 minutes. The pre-work for the 

Master-Training will be completed by 

the two trainers selected for each site 

and will take about 30 minutes. The 

Master-Training will be conducted with 

2 staff members from each hospital and 

will last 41⁄2 hours; the burden estimate 

of 12.5 hours includes 8 hours of travel 

time to and from the training site. Staff 

Training will include up to 30 staff 

members at each hospital (plus the 2 

trainers who are staff members) and will 

last 1 hour. The Training Participant 

Satisfaction Survey will be completed 

by Staff Training participants at the end 

of the training and takes 5 minutes to 

complete. The Learning Outcomes 

Survey will be administered twice, 

before and after the training, and will 

require 10 minutes. The Pre-Training 

Behavior Survey will be administered to 

all staff invited to the training except for 

interpreters. It will require 

approximately 5 minutes. Interpreters 

do not complete this questionnaire 

because the questions relate to 

interpreter use. The Post-training 

Behavior survey will be administered 

two or more weeks after the training to 

all staff who were invited to the 

training, and will take approximately 

7.5 minutes to complete. The Patient 

Outcome Survey will be administered 

twice, before and after the intervention, 

to a sample of approximately 90 patients 

(30 from each of the 3 participating 

hospitals) and requires about 10 

minutes to complete. Semi-Structured 

Follow-up interviews will be conducted 

three times over a 12-week period with 

two master trainers or change team 

members from each hospital. Each semistructured follow-up interview will last 

for about an hour. Semi-Structured Site 

visit interviews will be conducted with 

6 staff members from each hospital and 

will take an hour to complete. The total 

annualized burden hours are estimated 

to be 295 hours. 

Exhibit 2 presents the estimated 

annualized cost burden associated with 

the respondents’ time to participate in 

this research. The total cost burden is 

estimated to be about $6,980. 


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76738 Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Notices 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Data collection method Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Readiness Assessment Survey ....................................................................... 3 1 5/60 0.25 

Pre-Work for Master-Training .......................................................................... 3 2 30/60 3 

Train the Trainer Training ................................................................................ 3 2 12.5 75 

Staff Training ................................................................................................... 3 32 1 96 

Training Participant Satisfaction Survey .......................................................... 3 30 5/60 8 

Learning Outcomes Survey ............................................................................. 3 60 10/60 30 

Pre-Training Behavior Survey ......................................................................... 3 25 5/60 6 

Post-training Behavior Survey ......................................................................... 3 30 7.5/60 11 

Patient Outcome Survey .................................................................................. 90 2 10/60 30 

Semi-Structured Follow-Up Interview .............................................................. 3 6 1 18 

Semi-Structured Site Visit Interview ................................................................ 3 6 1 18 

Totals ........................................................................................................ 117 na na 295 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Data collection method Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate* 

Total cost 

burden 

Readiness Assessment Survey ....................................................................... 3 0.25 $26.50 $7 

Pre-Work for Master-Training .......................................................................... 3 3 26.50 80 

Train the Trainer Training ................................................................................ 3 75 26.50 1,988 

Staff Training ................................................................................................... 3 96 22.02 2,114 

Training Participant Satisfaction Survey .......................................................... 3 8 22.02 176 

Learning Outcomes Survey ............................................................................. 3 30 22.02 661 

Pre-training Behavior Survey ........................................................................... 3 6 22.04 132 

Post-training Behavior Survey ......................................................................... 3 11 22.02 242 

Patient Outcome Survey .................................................................................. 90 30 20.90 627 

Semi-Structured Follow-Up Interview .............................................................. 3 18 26.50 477 

Semi-Structured Site Visit Interview ................................................................ 3 18 26.50 477 

Totals ........................................................................................................ 117 295 na 6,980 

*The average hourly wage rate for readiness assessments, train-the-trainer trainings, semi-structured site visit interviews, and semi-structured 

follow-up interviews was calculated based on the average of the mean hourly wage rate for healthcare practitioners and medical occupations (all 

professions), $31.02 and the average hourly wage rate for interpreters and translators, $21.97. The average hourly rate for staff receiving training 

was calculated based on the average of the mean hourly wage rate for healthcare practitioners and medical occupations (all professions), 

$31.02, mean hourly wage rate for interpreters and translators, $21.97, and mean hourly wage rate for healthcare support occupations, $13.06. 

The average hourly wage rate for respondents to the pre-training behavior survey was calculated based on the average of the mean hourly wage 

rate for healthcare practitioners and medical occupations (all professions), $31.02, and mean hourly wage rate for healthcare support occupations, $13.06. The average hourly wage rate for patients was calculated on the mean hourly wage rate for all occupations. Average hourly rate 

for unit staff, non-interpreter was calculated based on the average of the mean hourly rate for healthcare practitioners and medical occupations 

(all professions), $31.02, and occupations (all professions), $31.02, mean hourly wage rate for interpreters and translators, $21.97, and mean 

hourly wage rate for healthcare support occupations, $13.06. Mean hourly wage rates for these groups of occupations were obtained from the 

Bureau of Labor Statistics on ‘‘Occupational Employment and Wages, May 2009’’ found at the following urls: http://www.bls.gov/oes/current/ 

naics4_622100.htm, http://www.bls.gov/oes/current/oes273091.htm http://www.bls.gov/oes/current/oes_nat.htm. 

Estimated Annual Costs to the Federal 

Government 

The total cost of this contract to the 

government is $499,978. The project 

extends over 4 fiscal years, although 

data collection will take place over the 

course of a single year. Exhibit 3 shows 

a breakdown of the total cost as well as 

the annualized cost for the data 

collection, processing and analysis 

activity. 

EXHIBIT 3—ESTIMATED COST

Cost component Total cost Annual cost 

Project Development ....................................................................................................................................................... $301,664 $75,416 

Data Collection Activities ................................................................................................................................................. 52,629 13,157 

Data Processing and Analysis ......................................................................................................................................... 52,629 13,157 

Publication of Results ...................................................................................................................................................... 51,658 12,915 

Project Management ........................................................................................................................................................ 41,399 10,350 

Total .......................................................................................................................................................................... 499,978 124,995 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Notices 76739 

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: November 30, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–30902 Filed 12–8–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–E–0047] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ILARIS 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for ILARIS 

and is publishing this notice of that 

determination as required by law. FDA 

has made the determination because of 

the submission of an application to the 

Director of Patents and Trademarks, 

Department of Commerce, for the 

extension of a patent which claims that 

human biological product. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

petitions along with three copies and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6222, 

Silver Spring, MD 20993–0002 301– 

796–3602. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

and the Generic Animal Drug and Patent 

Term Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug product, animal drug product, 

medical device, food additive, or color 

additive) was subject to regulatory 

review by FDA before the item was 

marketed. Under these acts, a product’s 

regulatory review period forms the basis 

for determining the amount of extension 

an applicant may receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human 

biological products, the testing phase 

begins when the exemption to permit 

the clinical investigations of the 

biological becomes effective and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the human biological product and 

continues until FDA grants permission 

to market the biological product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of Patents and Trademarks may 

award (for example, half the testing 

phase must be subtracted as well as any 

time that may have occurred before the 

patent was issued), FDA’s determination 

of the length of a regulatory review 

period for a human biological product 

will include all of the testing phase and 

approval phase as specified in 35 U.S.C. 

156(g)(1)(B). 

FDA recently approved for marketing 

the human biologic product ILARIS 

(canakinumab). ILARIS is indicated for 

the treatment of Cryopyrin Associated 

Periodic Syndromes in adults and 

children 4 years of age and older 

including Familial Cold 

Autoinflammatory Syndrome and 

Muckle-Wells Syndrome. Subsequent to 

this approval, the Patent and Trademark 

Office received a patent term restoration 

application for ILARIS (U.S. Patent No. 

7,446,175) from Novartis AG, and the 

Patent and Trademark Office requested 

FDA’s assistance in determining this 

patent’s eligibility for patent term 

restoration. In a letter dated March 24, 

2010, FDA advised the Patent and 

Trademark Office that this human 

biological product had undergone a 

regulatory review period and that the 

approval of ILARIS represented the first 

permitted commercial marketing or use 

of the product. Thereafter, the Patent 

and Trademark Office requested that 

FDA determine the product’s regulatory 

review period. 

FDA has determined that the 

applicable regulatory review period for 

ILARIS is 1,072 days. Of this time, 889 

days occurred during the testing phase 

of the regulatory review period, while 

183 days occurred during the approval 

phase. These periods of time were 

derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355(i)) 

became effective: July 13, 2006. The 

applicant claims July 12, 2006, as the 

date the investigational new drug 

application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was July 13, 2006, 

which was 30 days after FDA receipt of 

the IND. 

2. The date the application was 

initially submitted with respect to the 

human biological product under section 

351 of the Public Health Service Act (42 

U.S.C. 262: December 17, 2008. The 

applicant claims December 15, 2008, as 

the date the biologics license 

application (BLA) for ILARIS (BLA 

125319) was initially submitted. 

However, FDA records indicate that 

BLA 125319 was submitted on 

December 17, 2008. 

3. The date the application was 

approved: June 17, 2009. FDA has 

verified the applicant’s claim that BLA 

125319 was approved on June 17, 2009. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 177 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) either 

electronic or written comments and ask 

for a redetermination by February 7, 

2011. Furthermore, any interested 

person may petition FDA for a 

determination regarding whether the 

applicant for extension acted with due 

diligence during the regulatory review 

period by June 7, 2011. To meet its 

burden, the petition must contain 

sufficient facts to merit an FDA 


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