Agency Information Collection Activities: Proposed Collection; Comment Request, 76736-76739 [2010-30902]

Download as PDF 76736 Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Notices ET Date ET req. status Trans No. 20110168 17–NOV–10 ........................................................................... 20101200 20110151 18–NOV–10 ........................................................................... 20110159 20110160 20110164 FOR FURTHER INFORMATION CONTACT: 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 SUPPLEMENTARY INFORMATION: Agency Information Collection Activities: Proposed Collection; Comment Request Agency for Healthcare Research and Quality, HHS. ACTION: Notice. AGENCY: 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. erowe on DSK5CLS3C1PROD with NOTICES 15:35 Dec 08, 2010 Jkt 223001 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. Proposed Project Agency for Healthcare Research and Quality VerDate Mar<15>2010 B&H Contracting, L.P. RHMB Capital, LLC. Blackstone Capital Partners (Cayman) V–NQ L.P. Mark Buster. RHMB Capital, LLC. B&H Contracting, L.P. SCS Materials, L.P. RK Hall Construction Limited. Hall Materials, LTD. Laboratory Corporation of America Holdings. Genzyme Corporation. Genzyme Genetic Counseling, LLC. General Electric Company. Clarient, Inc. Clarient, Inc. Carlyle Partners V, L.P. Syniverse Holdings, Inc. Syniverse Holdings, Inc. Lion Capital Fund III (USD), L.P. Bumble Bee Foods, L.P. Stinson Seafood (2001), Inc. Athene Group Ltd. Royal Bank of Canada. Liberty Life Insurance Company. DATES: 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. SUMMARY: G G G G G G G G G G G G G G G G G G G G G G G G Party name 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 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 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 E:\FR\FM\09DEN1.SGM 09DEN1 Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Notices erowe on DSK5CLS3C1PROD with NOTICES 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 VerDate Mar<15>2010 15:35 Dec 08, 2010 Jkt 223001 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 10week 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 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 76737 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. E:\FR\FM\09DEN1.SGM 09DEN1 76738 Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Notices EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Data collection method Number of responses per respondent Hours per response Total burden hours Readiness Assessment Survey ....................................................................... Pre-Work for Master-Training .......................................................................... Train the Trainer Training ................................................................................ Staff Training ................................................................................................... Training Participant Satisfaction Survey .......................................................... Learning Outcomes Survey ............................................................................. Pre-Training Behavior Survey ......................................................................... Post-training Behavior Survey ......................................................................... Patient Outcome Survey .................................................................................. Semi-Structured Follow-Up Interview .............................................................. Semi-Structured Site Visit Interview ................................................................ 3 3 3 3 3 3 3 3 90 3 3 1 2 2 32 30 60 25 30 2 6 6 5/60 30/60 12.5 1 5/60 10/60 5/60 7.5/60 10/60 1 1 0.25 3 75 96 8 30 6 11 30 18 18 Totals ........................................................................................................ 117 na na 295 EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN Number of respondents Data collection method Total burden hours Average hourly wage rate* Total cost burden Readiness Assessment Survey ....................................................................... Pre-Work for Master-Training .......................................................................... Train the Trainer Training ................................................................................ Staff Training ................................................................................................... Training Participant Satisfaction Survey .......................................................... Learning Outcomes Survey ............................................................................. Pre-training Behavior Survey ........................................................................... Post-training Behavior Survey ......................................................................... Patient Outcome Survey .................................................................................. Semi-Structured Follow-Up Interview .............................................................. Semi-Structured Site Visit Interview ................................................................ 3 3 3 3 3 3 3 3 90 3 3 0.25 3 75 96 8 30 6 11 30 18 18 $26.50 26.50 26.50 22.02 22.02 22.02 22.04 22.02 20.90 26.50 26.50 $7 80 1,988 2,114 176 661 132 242 627 477 477 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 erowe on DSK5CLS3C1PROD with NOTICES Cost component Total cost Annual cost Project Development ....................................................................................................................................................... Data Collection Activities ................................................................................................................................................. Data Processing and Analysis ......................................................................................................................................... Publication of Results ...................................................................................................................................................... Project Management ........................................................................................................................................................ $301,664 52,629 52,629 51,658 41,399 $75,416 13,157 13,157 12,915 10,350 Total .......................................................................................................................................................................... 499,978 124,995 VerDate Mar<15>2010 15:35 Dec 08, 2010 Jkt 223001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1 Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Notices 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. 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 erowe on DSK5CLS3C1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 15:35 Dec 08, 2010 Jkt 223001 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, PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 76739 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 E:\FR\FM\09DEN1.SGM 09DEN1

Agencies

[Federal Register Volume 75, Number 236 (Thursday, December 9, 2010)]
[Notices]
[Pages 76736-76739]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30902]


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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 e-mail 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 
English-speaking 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 
evidence-based 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

[[Page 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 pre-work 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 4\1/2\ 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 semi-
structured 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.

[[Page 76738]]



                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
             Data collection method                  Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          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
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
             Data collection method                  Number of     Total burden     hourly wage     Total cost
                                                    respondents        hours           rate*          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
------------------------------------------------------------------------


[[Page 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