5084 Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Notices 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQs 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: January 15, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–1953 Filed 1–29–10; 8:45 am] 

BILLING CODE 4160–90–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: 

‘‘Evaluation of the GuideLines Into 

Decision Support (GLIDES).’’ In 

accordance with the Paperwork 

Reduction Act of 1995, 44 U.S.C. 

3506(c)(2)(A), AHRQ invites the public 

to comment on this proposed 

information collection. 

This proposed information collection 

was previously published in the Federal 

Register on November 27th, 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 March 3, 2010. 

ADDRESSES: Written comments should 

be submitted to: AHRQs 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: 

Doris Lefkowitz, AHRQ Reports 

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

e-mail at 

doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Evaluation of the GuideLines Into 

Decision Support (GLIDES) 

With this project AHRQ proposes to 

evaluate how the translation of clinical 

knowledge into clinical decision 

support can be routinized in practice 

and taken to scale in ways that improve 

the quality of healthcare delivery for 

children in the U.S. Previously in the 

GLIDES project, AHRQ designed and 

implemented decision support tools 

based on guidelines for the prevention 

of pediatric overweight and obesity and 

the management of chronic asthma in 

the pediatric population (publication 

forthcoming). In this phase of the 

project, conducted for AHRQ through a 

contract with Yale University and 

Nemours, physicians will be surveyed 

about their experiences with the 

decision support tools developed in the 

previous phase. The participating study 

institutions (Yale University and 

Nemours) are geographically and 

organizationally diverse, and include a 

wide range of patients from a variety of 

social, economic and ethnic 

backgrounds. This project directly 

addresses AHRQ’s mission of improving 

health systems practices, in particular 

for priority populations, including lowincome groups, minority groups, 

women, children, and individuals with 

chronic diseases. See 42 USC 

299(c)(1)(B). 

The evaluation plan includes a 

physician survey component and an 

extraction of electronic medical record 

data. Participating physicians will be 

surveyed about their experiences with 

the decision support tools developed for 

this project. This will allow AHRQ to 

evaluate the fulfillment of knowledge 

transformation goals and the 

effectiveness of the decision support 

tools in improving the quality of health 

care at the chosen sites. Without such 

an evaluation, it would be difficult to 

determine whether this project has met 

AHRQ’s goals of enhancing the ‘‘quality, 

appropriateness and effectiveness of 

health services.’’ See 42 USC 299(b); 42 

USC 299a(a)(1). Consequently, it is 

necessary to collect this information to 

fulfill AHRQ’s mission. 

Method of Collection 

Self-administered questionnaires will 

be used to elicit physicians’ general 

opinions of guideline-based care and 

clinical decision support tools on a five 

point Likert-type scale. Results from 

low-utilizing physicians will be 

compared to high-utilizing physicians to 

determine whether general opinions of 

guidelines and technology correlate 

with actual practice. Results will also be 

analyzed by demographic characteristics 

included in the survey questionnaire to 

determine whether opinions vary by 

age, degree of computer experience and 

skill, level of training and professional 

degree. These analyses will be 

important to future studies and decision 

support designers because they will 

help us understand whether 

interventions need to be targeted 

differently to different audiences. For 

example, senior level specialists may 

have less desire or need for clinical 

decision support tools than novice 

generalists have. In-person qualitative 

interviews lasting approximately 30 

minutes will be conducted with key 

personnel at each site (including 

physicians, nurse practitioners, and 

respiratory therapists). Participants will 

remain anonymous in the transcribed 

interviews. The interviews will be 

analyzed using standard qualitative 

techniques to explore barriers and 

facilitators to using the clinical decision 

support tool. The Human Investigation 

Committee (HIC) at Yale University has 

reviewed this protocol. The HIC found 

the survey study to be exempt from 

review under 45 CFR 46.101(b)(2). The 

HIC approved the interview study and 

required signed informed consent from 

participants. 

Electronic medical record data will be 

extracted into an electronic spreadsheet 

for analysis. This extraction will occur 

at regular intervals to ensure continued 

maintenance and uptake of the tool. 

Utilization of the decision support tools 

at the provider and site level will be 

assessed based on the rate of electronic 

chart documentation. This is important 

to determine the rate of uptake of the 

intervention, as well as to determine 

whether there are any flaws in the 

design of the tool. Congruence of actual 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Notices 5085 

practice with guideline 

recommendations will be assessed 

based on automatically generated 

disagreement flags in the electronic 

medical record as well as by manual 

chart review. This data collection, 

including the manual chart review, will 

be performed by project staff and will 

not impose a burden on the 

participating sites. In addition, project 

staff will directly observe a random 

sampling of clinicians using the tool in 

clinical settings to determine how the 

tool affects workflow. These 

observations will not require any effort, 

time or action on the part of the 

clinicians themselves and will not 

impose a burden on the participating 

sites. 

Signed informed consent will be 

obtained prior to any observations. The 

Human Investigation Committee at Yale 

University has reviewed this protocol. It 

approved the medical record review, 

approved direct observation of 

clinicians and interviews of clinicians, 

required signed informed consent from 

clinicians, granted a waiver of informed 

consent from patients per 45 CFR 

46.116(d), and granted a waiver of 

HIPAA authorization. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

respondents’ time to participate in this 

research. The Asthma Management and 

Clinical Decision Support System 

Usability and User Satisfaction Survey 

(asthma questionnaire) will be 

completed by 172 health care 

professionals across 3 sites and is 

expected to require about 6 minutes to 

complete. The Obesity Prevention and 

Clinical Decision Support System 

Usability and User Satisfaction Survey 

(obesity questionnaire) will be 

completed by 82 health care 

professionals across 2 sites and is 

expected to require about 6 minutes to 

complete. The in-person interviews will 

be conducted with a total of 50 

clinicians at 3 sites and are expected to 

last 30 minutes each. The total burden 

is estimated to be 51 hours. 

Exhibit 2 shows the estimated 

annualized cost burden associated with 

the respondents’ time to participate in 

this research. The total cost burden is 

estimated to be $2,781. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of sites 

Number of 

responses per 

site 

Hours per 

response 

Total burden 

hours 

Asthma questionnaire—Yale ........................................................... 2 31 6/60 6 

Asthma questionnaire—Nemours .................................................... 1 110 6/60 11 

Obesity questionnaire—Yale ........................................................... 1 57 6/60 6 

Obesity questionnaire—Nemours .................................................... 1 25 6/60 3 

In-person interviews—Yale .............................................................. 2 15 30/60 15 

In-person interviews—Nemours ...................................................... 1 20 30/60 10 

Total .......................................................................................... 8 ............................ ............................ 51 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of sites Total burden 

hours 

Average hourly 

wage rate* Total cost burden 

Asthma questionnaire—Yale ........................................................... 2 6 $59.83 $359 

Asthma questionnaire—Nemours .................................................... 1 11 59.83 658 

Obesity questionnaire—Yale ........................................................... 1 6 47.25 284 

Obesity questionnaire—Nemours .................................................... 1 3 47.25 142 

In-person Interviews—Yale .............................................................. 2 15 53.54 803 

In-person Interviews—Nemours ...................................................... 1 10 53.54 535 

Total .......................................................................................... 8 51 ............................ 2,781 

*Based upon the mean of the average wages for other physicians and surgeons, general pediatricians, and pediatric trainees (asthma questionnaire), and general pediatricians and pediatric trainees (obesity questionnaire), National Compensation Survey: Occupational wages in the 

United States 2008, ‘‘U.S. Department of Labor, Bureau of Labor Statistics,’’ and Yale Pediatric Residency Program, 2008. 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the total and 

annualized cost for this research. Since 

this project will not exceed one year the 

total and annualized costs are identical. 

The total cost is estimated to be $5,703. 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

Cost component Total cost Annualized cost 

Project Development ....................................................................................................................................... $1,406 $1,406 

Data Collection Activities ................................................................................................................................. 416 416 

Data Processing and Analysis ......................................................................................................................... 780 780 

Publication of Results ...................................................................................................................................... 1,601 1,601 

Project Management ........................................................................................................................................ 200 200 

Overhead ......................................................................................................................................................... 1,299 1,299 


jlentini on DSKJ8SOYB1PROD with NOTICES
5086 Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Notices 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued 

Cost component Total cost Annualized cost 

Total .......................................................................................................................................................... 5,703 5,703 

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 health care research, quality 

improvement and 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: January 25, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–1894 Filed 1–29–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–10–0745] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 and 

send comments to Maryam Daneshvar, 

CDC Acting Reports Clearance Officer, 

1600 Clifton Road, MS–D74, Atlanta, 

GA 30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection 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 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Colorectal Cancer Screening Program 

(OMB Number 0920–0745, exp. 7/31/ 

2010)—Revision—Division of Cancer 

Prevention and Control (DCPC), 

National Center for Chronic Disease 

Prevention and Health Promotion 

(NCCDPHP), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

Colorectal Cancer (CRC) is the second 

leading cause of cancer-related deaths in 

the United States, following lung 

cancer. Based on scientific evidence 

which indicates that regular screening is 

effective in reducing CRC incidence and 

mortality, regular CRC screening is now 

recommended for average-risk persons. 

Screening tests that are recommended 

by the United States Preventive Services 

Task Force, and that may be used alone 

or in combination, include fecal occult 

blood testing (FOBT), fecal 

immunochemical testing (FIT), flexible 

sigmoidoscopy, colonoscopy, and/or 

double-contrast barium enema (DCBE). 

In 2005, CDC established a three-year 

demonstration program, subsequently 

extended to four years, to screen lowincome individuals 50 years of age and 

older who have no health insurance or 

inadequate health insurance for CRC. 

The five demonstration sites report 

information to CDC including deidentified, patient-level demographic, 

screening, diagnostic, treatment, 

outcome and cost reimbursement data 

(OMB No. 0920–0745, exp. 7/31/2010). 

The information is being used to assess 

the feasibility and cost effectiveness of 

a publicly funded screening program 

and describe key outcomes, and has 

been critical in guiding the expansion of 

the program. 

CDC will request OMB approval to 

continue the information collection for 

three years, with changes. First, the 

number of funded sites will increase 

from 5 to 26, and the term 

‘‘Demonstration’’ will be deleted from 

the title of the program. Second, there 

will be a reduction in the burden per 

respondent associated with the 

collection of clinical information. 

Reporting forms for medical 

complications and medically ineligible 

clients will be discontinued, and 

reporting forms for colorectal cancer 

clinical data elements (CCDE) will be 

streamlined. Data elements that were 

underused in analysis of the 

demonstration program data, or difficult 

to standardize across programs, will be 

removed, and the level of detail 

collected from endoscopy and pathology 

reports will be reduced. As a result, the 

reporting burden per CCDE form will be 

similar regardless of primary test 

provided. Third, the collection of 

patient-level reimbursement cost data 

will be discontinued and will be 

replaced by the collection of programlevel activity-based cost data. The 

revised information collection will 

utilize a Cost Assessment Tool (CAT) 

currently in use by another CDC-funded 

cancer program (OMB No. 0920–0812, 

exp. 6/30/2012). The information to be 

collected through the CAT will allow 

CDC to compare activity-based costs 

across multiple sites and programs, and 

will provide a more effective means of 

monitoring and improving the 

performance and cost-effectiveness of 

the CRC screening program. 

The goals of the expanded CRC 

screening program are to increase 

population-based screening and to 

reduce health disparities in CRC 

screening, incidence and mortality. The 

program will continue to provide 

services to low-income individuals age 

50 and older with inadequate or no 

health insurance. Each site will screen 

an estimated 375 patients per year (186 

semiannually). The increase in the 

number of funded sites and the 

proposed changes will result in an 


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