Federal Register / Vol. 77, No. 17 / Thursday, January 26, 2012 / Notices 4041 

Dated: January 17, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–1400 Filed 1–25–12; 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: 

‘‘Assessing the Feasibility of 

Disseminating Effective Health Care 

Products through a Shared Electronic 

Medical Record Serving Member 

Organization of a Health Information 

Exchange.’’ In accordance with the 

Paperwork Reduction Act, 44 U.S.C. 

3501–3521, AHRQ invites the public to 

comment on this proposed information 

collection. 

This proposed information collection 

was previously published in the Federal 

Register on November 15th, 2011 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 February 27, 2012. 

ADDRESSES: Written comments should 

be submitted to: AHRQ’s OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQ’s desk officer) or by 

email at 

OIRA_submission@omb.eop.gov 

(attention: AHRQ’s desk officer). 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

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

email at doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Assessing the Feasibility of 

Disseminating Effective Health Care 

Products through a Shared Electronic 

Medical Record Serving Member 

Organization of a Health Information 

Exchange 

The Agency for Healthcare Research 

and Quality (AHRQ) requests that the 

Office of Management and Budget 

(OMB) approve under the Paperwork 

Reduction Act of 1995 this collection of 

information from users of work products 

and services initiated by the John M. 

Eisenberg Clinical Decisions and 

Communications Science Center 

(Eisenberg Center). 

AHRQ is the lead agency charged 

with supporting research designed to 

improve the quality of healthcare, 

reduce its cost, improve patient safety, 

decrease medical errors, and broaden 

access to essential services. AHRQ’s 

Eisenberg Center’s mission is improving 

communication of findings to a variety 

of audiences (‘‘customers’’), including 

consumers, clinicians, and health care 

policy makers. The Eisenberg Center 

compiles research results into useful 

formats for customer stakeholders. The 

Eisenberg Center also conducts 

investigations into effective 

communication of research findings in 

order to improve the usability and rapid 

incorporation of findings into medical 

practice. The Eisenberg Center is one of 

three components of AHRQ’s Effective 

Health Care (EHC) Program. The 

collections proposed under this 

clearance include activities to assess the 

feasibility of disseminating materials 

developed by the Eisenberg Center 

through the use of an electronic medical 

record (EMR) shared by a network of 

clinical care providers that are part of a 

Health Information Exchange (HIE) 

operating in multiple sites in several 

states. Our Community Health 

Information Network (OCHIN) members 

include 30 clinical care organizations 

operating more than 230 primary care 

clinics in six states. Data will be 

gathered from three different OCHINmember organizations representing a 

total of 10 primary care clinics. The 

information generated will be provided 

to AHRQ to guide decision making and 

planning for additional efforts to foster 

EHC Program product distribution via 

EMR prompting and product linkages. 

This research has the following goals: 

(1) Identify facilitators and barriers to 

successful efforts to implement 

processes that: (a) Support use of EHC 

Program products by clinicians in 

practice, and (b) place relevant clinical 

information in the hands of patients and 

family members in languages and 

formats that are appropriate to patients’ 

information needs; 

(2) Examine ways in which EHC 

Program products can be used in 

concert with other support programs 

and products (e.g., healthwise® 

resources available through the EMR; 

brief patient instructions and letters, 

including those designed for use with 

persons having very low literacy skills); 

(3) Assess the extent to which EHC 

Program products are used (e.g., 

accessed by clinicians, provided to 

patients in relevant formats) in settings 

where use is supported by automated 

EMR features, such as on-screen 

prompts and reminders; and 

(4) Document the perceived value of 

integrating EHC Program products into 

systems of care supported by an EMR 

system as self-reported by clinicians 

involved in direct care of patients and 

clinic support personnel who interact 

with patients. 

This study is being conducted by 

AHRQ through its contractor, the 

Eisenberg Center—Baylor College of 

Medicine, pursuant to AHRQ’s statutory 

authority to conduct and support 

research, and disseminate information, 

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 clinical practice. 42 U.S.C. 

299a(a)(1) and (4). 

Method of Collection 

To achieve the goals of this project the 

following data collections will be 

implemented: 

(1) Automated Data Capture from 

EMR Usage Logs. Electronic usage data 

will be collected to determine the extent 

to which EHC Program guides for 

clinicians and patients were accessed to 

support shared decision making and 

patient education. The data will be 

retrieved from the existing EMR-linked 

database operated by the Kaiser 

Permanente staff in their coordination of 

activities related to the OCHIN HIE. 

Data will include: (a) Number and 

frequency of retrieval of EHC resource 

materials; (b) specific types of materials 

retrieved; and (c) health topic or 

condition targeted in the EHC materials. 

These data will inform the development 

of follow-up questions to be 

administered to clinicians and patients 

in the interviews and surveys described 

below. Because the data will be 

obtained using automated systems 

already in place, no special effort will 

be needed to generate these data, and 

thus this task is not included in the 

burden estimates in Exhibits 1 and 2. 

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4042 Federal Register / Vol. 77, No. 17 / Thursday, January 26, 2012 / Notices 

(2) Interviews with Clinicians. 

Interviews will be held with clinical 

service providers for the following 

purposes: (a) Obtain perceptions of the 

overall value, relevancy, currency and 

appropriateness of EHC Program 

products in addressing the health 

service needs of patients treated in 

clinical settings; (b) assess ease of use of 

the materials in terms of access via the 

EMR; (c) determine perceived success of 

efforts to employ EHC Program products 

and related materials in addressing the 

needs of patients with limited language 

skills and/or low literacy levels; and (d) 

describe the relative success of efforts to 

use the EHC Program products in 

concert with other tools (e.g., 

healthwise® resources) in promoting 

patient engagement in their own health 

care or in the care of family members. 

(3) Interviews with Support Staff. 

Interviews will be held with nonclinical support staff to characterize 

perceptions of how the introduction of 

EHC Program products: (a) Affected 

clinic workflows and influenced the 

work that staff was required to do in 

supporting clinician-patient 

interactions; and (b) facilitated or 

impeded efforts to inform patients about 

actions they could take in being more 

fully involved in their own health care. 

(4) Interviews with Patients. 

Interviews will be held with recruited 

patients to determine if they: (a) Viewed 

the EHC Program products that they 

were provided as useful to them in 

understanding their health issues; (b) 

were able to understand the EHC 

Program-related information that was 

provided to them sufficiently to take 

actions in their own health care; and (c) 

have suggestions about how the EHC 

Program materials could be changed or 

the delivery of them done in a different 

way to make the materials more useful 

and/or accessible to patients. 

(5) Survey of Clinicians. A 

questionnaire will be administered to 

clinical care providers near the end of 

the study to gather quantitative data 

around their assessments of: (a) The 

relevancy of the EHC Program materials 

to the patients they serve; (b) the 

appropriateness of the products in 

addressing specific clinical issues; (c) 

the ease of use of the system created to 

provide access to EHC Program products 

through the EMR; and (d) overall ratings 

of the approach in addressing patient 

needs with regard to specific conditions 

addressed by the products available. 

The interviews with clinicians, 

clinical staff, and patients will be 

conducted throughout the project 

period, approximately every three 

months with different sets of 

participants, to inform and refine 

delivery mechanisms and monitor 

progress. 

This information will be used to 

determine the feasibility of: (a) 

Mounting broader efforts to distribute 

clinician and consumer guides, as well 

as other EHC products using EMRs as 

the primary vehicle for providing 

product access at the point of care; and 

(b) initiating additional studies to 

identify factors that encourage or deter 

effective integration of EHC products 

into care processes using electronic 

tools and care delivery support systems, 

like the EMR, that are increasingly 

common in clinical work settings. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden for the respondents’ 

time to participate in this research. 

Three rounds of interviews will be 

conducted during the project period 

(each round of interviews to be held 

approximately every three months with 

separate sets of participants) to assess 

progress and adjust methods or refine 

materials as needed. Interviews will be 

conducted with 100 patients, 50 

clinicians and 50 clinical support staff. 

Each interview is estimated to last no 

more than 30 minutes. All clinicians in 

each participating clinic will have 

access to the EMR and will be invited 

to participate in an online 

questionnaire. Approximately 200 

clinicians will complete the 10-minute 

questionnaire. 

Exhibit 2 shows the estimated 

annualized cost burden associated with 

the respondents’ time to participate in 

this research. The total annual cost 

burden is estimated to be $6,274. 

EXHIBIT 1—ESTIMATED ANNUALIZED TOTAL BURDEN HOURS

Type of data collection Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Interviews with Clinicians ................................................................. 50 1 30/60 25 

Interviews with Support Staff ........................................................... 50 1 30/60 25 

Interviews with Patients ................................................................... 100 1 30/60 50 

Survey of Clinicians ......................................................................... 200 1 10/60 33 

Total .......................................................................................... 400 na na 133 

EXHIBIT 2—ESTIMATED ANNUALIZED TOTAL COST BURDEN’> 

Type of data collection Number of 

respondents 

Total burden 

hours 

Average hourly 

wage rate Total cost burden 

Interviews with Clinicians ................................................................. 50 25 $83.59 $2,090 

Interviews with Support Staff ........................................................... 50 25 14.31 358 

Interviews with Patients ................................................................... 100 50 21.35 1,068 

Survey of Clinicians ......................................................................... 200 33 83.59 2,758 

Total .......................................................................................... 400 133 na 6,274 

Based upon the mean wages for clinicians (29–1062 family and general practitioners), clinical team members (31–9092 medical assistants) 

and patients/consumers (00–0000 all occupations), National Compensation Survey: Occupational wages in the United States May 2010, ‘‘U.S. 

Department of Labor, Bureau of Labor Statistics.’’ 

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Federal Register / Vol. 77, No. 17 / Thursday, January 26, 2012 / Notices 4043 

Estimated Annual Costs to the Federal 

Government 

The maximum cost to the Federal 

Government is estimated to be $217,451 

annually for two years. 

Exhibit 3 shows the total and 

annualized cost by the major cost 

components. 

EXHIBIT 3—ESTIMATED TOTAL AND

ANNUALIZED COST

Cost component Total cost Annualized 

cost 

Project Development .................. $153,750 $76,875 

Data Collection Activities ................ 162,465 81,233 

Data Processing 

and Analysis ...... 33,563 16,781 

Project Management .................. 22,625 11,313 

Overhead .............. 62,500 31,250 

Total ............... 434,903 217,451 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, 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: January 17, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–1398 Filed 1–25–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on the 

Use of Natriuretic Peptide 

Measurement in the Management of 

Heart Failure 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for scientific 

information submissions. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) is seeking 

scientific information submissions from 

medical device manufacturers of 

natriuretic peptide measurement assays. 

Scientific information is being solicited 

to inform our Comparative Effectiveness 

Review of Use of Natriuretic Peptide 

Measurement in the Management of 

Heart Failure, which is currently being 

conducted by the Evidence-based 

Practice Centers for the AHRQ Effective 

Health Care Program. Access to 

published and unpublished pertinent 

scientific information on this device 

will improve the quality of this 

comparative effectiveness review. 

AHRQ is requesting this scientific 

information and conducting this 

comparative effectiveness review 

pursuant to Section 1013 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, Public Law 108–173. 

DATES: Submission Deadline on or 

before February 27, 2012. 

ADDRESSES: Online submissions: http:// 

effectivehealthcare.AHRQ.gov/

index.cfm/submit-scientificinformation-packets/. Please select the 

study for which you are submitting 

information from the list of current 

studies and complete the form to upload 

your documents. 

Email submissions: ehcsrc@ohsu.edu 

(please do not send zipped files—they 

are automatically deleted for security 

reasons). 

Print submissions: Robin Paynter, 

Oregon Health and Science University, 

Oregon Evidence-based Practice Center, 

3181 SW. Sam Jackson Park Road, Mail 

Code: BICC, Portland, OR 97239–3098. 

FOR FURTHER INFORMATION CONTACT: 

Robin Paynter, Research Librarian, 

Telephone: (503) 494–0147 or Email: 

ehcsrc@ohsu.edu. 

SUPPLEMENTARY INFORMATION: In 

accordance with Section 1013 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, Public Law 108–173, the Agency 

for Healthcare Research and Quality has 

commissioned the Effective Health Care 

(EHC) Program Evidence-based Practice 

Centers to complete a comparative 

effectiveness review of the evidence for 

use of natriuretic peptide measurement 

in the management of heart failure. 

The EHC Program is dedicated to 

identifying as many studies as possible 

that are relevant to the questions for 

each of its reviews. In order to do so, we 

are supplementing the usual manual 

and electronic database searches of the 

literature by systematically requesting 

information (e.g., details of studies 

conducted) from medical device 

industry stakeholders through public 

information requests, including via the 

Federal Register and direct postal and/ 

or online solicitations. We are looking 

for studies that report on natriuretic 

peptide measurement assays, including 

those that describe adverse events, as 

specified in the key questions detailed 

below. The entire research protocol, 

including the key questions, is also 

available online at: http:// 

effectivehealthcare.ahrq.gov/index.cfm/ 

search-for-guides-reviews-and-reports/

?pageaction=displayproduct&

productid=899#4210. 

This notice is a request for industry 

stakeholders to submit the following: 

• A current product label, if 

applicable (preferably an electronic PDF 

file). 

• Information identifying published 

randomized controlled trials and 

observational studies relevant to the 

clinical outcomes. Please provide both a 

list of citations and reprints if possible. 

• Information identifying 

unpublished randomized controlled 

trials and observational studies relevant 

to the clinical outcomes. If possible, 

please provide a summary that includes 

the following elements: Study number, 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, primary and secondary 

outcomes, baseline characteristics, 

number of patients screened/eligible/ 

enrolled/lost to withdrawn/follow-up/ 

analyzed, and effectiveness/efficacy and 

safety results. 

• Registered ClinicalTrials.gov 

studies. Please provide a list including 

the ClinicalTrials.gov identifier, 

condition, and intervention. 

Your contribution is very beneficial to 

this program. AHRQ is not requesting 

and will not consider marketing 

material, health economics information, 

or information on other indications. 

This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. In addition to your scientific 

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