Federal Register / Vol. 71, No. 238 / Tuesday, December 12, 2006 / Notices 74537 

Estimated Annual Costs to the Federal 

Government 

The total cost to the Government for 

developing this survey is approximately 

$319,000, and is being funded solely by 

AHRQ. This estimate includes the costs 

of a background literature review, 

survey development, cognitive testing, 

pilot data collection, data analysis, and 

preparation of final deliverables and 

reports. 

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 and health 

care 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: December 1, 2006. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 06–9642 Filed 12–11–06; 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, Department of Health and 

Human Services. 

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) allow the proposed 

information collection project: 

‘‘Development of an Electronic System 

for Reporting Medication Errors and 

Adverse Drug Events in Primary Care 

Practice (MEADERS).’’ In accordance 

with the Paperwork Reduction Act of 

1995, Public Law 104–13 (44 U.S.C. 

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

to comment on this proposed 

information collection. 

DATES: Comments on this notice must be 

received by February 12, 2007. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, 540 

Gaither Road, Room #5036, Rockville, 

MD 20850. 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from AHRQ’s Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ, Reports 

Clearance Officer, (301) 427–1477. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

‘‘Development of an Electronic System 

for Reporting Medication Errors and 

Adverse Drug Events in Primary Care 

Practice (MEADERS)’’

The project is being conducted in 

response to an AHRQ RFP entitled 

‘‘Resource Center for Primary Care 

Practice-Based Research Networks 

(PBRNs)’’ (issued under Contract 290–

88–0008). 

In response to a proposed 

modification to AHRQ contract no. 

290.02.0008, the PBRN Resource Center 

is proposing to assist AHRQ in its 

continued commitment to assessing the 

status and capabilities of its funded 

PBRNs and making available to them 

the tools and resources necessary to 

improve the quality of care they 

provide. Through the modification of 

this contract, the PBRN Resource Center 

will develop and make available an 

electronic system for reporting 

medication errors and adverse drug 

events that occur in outpatient 

physician practices of selected PBRNs to 

their own practices for quality 

improvement purposes and to the Food 

and Drug Administration (FDA). 

The landmark Harvard Medical 

Practice Study was published in 1991 

and stated that 98,000 Americans die 

each year from medical errors. 1

Although the exact figure has been 

disputed, no one disputes the fact that 

too many Americans are injured 

unnecessarily by medical mistakes that 

could be avoided.2 3 Another study 

performed by the Department of 

Veterans Affairs suggests that in one out 

of every 10,000 hospitalizations, a 

patient dies due directly to a medical 

error .4

In response to the growing concern 

over medical errors, the Agency for 

Healthcare Research and Quality 

(AHRQ) has published three important 

monographs outlining the problem of 

errors,5 their effects on the quality of 

care,6 and offering suggestions on 

improving patient safety.7 The first 

recommendation of this third 

monograph was to ‘‘capture information 

on patient safety—including both 

adverse events and near misses—as a 

byproduct of care, and use this 

information to design even safer care 

delivery systems.’’ One central theme to 

each of these monographs is that there 

simply is too much chaotic information 

flowing in the medical environment for 

a single provider to handle effectively. 

Therefore, solutions to the problem of 

medical errors should include some 

combination of health information 

technology and redesign of health care 

systems to enhance the prevalence of 

appropriate decisions (i.e., avoiding 

errors of omission) and reduce the 

occurrence of avoidable mistakes (i.e., 

avoiding errors of commission). 

A recent conference sponsored by 

AHRQ highlighted interventions to 

improve medical decision-making and 

reduce medical errors.8 Most of the 

interventions presented were based in 

hospitals, where the most intensive and 

immediately life-threatening events 

occur. Yet the majority of medical 

decisions are made in outpatient 

practices and offices where there has 

been little error-reduction research 

performed. Further, most outpatient 

studies have been performed in 

academic medical centers which have 

capabilities, providers, and patients that 

may not typify the average U.S. medical 

practice.9

With the recent passing of the Patient 

Safety and Quality Improvement Act of 

2005, 42 U.S.C. 299b–21–b–26, now is 

an opportune time to evaluate a primary 

care error reporting system, and PBRNs 

are an ideally suited place to study 

interventions aimed at reporting and 

reducing medical errors. In most 

primary care practices there is no 

mechanism in place to report medical 

errors as they occur. We propose to 

develop, implement, and study an 

outpatient error reporting system to 

better understand the ability of 

physicians to identify their own errors 

and their willingness to report them to 

their own practices and the FDA and 

AHRQ. We will focus on the most 

common invasive intervention invoked 

in outpatient practice—drug treatment 


jlentini on PROD1PC65 with NOTICES
74538 Federal Register / Vol. 71, No. 238 / Tuesday, December 12, 2006 / Notices 

of acute and chronic conditions—and 

will create and test a paper- and 

computer-based system for both 

capturing medication errors and 

reporting adverse drug events, which 

are also under-reported.10

The fundamental objective is to 

utilize the Resource Center’s expertise 

in health information technology and its 

working relationships with PBRNs to 

support AHRQ’s objectives in 

developing and evaluating systems for 

reporting medication errors and adverse 

drug events in primary care. We will 

accomplish this objective through (1) 

Developing and implementing an 

electronic and paper-based outpatient 

medication error and adverse event 

reporting system, (2) evaluating the 

usefulness, ease of use, and actual use 

of the system in everyday clinical 

practices, and (3) identifying patient, 

provider, and practice characteristics 

that predict uptake and use of this 

system in participating primary care 

practices. 

Methods of Collection 

The value of MEADERS to practicing 

primary care clinicians will be 

illustrated by performing demonstration 

implementations in two PBRNs. A 

PBRN is a group of clinicians working 

together, either locally or nationally, to 

conduct research and implement 

research findings into practice settings. 

A total of 45 physicians and their 

practice staff will participate in the field 

test in addition to completing baseline 

surveys of their practice. 

A request for proposals will be sent to 

all PBRNs that have registered with the 

PBRN Resource Center. A review 

committee consisting of a selection of 

four expert panel members, one or two 

PBRN representatives, and some 

members of the PBRN Resource Center 

will evaluate the applications. The 

AHRQ Project Officer will chair the 

review committee and, together with 

PBRN Resource Center staff, develop a 

set of review criteria. The review 

committee will make recommendations 

to the PBRN Resource Center who will 

make the final determination of 

participating PBRNs. Once the PBRNs 

are selected, each PBRN will choose up 

to three of its affiliated practices to 

participate in this trial. Although initial 

participation by a practice is voluntary, 

once selected the practice must provide 

assurances that at least three to five 

clinicians will agree to use the system 

and that the practice will support the 

project. 

The PBRN Resource Center will 

develop a series of surveys to capture 

data describing the practice and the 

patients it serves, the extent of the error 

reporting system’s use, and an 

assessment of the users’ overall 

satisfaction with the system. practice 

and provider information will be 

collected at baseline along with 

characteristics that could be facilitators 

(such as an electronic medical record 

system) or barriers (such as lack of time 

and resources needed to report 

information) to implementation of the 

MEADER system. Data collected on the 

system’s use will include the number of 

clinicians who have used MEADERS at 

least once, the number of times used 

overall, the time it takes to enter data 

into the electronic MEADERS, and the 

types of medication errors and adverse 

drug events that are being reported. 

Both the paper and electronic versions 

of the system will be assessed at the 

conclusion of the evaluation period. The 

follow-up assessment will include 

clinicians’ and managers’ satisfaction 

with the system (e.g., ease of use, 

usefulness of the generated reports and 

individual feedback) and whether they 

intend to continue its use after the 

initial study period has concluded. 

Finally, semi-structured interviews and 

conference call discussions will be used 

to collect additional comments and 

suggestions for future implementation of 

MEADERS. 

Although any clinician in the practice 

will be able to use the system, 

physicians are likely to be the primary 

users of the system. The Resource 

Center is estimating that physicians will 

account for about 80% of MEADERS use 

and Nurse Practitioners, Physician 

Assistants and Medical Assistants will 

make up the remainder (See Exhibit 1). 

The time for entering an event into the 

system is estimated to require no more 

than 8 minutes of a clinician’s time. 

Wherever possible, existing validated 

measures will be used. Where validated 

measures do not exist, new measures 

will be developed and assessed. The 

final instruments will be field tested 

within selected practices in the PBRNs 

chosen to participate in the 

implementation study. 

Estimated Annual Respondent Burden 

EXHIBIT 1.—ESTIMATE OF COST BURDEN TO RESPONDENTS

Data collection effort Number of 

responses* 

Estimated 

time per 

respondent 

in hours 

Estimated 

total burden 

hours 

Average 

hourly wage 

rate** 

Estimated 

annual cost 

burden to 

respondents 

Office Manager baseline survey ................................................................ 45 0 .25 11 .25 $34 .67 $390 .04 

Physician baseline survey ......................................................................... 45 0 .25 11 .25 57 .90 651 .38 

Physician opinion survey of system .......................................................... 45 0 .25 11 .25 57 .90 651 .83 

Physician entry of medication error ........................................................... 216 0 .134 28 .94 57 .90 1675 .63 

Nurse opinion survey of system ................................................................ 45 0 .25 11 .25 27 .35 307 .69 

Nurse entry of medication error ................................................................. 18 0 .134 2 .4 27 .35 65 .64 

PA/NP opinion survey of system ............................................................... 45 0 .25 11 .25 34 .17 384 .41 

PA/NP entry of medication error ................................................................ 18 0 .134 2 .4 34 .17 82 .00 

Medical assistant survey of system ........................................................... 45 0 .25 11 .25 12 .58 141 .53 

Medical assistant entry of medication error ............................................... 18 0 .134 2 .4 12 .58 30 .19 

Officer Manager opinion-survey of system ................................................ 45 0 .25 11 .25 34 .67 390 .04 

Total .................................................................................................... 585 .................... 114 .89 .................... 4769 .93 

*Based on a six month trial period of MEADER reporting system. 

**Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States 2004, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’

This information collection will not 

impose a cost burden on the respondent 

beyond that associated with their time 

to provide the required data. There will 

be no additional costs for capital 

equipment, software, computer services, 

etc. 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 71, No. 238 / Tuesday, December 12, 2006 / Notices 74539 

Estimated Costs to the Federal 

Government 

The total cost to the government for 

this activity is estimated to be 

$1,000,000.00. 

Request for Comments 

In accordance with the above-cited 

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 health care research and 

information dissemination functions of 

AHRQ, 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 request for OMB 

approval of the proposed information 

collection. All comments will become a 

matter of public record. 

References 

1Brennan TA, Leape LL, Laird NM, et al. 

Incidence of adverse events and negligence 

in hospitalized patients: Results of the 

Harvard Medical Practice Study. N Engl J 

Med 1991; 324:370–376. 2McDonald CJ, Weiner M, Hui SL. Deaths 

due to medical errors are exaggerated in the 

Institute of Medicine Report. JAMA 2000; 

284:93–95. 3Leape LL. Institute of Medicine medical 

error figures are not exaggerated. JAMA. 

2000; 28:95–97. 4Hayward RA, Hofer TP. Estimating 

hospital deaths due to medical errors: 

preventability is in the eye of the reviewer. 

JAMA. 2001; 286:415–420. 5 Institute of Medicine. To Err is Human: 

Building a Safer Health System. Washington, 

DC: National Academy Press, 2000. 6 Institute of Medicine. Crossing the 

Quality Chasm: A New System for the 21st 

Century. Washington, DC: National Academy 

Press, 2001. 7 Institute of Medicine. Patient Safety: 

Achieving a New Standard for Care. 

Washington, DC: National Academy Press, 

2004. 8http://www.blsmeetings.net/ 

PatientSafetyandHIT/ (Accessed August 11, 

2005). 9 Green LA, Fryer GE, Yawn BP, Lanier D, 

Dovey SM: The ecology of medical care 

revisited. N Engl J Med 2001; 344:2021–2025. 10Uribe CL, Schweikhart SB, Pathak DS, 

Dow M, Marsh GB. Perceived barriers to 

medical-error reporting: an exploratory 

investigation. J Healthcare Management. 

2002;47(4):263–79. 

Dated: December 1, 2006. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 06–9643 Filed 12–11–06; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–07–0008] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–6974. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Emergency Epidemic Investigations 

(0920–0008)—Revision—Office of 

Workforce and Career Development 

(OWCD), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

One of the objectives of CDC’s 

epidemic services is to provide for the 

prevention and control of epidemics 

and protect the population from public 

health crises such as man made or 

natural biological disasters and 

chemical emergencies. This objective is 

carried out, in part, by training 

investigators, maintaining laboratory 

capabilities for identifying potential 

problems, collecting and analyzing data, 

and recommending appropriate actions 

to protect the public’s health. When 

state, local, or foreign health authorities 

request help in controlling an epidemic 

or solving other health problems, CDC 

dispatches skilled epidemiologists from 

the Epidemiologist Intelligence Service 

(EIS) to investigate and resolve the 

problem. 

The purpose of the Emergency 

Epidemic Investigation surveillance is 

to collect data on the conditions 

surrounding and preceding the onset of 

a problem. The data must be collected 

in a timely fashion so that information 

can be used to develop prevention and 

control techniques, to interrupt disease 

transmission and to help identify the 

cause of an outbreak. Since the events 

necessitating the collections of 

information are of an emergency nature, 

most data collection is done by direct 

interview or written questionnaire and 

are one-time efforts related to a specific 

outbreak or circumstance. If during the 

emergency investigation, the need for 

further study is recognized, a project is 

designed and separate OMB clearance is 

required. Interviews are conducted to be 

as unobtrusive as possible and only the 

minimal information necessary is 

collected. The Emergency Epidemic 

Investigations is the principal source of 

data on outbreaks of infectious and 

noninfectious diseases, injuries, 

nutrition, environmental health and 

occupational problems. 

Each investigation does contribute to 

the general knowledge about a 

particular type of problem or 

emergency, so that data collections are 

designed to take into account similar 

situations in the past. Some 

questionnaires are standardized, such as 

investigations of outbreaks aboard 

aircraft or cruise vessels. 

The Emergency Epidemic 

Investigations provides a range of data 

on the characteristics of outbreaks and 

those affected by them. Data collected 

include demographic characteristics, 

exposure to the causative agent(s), 

transmission patterns and severity of the 

outbreak on the affected population. 

These data, together with trend data, 

may be used to monitor the effects of 

change in the health care system, 

planning of health services, improving 

the availability of medical services and 

assessing the health status of the 

population. 

Users of the Emergency Epidemic 

Investigations data include, but are not 

limited to EIS Officers in investigating 

the patterns of disease or injury, 

investigating the level of risky 

behaviors, identifying the causative 

agent and identifying the transmission 

of the condition and the impact of 

interventions. 

Epi Trip Reports are delivered to the 

state health agency official requesting 

assistance shortly after completion of 

the Emergency Epidemic Investigation. 

The official can comment on both the 

timeliness and the practical utility of 

the recommendations from the 

investigation. CDC is requesting that a 

new form be added to the current 

clearance. Upon completion of the 

Emergency Epidemic Investigation, 

requesting officials at the state or local 

health department will be asked to 

complete a brief questionnaire to assess 


jlentini on PROD1PC65 with NOTICES