74536 Federal Register / Vol. 71, No. 238 / Tuesday, December 12, 2006 / Notices 

Susan R. Woskie, PhD ............................................................................. University of Massachusetts Lowell, Lowell, MA. 

Background Information on the CERHR 

The NTP established CERHR in June 

1998 [Federal Register, December 14, 

1998 (Volume 63, Number 239, page 

68782)]. CERHR is a publicly accessible 

resource for information about adverse 

reproductive and/or developmental 

health effects associated with exposure 

to environmental and/or occupational 

exposures. Expert panels conduct 

scientific evaluations of agents selected 

by the CERHR in public forums. 

CERHR invites the nomination of 

agents for review or scientists for its 

expert registry. Information about 

CERHR and the nomination process can 

be obtained from its homepage (http:// 

cerhr.niehs.nih.gov) or by contacting Dr. 

Shelby (see FOR FURTHER INFORMATION

CONTACT above). CERHR selects 

chemicals for evaluation based upon 

several factors including production 

volume, potential for human exposure 

from use and occurrence in the 

environment, extent of public concern, 

and extent of data from reproductive 

and developmental toxicity studies. 

CERHR follows a formal, multi-step 

process for review and evaluation of 

selected chemicals. The formal 

evaluation process was published in the 

Federal Register on July 16, 2001 

(Volume 66, Number 136, pages 37047–

37048) and is available on the CERHR 

Web site under ‘‘About CERHR’’ or in 

printed copy from CERHR. 

Dated: November 27, 2006. 

Samuel H. Wilson, 

Deputy Director, National Institute of 

Environmental Health Sciences and National 

Toxicology Program. 

[FR Doc. E6–21040 Filed 12–11–06; 8:45 am] 

BILLING CODE 4140–01–P 

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: ‘‘Pilot 

Study of Proposed Nursing Home 

Survey on Resident Safety’’. 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 

‘‘Pilot Study of Proposed Nursing Home 

Survey on Resident Safety’’

This activity is an expansion and 

refinement of AHRQ’s Hospital Survey 

on Patient Safety Culture (HSOPSC) 

which was developed and released to 

the public for use in November 2004. 

This proposed new tool is based on the 

HSOPSC but also contains new and 

revised items as well as dimensions that 

more accurately apply to the nursing 

home setting. The instrument will be 

pilot tested with staff in 40 nursing 

homes. The data collected will be 

analyzed to determine the psychometric 

properties of the survey’s items and 

dimensions and provide information for 

the revision and shortening of the final 

survey based on an assessment of its 

reliability and construct validity. The 

final survey will be made publicly 

available to enable nursing homes to 

assess their resident safety culture. 

Methods of Collection 

A purposive sample of 40 nursing 

homes will be recruited and selected. 

These nursing homes will represent a 

distrubition of bed size, nature of 

ownership (non-profit/for-profit), 

urbanity (urban/rural), and geographic 

region of the United States. Recruited 

nursing homes will be allocated to each 

category in numbers roughly 

proportionate to the national 

distribution of homes in each category. 

All employees, contractors and 

agency staff in all job classes in nursing 

homes with up to 200 employees will be 

asked to respond to the survey. In 

nursing homes with more than 200 

employees, a random sample of 200 

employees will be selected. Since not all 

nursing homes staff have access to or are 

familiar with e-mail or the internet, 

paper surveys will be administered. 

Standard non-response follow-up 

techniques such as reminder postcards 

and distrubiton of a second survey will 

be used. Individuals and organizations 

contacted will be assured of the 

confidentiality of their replies under 

Section 924(c) of the Healthcare 

Research and Quality Act of 1999. 

Estimated Annual Respondent Burden 

The survey will be distributed to 

approximately 5,500 nursing home 

employees, with a target response rate of 

70%, or 3,850 returned surveys. 

Respondents should take approximately 

15 minutes to complete the survey. 

Therefore, we estimate that the 

respondent burden for completing the 

survey will be 963 hours (3,850 

completes multiplied by 0.25 hours per 

completed survey). 

Type of Respondent Number of Respondents 

Number of Responses per 

Respondent 

Estimated 

Time per Respondent 

(hours) 

Estimated 

Total Respondent Burden Hours 

Nursing home staff member ............................................................................ 3,850 1 0.25 963 


jlentini on PROD1PC65 with NOTICES
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