38102 Federal Register / Vol. 75, No. 126 / Thursday, July 1, 2010 / Notices 

objectives of the Strategic Plan. Program 

staff will communicate anticipated 

actions to grantees, reviewers, and 

stakeholders. The staff will be open for 

suggestions to improve transparency or 

identify areas where clarification is 

needed. 

Conclusion 

There remains a need for fundamental 

research to address SRP’s original 

mandates. The Program’s sister agencies 

tasked with developing and 

implementing policies to protect health 

rely upon the best science. Likewise, 

communities living near sites impacted 

by hazardous substances need 

accessible science to fully participate in 

decisions made about site management. 

The stated objectives of the Strategic 

Plan (addressing relevant issues, 

maximizing impact, and fostering 

innovation) have been designed to better 

address stakeholders’ needs. This 

Strategic Plan, as a living document, 

will guide the Program over the next 

five years. Program staff look forward to 

embracing this future with grantees, 

stakeholders, and others who share the 

greater vision of improving human 

health and the environment through 

reducing or eliminating the negative 

impacts of exposure to hazardous 

substances from hazardous waste sites. 

Program staff thank the many 

contributors who have provided 

constructive comments during the 

strategic planning process and thereby 

assisted in the development of this draft 

strategic plan. We are now seeking 

comments on the draft strategic plan. 

Comments will be accepted for 30 days 

following the publication of this notice. 

Please e-mail comments to 

Srpinfo@neihs.nih.gov. 

Dated: June 24, 2010. 

William A. Suk, 

Director, Center for Risk and Integrated 

Sciences, Director, Superfund Research 

Program, Division of Extramural Research 

and Training, National Institute of 

Environmental Health Sciences, National 

Institutes of Health. 

[FR Doc. 2010–16072 Filed 6–30–10; 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, 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: ‘‘National 

Hospital Adverse Event Reporting 

System: Questionnaire Redesign and 

Testing.’’ In accordance with the 

Paperwork Reduction Act, 44 U.S.C. 

3501–3520, AHRQ invites the public to 

comment on this proposed information 

collection. 

This proposed information collection 

was previously published in the Federal 

Register on May 3rd 2010 and allowed 

60 days for public comment. One 

comment was 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 August 2, 2010. 

ADDRESSES: Written comments should 

be submitted to: AHRQs OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQs 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 

National Hospital Adverse Event 

Reporting System: Questionnaire 

Redesign and Testing 

As provider of operational support to 

the chair of the Quality Interagency 

Task Force (QuIC), AHRQ coordinated 

the Federal response to the Institute of 

Medicine’s (IOM) 1999 report on 

medical errors and outlined specific 

initiatives the QuIC agencies will take. 

The Errors Workgroup within the QuIC 

identified the need for measures to 

evaluate the use of adverse medical 

event reporting for managing and 

improving patient safety within 

healthcare institutions. In response, 

AHRQ created the Hospital Adverse 

Event Reporting Survey to provide 

national estimates. This survey has been 

fielded twice, first in 2005 and again in 

2008. 

Revisions to the questionnaire and 

sample selection are now necessary in 

response to the Patient Safety and 

Quality Improvement Rule (Patient 

Safety Rule), 42 CFR Part 3, issued by 

the United States Department of Health 

and Human Services, which implements 

the Patient Safety and Quality 

Improvement Act of 2005 (Patient Safety 

Act), 42 U.S.C. 299b–21 through 299b– 

26. The Patient Safety Rule and Patient 

Safety Act authorize the creation of 

Patient Safety Organizations (PSO) to 

enhance quality and safety by collecting 

patient safety reports of adverse events. 

AHRQ started listing PSOs in late 2008 

pursuant to the Patient Safety Act. 

These organizations have begun 

working with hospitals and other 

providers to monitor patient safety 

events according to common reporting 

formats, and to improve patient safety. 

This revised survey will be used for the 

third round of data collection in 2011, 

under a separate OMB clearance, to 

assess the impact of the PSOs and the 

Patient Safety Act on the use of adverse 

event reporting systems and will 

incorporate questions about reporting 

using the AHRQ Common Formats, and 

reporting information to a Patient Safety 

Organization. 

This project is being conducted by 

AHRQ’s contractor, Westat, pursuant to 

AHRQ’s statutory mandates to (1) 

promote health care quality 

improvement by conducting and 

supporting research that develops and 

presents scientific evidence regarding 

all aspects of health care, including 

methods for measuring quality and 

strategies for improving quality (42 

U.S.C. 299(b)(1)(F)) and (2) conduct and 

support research on health care and on 

systems for the delivery of such care, 

including activities with respect to 

quality measurement and improvement 

(42 U.S.C. 299a(a)(2). 

Method of Collection 

This project will include the 

following data collections: 

(1) Semi-structured interviews will be 

conducted with one risk manager or 

other representative responsible for 

adverse event reporting from 7 

participating hospitals and with one 

person from the two participating PSOs. 

These interviews will be conducted to 

learn more about the current hospital 

adverse event reporting environment 

and to understand how adverse event 

reporting may have changed in response 

to the Patient Safety Act. Survey 

developers will use the information 

from these interviews to develop 

questions for the revised questionnaire. 

(2) Cognitive interviews will be 

conducted with one risk manager or 

other representative responsible for 

adverse event reporting in 30 

participating hospitals. The purpose of 

these cognitive interviews is to test and 

refine the revised questionnaire. The 


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Federal Register / Vol. 75, No. 126 / Thursday, July 1, 2010 / Notices 38103 

questionnaire will be tested among 

respondents in hospitals with no 

reporting affiliation with a PSO, with 

reporting affiliations with one PSO, and 

with reporting affiliations with more 

than one PSO. 

Results from these interviews will 

help inform actions by AHRQ to 

encourage effective adverse event 

reporting by hospitals, as part of its 

patient safety initiative, including 

standardization of reporting so that 

consistent concepts, information, and 

terminology are used in the patient 

safety arena. The survey can also serve 

as a baseline for changes about hospitalbased adverse event reporting to Patient 

Safety Organizations and how the 

Patient Safety Act might have affected 

reporting structures and processes. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

respondents time to participate in this 

project. Semi-structured interviews will 

be conducted with 9 persons 

representing 7 hospitals and 2 PSOs and 

will last for about an hour. Cognitive 

interviews will be conducted with one 

person in each of 30 participating 

hospitals and are expected to take one 

hour to complete. The total annual 

burden hours are estimated to be 39 

hours. Exhibit 2 shows the estimated 

annual cost burden associated with the 

respondents’ time to participate in the 

research. The total annual cost burden 

is estimated to be $1,664. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of organizations 

Number of responses per 

organization 

Hours per 

response 

Total burden 

hours 

Semi-structured interviews .............................................................................. 9 1 1 9 

Cognitive interviews ......................................................................................... 30 1 1 30 

Total .......................................................................................................... 39 NA NA 39 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of organizations 

Total burden 

hours 

Average 

hourly wage 

rate* 

Total cost 

burden 

Semi-structured interviews .............................................................................. 9 9 $42.67 $384 

Cognitive interviews ......................................................................................... 30 30 42.67 1,280 

Total .......................................................................................................... 39 39 NA 1,664 

* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States 2008, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the estimated total 

and annualized cost to the Federal 

government to conduct this redesign of 

the Adverse Event Reporting 

Questionnaire and associated sample 

design. Since this project will last for 

one year the total and annualized costs 

are the same. The total cost is estimated 

to be $120,000. 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

Cost component Total cost Annualized 

cost 

Project Development ............................................................................................................................................... $24,000 $24,000 

Data Collection Activities ......................................................................................................................................... 46,000 46,000 

Data Processing and Analysis ................................................................................................................................. 26,000 26,000 

Project Management ................................................................................................................................................ 24,000 24,000 

Total .................................................................................................................................................................. 120,000 120,000 

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: June 22, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–15797 Filed 6–30–10; 8:45 am] 

BILLING CODE 4160–90–M 


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