Federal Register / Vol. 75, No. 84 / Monday, May 3, 2010 / Notices 23271 

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: April 22, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–10199 Filed 4–30–10; 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: ‘‘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. 

DATES: Comments on this notice must 

he received by July 2, 2010. 

ADDRESSES: Written comments should 

he submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@AHRQ.hhs.gov. 

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 (I) 

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 

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 I 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. 


erowe on DSK5CLS3C1PROD with NOTICES
23272 Federal Register / Vol. 75, No. 84 / Monday, May 3, 2010 / Notices 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

organizations 

Number of 

responses per 

responding 

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 

respondents 

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 in formation 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: April 20, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–10195 Filed 4–30–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Retroviral Vectors for Selective 

Reversible Immortalization of 

Stimulus-responding Primary Cells 

Description of Invention: Researchers 

at the National Cancer InstituteFrederick, NIH, have developed a novel 

set of retroviral vectors and producer 

cell lines useful for selective reversible 

immortalization of primary cells (i.e. 

lymphocytes) that respond to a 

stimulus, such as a viral antigen (e.g. 


erowe on DSK5CLS3C1PROD with NOTICES