45194 Federal Register / Vol. 79, No. 149 / Monday, August 4, 2014 / Notices 

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: July 24, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–18296 Filed 8–1–14; 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: 

‘‘Updating and Expanding the AHRQ QI 

Toolkit for Hospitals.’’ 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. 

This proposed information collection 

was previously published in the Federal 

Register on May 12th 2014 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 September 3, 2014. 

ADDRESSES: Written comments should 

be 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 

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

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Updating and Expanding the AHRQ QI 

Toolkit for Hospitals 

AHRQ has developed sets of Quality 

Indicators (QIs) that can be used to 

document quality and safety conditions 

at U.S. hospitals. Three sets of QIs are 

particularly relevant for hospitals and 

include: The Inpatient Quality 

Indicators (IQIs), the Patient Safety 

Indicators (PSIs), and the Pediatric 

Quality Indicators (PDIs). The IQIs 

contain measures of volume, mortality, 

and utilization for common medical 

conditions and major surgical 

procedures. The PSIs are a set of 

measures to screen for potentially 

preventable adverse events that patients 

may experience during hospitalization. 

The PDIs measure the quality of 

pediatric health care, mainly focusing 

on preventable complications that occur 

as a consequence of hospitalization 

among pediatric patients. These QIs 

have been previously developed and 

evaluated by AHRQ, and are in use at 

a number of hospitals throughout the 

country. The QIs and supportive 

documentation on how to work with 

them are posted on AHRQ’s Web site at 

www.qualityindicators.ahrq.gov. 

Despite the availability of the QIs as 

tools to help hospitals assess their 

performance, many U.S. hospitals have 

limited experience with the use of such 

measurement tools, or in using quality 

improvement methods to improve their 

performance as assessed by these 

measures. To this end, RAND has 

previously contracted with AHRQ to 

develop an AHRQ Quality Indicators 

Toolkit for Hospitals (Toolkit). This 

Toolkit is publicly available and is 

posted on AHRQ’s Web site at http://

www.ahrq.gov/professionals/systems/

hospital/qitoolkit/index.html. The 

Toolkit assists hospitals in both using 

the QIs and improving the quality and 

safety of the care they provide, as 

measured by those indicators. As such, 

the Toolkit includes: (1) Instruction on 

how a hospital can apply the QIs to its 

inpatient data to estimate rates for each 

indicator; (2) methods the hospital can 

use to evaluate these QI rates for 

identifying opportunities for 

improvement; (3) strategies for 

implementing interventions (or 

evidence-based best practices); (4) 

methods to measure progress and 

performance on the QIs; (5) tools for 

evaluating the cost-effectiveness of these 

changes; and (6) discussion of the value 

of using the QIs for quality 

improvement as well as potential 

challenges and barriers to quality 

improvement efforts that incorporate the 

QIs and how to help overcome them. 

OMB approval was obtained for the 

development and evaluation of the 

original Toolkit in 2012, Development 

and Evaluation of AHRQ’s Quality 

Indicators Improvement Toolkit (OMB 

#0935–0164), which consisted of a 

protocol very similar to the one 

described in this statement. 

Since the release of the Toolkit in 

2012, the QIs have been updated and 

expanded, best practices have advanced, 

and many hospitals have improved their 

understanding of their quality 

improvement needs as well as increased 

their familiarity with the use of the 

Toolkit. These factors all point to the 

critical need to update the Toolkit. 

AHRQ has funded RAND which 

partners with the University 

HealthSystem Consortium (UHC) to 

update and expand the Toolkit, and 

field test the updated Toolkit with 

hospitals as they carry out initiatives 

designed to improve performance on the 

QIs. 

This research has the following goals: 

(1) To assess the usability of the 

updated Toolkit for hospitals—with an 

emphasis on the Pediatric Quality 

Indicators (PDI)—in order to improve 

the Toolkit, and 

(2) To examine hospitals’ experiences 

in implementing interventions to 

improve their performance on the 

AHRQ QIs, the results of which will be 

used to guide successful future 

applications of the Toolkit. 

This study is being conducted by 

AHRQ through its contractor, the RAND 

Corporation, under contract number 

HHSA290201000017I, pursuant to 

AHRQ’s statutory authority to conduct 

and support research on health care and 

on systems for the delivery of such care, 

including activities with respect to the 

quality, effectiveness, efficiency, 

appropriateness and value of health care 

services and with respect to quality 

measurement and improvement. 42 

U.S.C. 299a(a)(1) and (2). 

Method of Collection 

To achieve the goals of this project, 

the following data collections will be 

implemented: 

(1) Pre/post-test interview protocol— 

consisting of both open and closed 

ended questions will be administered 

prior to implementation of the Toolkit 

and again post implementation. The 

purpose of this data collection is to 

obtain data on the steps the hospitals 

took to implement actions to improve 

performance on the QIs; their plans for 

making process changes; and their 

experiences in achieving changes and 

perceptions regarding lessons learned 

that could be shared with other 

hospitals. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 149 / Monday, August 4, 2014 / Notices 45195 

(2) Update protocol—consisting of 

both open and closed ended questions 

will be administered three times during 

the study (quarterly during the 

implementation year). The purpose of 

this data collection is to capture 

longitudinal data regarding hospitals’ 

progress in implementing changes, 

successes and challenges, and plans for 

subsequent actions. These data will 

include descriptive information on 

changes over time in the hospitals’ 

implementation actions and how they 

are using the Toolkit, as well as 

experiential information on the 

perceptions of participants regarding the 

improvement implementation process 

and its effects. It also ensures the 

collection of information close to 

pertinent events, which avoids the 

recall bias associated with retrospective 

reporting of experiences. 

(3) Usability testing protocol—also 

consisting of both open and closed 

ended questions will be administered 

once at the end of the evaluation period. 

The purpose of this data collection is to 

gather information from the hospitals on 

how they used each tool in the updated 

Toolkit, the ease of use of each tool, 

which tools were most helpful, 

suggested changes to improve each tool, 

and suggestions for other tools to add to 

the updated Toolkit. This information 

will be used in the revisions of the 

updated Toolkit following the end of the 

field test. 

All the information obtained from the 

proposed data collection will be used to 

strengthen the updated Toolkit before 

finalizing and disseminating it to 

hospitals for their use. First, information 

will be collected from the six hospitals 

participating in the Toolkit field test 

about their experiences in implementing 

performance improvements related to 

the AHRQ QIs, which will be used to 

prepare experiential case examples for 

inclusion in the Toolkit as a resource for 

other hospitals. Second, feedback will 

be elicited from them about the usability 

of the Toolkit, which will be applied to 

modify and refine the Toolkit so that it 

is as responsive as possible to the needs 

and priorities of the hospitals for which 

it is intended. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

respondents’ time to participate in this 

information collection. Three protocols 

will be used to collect data from 

respondents in interviews that will take 

one hour each. The pre/post-test 

interview protocol will be administered 

twice—at the beginning and end of the 

field-test year. The pre-test interviews 

will be performed as one-hour group 

interviews with the six hospitals’ 

implementation teams at the start of the 

year. Each hospital’s implementation 

team is expected to consist of about five 

people. At the end of the year, post-test 

interviews that last one hour each and 

use the same protocol as the pre-test 

interviews will be conducted during site 

visits at the six hospitals with the 

implementation team. The five people 

of the implementation team at each 

hospital will be interviewed twice, both 

pre- and post-field test. At the post-test 

site visits, data will also be collected 

through one-hour interviews performed 

separately with four key stakeholder 

groups—physicians, nurses, clerks, and 

others—that are not on the 

implementation team. Each stakeholder 

group is expected to consist of about 

five people. These 20 people from the 

four stakeholder groups at each hospital 

will be interviewed once in a one hour 

post-field test. Interviewing these 

additional stakeholder groups will 

ensure that information is gathered on 

stakeholder variations in perceptions 

and experiences, of which the 

implementation teams might not be 

aware. 

The quarterly update protocol will be 

administered quarterly to two hospital 

staff members from each hospital during 

the year (in months 3, 6, and 9). The 

usability testing protocol will be 

administered to four staff members once 

at the end of the evaluation period. The 

total burden is estimated to be 240 

hours. 

Exhibit 2 shows the estimated 

annualized cost burden associated with 

the respondents’ time to participate in 

the evaluation. The total cost burden is 

estimated to be $7,179. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Data collection Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Pre/Post-Test Interview Protocol with Implementation Team ......................... 30 2 1 60 

Pre/Post-Test Interview Protocol with Stakeholder Groups ............................ 120 1 1 120 

Quarterly Update Protocol ............................................................................... 12 3 1 36 

Usability Testing Protocol ................................................................................ 24 1 1 24 

Total .......................................................................................................... 186 NA NA 240 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Data collection Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate * 

Total cost 

burden 

Pre/Post-Test Interview Protocol (Implementation Team and Stakeholder 

Groups) ........................................................................................................ 150 180 29.91 5,384 

Quarterly Update Protocol ............................................................................... 12 36 29.91 1,077 

Usability Testing Protocol ................................................................................ 24 24 29.91 718 

Total .......................................................................................................... 186 240 NA $7,179 

* Based upon the mean of the average wages taken from an average of hourly rates for occupations likely to be involved in the QI process 

(registered nurses, nurse practitioners, medical records and health information technicians, statisticians, and health technologists and technicians). Statistics are taken from the General Medical and Surgical Hospitals industry category in the May 2012 National Industry-Specific Occupational Employment and Wage Estimates from the Bureau of Labor Statistics, U.S. Department of Labor, accessed on January 22, 2014 

[www.bls.gov/oes/]. 


tkelley on DSK3SPTVN1PROD with NOTICES
45196 Federal Register / Vol. 79, No. 149 / Monday, August 4, 2014 / Notices 

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 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: July 24, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–18297 Filed 8–1–14; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1072] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Application for 

Participation in the Food and Drug 

Administration Commissioner’s 

Fellowship Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the application for participation in the 

FDA Commissioner’s Fellowship 

Program (CFP). 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 3, 2014. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Application for Participation in the 

FDA Commissioner’s Fellowship 

Program; (OMB Control Number 0910— 

New) 

Sections 1104, 1302, 3301, 3304, 

3320, 3361, 3393, and 3394 of Title 5 of 

the United States Code authorize 

Federal Agencies to rate applicants for 

Federal jobs. Collecting applications for 

the CFP will allow FDA’s Office of the 

Commissioner to easily and efficiently 

elicit and review information from 

students and health care professionals 

who are interested in becoming 

involved in FDA-wide activities. The 

process will reduce the time and cost of 

submitting written documentation to the 

Agency and lessen the likelihood of 

applications being misrouted within the 

Agency mail system. It will assist the 

Agency in promoting and protecting the 

public health by encouraging outside 

persons to share their expertise with 

FDA. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/5 U.S.C. Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

1104,1302, 3301, 3304, 3320, 3361, 3393, and 3394 ........ 600 1 600 1.33 798 

Total .............................................................................. ........................ ........................ ........................ ........................ 798 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


tkelley on DSK3SPTVN1PROD with NOTICES