Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 24955 

FEDERAL DEPOSIT INSURANCE 

CORPORATION 

Sunshine Act Meeting 

Pursuant to the provisions of the 

‘‘Government in the Sunshine Act’’ 

(5 U.S.C. 552b), notice is hereby given 

that at 2:22 p.m. on Monday, April 23, 

2012, the Board of Directors of the 

Federal Deposit Insurance Corporation 

met in closed session to consider 

matters related to the Corporation’s 

supervision, corporate, and resolution 

activities. 

In calling the meeting, the Board 

determined, on motion of Director 

Thomas M. Hoenig (Appointive), 

seconded by Director Richard Cordray 

(Director, Consumer Financial 

Protection Bureau), concurred in by 

Director Thomas J. Curry (Comptroller 

of the Currency), Director Jeremiah O. 

Norton (Appointive), and Acting 

Chairman Martin J. Gruenberg, that 

Corporation business required its 

consideration of the matters which were 

to be the subject of this meeting on less 

than seven days’ notice to the public; 

that no earlier notice of the meeting was 

practicable; that the public interest did 

not require consideration of the matters 

in a meeting open to public observation; 

and that the matters could be 

considered in a closed meeting by 

authority of subsections (c)(4), (c)(6), 

(c)(8), (c)(9)(A)(ii), (c)(9)(B), and (c)(10) 

of the ‘‘Government in the Sunshine 

Act’’ (5 U.S.C. 552b(c)(4), (c)(6), (c)(8), 

(c)(9)(A)(ii), (c)(9)(B), and (c)(10)). 

The meeting was held in the Board 

Room of the FDIC Building located at 

550 17th Street NW., Washington, DC. 

Federal Deposit Insurance Corporation. 

Dated: April 23, 2012. 

Robert E. Feldman, 

Executive Secretary. 

[FR Doc. 2012–10161 Filed 4–24–12; 11:15 am] 

BILLING CODE 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: ‘‘System 

Redesign for Value in Safety Net 

Hospitals and Delivery Systems.’’ In 

accordance with the Paperwork 

Reduction Act, 44 U.S.C. 3501–3521, 

AHRQ invites the public to comment on 

this proposed information collection. 

This proposed information collection 

was previously published in the Federal 

Register on February 24th, 2012 and 

allowed 60 days for public comment. No 

substantive 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 May 29, 2012. 

ADDRESSES: Written comments should 

be submitted to: AHRQ’s OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQ’s 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 

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

SUPPLEMENTARY INFORMATION: 

Proposed Project 

System Redesign for Value in Safety Net 

Hospitals and Delivery Systems 

This proposed project is a case study 

of 8 safety net (SN) hospitals. The goals 

of the project are to: 

(1) Identify the tools and resources 

needed to facilitate system redesign in 

SN hospitals and; 

(2) Identify any barriers to adoption of 

these in SN environments, or any gaps 

that exist in the available resources. 

These goals are consistent with The 

National Strategy for Quality 

Improvement in Health Care, published 

by the U.S. Department of Health and 

Human Services in March 2011, which 

articulated a need for progress toward 

three goals: (1) Better Care, (2) Healthy 

People/Healthy Communities and (3) 

Affordable Care. SN hospitals and 

systems are critical to achieving all 

three. SN hospitals are hospitals and 

health systems which provide a 

significant portion of their services to 

vulnerable, uninsured and Medicare 

patients. While all hospitals face 

challenges in improving both quality 

and operating efficiency, safety net (SN) 

hospitals face even greater challenges 

due to growing demand for their 

services and decreasing funding 

opportunities. 

Despite these challenging 

environmental factors, some SN 

hospitals and health systems have 

achieved financial stability and 

implemented broad-ranging efforts to 

improve the quality of care they deliver. 

However, while there have been 

successful quality improvement 

initiatives for SN providers, most 

initiatives aim at specific units within 

large organizations. The improvements 

introduced into these units have not 

often been spread throughout the 

organization. Additionally, these 

improvements often are hard to sustain. 

‘‘System redesign’’ refers to aligned and 

synergistic quality improvement efforts 

across a hospital or health system 

leading to multidimensional changes in 

the management or delivery of care or 

strategic alignment of system changes 

with an organization’s business strategy. 

System redesign, if done successfully, 

will allow SN providers to improve 

their operations, remain afloat 

financially, and provide better quality 

healthcare to vulnerable and 

underserved populations. Resources, as 

defined here, may include learning 

materials and environments developed 

to support, advance, and facilitate 

quality improvement efforts (e.g., tools, 

guides, webinars, learning 

collaboratives, training programs). The 

term ‘‘resources’’ should not be 

interpreted here to imply financial 

support for routine staffing or 

operations of Safety Net systems, but 

may include quality improvement 

grants, fellowships, collaboratives and 

trainings. 

Many tools, guides, and other learning 

environments have been developed to 

support the implementation of 

individual quality improvement 

initiatives. However, the development 

of resources to support alignment across 

multiple domains of a health system has 

been limited. Furthermore, the 

applicability of existing resources to SN 

environments is unknown. 

This study is being conducted by 

AHRQ through its contractor, Boston 

University, pursuant to AHRQ’s 

statutory authority to conduct and 

support research on healthcare and on 

systems for the delivery of such care, 

including activities with respect to the 

quality, effectiveness, efficiency, 

appropriateness and value of healthcare 

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 activities and data collections 

will be implemented: 


tkelley on DSK3SPTVN1PROD with NOTICES
24956 Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 

(1) In-person interviews will be 

conducted during a 2-day site visit with 

senior medical center leaders, clinical 

managers and staff involved in system 

redesign from each of the 8 participating 

SN hospitals. These interviews may be 

conducted one-on-one or in small 

groups, depending upon the 

participants’ availability. The purpose 

of these interviews is to learn directly 

from hospital leadership and staff about 

the resources they have used to support 

and guide their system redesign efforts 

and what, if any, gaps there are in the 

resources available to them. 

(2) Collection of documentation from 

each SN hospital. The documentation to 

be collected includes annual reports, 

performance dashboards, reports on 

specific system redesign and quality 

improvement projects and hospital 

newsletters. The purpose of this task is 

to provide supplementary information 

about the hospitals and their quality 

improvement and system redesign 

efforts. Collection of documentation 

from participating hospitals will allow 

the research team to collect additional 

information that is readily available in 

hospital documents, but may not be 

known or readily accessible to interview 

subjects during their interviews. 

The findings and recommendations 

developed from this project will be 

disseminated through AHRQ networks 

and through our partnership with the 

National Association of Public Hospitals 

and its membership group to ensure that 

findings are reaching administrators at 

public and SN hospitals directly. In 

addition, findings will be published in 

peer-reviewed and trade literature so 

that they will be available to a wide 

range of SN delivery system managers 

and clinicians for use in hospitals and 

healthcare systems. Findings will be 

presented as illustrative of the issues 

facing SN hospitals engaging in system 

redesign—rather than as representing 

the quantity or distribution of 

conditions and practices within SN 

hospitals. All presentations and 

publications will state the limitations of 

our case-study methodology. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

respondents’ time to participate in this 

data collection. In-person interviews 

will be conducted with a total of 160 

hospital staff members (20 from each of 

the 8 participating SN hospitals) and 

will last about 1 hour. The collection of 

documentation will require 2 hours 

work from 1 staff member at each 

hospital. The total burden is estimated 

to be 176 hours. 

EXHIBIT 1—ANNUALIZED BURDEN HOURS

Data collection Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

In-person interviews ......................................................................................... 160 1 1 160 

Collection of documentation ............................................................................ 8 1 2 16 

Total .......................................................................................................... 168 n/a n/a 176 

Exhibit 2 shows the estimated 

annualized cost burden associated with 

the respondents’ time to provide the 

requested data. The total cost burden is 

estimated to be $9,242 annually. 

EXHIBIT 2—ESTIMATED ANNUALIZED BURDEN COST

Data collection Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate * 

Total cost 

burden 

In-person interviews ......................................................................................... 160 160 $56.23 $8,997 

Collection of documentation ............................................................................ 8 16 15.30 245 

Total .......................................................................................................... 168 176 na 9,242

* The hourly rate of $56.23 is an average of the clinical personnel hourly wage of $91.10 for physicians and $32.56 for registered nurses, and 

the administrative personnel hourly wage of $45.03 for medical and health services managers. The hourly rate of $15.30 is median hourly rate 

for medical administrative support staff. All hourly rates are based on median salary data provided by the U.S. Bureau of Labor Statistics. 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the estimated total 

and annualized cost to the government 

for this 3 year project. The total cost is 

$499,877 and includes the cost of data 

collection, data analysis, reporting, and 

government oversight of the contract. 

The costs associated with data 

collection activities are not all for the 

primary data collection of the case 

studies but include the review of 

existing literature and other available 

data sources. 

TABLE 3—COST TO THE FEDERAL GOVERNMENT

Cost component Total cost Annualized 

cost 

Project Development ............................................................................................................................................... $49,161 $16,377 

Data Collection Activities ......................................................................................................................................... 123,478 41,159 

Data Processing and Analysis ................................................................................................................................. 109,433 36,478 

Publication of Results .............................................................................................................................................. 81,836 27,279 

Project Management ................................................................................................................................................ 18,438 6,146 

Overhead ................................................................................................................................................................. 117,531 39,177 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 24957 

TABLE 3—COST TO THE FEDERAL GOVERNMENT—Continued 

Cost component Total cost Annualized 

cost 

Government Oversight ............................................................................................................................................. 13,710 4,570 

Total .................................................................................................................................................................. 499,877 166,626 

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 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: April 19, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–10007 Filed 4–25–12; 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: 

‘‘American Recovery and Reinvestment 

Act ‘‘Developing a Registry of 

Registries’’.’’ In accordance with the 

Paperwork Reduction Act, 44 U.S.C. 

3501–3521, AHRQ invites the public to 

comment on this proposed information 

collection. 

This proposed information collection 

was previously published in the Federal 

Register on February 23, 2012 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 May 29, 2012. 

ADDRESSES: Written comments should 

be submitted to: AHRQ’s OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQ’s 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 

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

SUPPLEMENTARY INFORMATION: 

Proposed Project 

American Recovery and Reinvestment 

Act ‘‘Developing a Registry of 

Registries’’ 

The Food and Drug Administration 

Modernization Act of 1997, Public Law 

105–115, provided for the creation of a 

Clinical Trials Data Bank, known as 

ClinicalTrials.gov. Since its launch in 

2000, the ClinicalTrials.gov system has 

registered over 90,500 trials. The large 

volume of studies currently listed in 

ClinicalTrials.gov and the high usage 

numbers suggest that the system has 

been successful at improving access to 

information about clinical studies. 

However, while ClinicalTrials.gov 

supports the listing of observational 

studies, such listing is not required. 

Patient registries are a distinct type of 

observational study. Patient registries 

may be designed for many purposes, 

such as to observe the natural history of 

disease, examine comparative 

effectiveness, or fulfill post-approval 

commitments. Patient registries have 

specific characteristics that are not 

currently captured on 

ClinicalTrials.gov. To date, some 

registry sponsors have attempted to 

leverage the observational study model 

to post patient registry-type records on 

ClinicalTrials.gov. However, 

stakeholders have noted that the system 

does not fully meet their needs. 

Patient registries have received 

significant attention and funding in 

recent years. Similar to controlled 

interventional studies, patient registries 

represent some burden to patients (e.g., 

time to complete patient reported 

outcome measures, risk of loss of 

privacy), who often participate 

voluntarily in hopes of improving 

knowledge about a disease or condition. 

Patient registries also represent a 

substantial investment of health 

research resources. Despite these 

factors, registration of patient registries 

in ClinicalTrials.gov is not currently 

required, presenting the potential for 

duplication of efforts and insufficient 

dissemination of findings that are not 

published in the peer-reviewed 

literature. To ensure that resources are 

used in the most efficient manner, 

registries need to be listed in a manner 

similar to that of trials in 

ClinicalTrials.gov. 

By creating a central point of 

collection for information about all 

patient registries in the United States, 

the Registry of Patient Registries (RoPR) 

helps to further AHRQ’s goals by 

making information regarding quality, 

appropriateness, and effectiveness of 

health services (and patient registries in 

particular) more readily available and 

centralized. 

The primary goal of this project is to 

engage stakeholders in the design and 

development of a RoPR database system 

that is compatible with 

ClinicalTrials.gov and meets the 

following objectives: 

(1) Provides a searchable database of 

patient registries in the United States (to 

promote collaboration, reduce 

redundancy, and improve 

transparency); 

(2) Facilitates the use of common data 

fields and definitions in similar health 

conditions (to improve opportunities for 

sharing, comparing, and linkage); 

(3) Provides a public repository of 

searchable summary results (including 


tkelley on DSK3SPTVN1PROD with NOTICES