Federal Register / Vol. 75, No. 106 / Thursday, June 3, 2010 / Notices 31445 

RETRIEVABILITY: 

Information is most frequently 

retrieved by first name, last name, 

middle initial, date of birth, or Social 

Security Number (SSN). 

SAFEGUARDS: 

HHS has safeguards in place for 

authorized users and monitors such 

users to ensure against unauthorized 

use. Personnel having access to the 

system have been trained in the Privacy 

Act and information security 

requirements. Employees who maintain 

records in this system are instructed not 

to release data until the intended 

recipient agrees to implement 

appropriate management, operational 

and technical safeguards sufficient to 

protect the confidentiality, integrity and 

availability of the information and 

information systems and to prevent 

unauthorized access. 

This system will conform to all 

applicable Federal laws and regulations 

and Federal, HHS, and HHS policies 

and standards as they relate to 

information security and data privacy. 

These laws and regulations include but 

are not limited to: The Privacy Act of 

1974; the Federal Information Security 

Management Act of 2002; the Computer 

Fraud and Abuse Act of 1986; the EGovernment Act of 2002, and the 

Clinger-Cohen Act of 1996. OMB 

Circular A–130, Management of Federal 

Resources, Appendix III, Security of 

Federal Automated Information 

Resources also applies. Federal, HHS, 

and HHS policies and standards include 

but are not limited to: all pertinent 

National Institute of Standards and 

Technology publications; and the HHS 

Information Systems Program 

Handbook. HHS will give a contractor, 

consultant, or HHS grantee the 

information necessary for the contractor 

or consultant to fulfill its duties. In 

these situations, safeguards are provided 

in the contract prohibiting the 

contractor, consultant, or grantee from 

using or disclosing the information for 

any purpose other than that described in 

the contract and requires the contractor, 

consultant, or grantee to return or 

destroy all information at the 

completion of the contract. Contractors 

are also required to provide the 

appropriate management, operational, 

and technical controls to secure the 

data. 

RETENTION AND DISPOSAL: 

Records are maintained with 

identifiers for all transactions after they 

are entered into the system for a period 

of 10 years. Records are housed in both 

active and archival files in accordance 

with HHS data and document 

management policies and standards. All 

sponsor applications, claims, and other 

program-related records are 

encompassed by the document 

preservation order and will be retained 

until notification is received from the 

Department of Justice. 

SYSTEM MANAGER AND ADDRESS: 

David Gardner, Acting Director, Early 

Retiree Reinsurance Division, Office of 

Insurance Programs, Office of Consumer 

Information and Insurance Oversight, 

U.S. Department of Health & Human 

Services, 200 Independence Avenue, 

SW., Suite 738F, Washington, DC 

20201. 

NOTIFICATION PROCEDURE: 

For purpose of notification, the 

subject individual should write to the 

system manager who will require the 

system name, and the retrieval selection 

criteria (e.g., name, SSN, etc.). 

RECORD ACCESS PROCEDURE: 

For purpose of access, use the same 

procedures outlined in Notification 

Procedures above. Requestors should 

also reasonably specify the record 

contents being sought. (These 

procedures are in accordance with 

Department regulation 45 CFR 

5b.5(a)(2)). 

CONTESTING RECORD PROCEDURES: 

The subject individual should contact 

the system manager named above, and 

reasonably identify the record and 

specify the information to be contested. 

State the corrective action sought and 

the reasons for the correction with 

supporting justification. (These 

procedures are in accordance with 

Department regulation 45 CFR 5b.7). 

RECORD SOURCE CATEGORIES: 

Record source categories include 

program participants, individuals on 

whose behalf reimbursements are being 

sought, and those who voluntarily 

submit data and personal information 

for the ERRP program. 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None. 

[FR Doc. 2010–13178 Filed 6–2–10; 8:45 am] 

BILLING CODE 4150–65–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: 

‘‘Reductions of Infection Caused by 

Carbapenem Resistant 

Enterobacteriaceae (KPC) Producing 

Organisms through the Application of 

Recently Developed CDC/HICPAC 

Recommendations.’’ 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 March 31st, 2010 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 July 6, 2010. 

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 

e-mail at 

doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Reductions of Infections Caused by 

Carbapenem Resistant 

Enterobacteriaceae (KPC) Producing 

Organisms Through the Application of 

Recently Developed CDC/HICPAC 

Recommendations. 

Healthcare Acquired Infections (HAIs) 

caused almost 100,000 deaths among 

the 2.1 million people who acquired 

infections while hospitalized in 2000, 

and HAI rates have risen relentlessly 


sroberts on DSKD5P82C1PROD with NOTICES
31446 Federal Register / Vol. 75, No. 106 / Thursday, June 3, 2010 / Notices 

since then. On March 20, 2009, the 

Centers for Disease Control (CDC) and 

the Healthcare Infections Control 

Practices Advisory Committee (HICPAC) 

developed infection control (IC) 

guidance for Klebsiella pneumonia 

carbapenemase-producing (KPC) 

isolates, as they have been rapidly 

emerging as a significant challenge in 

healthcare settings. The danger of these 

bacteria is that they are resistant to 

carbapenem (a class of beta-lactam 

antibiotics with a broad spectrum of 

antibacterial activity) and cannot be 

treated by the most commonly 

prescribed antibiotics. Limited 

treatment options mean that infections 

caused by carbapenem-resistant bacteria 

result in substantial mortality and 

morbidity. 

The CDC and HICPAC 

recommendations draw on infection 

control strategies which have been 

applied to these pathogens in other 

settings, and other evidence-based 

strategies in infection control. There has 

been little research, however, on the 

implementation of control strategies to 

prevent the spread of these KPC 

infections. The goal of this project is to 

understand how these recommendations 

can best be implemented and how 

effective these recommendations will be 

in practice. This research will advance 

private and public efforts to improve 

health care quality by improving 

measures to control the spread of a 

dangerous organism. This research will 

also provide data for the development of 

an implementation toolkit that hospitals 

can use to prevent the spread of 

carbapenem resistant bacteria. The 

toolkit may include the following types 

of resources: General information about 

the implementation of evidence-based 

clinical practices, resource materials, 

and tools and methods that users can 

adopt to conduct point prevalence 

surveys, protocols and tools that users 

can adopt to specify when active KPC 

surveillance is needed, and resources 

for approaching the problem as a teambased quality-improvement effort. OMB 

clearance will be sought for this toolkit 

once it is developed. 

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 

This project will include the following 

data collections from the intensive care 

unit (ICU) staff within each of three 

participating hospitals: 

(1) Pre-intervention focus groups will 

be conducted separately with managers 

and staff. The purpose of these focus 

groups is to identify potential problems 

in the implementation that can be 

addressed through various means (e.g., 

additional education, other changes in 

process). Another purpose is to 

understand the existing approach to 

quality improvement, the connection(s) 

between overall approach to quality 

improvement and to KPC infection 

control practices, current practices at 

the hospital of quality reporting and 

accountability, and constraints and 

obstacles to quality improvement as 

seen in their roles. Staff members 

identified for the focus groups will be 

those with the most first-hand 

knowledge of existing quality 

improvement efforts, and KPC infection 

control practices. 

(2) Clinical staff survey. Factors 

identified in the pre-intervention focus 

groups will be used to inform the 

development of a self-administered 

survey of staff knowledge of and 

attitudes toward KPC surveillance and 

infection control procedures. 

Respondents will be health care workers 

on the units where these new guidelines 

have been implemented. Findings from 

the survey will be used to assess barriers 

perceived by the staff, potential 

differences across units, and potential 

differences by employee/occupational 

group. 

(3) Post-intervention focus groups (6 

months after implementation of new 

KPC IC guidelines) will be conducted 

separately with managers and staff. The 

purpose of these focus groups is to 

identify actual problems experienced in 

the initial implementation and possible 

measures to address, and to identify 

successful practices to include in a 

toolkit that hospitals can use to 

implement the CDC and HICPAC 

recommendations. 

In addition to developing a toolkit, 

AHRQ plans to disseminate the lessons 

learned from this project about how 

hospitals can best implement the CDC 

guidance for KPC screening and 

infection control, in order to inform 

efforts to change practice in this area. 

Estimated Annual Respondent Burden 

The estimated annualized burden 

hours for respondents to participate in 

this two year research project are 

presented in Exhibit 1. Pre-intervention 

focus groups with clinical staff will be 

conducted with 18 staff members (an 

average of 9 per year for 2 years) from 

each of the 3 participating hospitals and 

will take about 1 hour. Pre-intervention 

focus groups with also be conducted 

with 2 managers (an average of I per 

year for 2 years) from each hospital and 

will take about an hour to complete. 

The clinical staff survey will be 

administered to 20 clinical staff (an 

average of 10 per year for years) from 

each hospital and will take 15 minutes 

to complete. 

Finally, respondents from the preintervention focus groups will 

participate in post-intervention focus 

groups approximately four months after 

the initiation of the intervention. They 

will not last more than an hour each. 

The total annualized burden hours are 

estimated to be 68 hours. 

Exhibit 2 shows the estimated 

annualized cost burden associated with 

the respondents’ time to participate in 

this research. The total annualized cost 

burden is estimated to be $3,108. 

EXHIBIT 1. ESTIMATED ANNUALIZED BURDEN HOURS

Data collection Number of respondents 

Number of responses per 

respondent 

Hours per response Total burden 

hours 

Pre-intervention focus groups with clinical staff * ............................................ 3 9 1 27 

Pre-intervention focus groups with managers* ................................................ 3 1 1 3 

Clinical staff survey .......................................................................................... 3 10 15/60 8 

Post-intervention focus groups with clinical staff * ........................................... 3 9 1 27 

Post-intervention focus groups with managers* .............................................. 3 1 1 3 


sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 75, No. 106 / Thursday, June 3, 2010 / Notices 31447 

EXHIBIT 1. ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Data collection Number of respondents 

Number of responses per 

respondent 

Hours per response Total burden 

hours 

Total .......................................................................................................... 15 n/a n/a 68 

* Individuals that cannot attend the focus groups will be interviewed one-on-one. Clinical staff includes IC leaders, QI team members and unit 

staff. Managers include the chief nursing officer and chief medical officer. 

EXHIBIT 2. ESTIMATED ANNUALIZED COST BURDEN

Data collection Number of respondents 

Total burden 

hours 

Average hourly wage rate Total cost burden 

Pre-intervention focus groups with clinical staff * ............................................ 3 27 $36.73 * $992 

Pre-intervention focus groups with managers * ............................................... 3 3 $138.38 ** $415 

Clinical staff survey .......................................................................................... 3 8 $36.73 * $294 

Post-intervention focus groups with clinical staff * ........................................... 3 27 $36.73 * $992 

Post-intervention focus groups with managers * .............................................. 3 3 $138.38 ** $415 

Total .......................................................................................................... 15 68 na $3,108 

*Based upon the mean hourly wage for Registered Nurses in Nassau and Suffolk County, NY as reported by the Bureau of Labor Statistics in 

May 2008. **Based on report of a private survey of HR departments conducted in November 2009 in New York, NY published by http://www.saIary.com; 3 

chief nursing officers at $101.14/hr and 3 chief medical officers at $175.61/hour. 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the annualized and 

total cost to the federal government for 

this two year research project. Project 

development covers steps taken to 

revise the research plan and begin 

implementation. The total cost is 

estimated to be $500,001. 

EXHIBIT 3. ANNUALIZED AND TOTAL COST TO THE FEDERAL GOVERNMENT

Cost component Annualized 

cost Total cost 

Project Management ................................................................................................................................................ $125,526 $251,052 

Project Development ............................................................................................................................................... $54,622 $109,244 

Data Collection Activities ......................................................................................................................................... $41,864 $83,728 

Travel ....................................................................................................................................................................... $4,000 $8,000 

Overhead ................................................................................................................................................................. $23,754 $47,507 

Total .................................................................................................................................................................. $250,001 $500,001 

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 

will become a matter of public record. 

Dated: May 21, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–13107 Filed 6–2–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Agency Recordkeeping/Reporting 

Requirements Under Emergency 

Review by the Office of Management 

and Budget 

Title: State Personal Responsibility 

Education Program. 

OMB No.: New Collection. 

Description: An emergency request is 

being made to solicit comments from 

the public on paperwork reduction as it 

relates to ACYF’s receipt of the 

following documents from applicants 

and awardees: 

• Application for Formula Grant 

• Performance Progress Reports 

• Year 1 Implementation Plan 

• Performance Measure Reporting 


sroberts on DSKD5P82C1PROD with NOTICES