Attachment I -- 30 Day FR Notice

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

Information is most frequently
retrieved by first name, last name,
middle initial, date of birth, or Social
Security Number (SSN).
SAFEGUARDS:

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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.

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.

RETENTION AND DISPOSAL:

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

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

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31445

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

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 [email protected]
(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
[email protected].
SUPPLEMENTARY INFORMATION:
SUMMARY:

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

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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

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Data collection

Number of respondents

Number of responses per
respondent

3
3
3
3
3

9
1
10
9
1

Pre-intervention focus groups with clinical staff * ............................................
Pre-intervention focus groups with managers* ................................................
Clinical staff survey ..........................................................................................
Post-intervention focus groups with clinical staff * ...........................................
Post-intervention focus groups with managers* ..............................................

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Hours per response
1
1
15/60
1
1

Total burden
hours
27
3
8
27
3

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Federal Register / Vol. 75, No. 106 / Thursday, June 3, 2010 / Notices
EXHIBIT 1. ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Data collection

Number of respondents

Number of responses per
respondent

15

n/a

Total ..........................................................................................................

Hours per response

Total burden
hours

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
Number of respondents

Data collection

Total burden
hours

Average hourly wage rate

Total cost burden

Pre-intervention focus groups with clinical staff * ............................................
Pre-intervention focus groups with managers * ...............................................
Clinical staff survey ..........................................................................................

3
3
3

27
3
8

$36.73 *
$138.38 **
$36.73 *

$992
$415
$294

Post-intervention focus groups with clinical staff * ...........................................
Post-intervention focus groups with managers * ..............................................

3
3

27
3

$36.73 *
$138.38 **

$992
$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
Annualized
cost

Cost component
Project Management ................................................................................................................................................
Project Development ...............................................................................................................................................
Data Collection Activities .........................................................................................................................................
Travel .......................................................................................................................................................................
Overhead .................................................................................................................................................................

$125,526
$54,622
$41,864
$4,000
$23,754

$251,052
$109,244
$83,728
$8,000
$47,507

Total ..................................................................................................................................................................

$250,001

$500,001

Request for Comments

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Total cost

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

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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]
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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

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