Attachment F -- Federal Register Notice

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Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents

Number of
responses per
respondent

Average burden response
(in hours)

Total
burden
(in
hours)

Fellowship applicants ....................................................................................................
Fellowship alumni ..........................................................................................................

1122
454

1
1

40/60
15/60

748
114

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

1576

........................

........................

862

Dated: September 23, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2010–24479 Filed 9–29–10; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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:
‘‘Reduction of Clostridium difficile
Infections in a Regional Collaborative of
Inpatient Healthcare Settings through
Implementation of Antimicrobial
Stewardship.’’ 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 July 23, 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 November 1, 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
SUMMARY:

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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

Agency for Healthcare Research and
Quality

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Number of
respondents

Reduction of Clostridium Difficile
Infections in a Regional Collaborative of
Inpatient Healthcare Settings Through
Implementation of Antimicrobial
Stewardship
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
since then. Alarmingly, 70% of HAIs are
due to bacteria that are resistant to
commonly used antibiotics (Huang
2007). This project is designed to
evaluate the implementation of a
program to reduce Clostridium difficile
Infection (CDI) in acute care facilities
via Antimicrobial Stewardship
Programs (ASPs). Working with an
already existing collaborative network
of acute care facilities in New York that
currently collect and report mandatory
data on CDI rates and practice strict
environmental controls, this project will
go beyond environmental strategies in
order to attempt to reduce rates of CDI.
ASPs seek to promote the appropriate
use of antimicrobials via several
methods including selecting the
appropriate dose, duration and route of
administration of antibiotics. Using
antibiotics appropriately can potentially
improve efficacy, reduce costs, and keep
drug-related adverse events to a
minimum. The project is a partnership
with Boston University School of Public
Health (BUSPH), Montefiore Medical
Center (MMC), and Greater New York
Hospital Association (GNYHA).
The overall aims of the research are to
evaluate the implementation of ASPs
specific to CDI at 11 participating
hospitals (6 intervention sites and 5
control sites) and to create a draft ASP
Toolkit. More specifically, the pilot

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study has been designed to provide
information to meet the following
objectives:
1. Identify the antimicrobial
stewardship activities, both currently in
place and those yet to be identified,
specific to each site’s individual needs,
to optimize antimicrobial prescribing
practices to reduce CDI.
2. Assess prescriber perceptions
related to ASP.
3. Assess barriers and facilitators to
ASP implementation.
4. Develop a draft ASP Toolkit to help
hospitals optimize their antimicrobial
prescribing practices to reduce CDI.
New York (NY) State currently
requires ongoing reporting of C-difficile
data for both clinical and surveillance
purposes. As part of an arrangement
with NY State, the Greater New York
Hospital Association (GNYHA) also
collects and analyzes these data through
their CDI collaborative. These data
include tracking baseline rates of CDI,
including pharmacy data, data related to
rates of CDI, patient outcomes, and data
about infection control practices (such
as hand-washing and other
environmental controls to prevent
spread of infection). The data are
collected on standardized forms that are
required by both the state and the
Centers for Disease Control and
Prevention (CDC). The data collected at
these participating hospitals are also
collected at multiple hospitals
nationwide as part of routine patient
care and quality. In addition to new data
collections initiated specifically for this
project, this routine and ongoing
mandatory data collection will serve as
the project’s knowledge base to allow
the assessment of ASP programs.
From the GNYHA data, a three-month
sample from the participating hospitals
will be analyzed by Montefiore Medical
Center (MMC) and GNYHA to obtain
baseline information. This data will
enable a comparison of the rates of CDI
before and after the implementation of
an ASP. The ASP will be implemented
at 6 hospitals (intervention sites), while
5 other hospitals will serve as control
sites and continue with their current
practices, including conducting general

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Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Notices

infection and environmental controls.
The specific elements of the ASPs will
vary by hospital based on priorities and
what is possible at each facility as well
as by the antibiotic(s) targeted and will
likely include some of the following:
• Formulary review/changes,
restrictions and preauthorization of
implicated antimicrobials.
• Feedback to providers of implicated
antimicrobials.
• Processes and algorithms for
empiric and streamlined regimens for
Specific diagnoses/pathogens.
• Antibiotic order form with
automatic stop orders.
• Novel combinations of approaches
to the use of stewardship staff or
technology for stewardship (e.g.,
software, text paging, pyxis pharmacy
machines for tracking and promoting
proper antibiotic prescribing), and
• Educational efforts for clinicians
and patients upon diagnosis.
While the ongoing mandatory
reporting will allow the measurement of
change over time in CDI rates, it does
not provide the necessary information
that hospitals need about the challenges
of implementing an ASP.
Method of Collection
The following data collection
activities will be implemented to
achieve the objectives of this project:
1. Focus Groups with no more than 6
staff members at the intervention and
control hospitals. The focus groups will
be conducted one time only, by
telephone and approximately 12 months
after the implementation begins. The
focus group guides will differ for the
intervention and control sites, although
there will be a common core of
questions. The common core of the
focus group protocol will address the
following: Issues related to experience
with the GNYI–L& environmental and
infection control practices they have
already been utilizing, strategies they
have already used to reduce CDI and
perceptions of those strategies, barriers
to the environmental practices,
particular areas of challenge, facilitators,
and factors they think have contributed
most to their institution’s CDI rates. For
the intervention sites, the goal of the

focus group will be to understand in a
more in-depth and qualitative manner,
the experience of actually implementing
the ASP. For the control sites, the goal
will be to understand what they have
learned in being a control site and their
plans moving forward. In addition to the
core questions, questions will be asked
about their interest in starting an ASP
program, goals and priorities,
expectations of facilitators and barriers
and if and when they plan to implement
an ASP.
2. ASP Questionnaire will be
administered twice, pre and post
implementation, to a sample of about 70
hospital staff at both the intervention
and control hospitals. Intervention and
control facilities will receive the same
questionnaire. The purpose of this
survey is to measure the staff’s
perception of the scope of CDI at their
facility, current antibiotic prescribing
practices, the perceived need for ASPs
and how these change over time. The
questionnaire also collects some
background information such as the
staff members’ primary work area, time
worked in their profession and time
worked in this hospital.
While the reporting/surveillance data
required by the State of NY and the CDC
can measure rates of CDI and compare
how hospitals are doing, these data do
not capture many important issues. A
major reason that most hospitals do not
have active, robust ASPs is because they
can be incredibly challenging to
develop, administer and manage. They
require changes in prescribing practices
and the active agreement and
participation of physicians, pharmacists
and administrators. Physicians and
pharmacists may challenge restrictions
in formularies and determine that a
patient may not be given a specific
antibiotic. But the severity of CDI makes
it very important for hospitals to
determine optimal methods for
implementing successful ASPs. This
pilot study will collect data to allow the
comparison of perceptions and
experiences between hospitals that do
and do not attempt to implement an
ASP. Reflections and feedback directly
from prescribers and the ASP team

using qualitative data collection
procedures are needed to fully
understand what it means or would
mean to implement an ASP. The lessons
learned from this project will be useful
to health care facilities considering
implementing an ASP, and will inform
the development of a draft ASP Toolkit;
this Toolkit will be evaluated in a
separate project before being
disseminated.
This study is being conducted by
AHRQ through its contractor, BUSPH
and their partners Montefiore Medical
Center (MMC), and Greater New York
Hospital Association (GNYHA),
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).
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in this
pilot study. Focus Groups will be
conducted post-intervention with
approximately 6 staff members at each
of the 11 study sites (5 control sites and
6 intervention sites) for a total of 66
individuals, approximately 36 at the
intervention sites and approximately 30
at the control sites. The control site
focus groups will last approximately 45
minutes. The intervention site focus
groups will last approximately 60
minutes.
The ASP questionnaire will be
administered twice, pre and postintervention, to about 70 staff members
at each of the 11 participating sites and
takes about 7 minutes to complete. The
total annualized burden is estimated to
be 239 hours.
Exhibit 2 shows the estimated
annualized cost burden associated with
the respondents’ time to participate in
this study. The total cost burden is
estimated to be $15,037.

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EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
hospitals

Form name
Focus groups at intervention sites ..................................................................
Focus groups at control sites ..........................................................................
ASP Questionnaire ..........................................................................................
Total ..........................................................................................................

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Number of responses per
hospital

6
5
11
22

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6
6
140
n/a

30SEN1

Hours per response
1
45/60
7/60
n/a

Total burden
hours
36
23
180
239

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Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
hospitals

Form name
Focus groups at intervention sites ..................................................................
Focus groups at control sites ..........................................................................
ASP Questionnaire ..........................................................................................
Total ..........................................................................................................

* The hourly wage for the focus
groups is based upon the mean of the
average wages for physicians ($79.33),
pharmacists ($50.13), and medical and
health services managers ($42.67). The
hourly wage for the surveys is based
upon the average wages for physicians
($79.33) and pharmacists ($50.13).
These data come from the May 2008
National Occupational Employment and
Wage Estimates, United States,—U.S.

Total burden
hours

6
5
11
22

Bureau of Labor Statistics Division of
Occupational Employment Statistics,
May 2008, National Occupational
Employment and Wage Estimates,
http://www.bls.gov/oes/2008/may/
oes_nat.htmb#11-0000.
Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the annualized and
total cost to the federal government for

Average hourly wage rate*

Total cost burden

$57.38
57.38
64.73
n/a

$2,066
1,320
11,651
15,037

36
23
180
239

this two year research project. Project
Management includes activities related
to coordination between BUSPH staff,
contracted staff at MMC and GNYIIA,
and monthly phone calls with the task
order officer. Project development
covers steps taken to revise the research
plan and begin implementation. The
total cost is estimated to be $999,995.

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST TO THE GOVERNMENT
Annualized
cost

Cost component
Project Management ................................................................................................................................................
Project Development ...............................................................................................................................................
Data Collection and Analysis ...................................................................................................................................
Technical Assistance and Consultation ...................................................................................................................
Confirmatory lab testing ...........................................................................................................................................
Travel .......................................................................................................................................................................
Project Supplies and materials ................................................................................................................................
Overhead .................................................................................................................................................................
Total ..................................................................................................................................................................

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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
comments will become a matter of
public record.

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Dated: September 17, 2010.
Carolyn M. Clancy,
Director.

$28,315
84,944
169,888
60,750
20,000
7,500
2,450
126,395
499,998

Total cost
$56,629
169,400
339,776
121,500
40,000
15,000
4,900
252,790
999,995

[FR Doc. 2010–24423 Filed 9–29–10; 8:45 am]

information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.

BILLING CODE 4160–90–M

DATES:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

ADDRESSES:

Food and Drug Administration
[Docket No. FDA–2010–N–0374]

Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Petition to Request
an Exemption From 100 Percent
Identity Testing of Dietary Ingredients:
Current Good Manufacturing Practice
in Manufacturing, Packaging, Labeling,
or Holding Operations for Dietary
Supplements
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is announcing
that a proposed collection of

SUMMARY:

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Fax written comments on the
collection of information by November
1, 2010.
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0608. Also
include the FDA docket number found
in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT:

Denver Presley Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed

SUPPLEMENTARY INFORMATION:

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