Attachment L -- Federal Register Notice

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Estimated Annual Respondent Burden

grants programs and other agency
information exchange mechanisms.
Method of Collection
Grantees are required to enter data
related to the progress of their grant
funded research quarterly through a
secure online interface which requires a
user id and password.

Exhibit 1 shows the estimated
annualized burden hours for the
respondents. It will take grantees an
estimated 10 minutes to enter the
necessary data into the Grant Reporting
System (GRS) and reporting will occur
four times annually. The total

annualized burden hours are estimated
to be 333 hours.
Exhibit 2 shows the estimated
annualized cost burden for the
respondents. The total estimated cost
burden for respondents is $11,159.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name

Number of
responses per
respondent

Hours per
response

Total burden
hours

Data entry into GRS ........................................................................

500

4 ..............................

10/60 .....................

333

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

500

na ............................

na ..........................

333

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Form name

Total burden
hours

Average hourly
wage rate *

Total cost
burden

Data entry into GRS .................................................................................

500

333

$33.51 ..................

$11,159

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

500

333

na .........................

11,159

* Based upon the average wages for Healthcare Practitioner and Technical Occupations (29–0000), ‘‘National Compensation Survey: Occupational Wages in the United States, May 2009,’’ U.S. Department of Labor, Bureau of Labor Statistics.

Estimated Annual Costs to the Federal
Government
The annual cost to the government is
$100,000 for licensing, support and
maintenance.

srobinson on DSKHWCL6B1PROD with NOTICES

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: August 16, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–21501 Filed 8–30–10; 8:45 am]
BILLING CODE 4160–90–P

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.

AGENCY:
ACTION:

Notice.

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:
‘‘Avoiding Readmissions in Hospitals
Serving Diverse Patients.’’ 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 June 21st, 2010 and allowed
60 days for public comment. One
comment was received. The purpose of

SUMMARY:

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this notice is to allow an additional 30
days for public comment.
DATES: Comments on this notice must be
received by September 30, 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:
Proposed Project
Avoiding Readmissions in Hospitals
Serving Diverse Patients
An important part of AHRQ’s mission
is to disseminate information and tools
that can support improvement in quality
and safety in the U.S. health care
community. The transition process from
the hospital to the outpatient setting is
nonstandardized and frequently
inadequate in quality. One in five
hospital discharges is complicated by an
adverse event (AE) within 30 days, often
leading to an emergency department
visit and/or rehospitalization. Many

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srobinson on DSKHWCL6B1PROD with NOTICES

Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices
readmissions stem from errors that can
be directly attributed to the
discontinuity and fragmentation of care
at discharge. High rates of low health
literacy, lack of coordination in the
‘‘hand-off’’ from the hospital to
community care, gaps in social
supports, and other limitations also
contribute to the risk of
rehospitalization.
Boston University Medical Center
(BUMC), through a grant from AHRQ,
previously defined the discharge
process and determined what
improvements could be made to
improve this care transition for patients.
This new process was called the ‘‘reengineered discharge’’ (RED). The RED
consists of 11 elements, including
educating the patient throughout the
hospital stay, making follow-up
appointments, and giving the patient a
written discharge plan. The RED was
tested in a randomized controlled trial
in an academic safety net hospital at
BUMC with English speaking, general
medical patients being discharged to
home or community settings. Results of
this trial of 749 patients showed a
reduction in rehospitalizations within
30 days and emergency department
visits following hospital discharge.
Participants also followed up with
primary care providers more often and
reported higher patient satisfaction with
the discharge process. Project RED
researchers created several tools to help
hospitals replicate RED. After AHRQ
and Project RED researchers fielded
many inquiries about how to implement
Project RED at hospitals nationwide,
AHRQ realized that the Project RED
Toolkit did not provide sufficient
guidance to potential replicators.
Various components of the RED were
not documented, and issues regarding
implementing the RED at hospitals
serving linguistically and culturally
diverse patient populations had not
been addressed. AHRQ has therefore
contracted with the RED researchers to
create a revised RED Toolkit that will
address these issues.
This proposed information collection
supports AHRQ’s mission by improving
upon the RED Toolkit. This project has
the following 2 goals:
(1) To pre-test the revised RED Toolkit
in ten varied hospital settings,
evaluating how the RED Toolkit is
implemented in varied hospital settings
by: (a) Documenting the implementation
process; (b) assessing the fidelity of
implementation; and (c) identifying the
factors that affect redesign fidelity,
including intensity of technical
assistance (TA).

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(2) To modify the revised RED Toolkit
based on pre-testing and to disseminate
it.
BUMC will provide TA at two varying
levels. Four selected hospitals will
receive ‘‘train-the-trainer’’ TA, which
includes:
(1) Telephone assistance in
conducting a baseline needs assessment;
(2) Master trainer training;
(3) Access to webinar trainings
specifically designed for each user
(nurse, IT professional, hospital
leadership, and pharmacist);
(4) An electronic template to print an
After Hospital Care Plan (AHCP)
booklet; and
(5) E-mails regarding updates to the
RED Web site and the opportunity to ask
questions about the newly revised and
enhanced RED tools and
implementation via telephone and email.
Six selected hospitals will receive
intensive TA, which includes:
(1) Telephone baseline needs
assessment;
(2) On-site training;
(3) Monthly semi-structured
interviews via phone calls with the
implementation team to discuss
implementation efforts and barriers;
(4) Adaptation of the revised RED
Toolkit to include specific details about
the hospital (such as the hospital name
on the cover of the AHCP booklet and
hospital-specific services provided to
patients included in the AHCP booklet);
(5) An assessment and evaluation site
visit by the organizational change
evaluator (a member of the
implementation team), at baseline and
12 months after the start of
implementation efforts to interview
select participating hospital staff;
(6) IT support to install and support
the RED Toolkit software to
automatically generate the AHCP
booklet; and
(7) E-mails regarding updates to the
RED Web site and the opportunity to ask
questions about the newly revised and
enhanced RED tools and
implementation via telephone and email.
A diverse group of hospitals will be
selected to receive each level of TA,
based upon hospital size, location,
readmission rate and patient
population. Implementing the revised
RED Toolkit in diverse settings will
provide a better understanding of
whether and how RED can be best
implemented in different hospital
settings.
The project will be framed within a
model of organizational change and
transformation called the Organizational
Transformation Model (OTM), which is

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based on the evaluation of Robert Wood
Johnson Foundation’s Pursuing
Perfection initiative. OTM identifies key
elements that drive dramatic system
change and informs the implementation
process and impact evaluation. Using a
mixed-methods design, the evaluation
tracks change over time and across the
implementation period within each
hospital. The evaluation therefore will
encompass feedback on specific
implementation processes and factors in
microsystems where RED is adopted, in
the larger organizational context, and
interactions between the two.
This research study is being
conducted by AHRQ through its
contractor, BUMC, pursuant to AHRQ’s
statutory authority to conduct and
support research on healthcare and
disseminate information 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. 299(b) and 299a(a)(1) and (2).
Method of Collection
To achieve the projects’ goals, the
following data collections and training
will be implemented for the six
hospitals that will receive intensive TA
as well as the 4 hospitals receiving
train-the trainer TA, unless otherwise
noted:
(1) Baseline needs assessment to help
each hospital plan and prepare for
implementation of the revised RED
Toolkit and to evaluate it in varied
settings (see Attachment C). This is not
a data collection but will impose a time
burden on the participating hospitals as
they prepare to participate in this
project. The purpose of the needs
assessment is for the hospital to become
familiar with their discharge process
and what parts of the process are being
done well and what parts of the process
need improvement. In order to
implement the new RED discharge
process, it is important for a hospital to
plan how they will do this. This
information will be shared during the
baseline key contact semi-structured
interview.
(2) Baseline key contact semistructured interviews will be
administered by telephone,
approximately two months prior to
implementation, to the key contact at
each of the ten study hospitals (see
Attachment D). The purpose of the
interview is to identify the
implementation team, collect some
basic information about the hospital,
such as the number of beds and if
electronic medical records are used, and

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Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices

to establish the baseline readmission
rate.
(3) Monthly semi-structured
interviews with the key contact or other
implementation team member will be
conducted monthly for 12 months after
implementation (see Attachment E).
These interviews will be conducted by
phone with each of the six hospitals
receiving intensive technical assistance
(TA) (the two levels of TA are described
above). The purpose of these interviews
are to allow hospitals to share their
experiences with implementing the
revised RED Toolkit, their use of
specific tools, changes resulting from
using the tools and problems
encountered implementing the revised
RED Toolkit and how they are being
addressed.
(4) Baseline semi-structured
interviews will be conducted prior to
the implementation of the revised RED
Toolkit with 15 hospital staff from each
of the six study hospitals receiving
intensive TA (see Attachment F). The
purpose of this interview is to measure
the staff’s opinion of the current
discharge process, their perceived need
for a redesigned process, and the
perceived barriers and facilitators to
redesigning the discharge process.
(5) Post implementation semistructured interviews will be conducted
12 months after the implementation of
the revised RED Toolkit with 15
hospital staff from each of the six study
hospitals receiving intensive TA (see
Attachment G). The purpose of this
interview is to measure the staff’s
opinion of the redesigned discharge
process, which tools were used and
their opinion of the tools, and the
observed barriers and facilitators to
redesigning the discharge process.
(6) Patient surveys will be
administered by telephone to a random
sample of patients 30 days after being
discharged from one of the six intensive
TA study hospitals (see Attachment H).
The purpose of this survey is to measure
patient outcomes, including satisfaction
with the care they received, 30-day
hospital and emergency department
visits, and physician appointments, to
help determine the success of the RED

Toolkit implementation in diverse
patient populations. The survey will be
administered by a hospital staff member
to patients during the preimplementation period and again during
the post-implementation period to
compare patient outcomes.
(7) Medical record review of patient
outcomes at all ten study hospitals (see
Attachment I). This data collection will
be conducted both pre- and postimplementation of the revised RED
Toolkit and will inform the success of
the revised RED Toolkit implementation
in diverse patient populations.
Outcomes to be collected include
process outcomes, such as primary care
provider appointments scheduled prior
to discharge, and patient outcomes,
such as 30-day hospital and emergency
department visits.
(8) Master trainer training will be
conducted with 3 staff members from
each of the 4 hospitals receiving trainthe-trainer TA (see Attachment J). These
people will be trained to administer the
RED Toolkit and be able to use recorded
webinar training sessions within their
organization. They will be invited to
travel to BUMC for a 2-day onsite
orientation of the RED intervention.
These people will meet with several
members of the BUMC implementation
team (physician leader, discharge
advocate nurse) and will have the
opportunity to shadow the nurse
discharge advocates in conducting the
RED intervention.
(9) Intensive training will be
conducted with about 28 staff from each
of the 6 hospitals receiving intensive TA
(see Attachment K). The training will
consist of a two-day on-site orientation
and training at each hospital conducted
by the BUMC implementation team. The
BUMC implementation team will
consist of a physician researcher, a
discharge advocate nurse, an
organizational change champion/
evaluator and the information
technology expert. The BUMC team will
spend two days, 8 hours per day, to
train the relevant hospital staff to
perform the 11 components of the RED
discharge. The training will include
material for senior hospital

management, hospital physicians,
nurses, IT staff, and pharmacists.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours associated
with the respondent’s time to
participate in this research. The baseline
needs assessment will be conducted by
staff at each of the 10 participating
hospitals and takes about 8 hours to
complete. Baseline key contact semistructured interviews will be conducted
with the key contact at each hospital
and requires 1 hour to complete.
Monthly semi-structured interviews
with the key contact or other
implementation team member will be
conducted monthly for 12 months after
implementation. These interviews will
be conducted by phone with each of the
six hospitals receiving intensive TA and
will require 1 hour to complete. Both
the base-line and post-implementation
semi-structured interviews will be
conducted with 15 staff members from
each of the 6 hospitals receiving
intensive TA and will last about one
hour. The patient survey will be
administered twice, pre and post
implementation, to 3,108 patients
recently discharged from one of the 6
hospitals receiving intensive TA and
requires 10 minutes to complete. The
patient survey will be administered by
the hospital staff and will require 10
minutes of their time to administer.
Medical record review will be
performed at all 10 participating
hospitals both pre and post
implementation and will take about 41.6
hours. Master trainer training will be
conducted with 3 staff members from
each of the 4 hospitals receiving train
the trainer TA and will last 16 hours.
Intensive training will be conducted
with about 28 staff members from each
of the 6 hospitals receiving intensive TA
and will also last 16 hours. The total
annualized burden is estimated to be
6,126 hours.
Exhibit 2 shows the estimated
annualized cost burden associated with
the respondent’s time to participate in
this research. The total annualized cost
burden is estimated to be $194,163.

srobinson on DSKHWCL6B1PROD with NOTICES

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name
Baseline needs assessment ............................................................................
Baseline key contact semi-structured interview ..............................................
Monthly semi-structured interview ...................................................................
Baseline semi-structured interview ..................................................................
Post implementation semi-structured interview ...............................................
Patient survey ..................................................................................................

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Number of responses per
respondent

10
10
6
6
6
3,108

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1
1
12
15
15
2

31AUN1

Hours per
response
8
1
1
1
1
10/60

Total burden
hours
80
10
72
90
90
1,036

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Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents

Form name

Number of responses per
respondent

Hours per
response

Total burden
hours

Administration of patient survey by hospital staff ............................................
Medical record review ......................................................................................
Master trainer training ......................................................................................
Intensive training ..............................................................................................

6
10
4
6

1,036
2
3
28

10/60
41.6
16
16

1,036
832
192
2,688

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

3,172

na

na

6,126

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Form name

Total burden
hours

Average hourly wage rate*

Total cost
burden

Baseline needs assessment ............................................................................
Baseline key contact semi-structured interview ..............................................
Monthly semi-structured interviews .................................................................
Baseline semi-structured interview ..................................................................
Post implementation semi-structured interview ...............................................
Patient survey ..................................................................................................
Administration of patient survey by hospital staff ............................................
Medical record review ......................................................................................
Master trainer training ......................................................................................
Intensive training ..............................................................................................

10
10
6
6
6
3,108
6
10
4
6

80
10
72
90
90
1,036
1,036
832
192
2,688

a $41.94

i 40.91

$3,355
519
2,946
3,466
3,466
21,052
32,437
14,410
6,012
109,966

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

3,172

6,126

na

194,163

b 51.91
c 40.91
d 38.51
e 38.51
f 20.32
b31.31
g 17.32
h 31.31

* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States May 2008, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
(a) 75% Nurses (29–1111, $31.31/hr), 20% Physicians (29–1069, $79.33/hr) and 5% General and Operations Managers (29–1069, $51.91/hr).
b 100% General and Operations Managers (29–1069, $51.91/hr).
c 80% Nurses and 20% Physicians.
d ande 85% Nurses and 15% Physicians.
f 100% General public (00–0000, $20.32/hr).
g 100% Statistical assistants (439111, $17.32/hr).
h 100% Nurses.
i 80% Nurses and 20% Physicians.

Estimated Annual Costs to the Federal
Government

this clearance. The total cost is
$449,976.

Exhibit 3 shows the total and
annualized cost over the 18 months of

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST
Cost component

Annual cost

Project RED Toolkit Development ...........................................................................................................................
Dissemination Planning and Support ......................................................................................................................
Data Collection Activities .........................................................................................................................................
Data Processing and Analysis .................................................................................................................................
Publication of Results ..............................................................................................................................................
Project Management ................................................................................................................................................
Overhead .................................................................................................................................................................

$97,413
98,080
84,563
52,215
3,184
28,892
85,629

$64,942
65,387
56,375
34,810
2,123
19,261
57,086

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

449,976

299,984

Request for Comments
srobinson on DSKHWCL6B1PROD with NOTICES

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

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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
comments will become a matter of
public record.

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Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices

Dated: August 20, 2010.
Carolyn M. Clancy,
Director.

use of information technology. Written
comments should be received within 60
days of this notice.

[FR Doc. 2010–21503 Filed 8–30–10; 8:45 am]

Proposed Project
Clostridium difficile Infection (CDI)
Surveillance—New—National Center for
Emerging and Zoonotic Infectious
Diseases, (NCEZID), Centers for Disease
Control and Prevention, (CDC).

BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day 10–10GP]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects.
Alternatively, to obtain a copy of the
data collection plans and instrument,
call 404–639–5960 and send comments
to Maryam I. Daneshvar, CDC Reports
Clearance Officer, 1600 Clifton Road
NE., MS–D74, Atlanta, Georgia 30333;
comments may also be sent by e-mail to
[email protected].
Comments are invited on (a) whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have a
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarify of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the

difficile toxin and abstract data on cases
using a standardized case report form.
For a subset of cases (e.g., communityassociated C. difficile cases) sites will
administer a health interview. Remnant
stool specimens from cases testing
positive for C. difficile toxin will be
submitted to reference laboratories for
culturing, and isolates will be sent to
CDC for confirmation and molecular
typing. Outcomes of this surveillance
project will include the populationbased incidence of community- and
healthcare-associated CDI, and a
description of the molecular
characteristics of C. difficile strains and
the epidemiology of this infection
among the population under
surveillance.
For this proposed data collection,
there is no cost to respondents other
than their time. An estimated total of
8,750 CDI Surveillance Case Report
Forms (CRFs) will be completed during
a one-year study period. Approximately
4,370 cases will require a completed
CRF taking one hour; the remaining
4,380 cases will only require a partially
completed CRF taking 15 minutes. An
estimated total of 500 CDI Surveillance
Health Interviews (HI) will need to be
completed for the same time period. The
estimated time to complete the HI is 45
minutes. Therefore, the total estimated
annualized burden for this data
collection is 5,840 hours.
The proposed surveillance for CDI
through the Emerging Infections
Program will expand CDC capacity to
monitor incidence of C. difficile in
community and healthcare settings as
well as to monitor and detect
antimicrobial resistance. This activity
supports the HHS Action Plan for
elimination of healthcare-associated
infections.

Background and Brief Description
Steady increases in the rate and
severity of Clostridium difficile
infection (CDI) indicate a clear need to
conduct longitudinal assessments of the
impact of CDI in the United States. C.
difficile is an anaerobic, spore-forming,
gram positive bacillus that produces two
pathogenic toxins: A and B. CDI ranges
in severity from mild diarrhea to
fulminant colitis and death.
Transmission of C. difficile occurs
primarily in healthcare facilities, where
environmental contamination by C.
difficile spores and exposure to
antimicrobial drugs are common. No
longer limited to healthcare
environments, community-associated
CDI is the focus of increasing attention.
Recently, several cases of serious CDI
have been reported in what have been
considered low-risk populations,
including healthy persons living in the
community and peri-partum women.
The surveillance population will
consist of persons residing in the
catchment area of the participating
Emerging Infections Program (EIP) sites.
This surveillance poses no more than
minimal risk to the study participants as
there will be no interventions or
modifications to the care study
participants receive. EIP surveillance
personnel will perform active case
finding from laboratory reports of stool
specimens testing positive for C.

ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
respondents

Forms

CDI Surveillance Case Report Form—Complete ............................................
CDI Surveillance Case Report Form—Partial .................................................
CDI Surveillance Health Interview ...................................................................

Number of
responses per
respondent

10
10
10

437
438
50

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

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Average
burden per
response
(in hours)
1
15/60
45/60

Total burden
(in hours)
4,370
1,095
375
5,840

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