30-day FRN

30-Day FRN for 0920-05CJ - Pub 2-13-2007.pdf

Colorectal Cancer Screening Demonstration Program

30-day FRN

OMB: 0920-0745

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6733

Federal Register / Vol. 72, No. 29 / Tuesday, February 13, 2007 / Notices
EXHIBIT 1.—ESTIMATE OF COST BURDEN TO RESPONDENTS
Estimated
time per respondent in
hours

Number of
responses*

Date collection effort

Estimated
total burden
hours

Average
hourly wage
rate**
($)

Estimated annual cost burden to respondents
($)

Office Manager baseline survey ..................................................

45

0.25

11.25

$34.67

$390.04

Physician baseline survey ...........................................................
Physician opinion survey of system ............................................
Physician entry of medication error .............................................
Nurse opinion survey of system ..................................................
Nurse entry of medication error ...................................................
PA/NP opinion survey of system .................................................
PA/NP entry of medication error ..................................................
Medical assistant survey of system .............................................
Medical assistant entry of medication error .................................
Office Manager opinion-survey of system ...................................

45
45
216
45
18
45
18
45
18
45

0.25
0.25
0.134
0.25
0.134
0.25
0.134
0.25
0.134
0.25

11.25
11.25
28.94
11.25
2.4
11.25
2.4
11.25
2.4
11.25

57.90
57.90
57.90
27.35
27.35
34.17
34.17
12.58
12.58
34.67

651.38
651.38
1675.63
307.69
65.64
384.41
82.00
141.53
30.19
390.04

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

585

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

114.89

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

4769.93

*Based on a six month trial period of MEADER reporting.
**Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States 2004, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’

This information collection will not
impose a cost burden on the respondent
beyond that associated with their time
to provide the required data. There will
be no additional costs for capital
equipment, software, computer services,
etc.
Estimated Costs to the Federal
Government
The total cost to the government for
this activity is estimated to be
$1,000,000.00.

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Request for Comments
In accordance with the above-cited
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 health care research and
information dissemination functions of
AHRQ, 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 request for OMB
approval of the proposed information
collection. All comments will become a
matter of public record.

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16:55 Feb 12, 2007

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References
1 Brennan

TA, Leape LL, Laird NM, et al.
Incidence of adverse events and negligence
in hospitalized patients: Results of the
Harvard Medical Practice Study. N Engl J
Med 1991; 324:370–376.
2 McDonald CJ, Weiner M, Hui SL. Deaths
due to medical errors are exaggerated in the
Institute of Medicine Report. JAMA 2000;
284:93–95.
3 Leape LL. Institute of Medicine medical
error figures are not exaggerated. JAMA.
2000; 28:95–97.
4 Hayward RA, Hofer TP. Estimating
hospital deaths due to medical errors:
preventability is in the eye of the reviewer.
JAMA. 2001; 286:415–420
5 Institute of Medicine. To Err is Human:
Building a Safer Health System. Washington,
DC: National Academy Press, 2000.
6 Institute of Medicine. Crossing the
Quality Chasm: a New System for the 21st
Century. Washington, DC: National Academy
Press, 2001.
7 Institute of Medicine. Patient Safety:
Achieving a New Standard for Care.
Washington, DC: National Academy Press
2004.
8 http://www.blsmeetings.net/
PatientSafetyandHIT/ (accessed August 11,
2005).
9 Green LA, Fryer GE, Yawn BP, Lanier D,
Dovey SM: The ecology of medical care
revisited. N Engl J Med 2001; 344:2021–2025.
10 Uribe CL, Schweikhart SB, Pathak DS,
Dow M, Marsh GP. Perceived barriers to
medical-error reporting: an exploratory
investigation. J Healthcare Management.
2002; 47(4):263–79.
Dated: January 30, 2007.
Carolyn M. Clancy,
Director.
[FR Doc. 07–574 Filed 2–12–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day–07–05CJ]

Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 371–5960 or send an email to [email protected]. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
Colorectal Cancer Screening
Demonstration Program—New—
National Center for Chronic Disease
Prevention and Health Promotion
(NCDDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC) is seeking a 3-year
Office of Management and Budget
(OMB) approval to collect individual
patient-level screening, diagnostic, and
treatment data in association with a new
colorectal cancer screening
demonstration program. CDC funded 5
cooperative agreements in fiscal year

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6734

Federal Register / Vol. 72, No. 29 / Tuesday, February 13, 2007 / Notices

(FY) 2005 to implement these new
colorectal cancer (CRC) demonstration
programs. These 3-year demonstration
programs are designed to increase
population-based CRC screening among
persons 50 years and older in a
geographically defined area, focusing
screening efforts on persons age 50 years
and older with low incomes and
inadequate or no health insurance
coverage for CRC screening (priority
population).
Colorectal Cancer (CRC) is the second
leading cause of cancer-related deaths in
the United States, following lung
cancer. Based on scientific evidence
which indicates that regular screening is
effective in reducing CRC incidence and
mortality, regular CRC screening is now
recommended for average-risk persons
with one or a combination of the
following tests: fecal occult blood
testing (FOBT), flexible sigmoidoscopy,
colonoscopy, and/or double-contrast
barium enema (DCBE). Fecal
immunochemical testing (FIT) is
considered an acceptable alternative to
FOBT. In the absence of evidence
indicating a single most effective test,
selected programs chose the screening

test(s) they will use from the above list
of recommended tests.
All funded programs are required to
submit patient-level data to capture
demographic information, CRC
screening and diagnostic services
provided through this program, and
clinical results, and submit these data to
Information Management Services (IMS)
on a quarterly basis, so that CDC and the
programs can evaluate immediate and
long term (3 year) program effectiveness
and assess the quality and
appropriateness of the services
delivered, including medical
complications. While CDC funds will
not be used for treatment, programs will
need to monitor treatment and
document that patients are receiving
appropriate treatment services.
Submitted data must contain no patient
identifiers. CDC, the funded programs,
and IMS worked together to define the
key, standardized clinical data elements
which are included in a codebook to be
used by the programs and CDC known
as the Colorectal Cancer Clinical Data
Elements (CCDE). Data collection forms
have been developed by staff at the
programs to collect the standardized

Respondents

Form name

Colorectal Cancer Demonstration Program
Sites.

Colorectal Cancer Data Elements for
Colonoscopy Programs.
Colorectal Cancer Data Elements for Fecal
Occult Blood Test Programs.
Medical Complications Form ..........................
Annual Aggregate Data on Medically Ineligible Clients.
Reimbursement Data Reporting Form ...........

individual patient-level data. IMS will
assist CDC by receiving the data from
the programs, cleaning the data and
producing standardized data reports.
All programs will additionally submit
annual cost data to CDC to monitor cost
and cost-effectiveness over the 3-year
program period.
In developing the definition variable
and data definitions to be reported in
the CCDEs, CDC has consulted with
representatives of the American Cancer
Society, The National Cancer Institute,
The Agency for Health Care Research
and Quality, the Centers for Medicare
and Medicaid Services, representatives
from professional medical societies
involved in colorectal cancer screening,
representatives from managed care
organizations, representatives from state
health departments, and a variety of
individuals with expertise and interest
in this field.
There are no costs to the respondents
other than their time. The total
estimated annualized burden hours are
1270.
Estimated Annualized Burden Hours:
Average burden per response
(in hours)

Number of respondents

Number of responses per
respondent

2

240

1

3

1000

15/60

5
5

6
1

1
1

5

1

1

*Respondents include cooperative agreement recipients.
Dated: February 6, 2007.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–2429 Filed 2–12–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

jlentini on PROD1PC65 with NOTICES

Ethics Subcommittee, Advisory
Committee to the Director (ACD),
Centers for Disease Control and
Prevention (CDC); Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention announces the
aforementioned Subcommittee meeting.

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Times and Dates: 1 p.m.–5 p.m.,
February 27, 2007. 8:30 a.m.–12 p.m.,
February 28, 2007.
Place: Centers for Disease Control and
Prevention, 1825 Century Center,
Conference Room 1 A/B, Atlanta, GA
30345.
Status: Open to the public, limited
only by the space available. The meeting
room accommodates approximately 75
people.
Purpose: The Ethics Subcommittee
will provide counsel to the ACD, CDC,
regarding a broad range of public health
ethics questions and issues arising from
programs, scientists and practitioners.
Matters To Be Discussed: Agenda
items will include public health ethics
of genomics; public health ethics of
emergency preparedness and response;
ethical considerations in pandemic
influenza preparedness; ethical
considerations for non-research data

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collections; demonstration of CDC’s
public health ethics intranet site; and
procedural issues relating to the Ethics
Subcommittee. Agenda items are subject
to change as priorities dictate.
Due to programmatic matters, this
Federal Register Notice is being
published on less than 15 calendar days
notice to the public (41 CFR 102–
3.150(b)).
For Further Information Contact:
Please contact Drue Barrett, Ph.D.,
Designated Federal Official, Ethics
Subcommittee, CDC, 1600 Clifton Road,
NE., M/S D–50, Atlanta, Georgia 30333,
telephone 404/639–4690. E-mail:
[email protected]. The deadline for
notification of attendance is February
20, 2007. The Director, Management
Analysis and Services Office, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other

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File Typeapplication/pdf
File TitleDocument
SubjectExtracted Pages
AuthorU.S. Government Printing Office
File Modified2007-02-12
File Created2007-02-12

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