[Federal Register Volume 73, Number 46 (Friday, March 7, 2008)]
[Notices]
[Pages 12449-12451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-4492]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60 Day-08-08AR]
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
[[Page 12450]]
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960 or
send comments to Maryam Daneshvar, CDC Acting Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an 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 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 clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments should be received
within 60 days of this notice.
Proposed Project
CDC Cervical Cancer Study--New--National Center for Chronic Disease
Prevention and Health Promotion (NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The National Breast and Cervical Cancer Early Detection Program
(NBCCEDP) is the only organized national screening program in the
United States that offers breast and cervical cancer screening to
underserved women. Given resource limitations, the screening policies
for cervical cancer in the program include an annual Pap test until a
woman has had three consecutive normal Pap tests, at which time the Pap
test frequency is reduced to every three years. Human papillomavirus
(HPV) DNA testing has been approved in the U.S. as a secondary
screening tool for Atypical Squamous Cells of Undetermined Significance
(ASCUS), and as a primary screening tool for women 30 years of age and
older, but it is not currently a reimbursable expense under NBCCEDP
guidelines. Adopting HPV DNA testing along with Pap testing in women
over 30 could help the program better utilize resources by extending
the screening interval of women who are cytology negative and HPV test
negative, which is estimated to be 80-90% of women.
In 2005, the NBCCEDP convened an expert panel to evaluate policies
on reimbursement of the HPV DNA test as an adjunct to the Pap test for
primary screening. The panel recommended that the program not reimburse
for the HPV DNA test but instead requested that pilot studies be
performed to measure the feasibility, acceptability and barriers to use
of the test.
In response to the expert panel's recommendations, CDC proposes to
conduct a pilot study at 18 clinics in the state of Illinois. The
proposed study will examine whether or not there is an increase in the
cervical cancer screening interval to three years for women in the
target age range with a normal Pap test and a negative HPV DNA test.
Primary goals of the study are to: (1) Assess whether provider and
patient education will lead to extended screening intervals for women
who have negative screening results; (2) identify facilitators and
barriers to acceptance and appropriate use of the HPV test and longer
screening intervals; (3) track costs associated with HPV testing and
educational interventions; and (4) identify the HPV genotypes among
this sample of low income women. Secondary goals of the study are to:
(1) Assess follow-up of women with positive test results and (2)
determine provider knowledge and acceptability of the HPV vaccine.
Approximately 8,000 women between the ages of 35 and 60 who are
visiting one of 18 participating clinics for routine cervical cancer
screening will be recruited for the study. Approximately 10,000 women
must be screened in order to identify 8,000 who are both eligible and
willing to be enrolled in the study. The study design calls for data
collection over a five-year period. Information will be collected
primarily from a total of 70 clinical care providers, 18 clinic
coordinators, and a sample of 2,600 patients.
CDC plans to request OMB approval for data collection activities to
be conducted during the first three years (Phase I) of the five-year
project. The results of this study will provide information about
knowledge, attitudes, beliefs, and cervical cancer screening practices
involving low-income, underserved women, who represent the demographic
most needy of highly sensitive screening methodologies that can
increase the likelihood of detecting cervical dysplasia at less
frequent screening intervals. The findings from this study will help
inform policy regarding the HPV DNA test on a national level for
cervical cancer screening in the NBCCEDP.
There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response (in Total burden (in
respondents respondent hr) hr)
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Health Care Providers....................... Baseline Survey for Providers. 23 1 30/60 12
Follow-up Survey for Providers 23 2 30/60 23
Patients.................................... Screening Script for Patients. 3,333 1 5/60 278
Enrollment Form............... 2,667 1 5/60 222
Baseline Survey for Patients.. 867 1 15/60 217
Follow-up Survey for Patients. 624 1 10/60 104
Clinic Coordinators......................... Baseline Survey for Clinic 6 1 2 12
Coordinators.
Follow-up Survey for Clinic 6 11 1 66
Coordinators.
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Total................................... .............................. ................. ................. ................. 934
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[[Page 12451]]
Dated: February 28, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E8-4492 Filed 3-6-08; 8:45 am]
BILLING CODE 4163-18-P