[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