[Federal Register Volume 77, Number 33 (Friday, February 17, 2012)]
[Notices]
[Pages 9660-9661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3620]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-12-0814]


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. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 or 
send comments to Kimberly Lane, CDC Reports Clearance Officer, 1600 
Clifton Road, MS D-74, Atlanta, GA 30333 or send an email 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 (CX3)(OMB No. 0920-0814, exp. 6/30/
2012)--Revision--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. The program offers breast and cervical cancer screening 
to underserved women. Given resource limitations, the screening 
standards 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. HPV DNA testing 
has been approved in the U.S. as a secondary screening tool for ASCUS 
(Atypical Squamous Cells of Undetermined Significance), and as a 
primary screening tool for women 30 years of age and older, but it is 
not currently a reimbursable expense under program guidelines. Adopting 
HPV 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 determine policies on reimbursement of the HPV DNA test 
with the Pap test (co-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.
    A pilot study, the CDC Cervical Cancer Study (CX3), is currently 
being conducted in 15 clinics in the state of Illinois. A total of 
2,246 women between the ages of 30 and 60 who visited one

[[Page 9661]]

of the participating clinics for routine cervical cancer screening were 
recruited for the study. Patients who agreed to participate in the 
study received an HPV DNA test in addition to the Pap test. The clinics 
were assigned to one of two study arms. Clinics in the intervention 
group administered the HPV DNA tests to eligible patients, along with a 
multi-component educational intervention involving both providers and 
patients. Clinics in the comparison group administered the HPV tests 
but patients and providers did not receive the educational 
intervention.
    The purpose of the CX3 study is to 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.
    During the first three years (Phase I) of the study, data were 
collected from a number of sources. Completed data collection 
activities include: before beginning patient recruitment a provider 
baseline survey was administered to providers at the participating 
clinics who routinely perform Pap testing; a patient baseline survey 
was administered to a sample of patients during their initial clinic 
visit prior to the patient's HPV test; a monthly clinic survey was 
administered to all participating clinics during the first year of 
patient recruitment to obtain information regarding resources 
associated with participating in the study; and a provider follow-up 
survey was administered to clinic providers 12 months following study 
initiation. In addition, information collection for an 18-month follow-
up survey was initiated among patients who completed a baseline survey.
    Approval is currently being requested to continue data collection 
during Phase II of the study. These data collection activities include: 
continuing administration of the patient follow-up survey 18 months 
following the patient's initial clinic visit; administration of a 
provider follow-up survey 36 months following study initiation; and 
conducting qualitative interviews with providers to identify 
facilitators and barriers to acceptance and appropriate use of the HPV 
test and longer screening intervals. The follow-up surveys for patients 
and providers will assess changes in knowledge, attitudes, beliefs and 
behavior regarding cervical cancer screening. An additional source of 
data for the analysis includes patient medical and billing records, 
which will be reviewed to provide information necessary to determine 
whether or not HPV co-testing leads to extended screening intervals for 
women with negative results (and to determine what type of follow-up 
care was provided to women with positive HPV test results).
    The results of this study will provide information regarding the 
extent to which providers are willing to extend 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. It will also 
provide information regarding whether provider and patient education 
will lead to extended screening intervals for women who have negative 
screening results. In addition, the study results will provide 
information regarding the level of knowledge regarding cervical cancer 
screening among 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 standards regarding the HPV DNA test on a national level for 
cervical cancer screening in the NBCCEDP. Participation in the CX3 
study is voluntary and there are no costs to respondents other than 
their time. OMB approval is requested for one year.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondent            Form name       respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
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Patients......................  Follow-up                    150               1           10/60              25
                                 Patient Survey.
Providers.....................  Follow-up                     70               1           30/60              35
                                 Provider Survey.
                                Focus Group                   75               1               1              75
                                 Moderator Guide.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             135
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    Dated: February 10, 2012.
Ronald Otten,
Deputy Chief, Centers for Disease Control and Prevention.
[FR Doc. 2012-3620 Filed 2-16-12; 8:45 am]
BILLING CODE 4163-18-P