[Federal Register Volume 77, Number 95 (Wednesday, May 16, 2012)]
[Notices]
[Pages 28881-28882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-11874]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-12-0814]


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 at (404) 639-7570 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) 395-5806. Written comments should be 
received within 30 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 that offers breast and cervical cancer screening to 
underserved women. Current NBCCEDP screening standards for cervical 
cancer 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.
    An alternative cervical cancer screening strategy involves 
administration of both the Pap test and a human papillomavirus (HPV) 
DNA test. Because persistent, carcinogenic HPV is strongly predictive 
of cervical cancer, this strategy, called HPV co-testing, can be used 
to identify women who should be screened frequently for signs of 
cervical cancer. HPV co-testing can also be used to extend the 
screening interval for women who are low risk, i.e., both cytology 
negative and HPV negative. HPV co-testing is recommended by national 
organizations, but health care providers have been slow to adopt it or 
to use the results of HPV testing to modify the frequency of cervical 
cancer screening with the Pap test.
    CDC is currently conducting a pilot study in 15 clinics in Illinois 
to examine the effects of an educational intervention aimed at 
improving patient and provider understanding of HPV co-testing (CDC 
Cervical Cancer Study (CX3)). The specific aims of the study are to: 
(1) Assess whether provider and patient education leads 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 of the study, each participating 
clinic was 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 have not received the 
educational intervention. A total of 2,246 women between the ages of 30 
and 60 have been recruited into the study. Baseline information 
collection has been completed for an initial clinic survey, a 12-month 
follow-up clinic survey, a baseline provider survey, patient 
recruitment and enrollment, and a baseline patient survey. Information 
collection was initiated for a 36-month follow-up provider survey and 
an 18-month follow-up patient survey. These activities were described 
in the original Information Collection Request.
    In order to complete the study as planned, CDC requests one 
additional year of approval from OMB. Information collection will 
include completion of the 18-month follow-up survey for approximately 
150 patients and completion of the 36-month follow-up survey for 70 
providers. The final year of the study will also include focus

[[Page 28882]]

groups with approximately 75 providers.
    Information collected through follow-up surveys of patients and 
providers will be used to assess changes in knowledge, attitudes, 
beliefs and behavior regarding cervical cancer screening. Qualitative 
information collected during the focus groups with providers will be 
used to identify facilitators and barriers to acceptance and 
appropriate use of the HPV test and longer screening intervals. 
Findings from the CX3 study will help inform NBCCEDP standards for 
primary cervical cancer screening, including reimbursement guidelines 
for the HPV DNA test.
    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. Because the majority of information collection activities were 
completed in the first three years of the study, the estimated burden 
to respondents will decrease in the final year of OMB approval. The 
total estimated annualized burden hours are 135.

                                        Estimated Annualized Burden Hours
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                                                                                                      Average
                                                                     Number of       Number of      burden per
         Type of respondent                   Form name             respondents   responses  per   response  (in
                                                                                     respondent       hours)
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Patients...........................  Follow-up Patient Survey...             150               1           10/60
Providers..........................  Follow-up Provider Survey..              70               1           30/60
                                     Focus Group Moderator Guide              75               1               1
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Kimberly S. Lane,
Deputy Director, Office of Science Integrity, Office of the Associate 
Director for Science, Office of the Director, Centers for Disease 
Control and Prevention.
[FR Doc. 2012-11874 Filed 5-15-12; 8:45 am]
BILLING CODE 4163-18-P