E8-4492. 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 404-639-5960 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 [e-mail].

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

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hr)	Total burden (in hr)
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 Coordinators	6	1	2	12
	Follow-up Survey for Clinic Coordinators	6	11	1	66
Total					934

Dated: February 28, 2008.

Maryam I. Daneshvar,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.