E9-4720. 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 Reports Clearance Officer at [phone] or send an e-mail to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

CDC Cervical Cancer Study (CX3)—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. Screening policies for cervical cancer in the program include an annual Pap test until a woman has had three consecutive normal Pap tests. However, human papillomavirus (HPV) DNA testing is not currently a reimbursable expense under NBCCEDP guidelines, therefore 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.

CDC proposes to conduct a pilot study at 18 clinics in the state of Illinois in order to assess the feasibility, acceptability and barriers to use the HPV DNA test in conjunction with Pap test screening. Clinics will be assigned to an intervention group or a control group, matched on clinic attributes such as geographical location (urban, rural), HPV policy, and hospital versus non-hospital status, provider specialty mix, patient volume, and racial/ethnic characteristics of the patient population. Clinics in the intervention group will receive HPV DNA tests to administer to eligible patients presenting for a routine Pap test, as well as a multi-component educational intervention involving both health care providers and patients. Clinics in the control group will receive the HPV tests for eligible patients but will not receive the educational interventions involving health care providers and patients.

OMB approval is requested for the first three years of a planned five-year study period. Information will be collected primarily from clinical care providers, clinic coordinators, and a sample of women between the ages of 35 and 60 who visit one of the participating clinics for routine cervical cancer screening.

The results of this study will provide information about knowledge, attitudes, beliefs, and cervical cancer screening practices involving low-income, underserved women. The findings 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. The total estimated annualized burden hours are 1,006.

Estimated Annualized Burden Hours

Type of respondent	Form name	No. of respondents	No. of responses per respondent	Average burden per response (in hours)
Clinic Coordinators	Initial Clinic Survey	6	1	2
	Follow-up Clinic Survey	6	11	1
Health Care Providers	Baseline Provider Survey	23	1	30/60
	Follow-up Provider Survey	23	2	30/60
Patients	Patient Screening Script	3,333	1	5/60
	Patient Enrollment Form	2,667	1	5/60
	Baseline Patient Survey	867	1	20/60
	Follow-up Patient Survey	624	1	10/60

Dated: February 27, 2009.

Maryam I. Daneshvar,

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