[Federal Register Volume 74, Number 42 (Thursday, March 5, 2009)]
[Notices]
[Pages 9615-9616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4720]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-09-08AR]


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 (404) 639-4766 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-6974. 
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

[[Page 9616]]

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
----------------------------------------------------------------------------------------------------------------
                                                                                      No. of      Average burden
          Type of respondent                    Form name             No. of       responses per   per response
                                                                    respondents     respondent      (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                    23               2           30/60
                                         Survey.
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.
 [FR Doc. E9-4720 Filed 3-4-09; 8:45 am]
BILLING CODE 4163-18-P