[Federal Register: March 5, 2009 (Volume 74, Number 42)]
[Notices]
[Page 9615-9616]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr09-48]
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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 omb@cdc.gov. 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
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No. of Average burden
Type of respondent Form name No. of responses per per response
respondents respondent (in hours)
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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
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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