2017-04043. Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies' estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call [phone] or send an email to [e-mail]. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

Women's Preventive Health Services 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) provides free or low-cost breast and cervical cancer screening and diagnostic services to low-income, uninsured, and underserved women. The NBCCEDP is an organized screening program with a full complement of services including outreach and patient education, patient navigation, case management, professional development, and tracking and follow-up that contribute to the program's success. Compared to when the NBCCEDP was established, more women are eligible for insurance coverage but there are still many women who are not insured and many insured women not obtaining preventive services that they are eligible to receive. Currently, the NBCCEDP not only provides screening services to uninsured and underinsured, but has expanded its services to include population-based activities that prevent missed opportunities and ensure that all women receive appropriate breast and cervical cancer screening.

Previous research suggests that access to health care through insurance alone does not ensure adherence to cancer screening, as many individual, cultural, and community factors serve as barriers to preventive service use. With recent increases in the numbers of women who are insured, there is a need to understand the experiences of women who had been served by the NBCCEDP and become newly insured. This project will inform the development of future activities of the NBCCEDP so that all women receive the information and support services needed for obtaining clinical preventive services.

The purpose of this project is to examine the facilitators and barriers to receiving clinical preventive services among newly insured medically underserved women who had previously been served by the NBCCEDP. The Women's Preventive Services Study aims to survey newly insured women about what clinical preventive health services they receive, what barriers and facilitators they experience, and their ability to maintain consistent health insurance coverage.

While having newly acquired health insurance will improve access to preventive services, insurance coverage alone would not result in improved clinical preventive services utilization for all women, especially among underserved populations. This project proposes to follow a group of women previously served by the NBCCEDP over three years by administering a yearly questionnaire.

This study will focus on the following research questions:

1. What are the insurance coverage patterns (e.g., public or private insurance) for a sample of medically underserved women previously screened through the NBCCEDP?

2. What barriers and facilitators do these women face in enrolling in new insurance coverage?

3. What preventive health services, including cancer screening, do these women receive?

4. What barriers and facilitators do these women face in accessing preventive health services through their new coverage?

5. What are the non-financial and financial costs to these women?

The respondents will be uninsured or underinsured women who previously had been screened through the NBCCEDP but now have health insurance coverage. To be potentially eligible for the study, women must be between the ages of 30-62 years, a U.S. Citizen or U.S. permanent resident, resident of the state where they received NBCCEDP services, and English or Spanish speaking. Additionally, women must meet one of the prior screening criteria: (1) Having received a Pap test through a NBCCEDP state program not less than 1 year but not more than four years from the time of study implementation OR (2) received a Pap/HPV co-test through a NBCCEDP grantee not less than three years but not more than 5 years from the time of study implementation OR (3) received a mammogram through a NBCCEDP grantee not less than one year but not more than three years from the time of study implementation.

NBCCEDP state programs will identify potentially eligible women and consent the women to have their contact information shared for the study. The women who agree will receive an invitation letter to participate in the study through an on-line survey. The first step of the on-line survey will be a set of screener questions to determine whether they have insurance coverage. Only those who currently have insurance will be eligible to continue with the main survey instrument. Women who complete the survey will be asked to repeat the survey annually the next 2 years.

The sample design proposes that 14,240 women be identified as eligible. We estimate that 80% will be contacted and agree to participate. Of that, we expect 9,683 completed on-line screenings to occur during year one, representing an annualized 3,288 respondents. With an 85% expected completion rate and annual attrition, we estimate that 3,292 surveys will be completed in Year 1; 2,222 completed surveys in Year 2; and 1,500 completed surveys in Year 3. This represents an annualized 2,338 respondents for the survey.

Participation is voluntary. There are no costs to respondents other than their time. The total estimated annual burden hours are 1,243.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Responses per respondent	Average burden per response (in hours)
Women aged 30-62 who previously received services in the NBCCEDP	Screener Survey	3,228 2,338	1 1	5/60 25/60

Leroy A. Richardson,

Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.