[Federal Register Volume 81, Number 154 (Wednesday, August 10, 2016)]
[Notices]
[Pages 52867-52868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18938]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-16AWP; Docket No. CDC-2016-0075]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed study 
to examine the facilitators and barriers to receiving clinical 
preventive services among newly insured medically underserved women who 
had previously been served by the National Breast and Cervical Cancer 
Early Detection Program (NBCCEDP). The purpose of this survey is to 
assess if newly insured women receive appropriate clinical preventive 
health services, what barriers and facilitators these women experience, 
and if they are able to maintain consistent health insurance coverage.

DATES: Written comments must be received on or before October 11, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0075 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.
    Please note: All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    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; (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; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

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.

[[Page 52868]]

    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 3 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 4 years from the time of study implementation OR (2) received a 
Pap/HPV co-test through a NBCCEDP grantee not less than 3 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 1 year but not more 
than 3 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.
    OMB approval is requested for three years. Participation is 
voluntary and there are no costs to respondents other than their time. 
The estimated annualized burden hours for this data collection are 
1,243 hours.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Women aged 30-62 who            Screener........           3,228               1            5/60             269
 previously received services
 in the NBCCEDP.
                                Survey..........           2,338               1           25/60             974
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    Total.....................  ................  ..............  ..............  ..............           1,243
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Jeffrey M. Zirger,
Health Scientist, Acting 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.
[FR Doc. 2016-18938 Filed 8-9-16; 8:45 am]
 BILLING CODE 4163-18-P