[Federal Register Volume 81, Number 37 (Thursday, February 25, 2016)]
[Notices]
[Pages 9476-9477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04013]
[[Page 9476]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-16-15BDJ]
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
(404) 639-7570 or send an email to [email protected]. 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 (202) 395-5806. Written
comments should be received within 30 days of this notice.
Proposed Project
Insurance Coverage, Employment Status, and Copayments/Deductibles
Faced by Young Women Diagnosed with Breast Cancer--New--National Center
for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers
for Disease Control and Prevention (CDC).
Background and Brief Description
The Education and Awareness Requires Learning Young (EARLY) Act of
2009, which is outlined in section 10413 of the Patient Protection and
Affordable Care Act, authorizes the CDC to fund research and
initiatives that increase knowledge of breast health and breast cancer
among women, particularly among those under the age of 40. The EARLY
Act along with section 301 of the Public Health Service Act authorizes
the CDC to conduct research that will inform the prevention of physical
and mental diseases such as breast cancer, and serves as the main basis
for this data collection activity.
Research indicates that young women diagnosed with breast cancer
face many barriers accessing high-quality breast cancer care and
treatment. Some research indicates that employment status, financial
stability, and insurance coverage are variables that individually
affect treatment compliance, access to quality care, and ultimately
quality of life for young women with breast cancer. However, to date,
no comprehensive assessment exists examining the impacts of these
factors on young, female breast cancer patients' access to
comprehensive high quality breast cancer treatment and care.
CDC propose to address this gap by answering the following two
research questions: (1) What are young, female breast cancer survivors
experiencing after their diagnosis in terms of (a) continuation of
insurance coverage, access to care, and quality of care; (b) changes in
employment status after breast cancer diagnosis; and (c) out-of-pocket
medical costs? (2) What factors affect young breast cancer survivors'
access to comprehensive, high quality care?
To answer these research questions, CDC is sponsoring a study to
collect information from two groups of breast cancer survivors. Sample
1 will be a population-based cohort of approximately 1,200 female
breast cancer survivors recruited from four state cancer registries.
These respondents will be asked to complete a mail-in or web-based
questionnaire. Self-reported survey data from Sample 1 will be
supplemented by data maintained by their state's cancer registry,
including information about tumor characteristics, date of diagnosis,
and stage. The linked survey and cancer registry data will be used to
answer research question about the factors that affect young breast
cancer survivors' access to comprehensive, high quality care?). CDC's
data collection contractor will securely maintain identifiable
information from respondents recruited from state registries (Sample
1). No identifiable information will be transmitted to CDC.
Sample 2 will include a national convenience sample of 2,000 female
breast cancer survivors who were diagnosed between the ages of 18 and
49 and are associated with one of two breast cancer advocacy groups,
Living Beyond Breast Cancer and Young Survival Coalition. Respondents
from Sample 2 will complete the web-based version of the survey. A set
of screening questions will be included at the beginning of this web-
based survey to confirm eligibility and so that women from the four
states included in Sample 1 can be excluded. The survey data will not
be linked to any other data source.
Since the study uses two distinct samples and employs the same
instrument with minor modifications, survey responses from the two
samples can answer the following additional research questions: (1) How
generalizable are the results from the four cancer registries? (2) Are
there differences in the variables of interest between young breast
cancer survivors based on the length of time that has elapsed from
cancer diagnosis? (3) Do the experiences and barriers faced by women
diagnosed between 18 and 39 years of age differ from those of women
diagnosed between 40 and 44 years of age and 45 and 49 years of age?
The results can help inform future survey data collection
methodologies by showing whether drawing a convenience sample from
survivorship groups can be a more feasible, less expensive, but
generalizable method to recruit respondents for future breast cancer
survivor surveys.
The target number of responses for the overall study is estimated
to be 3,200 completed surveys. Sample 1 respondents will have the
option of completing a hardcopy questionnaire or an online
questionnaire, both of which are be estimated to take about 22 minutes
to complete. Sample 2 respondents will complete a screener and the
questionnaire online. Due to the inclusion of additional screening
questions for Sample 2, a completed survey by an eligible respondent is
expected to take about 24 minutes. If a respondent completes the
screening section and is found to be ineligible for the study, the
estimated burden per response is 2 minutes. Demographic information
will be collected from all patients who participate in the study.
Findings from this study will be used to identify interventions
that can
[[Page 9477]]
eliminate existing barriers to treatment so that young women have
access to high quality breast cancer treatment and care. Results will
also be used to improve care and services provided to young women
diagnosed with breast cancer. Study findings will be disseminated
through reports, presentations, and publications.
OMB approval is requested for one year. Participation is voluntary
and there are no costs to respondents other than their time. The total
estimated annualized burden hours are 1,241.
Estimated Total Burden Hours
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Average
Number of Number of burden per
Type of respondent Form name respondents responses per response (in
respondent hours)
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Sample 1--Breast cancer survivors Breast Cancer in Young 1,200 1 22/60
recruited from state cancer Women Survey (Mail-in
registries. or web-based
questionnaire).
Sample 2--Breast cancer survivors Breast Cancer in Young 25 1 2/60
associated with advocacy groups Women Survey (Screener
(ineligibles). only).
Sample 2--Breast cancer survivors Breast Cancer in Young 2,000 1 24/60
associated with advocacy groups Women Survey (Screener
(eligible and complete). and Web-based
questionnaire).
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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.
[FR Doc. 2016-04013 Filed 2-24-16; 8:45 am]
BILLING CODE 4163-18-P