[Federal Register Volume 80, Number 160 (Wednesday, August 19, 2015)]
[Notices]
[Pages 50288-50290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20479]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-15BDJ; Docket No. CDC-2015-0070]


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 effort 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 the proposed 
information collection request entitled ``Breast Cancer in Young Women 
Survey'',

[[Page 50289]]

which is designed to assess insurance coverage, employment status and 
out-of-pocket health care expenses among young women diagnosed with 
breast cancer and to look at the relationship between these variables 
and treatment decisions.

DATES: Written comments must be received on or before October 19, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0070 by any of the following methods: Federal eRulemaking Portal: 
Regulation.gov. Follow the instructions for submitting comments. Mail: 
Leroy A. Richardson, 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

    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. These barriers are compounded by the multiple roles that 
these young women serve in society including parenting young children, 
developing a career, and completing their education. Treatment 
decisions can be complicated for young women with breast cancer. Some 
research indicates that employment status, financial stability, and 
insurance coverage are variables that affect treatment compliance, 
access to quality care, and ultimately quality of life for young women 
with breast cancer. However, to date, no comprehensive assessment has 
been conducted to examine breast cancer care and treatment for young 
women.
    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: One 
randomly drawn from state-based cancer registries (Sample 1), the other 
a self-selected convenience sample drawn from two advocacy 
organizations (Sample 2).
    Sample 1 will include up to 1,750 young (diagnosed between the ages 
of 18 and 39), female breast cancer survivors diagnosed for the first 
time with breast cancer 12 months before the survey is fielded. 
Respondents will be recruited through approximately four state-based 
central 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 #2 (What factors affect 
young breast cancer survivors' access to comprehensive, high quality 
care?).
    Sample 2 will include a nation-wide convenience sample of 2,000 
female breast cancer survivors diagnosed between the ages of 18 and 49 
who are associated with one of two breast cancer advocacy groups 
(Living Beyond Breast Cancer and Young Survival Coalition). This cohort 
will exclude individuals from Sample 1 and will not be linked to any 
other data source.
    Comparing results between Sample 1 and Sample 2 will help us 
address these additional research questions: (1) How generalizable are 
the results from the convenience Sample 2? (2) Are there

[[Page 50290]]

differences 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 
(Samples 1 and 2) differ from those of women diagnosed between 40 and 
44 years of age and 45 and 49 years of age (Sample 2)? This comparison 
will also help CDC explore whether drawing a convenience sample from 
survivorship groups will be a methodologically legitimate, less 
expensive method to recruit respondents for future breast cancer 
survivor surveys.
    The target number of responses for the overall study will result in 
up to 3,750 completed surveys. Respondents will be asked to complete a 
questionnaire, which is estimated to take about 22 minutes. Sample 1 
respondents will have the option of completing a hardcopy questionnaire 
or an online questionnaire. Sample 2 respondents will complete the 
questionnaire online. Demographic information will be collected from 
all patients who participate in the study.
    Findings from this study will be used to identify interventions to 
ameliorate or eliminate existing barriers to treatment so that young 
women have access to high quality breast cancer treatment and care. 
Study findings will be disseminated through reports, presentations, and 
publications. Results will also be used by participating sites, CDC, 
and other federal agencies to improve care and services provided to 
young women diagnosed with breast cancer.
    OMB approval is requested for three years and the burden table 
presents annuitized estimates. CDC's data collection contractor will 
securely maintain identifiable information from respondents recruited 
from state registries (Sample 1). No identifiable information will be 
collected by CDC. Participation is voluntary and there are no costs to 
respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                                       Average
                                                         Number of      Number of     burden per   Total burden
        Type of respondent              Form name       respondents   responses per    response     (in hours)
                                                                       respondent     (in hours)
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Sample 1--Breast Cancer survivors  Breast Cancer in             583               1        22/60             214
 included in one of as many as      Young Women Survey.
 four state registries.            (Mail or web-based
                                    version
                                    questionnaire).
Sample 2--Breast Cancer survivors  Breast Cancer in             667               1        22/60             244
 associated with advocacy groups.   Young Women Survey.
                                   (Web-based
                                    questionnaire).
                                                                                                 ---------------
    Total........................  ...................  ...........  ..............  ...........             458
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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. 2015-20479 Filed 8-18-15; 8:45 am]
 BILLING CODE 4163-18-P