[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]]

-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondent                    Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
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).
----------------------------------------------------------------------------------------------------------------


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