[Federal Register Volume 81, Number 120 (Wednesday, June 22, 2016)]
[Notices]
[Pages 40702-40703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14725]
[[Page 40702]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-16-16UW]
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
Case Investigation of Cervical Cancer (CICC) Study--New--National
Center for Chronic Disease Prevention and Health Promotion (NCCDPHP),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Invasive cervical cancer occurs when cervical cancer spreads from
the surface of the cervix to deeper cervical tissue or to other parts
of the body. In the United States, invasive cervical cancer is largely
preventable due to the availability of (1) screening tests, which allow
for early detection and treatment of cervical pre-cancers, and (2) a
vaccine that prevents infection with types of human papillomavirus
(HPV) which are associated with over 80% of cervical cancers. However,
one previous study showed that half of the women who developed cervical
cancer had not been adequately screened, and a more recent study showed
that there were still approximately 8 million women in the U.S. who had
not been screened for cervical cancer in the previous five years.
CDC plans to conduct the Case Investigation of Cervical Cancer
(CICC) Study to improve understanding of the facilitators and barriers
to cervical cancer screening and timely follow-up of abnormal test
results. The proposed project will identify women recently diagnosed
with invasive cervical cancer (2014-2016) through cancer registries in
three states. Each registry will enroll cancer survivors within that
state who consent to participate in the study.
Three types of data will be collected. (1) Existing cancer registry
data will provide information on tumor characteristics, diagnosis, and
stage of cancer. This will be used to describe the characteristics of
the sample of survivors and for the identification of the eligible
sample. (2) Participants will be asked to complete a survey. The
purpose of the survey is to identify self-reported barriers and
facilitators to screening and care, and to examine recall of screening
tests. (3) Participants will also be asked to complete medical release
and healthcare source forms to permit medical chart abstraction. The
purpose of the medical chart abstraction is to obtain detailed clinical
information about all screening and treatment prior to diagnosis.
Together the information from these three sources of data will be used
to identify opportunities for intervention to reach women and their
providers in order to increase screening and appropriate follow-up
care.
Based on preliminary data from three state cancer registries, a
total of approximately 1,670 eligible cervical cancer survivors are
eligible for participation. CDC estimates a survey response rate of 50%
of across the entire sample (N = 835) followed by an 80% response rate
to the medical release and healthcare source forms (N = 668). These
estimates yield approximately 668 women with complete data for both
surveys and chart abstraction. The estimated burden per response for
completing the mail-in questionnaire is 15 minutes. The estimated
burden per response for the medical release and healthcare source forms
is five minutes. For each CICC participant, the medical chart
abstraction process is expected to require follow-up with 1-5 (average
of 3) health care providers (N = 2,004). The estimated burden for
support activities conducted by office assistants at the health care
facilities associated with each medical record abstraction is five
minutes.
OMB approval is requested for two years. Participation is voluntary
and there are no costs to respondents other than their time. The total
estimated annualized burden hours are 217.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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Invasive cervical cancer survivors.... Case Investigation of 418 1 15/60
Cervical Cancer Study
Survey.
Medical Release and 314 1 5/60
Healthcare Source Forms.
Health care office assistant.......... Support for medical 1,002 1 5/60
record abstraction.
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[[Page 40703]]
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. 2016-14725 Filed 6-21-16; 8:45 am]
BILLING CODE 4163-18-P