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