81 FR 15724 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 57 (March 24, 2016)

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 ``Case Investigation of Cervical Cancer (CICC) Study,'' which is designed to identify self- reported barriers and facilitators to cervical cancer screening and follow-up among women diagnosed with invasive cervical cancer. Medical charts will also be reviewed to further evaluate verify screening and follow-up of abnormal tests results prior to diagnosis.

[Federal Register Volume 81, Number 57 (Thursday, March 24, 2016)]
[Notices]
[Pages 15724-15725]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06706]



[[Page 15724]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-16UW; Docket No. CDC-16-0031]


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 ``Case Investigation of 
Cervical Cancer (CICC) Study,'' which is designed to identify self-
reported barriers and facilitators to cervical cancer screening and 
follow-up among women diagnosed with invasive cervical cancer. Medical 
charts will also be reviewed to further evaluate verify screening and 
follow-up of abnormal tests results prior to diagnosis.

DATES: Written comments must be received on or before May 23, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0031 by any of the following methods:
     Federal eRulemaking Portal: Regulations.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

    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 precancers, 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 to abnormal test 
results. The study is designed to address the following research 
questions: (1) Did women get a cervical cancer screening test during 
the five years prior to cervical cancer diagnosis? (2) What were 
facilitators or barriers to getting a screening test? (3) Did women get 
recommended follow-up of an abnormal test in a timely manner? (4) What 
were the facilitators or barriers to getting follow-up for an abnormal 
test? (5) What were the women's patterns when seeking medical care 
(i.e., routine medical care or symptoms)?
    To answer these questions, CDC will collect and analyze information 
from three sources, in collaboration with central cancer registries 
(CCR) in three states and a contract research organization.
    First, CCR will use existing information to recruit participants 
who are eligible for the study, i.e., women who were diagnosed with 
invasive cervical cancer between January 1, 2014 and December 31, 2016. 
Information about tumor characteristics, date of diagnosis, and cancer 
stage is already maintained by CCR and reported to CDC (National 
Program of Cancer Registries: Cancer Surveillance System, OMB Control 
No. 0920-0469).
    Second, women who agree to participate in the CICC study will be 
asked to complete a survey assessing facilitators and barriers to 
screening and follow-up health care. The estimated

[[Page 15725]]

burden per response for completing the mail-in questionnaire is 15 
minutes. In addition, respondents will be asked to provide contact 
information for all health care providers they have seen in the five 
years prior to their diagnosis with cervical cancer, and to complete a 
Health Insurance Portability and Accountability Act (HIPAA) Release 
form that allows study staff to access the medical records maintained 
by these providers. For each CICC participant, the estimated burden per 
response for the health care provider list and HIPAA Release form is 
five minutes.
    Third, medical chart abstractors will collect information from the 
health care providers who provided relevant services to study 
participants in the five years prior to their diagnosis with invasive 
cervical cancer. The medical record abstraction process does not entail 
burden to study participants, or to the medical chart abstractors who 
will review the medical charts on a fee-for-service basis. The medical 
record abstraction process does entail additional recordkeeping burden 
to office assistants for health care providers, who are required to 
maintain records of disclosures of medical information, e.g., the HIPAA 
Release Form for the CICC study. The estimated burden for support 
activities associated with each medical record abstraction is five 
minutes.
    CDC has identified three states as potential study sites. Based on 
preliminary data from their 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% acceptance of medical 
chart verification (N = 668). These estimates yield approximately 668 
women with complete data for both surveys and chart verification. 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 = 2004).
    Findings from this study will be used to inform interventions 
targeted to reach women who are never or rarely screened for cervical 
cancer. 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 
services provided to women at risk of invasive cervical cancer.
    OMB approval is requested for two years. All personal identifier 
information will be maintained by the cancer registries where it is 
stored as part of the standard registry data repository. No 
identifiable information will be collected by CDC or CDC's main 
contractor. Participation is voluntary and there are no costs to 
respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Invasive cervical cancer        Case                         418               1           15/60             105
 survivors.                      Investigation
                                 of Cervical
                                 Cancer Study
                                 Survey.
                                HIPAA Release                314               1            5/60              28
                                 and Listing of
                                 medical
                                 providers in
                                 last 5 years.
Health care office assistant..  Support for                1,002               1            5/60              84
                                 medical record
                                 abstraction.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             217
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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. 2016-06706 Filed 3-23-16; 8:45 am]
BILLING CODE 4163-18-P