Proposed Data Collection Submitted for Public Comment and Recommendations, 15724-15725 [2016-06706]
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15724
Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / Notices
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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
17:44 Mar 23, 2016
Jkt 238001
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: omb@cdc.gov.
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
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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
E:\FR\FM\24MRN1.SGM
24MRN1
15725
Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / Notices
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-
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.
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
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Form name
Invasive cervical cancer survivors ....
Case Investigation of Cervical Cancer Study Survey.
HIPAA Release and Listing of medical providers in last 5 years.
Support for medical record abstraction.
Health care office assistant ..............
Total ...........................................
...........................................................
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
asabaliauskas on DSK3SPTVN1PROD with NOTICES
[60Day–16–16VB; Docket No. CDC–2016–
0032]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
AGENCY:
ACTION:
Notice with comment period.
VerDate Sep<11>2014
17:44 Mar 23, 2016
Jkt 238001
1
15/60
105
314
1
5/60
28
1,002
1
5/60
84
........................
........................
........................
217
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts 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 a proposed information
collection request entitled ‘‘HIV
Knowledge, Beliefs, Attitudes, and
Practices of Providers in the Southeast
(K–BAP Study)’’. CDC is requesting a
three-year approval for new data
collection to identify areas of HIV
prevention knowledge and practice
strengths and deficits among primary
care providers, in order to target limited
HIV prevention resources to achieve the
greatest reduction in new HIV infections
and optimize HIV clinical care in
clinical settings. The target population
will be primary care providers
practicing in high-prevalence
Frm 00049
Fmt 4703
Total burden
(in hours)
418
SUMMARY:
PO 00000
Average
burden per
response
(in hours)
Number of
responses per
respondent
Sfmt 4703
metropolitan statistical geographic areas
with large at-risk African American
populations.
Written comments must be
received on or before May 23, 2016.
DATES:
You may submit comments,
identified by Docket No. CDC–2016–
0032 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.
ADDRESSES:
E:\FR\FM\24MRN1.SGM
24MRN1
]]>Agencies
[Federal Register Volume 81, Number 57 (Thursday, March 24, 2016)]
[Notices]
[Pages 15724-15725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06706]
[[Page 15724]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: omb@cdc.gov.
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
----------------------------------------------------------------------------------------------------------------
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
