Agency Forms Undergoing Paperwork Reduction Act Review, 9476-9477 [2016-04013]
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9476
Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Notices
for Disease Control and Prevention
(CDC).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–16–15BDJ]
mstockstill on DSK4VPTVN1PROD with NOTICES
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 omb@cdc.gov. 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
VerDate Sep<11>2014
18:07 Feb 24, 2016
Jkt 238001
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-ofpocket 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
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
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
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9477
Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Notices
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
Number of
respondents
Type of respondent
Form name
Sample 1—Breast cancer survivors recruited
from state cancer registries.
Sample 2—Breast cancer survivors associated with advocacy groups (ineligibles).
Sample 2—Breast cancer survivors associated with advocacy groups (eligible and
complete).
Breast Cancer in Young Women Survey
(Mail-in or web-based questionnaire).
Breast Cancer in Young Women Survey
(Screener only).
Breast Cancer in Young Women Survey
(Screener 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Healthcare Infection Control Practices
Advisory Committee (HICPAC)
mstockstill on DSK4VPTVN1PROD with NOTICES
In accordance with section 10(a) (2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC) announce
the following meeting for the
aforementioned committee:
Times and Dates: 9:00 a.m.–5:00 p.m.,
EDT, March 31, 2016; 9:00 a.m.–12:00 p.m.,
EDT, April 1, 2016.
Place: Centers for Disease Control and
Prevention, Global Communications Center,
Building 19, Auditorium B, 1600 Clifton
Road NE., Atlanta, Georgia, 30333.
Status: Open to the public, limited only by
the space available. Please register for the
meeting at www.cdc.gov/hicpac.
Purpose: The Committee is charged with
providing advice and guidance to the
Director, Division of Healthcare Quality
Promotion, the Director, National Center for
Emerging and Zoonotic Infectious Diseases
(NCEZID), the Director, CDC, the Secretary,
Health and Human Services regarding (1) the
practice of healthcare infection prevention
and control; (2) strategies for surveillance,
prevention, and control of infections,
antimicrobial resistance, and related events
in settings where healthcare is provided; and
(3) periodic updating of CDC guidelines and
other policy statements regarding prevention
of healthcare-associated infections and
healthcare-related conditions.
VerDate Sep<11>2014
18:07 Feb 24, 2016
Jkt 238001
Matters for Discussion: The agenda will
include updates on CDC’s activities for
prevention of healthcare associated
infections (HAIs), updates on antimicrobial
stewardship, an update on Draft Guideline
for Prevention of Infections in Healthcare
Personnel, chlorhexidine gluconateimpregnated dressings, and an update from
the workgroup for considerations on
endoscope reprocessing.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information: Erin
Stone, M.S., HICPAC, Division of Healthcare
Quality Promotion, NCEZID, CDC, 1600
Clifton Road NE., Mailstop A–07, Atlanta,
Georgia 30333. Telephone (404) 639–4045.
Email: hicpac@cdc.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Claudette Grant,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2016–03929 Filed 2–24–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Center for Health Statistics
(NCHS), Classifications and Public
Health Data Standards Staff,
Announces the Following Meeting
Name: ICD–10 Coordination and
Maintenance (C&M) Committee meeting.
Time and Date: 9:00 a.m.–5:00 p.m.,
EST, March 9–10, 2016.
Place: Centers for Medicare and
Medicaid Services (CMS) Auditorium,
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
1,200
1
22/60
25
1
2/60
2,000
1
24/60
7500 Security Boulevard, Baltimore,
Maryland 21244.
Status: Open to the public, limited
only by the space available. The meeting
room accommodates approximately 240
people. We will be broadcasting the
meeting live via Webcast at https://
www.cms.gov/live/.
Security Considerations: Due to in
creased security requirements CMS has
instituted stringent procedures for
entrance into the building by nongovernment employees. Attendees will
need to present valid government-issued
picture identification, and sign-in at the
security desk upon entering the
building.
Attendees who wish to attend the
March 9–10, 2016 ICD–10–CM C&M
meeting must submit their name and
organization by March 1, 2016 for
inclusion on the visitor list. This visitor
list will be maintained at the front desk
of the CMS building and used by the
guards to admit visitors to the meeting.
Participants who attended previous
Coordination and Maintenance meetings
will no longer be automatically added to
the visitor list. You must request
inclusion of your name prior to each
meeting you wish attend.
Please register to attend the meeting
on-line at: https://www.cms.hhs.gov/
apps/events/. Please contact Mady Hue
(410–786–4510 or Marilu.hue@
cms.hhs.gov), for questions about the
registration process.
Purpose: The ICD–10 Coordination
and Maintenance (C&M) Committee is a
public forum for the presentation of
proposed modifications to the
International Classification of Diseases,
Tenth Revision, Clinical Modification
and ICD–10 Procedure Coding System.
Matters for Discussion: Agenda items
include: March 9–10, 2016.
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]]>Agencies
[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 omb@cdc.gov. 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
