81_FR_9513 81 FR 9476 - Agency Forms Undergoing Paperwork Reduction Act Review

81 FR 9476 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 81, Issue 37 (February 25, 2016)

Page Range9476-9477
FR Document2016-04013

Federal Register, Volume 81 Issue 37 (Thursday, February 25, 2016)
[Federal Register Volume 81, Number 37 (Thursday, February 25, 2016)]
[Notices]
[Pages 9476-9477]
From the Federal Register Online  [www.thefederalregister.org]
[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 [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

    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



                                                  9476                        Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Notices

                                                  DEPARTMENT OF HEALTH AND                                for Disease Control and Prevention                    care?). CDC’s data collection contractor
                                                  HUMAN SERVICES                                          (CDC).                                                will securely maintain identifiable
                                                                                                                                                                information from respondents recruited
                                                  Centers for Disease Control and                         Background and Brief Description
                                                                                                                                                                from state registries (Sample 1). No
                                                  Prevention                                                 The Education and Awareness                        identifiable information will be
                                                                                                          Requires Learning Young (EARLY) Act                   transmitted to CDC.
                                                  [30Day–16–15BDJ]                                        of 2009, which is outlined in section                    Sample 2 will include a national
                                                                                                          10413 of the Patient Protection and                   convenience sample of 2,000 female
                                                  Agency Forms Undergoing Paperwork                       Affordable Care Act, authorizes the CDC               breast cancer survivors who were
                                                  Reduction Act Review                                    to fund research and initiatives that                 diagnosed between the ages of 18 and 49
                                                                                                          increase knowledge of breast health and               and are associated with one of two
                                                     The Centers for Disease Control and                  breast cancer among women,                            breast cancer advocacy groups, Living
                                                  Prevention (CDC) has submitted the                      particularly among those under the age                Beyond Breast Cancer and Young
                                                  following information collection request                of 40. The EARLY Act along with                       Survival Coalition. Respondents from
                                                  to the Office of Management and Budget                  section 301 of the Public Health Service              Sample 2 will complete the web-based
                                                  (OMB) for review and approval in                        Act authorizes the CDC to conduct                     version of the survey. A set of screening
                                                  accordance with the Paperwork                           research that will inform the prevention              questions will be included at the
                                                  Reduction Act of 1995. The notice for                   of physical and mental diseases such as               beginning of this web-based survey to
                                                  the proposed information collection is                  breast cancer, and serves as the main                 confirm eligibility and so that women
                                                  published to obtain comments from the                   basis for this data collection activity.              from the four states included in Sample
                                                  public and affected agencies.                              Research indicates that young women                1 can be excluded. The survey data will
                                                     Written comments and suggestions                     diagnosed with breast cancer face many                not be linked to any other data source.
                                                  from the public and affected agencies                   barriers accessing high-quality breast                   Since the study uses two distinct
                                                  concerning the proposed collection of                   cancer care and treatment. Some                       samples and employs the same
                                                  information are encouraged. Your                        research indicates that employment                    instrument with minor modifications,
                                                  comments should address any of the                      status, financial stability, and insurance            survey responses from the two samples
                                                  following: (a) Evaluate whether the                     coverage are variables that individually              can answer the following additional
                                                  proposed collection of information is                   affect treatment compliance, access to                research questions: (1) How
                                                  necessary for the proper performance of                 quality care, and ultimately quality of               generalizable are the results from the
                                                  the functions of the agency, including                  life for young women with breast                      four cancer registries? (2) Are there
                                                  whether the information will have                       cancer. However, to date, no                          differences in the variables of interest
                                                  practical utility; (b) Evaluate the                     comprehensive assessment exists                       between young breast cancer survivors
                                                  accuracy of the agencies estimate of the                examining the impacts of these factors                based on the length of time that has
                                                  burden of the proposed collection of                    on young, female breast cancer patients’              elapsed from cancer diagnosis? (3) Do
                                                  information, including the validity of                  access to comprehensive high quality                  the experiences and barriers faced by
                                                  the methodology and assumptions used;                   breast cancer treatment and care.                     women diagnosed between 18 and 39
                                                  (c) Enhance the quality, utility, and                      CDC propose to address this gap by                 years of age differ from those of women
                                                  clarity of the information to be                        answering the following two research                  diagnosed between 40 and 44 years of
                                                  collected; (d) Minimize the burden of                   questions: (1) What are young, female                 age and 45 and 49 years of age?
                                                  the collection of information on those                  breast cancer survivors experiencing                     The results can help inform future
                                                  who are to respond, including through                   after their diagnosis in terms of (a)                 survey data collection methodologies by
                                                  the use of appropriate automated,                       continuation of insurance coverage,                   showing whether drawing a
                                                  electronic, mechanical, or other                        access to care, and quality of care; (b)              convenience sample from survivorship
                                                  technological collection techniques or                  changes in employment status after                    groups can be a more feasible, less
                                                  other forms of information technology,                  breast cancer diagnosis; and (c) out-of-              expensive, but generalizable method to
                                                  e.g., permitting electronic submission of               pocket medical costs? (2) What factors                recruit respondents for future breast
                                                  responses; and (e) Assess information                   affect young breast cancer survivors’                 cancer survivor surveys.
                                                  collection costs.                                       access to comprehensive, high quality                    The target number of responses for the
                                                     To request additional information on                 care?                                                 overall study is estimated to be 3,200
                                                  the proposed project or to obtain a copy                   To answer these research questions,                completed surveys. Sample 1
                                                  of the information collection plan and                  CDC is sponsoring a study to collect                  respondents will have the option of
                                                  instruments, call (404) 639–7570 or                     information from two groups of breast                 completing a hardcopy questionnaire or
                                                  send an email to omb@cdc.gov. Written                   cancer survivors. Sample 1 will be a                  an online questionnaire, both of which
                                                  comments and/or suggestions regarding                   population-based cohort of                            are be estimated to take about 22
                                                  the items contained in this notice                      approximately 1,200 female breast                     minutes to complete. Sample 2
                                                  should be directed to the Attention:                    cancer survivors recruited from four                  respondents will complete a screener
                                                  CDC Desk Officer, Office of Management                  state cancer registries. These                        and the questionnaire online. Due to the
                                                  and Budget, Washington, DC 20503 or                     respondents will be asked to complete                 inclusion of additional screening
                                                  by fax to (202) 395–5806. Written                       a mail-in or web-based questionnaire.                 questions for Sample 2, a completed
                                                  comments should be received within 30                   Self-reported survey data from Sample 1               survey by an eligible respondent is
                                                  days of this notice.                                    will be supplemented by data                          expected to take about 24 minutes. If a
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                                                                                                          maintained by their state’s cancer                    respondent completes the screening
                                                  Proposed Project                                        registry, including information about                 section and is found to be ineligible for
                                                    Insurance Coverage, Employment                        tumor characteristics, date of diagnosis,             the study, the estimated burden per
                                                  Status, and Copayments/Deductibles                      and stage. The linked survey and cancer               response is 2 minutes. Demographic
                                                  Faced by Young Women Diagnosed with                     registry data will be used to answer                  information will be collected from all
                                                  Breast Cancer—New—National Center                       research question about the factors that              patients who participate in the study.
                                                  for Chronic Disease Prevention and                      affect young breast cancer survivors’                    Findings from this study will be used
                                                  Health Promotion (NCCDPHP), Centers                     access to comprehensive, high quality                 to identify interventions that can


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                                                                                Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Notices                                                9477

                                                  eliminate existing barriers to treatment                  young women diagnosed with breast                       OMB approval is requested for one
                                                  so that young women have access to                        cancer. Study findings will be                        year. Participation is voluntary and
                                                  high quality breast cancer treatment and                  disseminated through reports,                         there are no costs to respondents other
                                                  care. Results will also be used to                        presentations, and publications.                      than their time. The total estimated
                                                  improve care and services provided to                                                                           annualized burden hours are 1,241.
                                                                                                              ESTIMATED TOTAL BURDEN HOURS
                                                                                                                                                                                                      Average
                                                                                                                                                                                      Number of
                                                                                                                                                                  Number of                         burden per
                                                                   Type of respondent                                         Form name                                             responses per
                                                                                                                                                                 respondents                         response
                                                                                                                                                                                      respondent     (in hours)

                                                  Sample 1—Breast cancer survivors recruited               Breast Cancer in Young Women Survey                             1,200                1          22/60
                                                    from state cancer registries.                            (Mail-in or web-based questionnaire).
                                                  Sample 2—Breast cancer survivors associ-                 Breast Cancer in Young Women Survey                               25                 1           2/60
                                                    ated with advocacy groups (ineligibles).                 (Screener only).
                                                  Sample 2—Breast cancer survivors associ-                 Breast Cancer in Young Women Survey                             2,000                1          24/60
                                                    ated with advocacy groups (eligible and                  (Screener and Web-based questionnaire).
                                                    complete).



                                                  Leroy A. Richardson,                                        Matters for Discussion: The agenda will             7500 Security Boulevard, Baltimore,
                                                  Chief, Information Collection Review Office,              include updates on CDC’s activities for               Maryland 21244.
                                                  Office of Scientific Integrity, Office of the             prevention of healthcare associated
                                                                                                            infections (HAIs), updates on antimicrobial              Status: Open to the public, limited
                                                  Associate Director for Science, Office of the
                                                                                                            stewardship, an update on Draft Guideline             only by the space available. The meeting
                                                  Director, Centers for Disease Control and
                                                  Prevention.                                               for Prevention of Infections in Healthcare            room accommodates approximately 240
                                                                                                            Personnel, chlorhexidine gluconate-                   people. We will be broadcasting the
                                                  [FR Doc. 2016–04013 Filed 2–24–16; 8:45 am]
                                                                                                            impregnated dressings, and an update from             meeting live via Webcast at http://
                                                  BILLING CODE 4163–18–P                                    the workgroup for considerations on                   www.cms.gov/live/.
                                                                                                            endoscope reprocessing.
                                                                                                              Agenda items are subject to change as                  Security Considerations: Due to in
                                                  DEPARTMENT OF HEALTH AND                                  priorities dictate.                                   creased security requirements CMS has
                                                  HUMAN SERVICES                                              Contact Person for More Information: Erin           instituted stringent procedures for
                                                                                                            Stone, M.S., HICPAC, Division of Healthcare           entrance into the building by non-
                                                  Centers for Disease Control and                           Quality Promotion, NCEZID, CDC, 1600                  government employees. Attendees will
                                                  Prevention                                                Clifton Road NE., Mailstop A–07, Atlanta,             need to present valid government-issued
                                                                                                            Georgia 30333. Telephone (404) 639–4045.              picture identification, and sign-in at the
                                                  Healthcare Infection Control Practices                    Email: hicpac@cdc.gov.                                security desk upon entering the
                                                  Advisory Committee (HICPAC)                                 The Director, Management Analysis and
                                                                                                            Services Office, has been delegated the
                                                                                                                                                                  building.
                                                    In accordance with section 10(a) (2) of                 authority to sign Federal Register notices               Attendees who wish to attend the
                                                  the Federal Advisory Committee Act                        pertaining to announcements of meetings and           March 9–10, 2016 ICD–10–CM C&M
                                                  (Pub. L. 92–463), the Centers for Disease                 other committee management activities, for            meeting must submit their name and
                                                  Control and Prevention (CDC) announce                     both the Centers for Disease Control and              organization by March 1, 2016 for
                                                                                                            Prevention and the Agency for Toxic                   inclusion on the visitor list. This visitor
                                                  the following meeting for the                             Substances and Disease Registry.
                                                  aforementioned committee:                                                                                       list will be maintained at the front desk
                                                                                                            Claudette Grant,                                      of the CMS building and used by the
                                                    Times and Dates: 9:00 a.m.–5:00 p.m.,
                                                  EDT, March 31, 2016; 9:00 a.m.–12:00 p.m.,                Acting Director, Management Analysis and              guards to admit visitors to the meeting.
                                                  EDT, April 1, 2016.                                       Services Office, Centers for Disease Control             Participants who attended previous
                                                    Place: Centers for Disease Control and                  and Prevention.                                       Coordination and Maintenance meetings
                                                  Prevention, Global Communications Center,                 [FR Doc. 2016–03929 Filed 2–24–16; 8:45 am]           will no longer be automatically added to
                                                  Building 19, Auditorium B, 1600 Clifton                   BILLING CODE 4163–18–P                                the visitor list. You must request
                                                  Road NE., Atlanta, Georgia, 30333.                                                                              inclusion of your name prior to each
                                                    Status: Open to the public, limited only by
                                                  the space available. Please register for the
                                                                                                                                                                  meeting you wish attend.
                                                                                                            DEPARTMENT OF HEALTH AND
                                                  meeting at www.cdc.gov/hicpac.                                                                                     Please register to attend the meeting
                                                                                                            HUMAN SERVICES
                                                    Purpose: The Committee is charged with                                                                        on-line at: http://www.cms.hhs.gov/
                                                  providing advice and guidance to the                                                                            apps/events/. Please contact Mady Hue
                                                                                                            Centers for Disease Control and
                                                  Director, Division of Healthcare Quality                                                                        (410–786–4510 or Marilu.hue@
                                                  Promotion, the Director, National Center for              Prevention
                                                                                                                                                                  cms.hhs.gov), for questions about the
                                                  Emerging and Zoonotic Infectious Diseases
                                                                                                            National Center for Health Statistics                 registration process.
                                                  (NCEZID), the Director, CDC, the Secretary,
                                                  Health and Human Services regarding (1) the               (NCHS), Classifications and Public                       Purpose: The ICD–10 Coordination
                                                  practice of healthcare infection prevention               Health Data Standards Staff,                          and Maintenance (C&M) Committee is a
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  and control; (2) strategies for surveillance,             Announces the Following Meeting                       public forum for the presentation of
                                                  prevention, and control of infections,                                                                          proposed modifications to the
                                                  antimicrobial resistance, and related events                Name: ICD–10 Coordination and
                                                                                                            Maintenance (C&M) Committee meeting.                  International Classification of Diseases,
                                                  in settings where healthcare is provided; and                                                                   Tenth Revision, Clinical Modification
                                                  (3) periodic updating of CDC guidelines and                 Time and Date: 9:00 a.m.–5:00 p.m.,
                                                  other policy statements regarding prevention              EST, March 9–10, 2016.                                and ICD–10 Procedure Coding System.
                                                  of healthcare-associated infections and                     Place: Centers for Medicare and                        Matters for Discussion: Agenda items
                                                  healthcare-related conditions.                            Medicaid Services (CMS) Auditorium,                   include: March 9–10, 2016.


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Document Created: 2018-02-02 14:35:25
Document Modified: 2018-02-02 14:35:25
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation81 FR 9476 

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