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)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 37 (February 25, 2016)
| Page Range | 9476-9477 | |
| FR Document | 2016-04013 |
[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
mstockstill on DSK4VPTVN1PROD with NOTICES
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
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 81 FR 9476 |
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