81 FR 40702 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 81, Issue 120 (June 22, 2016)

Page Range		40702-40703
FR Document		2016-14725

Federal Register, Volume 81 Issue 120 (Wednesday, June 22, 2016)

[Federal Register Volume 81, Number 120 (Wednesday, June 22, 2016)]
[Notices]
[Pages 40702-40703]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-14725]



[[Page 40702]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-16UW]


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

    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 pre-cancers, 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 of abnormal test 
results. The proposed project will identify women recently diagnosed 
with invasive cervical cancer (2014-2016) through cancer registries in 
three states. Each registry will enroll cancer survivors within that 
state who consent to participate in the study.
    Three types of data will be collected. (1) Existing cancer registry 
data will provide information on tumor characteristics, diagnosis, and 
stage of cancer. This will be used to describe the characteristics of 
the sample of survivors and for the identification of the eligible 
sample. (2) Participants will be asked to complete a survey. The 
purpose of the survey is to identify self-reported barriers and 
facilitators to screening and care, and to examine recall of screening 
tests. (3) Participants will also be asked to complete medical release 
and healthcare source forms to permit medical chart abstraction. The 
purpose of the medical chart abstraction is to obtain detailed clinical 
information about all screening and treatment prior to diagnosis. 
Together the information from these three sources of data will be used 
to identify opportunities for intervention to reach women and their 
providers in order to increase screening and appropriate follow-up 
care.
    Based on preliminary data from three 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% response rate 
to the medical release and healthcare source forms (N = 668). These 
estimates yield approximately 668 women with complete data for both 
surveys and chart abstraction. The estimated burden per response for 
completing the mail-in questionnaire is 15 minutes. The estimated 
burden per response for the medical release and healthcare source forms 
is five minutes. 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 = 2,004). The estimated burden for 
support activities conducted by office assistants at the health care 
facilities associated with each medical record abstraction is five 
minutes.
    OMB approval is requested for two years. Participation is voluntary 
and there are no costs to respondents other than their time. The total 
estimated annualized burden hours are 217.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Invasive cervical cancer survivors....  Case Investigation of                418               1           15/60
                                         Cervical Cancer Study
                                         Survey.
                                        Medical Release and                  314               1            5/60
                                         Healthcare Source Forms.
Health care office assistant..........  Support for medical                1,002               1            5/60
                                         record abstraction.
----------------------------------------------------------------------------------------------------------------



[[Page 40703]]

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. 2016-14725 Filed 6-21-16; 8:45 am]
 BILLING CODE 4163-18-P

40702 Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Notices

DEPARTMENT OF HEALTH AND should be directed to the Attention: characteristics of the sample of
HUMAN SERVICES CDC Desk Officer, Office of Management survivors and for the identification of
and Budget, Washington, DC 20503 or the eligible sample. (2) Participants will
Centers for Disease Control and by fax to (202) 395–5806. Written be asked to complete a survey. The
Prevention comments should be received within 30 purpose of the survey is to identify self-
[30Day–16–16UW] days of this notice. reported barriers and facilitators to
Proposed Project screening and care, and to examine
Agency Forms Undergoing Paperwork recall of screening tests. (3) Participants
Reduction Act Review Case Investigation of Cervical Cancer
will also be asked to complete medical
(CICC) Study—New—National Center
The Centers for Disease Control and release and healthcare source forms to
for Chronic Disease Prevention and
Prevention (CDC) has submitted the Health Promotion (NCCDPHP), Centers permit medical chart abstraction. The
following information collection request for Disease Control and Prevention purpose of the medical chart abstraction
to the Office of Management and Budget (CDC). is to obtain detailed clinical information
(OMB) for review and approval in about all screening and treatment prior
accordance with the Paperwork Background and Brief Description to diagnosis. Together the information
Reduction Act of 1995. The notice for Invasive cervical cancer occurs when from these three sources of data will be
the proposed information collection is cervical cancer spreads from the surface used to identify opportunities for
published to obtain comments from the of the cervix to deeper cervical tissue or intervention to reach women and their
public and affected agencies. to other parts of the body. In the United providers in order to increase screening
Written comments and suggestions States, invasive cervical cancer is and appropriate follow-up care.
from the public and affected agencies largely preventable due to the Based on preliminary data from three
concerning the proposed collection of availability of (1) screening tests, which
state cancer registries, a total of
information are encouraged. Your allow for early detection and treatment
comments should address any of the approximately 1,670 eligible cervical
of cervical pre-cancers, and (2) a vaccine
following: (a) Evaluate whether the that prevents infection with types of cancer survivors are eligible for
proposed collection of information is human papillomavirus (HPV) which are participation. CDC estimates a survey
necessary for the proper performance of associated with over 80% of cervical response rate of 50% of across the entire
the functions of the agency, including cancers. However, one previous study sample (N = 835) followed by an 80%
whether the information will have showed that half of the women who response rate to the medical release and
practical utility; (b) Evaluate the developed cervical cancer had not been healthcare source forms (N = 668).
accuracy of the agencies estimate of the adequately screened, and a more recent These estimates yield approximately
burden of the proposed collection of study showed that there were still 668 women with complete data for both
information, including the validity of approximately 8 million women in the surveys and chart abstraction. The
the methodology and assumptions used; U.S. who had not been screened for estimated burden per response for
(c) Enhance the quality, utility, and cervical cancer in the previous five completing the mail-in questionnaire is
clarity of the information to be years. 15 minutes. The estimated burden per
collected; (d) Minimize the burden of CDC plans to conduct the Case response for the medical release and
the collection of information on those Investigation of Cervical Cancer (CICC) healthcare source forms is five minutes.
who are to respond, including through Study to improve understanding of the For each CICC participant, the medical
the use of appropriate automated, facilitators and barriers to cervical chart abstraction process is expected to
electronic, mechanical, or other cancer screening and timely follow-up require follow-up with 1–5 (average of
technological collection techniques or of abnormal test results. The proposed 3) health care providers (N = 2,004). The
other forms of information technology, project will identify women recently estimated burden for support activities
e.g., permitting electronic submission of diagnosed with invasive cervical cancer conducted by office assistants at the
responses; and (e) Assess information (2014–2016) through cancer registries in health care facilities associated with
collection costs. three states. Each registry will enroll
each medical record abstraction is five
To request additional information on cancer survivors within that state who
minutes.
the proposed project or to obtain a copy consent to participate in the study.
of the information collection plan and Three types of data will be collected. OMB approval is requested for two
instruments, call (404) 639–7570 or (1) Existing cancer registry data will years. Participation is voluntary and
send an email to omb@cdc.gov. Written provide information on tumor there are no costs to respondents other
comments and/or suggestions regarding characteristics, diagnosis, and stage of than their time. The total estimated
the items contained in this notice cancer. This will be used to describe the annualized burden hours are 217.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)

Invasive cervical cancer survivors .................. Case Investigation of Cervical Cancer Study 418 1 15/60
mstockstill on DSK3G9T082PROD with NOTICES

Survey.
Medical Release and Healthcare Source 314 1 5/60
Forms.
Health care office assistant ............................ Support for medical record abstraction .......... 1,002 1 5/60

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Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Notices 40703

Leroy A. Richardson, Healthcare Quality Promotion, NCEZID, To request additional information on
Chief, Information Collection Review Office, CDC, 1600 Clifton Road NE., Mailstop the proposed project or to obtain a copy
Office of Scientific Integrity, Office of the A–07, Atlanta, Georgia 30333 Telephone of the information collection plan and
Associate Director for Science, Office of the (404) 639–4045, Email: hicpac@cdc.gov. instruments, call (404) 639–7570 or
Director, Centers for Disease Control and The Director, Management Analysis send an email to omb@cdc.gov. Direct
Prevention. and Services Office, has been delegated written comments and/or suggestions
[FR Doc. 2016–14725 Filed 6–21–16; 8:45 am] the authority to sign Federal Register regarding the items contained in this
BILLING CODE 4163–18–P notices pertaining to announcements of notice to the Attention: CDC Desk
meetings and other committee Officer, Office of Management and
management activities, for both the Budget, Washington, DC 20503 or by fax
DEPARTMENT OF HEALTH AND Centers for Disease Control and to (202) 395–5806. Written comments
HUMAN SERVICES Prevention and the Agency for Toxic should be received within 30 days of
Substances and Disease Registry. this notice.
Centers for Disease Control and
Prevention Elaine L. Baker, Proposed Project
Director, Management Analysis and Services Health Risks from Using Private Wells
Healthcare Infection Control Practices Office, Centers for Disease Control and for Drinking Water—New — National
Advisory Committee (HICPAC) Prevention. Center for Environmental Health
In accordance with section 10(a)(2) of [FR Doc. 2016–14788 Filed 6–21–16; 8:45 am] (NCEH), Centers for Disease Control and
the Federal Advisory Committee Act BILLING CODE 4163–18–P Prevention (CDC).
(Pub. L. 92–463), the Centers for Disease Background and Brief Description
Control and Prevention (CDC) announce
the following meeting for the DEPARTMENT OF HEALTH AND The Safe Drinking Water Act of 1974
aforementioned committee: HUMAN SERVICES (SDWA) ensures that most Americans
Times and Dates: 9:00 a.m.–5:00 p.m., are provided access to water that meets
EDT, July 14, 2016; 9:00 a.m.–12:00 Centers for Disease Control and established public health standards.
p.m., EDT, July 15, 2016. Prevention However, for over 38 million Americans
Place: Centers for Disease Control and [30Day–16–16TL] who rely on private wells or other
Prevention, Global Communications drinking water not protected by the
Center, Building 19, Auditorium B, 1600 Agency Forms Undergoing Paperwork SDWA (herein referred to as private
Clifton Road NE., Atlanta, Georgia Reduction Act Review wells), that is not the case. There is no
30333. comprehensive knowledge about the
Status: Open to the public, limited The Centers for Disease Control and locations of private wells, the
only by the space available. The meeting Prevention (CDC) has submitted the populations served by these sources,
room accommodates approximately 300 following information collection request potential contaminants that might be
people. Please register for the meeting at to the Office of Management and Budget present in private well water in specific
www.cdc.gov/hicpac. (OMB) for review and approval in areas of the country, or the potential
Purpose: The Committee is charged accordance with the Paperwork health risks associated with drinking
with providing advice and guidance to Reduction Act of 1995. The notice for water from these sources.
the Director, Division of Healthcare the proposed information collection is The purpose of this new generic
Quality Promotion, the Director, published to obtain comments from the clearance information collection request
National Center for Emerging and public and affected agencies. is to assess the health risks associated
Zoonotic Infectious Diseases (NCEZID), Written comments and suggestions with exposure to contaminants in
the Director, CDC, the Secretary, Health from the public and affected agencies drinking water from private wells across
and Human Services regarding (1) the concerning the proposed collection of varied geographic areas of the United
practice of healthcare infection information are encouraged. Your States in partnership with the
prevention and control; (2) strategies for comments should address any of the requesting agency (state, territorial,
surveillance, prevention, and control of following: (a) Evaluate whether the local, or tribal health department). The
infections, antimicrobial resistance, and proposed collection of information is information obtained from these
related events in settings where necessary for the proper performance of investigations will be used to describe
healthcare is provided; and (3) periodic the functions of the agency, including health risks from exposure to
updating of CDC guidelines and other whether the information will have contaminants in drinking water from
policy statements regarding prevention practical utility; (b) Evaluate the private wells within a defined time
of healthcare-associated infections and accuracy of the agencies estimate of the period and geographic distribution. This
healthcare-related conditions. burden of the proposed collection of information will be used to inform
Matters for Discussion: The agenda information, including the validity of public health protection activities
will include updates on CDC’s activities the methodology and assumptions used; conducted by the requesting agencies.
for prevention of healthcare associated (c) Enhance the quality, utility, and The respondents are defined as adults
infections (HAIs), updates on clarity of the information to be at least 18 years old, who use private
antimicrobial stewardship, an update on collected; (d) Minimize the burden of wells for drinking water, who are
Draft Guideline for Prevention of the collection of information on those willing to receive and return a tap water
who are to respond, including through sampling kit and urine specimen kit or
mstockstill on DSK3G9T082PROD with NOTICES

Infections in Healthcare Personnel, and
an update from the workgroup for the use of appropriate automated, to provide a blood specimen, and who
considerations on endoscope electronic, mechanical, or other are willing to answer survey questions.
reprocessing. technological collection techniques or They will be recruited from geographic
Agenda items are subject to change as other forms of information technology, areas of interest as defined by the
priorities dictate. e.g., permitting electronic submission of requesting agency.
Contact Person for More Information: responses; and (e) Assess information Based on our historical activities, we
Erin Stone, M.S., HICPAC, Division of collection costs. estimate that CDC will conduct up to 10

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Document Created: 2016-06-22 01:05:46
Document Modified: 2016-06-22 01:05:46

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 40702

81 FR 40702 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 81, Issue 120 (June 22, 2016)

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