Agency Forms Undergoing Paperwork Reduction Act Review, 26930-26931 [2017-12059]
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26930
Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices
International Travelers: Expanding and
Improving Data Collection, Guidance,
and Outreach’’, CK16–003.
Contact Person for More Information:
Gregory Anderson, M.S., M.P.H.,
Scientific Review Officer, CDC, 1600
Clifton Road NE., Mailstop E60, Atlanta,
Georgia 30333, Telephone: (404) 718–
8833.
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.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2017–12124 Filed 6–9–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
asabaliauskas on DSKBBXCHB2PROD with NOTICES
World Trade Center Health Program
Scientific/Technical Advisory
Committee: Notice of Charter Renewal
This gives notice under Public Law
111–347 (The James Zadroga 9/11
Health and Compensation Act of 2010)
and the Federal Advisory Committee
Act (Pub. L. 92–463) of October 6, 1972,
that the World Trade Center Health
Program Scientific/Technical Advisory
Committee, Centers for Disease Control
and Prevention, Department of Health
and Human Services, has been renewed
for a 2-year period through May 12,
2019.
For information, contact Paul J.
Middendorf, Ph.D., Designated Federal
Officer, National Institute for
Occupational Safety and Health, Centers
for Disease Control and Prevention,
Department of Health and Human
Services, 2400 Century Parkway NE.,
Mail Stop E–20, Atlanta, Georgia 30345,
telephone 1 (888) 982–4748; email: wtcstac@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
VerDate Sep<11>2014
17:28 Jun 09, 2017
Jkt 241001
Prevention and the Agency for Toxic
Substances and Disease Registry.
should be received within 30 days of
this notice.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
Proposed Project
ZEN Colombia Study: Zika in
Pregnant Women and Children in
Colombia—New—Pregnancy and Birth
Defects Task Force, National Center on
Birth Defects and Developmental
Disabilities, Centers for Disease Control
and Prevention (CDC).
[FR Doc. 2017–12125 Filed 6–9–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–17–17ABB]
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. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, Washington, DC 20503 or by fax
to (202) 395–5806. Written comments
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
Background and Brief Description
Zika virus (ZIKV) infection is a
mosquito-borne flavivirus transmitted
by Aedes species mosquitoes, and also
through sexual and mother-to-child
transmission; laboratory-acquired
infections have also been reported.
Evidence of human ZIKV infection was
observed sporadically in Africa and
Asia prior to 2007, when an outbreak of
ZIKV caused an estimated 5,000
infections in the State of Yap, Federated
States of Micronesia. Since then,
evidence of ZIKV has been found in 65
countries and territories, mostly in
Central and South America. Common
symptoms of ZIKV in humans include
rash, fever, arthralgia, and nonpurulent
conjunctivitis. The illness is usually
mild and self-limited, with symptoms
lasting for several days to a week;
however, based on previous outbreaks,
some infections are asymptomatic. The
prevalence of asymptomatic infection in
the current Central and South American
epidemic is unknown.
Although the clinical presentation of
ZIKV infection is typically mild, ZIKV
infection in pregnancy can cause
microcephaly and related brain
abnormalities when fetuses are exposed
in utero. Other adverse pregnancy
outcomes related to ZIKV infection
remain under study, and include
pregnancy loss, other major birth
defects, arthrogryposis, eye
abnormalities, and neurologic
abnormalities.
As the spectrum of adverse health
outcomes potentially related to ZIKV
infection continues to grow, large gaps
remain in our understanding of ZIKV
infection in pregnancy. These include
the full spectrum of adverse health
outcomes in pregnant women, fetuses,
and infants associated with ZIKV
infection; the relative contributions of
sexual transmission and mosquito-borne
transmission to occurrence of infections
in pregnancy; and variability in the risk
of adverse fetal outcomes by gestational
week of maternal infection or symptoms
of infection. There is an urgency to fill
these large gaps in our understanding
given the rapidity of the epidemic’s
spread and the severe health outcomes
associated with ZIKV to date.
E:\FR\FM\12JNN1.SGM
12JNN1
26931
Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices
Colombia’s Instituto Nacional de
Salud (INS) began surveillance for ZIKV
in 2015, reporting the first
autochthonous transmission in October
2015 in the north of the country. As of
October 2016, Colombia has reported
over 105,000 suspected ZIKV cases,
with over 19,000 of them among
pregnant women. With a causal link
established between ZIKV infection in
pregnancy and microcephaly, there is an
urgent need to understand: How ZIKV
transmission can be prevented; the full
spectrum of adverse maternal, fetal, and
infant health outcomes associated with
ZIKV infection; and risk factors for
occurrence of these outcomes. To
answer these questions, INS and the
U.S. Centers for Disease Control and
Prevention (CDC) will follow 5,000
women enrolled in the first trimester of
pregnancy, their male partners, and
their infants, in various cities in
Colombia where ZIKV transmission is
currently ongoing.
The primary study objectives are to:
(1) Describe the sociodemographic and
clinical characteristics of the study
population; (2) Identify risk factors for
ZIKV infection in pregnant women and
their infants. These include behaviors
such as use of mosquito-bite prevention
measures or condoms, and factors
associated with maternal-to-child
transmission; (3) Assess the risk for
adverse maternal, fetal, and infant
outcomes associated with ZIKV
infection; (4) Assess modifiers of the
risk for adverse outcomes among
pregnant women and their infants
following ZIKV infection. This includes
investigating associations with
gestational age at infection, presence of
ZIKV symptoms, extended viremia,
mode of transmission, prior infections
or immunizations, and co-infections.
The project aims to enroll
approximately 5,000 women, 1,250 male
partners, and 4,500 newborns. Pregnant
women will be recruited in the first
trimester of pregnancy for study
enrollment, followed by assessments
during pregnancy (every other week
until 32 weeks gestation and monthly
thereafter), and within 10 days
postpartum. At all visits, participants
will complete visit-specific
questionnaires. In addition to the
questionnaires, at all pregnancy and
delivery visits, participants will receive
Colombian national recommended
clinical care and provide samples for
laboratory testing.
Male partners will be recruited
around the time of the pregnant
partners’ study enrollment, followed by
monthly visits until his pregnant
partner reaches the third trimester
(approximately 27 weeks gestation). If
the male partner contracts ZIKV during
this time, visits will occur every other
week until the partner has two negative
consecutive tests for ZIKV or the
pregnancy ends. At all study visits, male
partners will complete visit-specific
questionnaires and provide samples for
laboratory testing.
All newborns of mothers participating
in the study will be followed every
other week from birth to 6 months of
age. At all visits, infants will receive
national recommended clinical care (at
birth and clinic visits at 1, 2, and 6
months), provide samples for laboratory
testing, and mothers will complete
study-specific questionnaires about
infant ZIKV symptoms and
developmental milestones. During
follow-up, infants will also have cranial
ultrasounds, their head circumference
measured, and hearing and vision tests.
For mothers and their infants, relevant
information collected as part of clinical
care will be abstracted from medical
records. Study results will be used to
guide recommendations made by both
INS and CDC to prevent ZIKV infection;
to improve counseling of patients about
risks to themselves, their pregnancies,
their partners, and their infants; and to
help agencies prepare to provide
services to affected children and
families. Participation in this study is
voluntary. The estimated number of
annual Burden Hours are 20,548 and
there are no costs to participants other
than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
Form name
Pregnant women .............................................
Pregnant women eligibility questionnaire ......
Pregnant women enrollment questionnaire ...
Adult symptom questionnaire .........................
Pregnant women follow-up questionnaire ......
Infant symptoms questionnaire ......................
Infant Ages and Stages Questionnaire: 2
Month.
Infant Ages and Stages Questionnaire: 6
Month.
Male partner eligibility questionnaire .............
Male enrollment questionnaire .......................
Adult symptom questionnaire .........................
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Male partners ..................................................
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–12059 Filed 6–9–17; 8:45 am]
[30Day–17–17BZ]
BILLING CODE 4163–18–P
Centers for Disease Control and
Prevention
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
VerDate Sep<11>2014
17:28 Jun 09, 2017
Jkt 241001
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden
per response
(in hours)
3,125
2,500
2,500
2,500
2,250
2,250
1
1
15
8
14
1
5/60
35/60
10/60
15/60
10/60
15/60
2,250
1
15/60
2,500
625
625
1
1
7
5/60
25/60
10/60
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
E:\FR\FM\12JNN1.SGM
12JNN1
]]>Agencies
[Federal Register Volume 82, Number 111 (Monday, June 12, 2017)]
[Notices]
[Pages 26930-26931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12059]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-17-17ABB]
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. Direct written comments
and/or suggestions regarding the items contained in this notice 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
ZEN Colombia Study: Zika in Pregnant Women and Children in
Colombia--New--Pregnancy and Birth Defects Task Force, National Center
on Birth Defects and Developmental Disabilities, Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Zika virus (ZIKV) infection is a mosquito-borne flavivirus
transmitted by Aedes species mosquitoes, and also through sexual and
mother-to-child transmission; laboratory-acquired infections have also
been reported. Evidence of human ZIKV infection was observed
sporadically in Africa and Asia prior to 2007, when an outbreak of ZIKV
caused an estimated 5,000 infections in the State of Yap, Federated
States of Micronesia. Since then, evidence of ZIKV has been found in 65
countries and territories, mostly in Central and South America. Common
symptoms of ZIKV in humans include rash, fever, arthralgia, and
nonpurulent conjunctivitis. The illness is usually mild and self-
limited, with symptoms lasting for several days to a week; however,
based on previous outbreaks, some infections are asymptomatic. The
prevalence of asymptomatic infection in the current Central and South
American epidemic is unknown.
Although the clinical presentation of ZIKV infection is typically
mild, ZIKV infection in pregnancy can cause microcephaly and related
brain abnormalities when fetuses are exposed in utero. Other adverse
pregnancy outcomes related to ZIKV infection remain under study, and
include pregnancy loss, other major birth defects, arthrogryposis, eye
abnormalities, and neurologic abnormalities.
As the spectrum of adverse health outcomes potentially related to
ZIKV infection continues to grow, large gaps remain in our
understanding of ZIKV infection in pregnancy. These include the full
spectrum of adverse health outcomes in pregnant women, fetuses, and
infants associated with ZIKV infection; the relative contributions of
sexual transmission and mosquito-borne transmission to occurrence of
infections in pregnancy; and variability in the risk of adverse fetal
outcomes by gestational week of maternal infection or symptoms of
infection. There is an urgency to fill these large gaps in our
understanding given the rapidity of the epidemic's spread and the
severe health outcomes associated with ZIKV to date.
[[Page 26931]]
Colombia's Instituto Nacional de Salud (INS) began surveillance for
ZIKV in 2015, reporting the first autochthonous transmission in October
2015 in the north of the country. As of October 2016, Colombia has
reported over 105,000 suspected ZIKV cases, with over 19,000 of them
among pregnant women. With a causal link established between ZIKV
infection in pregnancy and microcephaly, there is an urgent need to
understand: How ZIKV transmission can be prevented; the full spectrum
of adverse maternal, fetal, and infant health outcomes associated with
ZIKV infection; and risk factors for occurrence of these outcomes. To
answer these questions, INS and the U.S. Centers for Disease Control
and Prevention (CDC) will follow 5,000 women enrolled in the first
trimester of pregnancy, their male partners, and their infants, in
various cities in Colombia where ZIKV transmission is currently
ongoing.
The primary study objectives are to: (1) Describe the
sociodemographic and clinical characteristics of the study population;
(2) Identify risk factors for ZIKV infection in pregnant women and
their infants. These include behaviors such as use of mosquito-bite
prevention measures or condoms, and factors associated with maternal-
to-child transmission; (3) Assess the risk for adverse maternal, fetal,
and infant outcomes associated with ZIKV infection; (4) Assess
modifiers of the risk for adverse outcomes among pregnant women and
their infants following ZIKV infection. This includes investigating
associations with gestational age at infection, presence of ZIKV
symptoms, extended viremia, mode of transmission, prior infections or
immunizations, and co-infections.
The project aims to enroll approximately 5,000 women, 1,250 male
partners, and 4,500 newborns. Pregnant women will be recruited in the
first trimester of pregnancy for study enrollment, followed by
assessments during pregnancy (every other week until 32 weeks gestation
and monthly thereafter), and within 10 days postpartum. At all visits,
participants will complete visit-specific questionnaires. In addition
to the questionnaires, at all pregnancy and delivery visits,
participants will receive Colombian national recommended clinical care
and provide samples for laboratory testing.
Male partners will be recruited around the time of the pregnant
partners' study enrollment, followed by monthly visits until his
pregnant partner reaches the third trimester (approximately 27 weeks
gestation). If the male partner contracts ZIKV during this time, visits
will occur every other week until the partner has two negative
consecutive tests for ZIKV or the pregnancy ends. At all study visits,
male partners will complete visit-specific questionnaires and provide
samples for laboratory testing.
All newborns of mothers participating in the study will be followed
every other week from birth to 6 months of age. At all visits, infants
will receive national recommended clinical care (at birth and clinic
visits at 1, 2, and 6 months), provide samples for laboratory testing,
and mothers will complete study-specific questionnaires about infant
ZIKV symptoms and developmental milestones. During follow-up, infants
will also have cranial ultrasounds, their head circumference measured,
and hearing and vision tests. For mothers and their infants, relevant
information collected as part of clinical care will be abstracted from
medical records. Study results will be used to guide recommendations
made by both INS and CDC to prevent ZIKV infection; to improve
counseling of patients about risks to themselves, their pregnancies,
their partners, and their infants; and to help agencies prepare to
provide services to affected children and families. Participation in
this study is voluntary. The estimated number of annual Burden Hours
are 20,548 and there are no costs to participants other than their
time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Pregnant women..................... Pregnant women eligibility 3,125 1 5/60
questionnaire.
Pregnant women enrollment 2,500 1 35/60
questionnaire.
Adult symptom questionnaire 2,500 15 10/60
Pregnant women follow-up 2,500 8 15/60
questionnaire.
Infant symptoms 2,250 14 10/60
questionnaire.
Infant Ages and Stages 2,250 1 15/60
Questionnaire: 2 Month.
Infant Ages and Stages 2,250 1 15/60
Questionnaire: 6 Month.
Male partners...................... Male partner eligibility 2,500 1 5/60
questionnaire.
Male enrollment 625 1 25/60
questionnaire.
Adult symptom questionnaire 625 7 10/60
----------------------------------------------------------------------------------------------------------------
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. 2017-12059 Filed 6-9-17; 8:45 am]
BILLING CODE 4163-18-P
