Agency Forms Undergoing Paperwork Reduction Act Review, 18464-18465 [2017-07879]
Download as PDF
18464
Federal Register / Vol. 82, No. 74 / Wednesday, April 19, 2017 / Notices
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. 2017–07881 Filed 4–18–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–17–17ABB]
jstallworth on DSK7TPTVN1PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. 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
VerDate Sep<11>2014
15:06 Apr 18, 2017
Jkt 241001
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.
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
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 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 research questions we
aim to address with the ZEN Colombia
study are:
1. Evaluate associations between
ZIKV in pregnancy and adverse
pregnancy or maternal outcomes, such
as preterm birth, preeclampsia, maternal
death, postpartum hemorrhage, and
intrapartum fetal demise, among others.
Effect modification by gestational age of
infection will also be explored.
2. Quantify the magnitude of the
association between ZIKV infection in
pregnancy and major birth defects, with
specific focus on microcephaly and
congenital Zika syndrome. The
prospective design of the study will
allow estimation of both absolute and
relative risk for microcephaly for
women with ZIKV infection during
pregnancy.
3. Identify risk factors for
symptomatic ZIKV infection in
pregnancy among all women with
laboratory-confirmed ZIKV in
pregnancy. A spectrum of risk factors
will be considered, including maternal
demographics, ZIKV infection
characteristics, and other potential risk
factors such as smoking and medication
use.
4. Identify risk factors for ZIKV
infection in infancy. A spectrum of risk
factors will be explored, including
maternal infection factors and birth and
pregnancy factors.
5. Identify risk factors for
symptomatic ZIKV infection in infancy
among infants with laboratoryconfirmed ZIKV born to women
enrolled in the study. A spectrum of risk
factors will be considered, including
maternal ZIKV infection in pregnancy
factors, co-infections, sociodemographic
characteristics and birth factors.
E:\FR\FM\19APN1.SGM
19APN1
18465
Federal Register / Vol. 82, No. 74 / Wednesday, April 19, 2017 / Notices
6. Investigate associations between
ZIKV infection in utero or in infancy
and hearing loss and other physical,
neurologic, and neurodevelopmental
outcomes at 6 months of age.
7. Estimate survival of infants born to
ZIKV infected mothers.
Secondary research questions we aim
to address with the ZEN Colombia study
are:
1. Identify risk factors for ZIKV
infection in pregnant women, partners
and infants. A spectrum of risk factors
will be explored, including mosquito
bites and mosquito bite preventive
measures, sexual transmission,
sociodemographic characteristics, and
medical risk factors. The results of this
analysis will provide information on the
reduction in risk associated with
adherence to recommended preventive
measures and risk factors for infection
in pregnant women.
2. Identify characteristics associated
with taking preventive measures
(mosquito bite prevention, sexual
transmission) against contracting Zika
virus among pregnant women and their
partners. The results of this analysis
will assist in targeting education or
intervention to individuals at greatest
risk for Zika infection.
3. Describe symptoms associated with
ZIKV and estimate the positive
predictive value of certain symptoms or
constellations of symptoms in pregnant
women, men, and infants to allow for
refinement of clinical diagnosis of ZIKV
infection in a setting in which testing
and/or results might not be readily
available.
4. Assess the duration of viremia
following ZIKV infection and
investigate risk factors (such as
sociodemographics, comorbidities, and
co-infections) associated with prolonged
viremia among pregnant women, men,
and infants with laboratory-confirmed
ZIKV infection in blood.
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 at or within 72 hours of
delivery. 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, 3, and 6
months), provide samples for laboratory
testing, and mothers will complete
study-specific questionnaires about
infant ZIKV symptoms. Infants will also
have cranial ultrasounds at birth, their
head circumference measured (birth, 72
hours, 1, 2, 3, and 6 months of age), and
enhanced hearing/vision tests at 1 and
6 months old. 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 total
estimated annualized burden hours are
19,415, 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 ......................
Male partner eligibility questionnaire .............
Male enrollment questionnaire .......................
Adult symptom questionnaire .........................
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.
jstallworth on DSK7TPTVN1PROD with NOTICES
[FR Doc. 2017–07879 Filed 4–18–17; 8:45 am]
15:06 Apr 18, 2017
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
BILLING CODE 4163–18–P
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jkt 241001
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
3,125
2,500
2,500
2,500
2,250
2,500
625
625
Number of
responses
per
respondent
Average
burden per
response
(in hours)
1
1
15
8
14
1
1
7
5/60
35/60
10/60
15/60
10/60
5/60
25/60
10/60
as amended. The grant applications/
contract proposals and the discussions
could disclose confidential trade secrets
or commercial property such as
patentable material, and personal
information concerning individuals
associated with the grant applications/
contract proposals, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; HPV
Review.
Date: May 10, 2017.
E:\FR\FM\19APN1.SGM
19APN1
Agencies
[Federal Register Volume 82, Number 74 (Wednesday, April 19, 2017)]
[Notices]
[Pages 18464-18465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07879]
-----------------------------------------------------------------------
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.
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 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 research questions we aim to address with the ZEN
Colombia study are:
1. Evaluate associations between ZIKV in pregnancy and adverse
pregnancy or maternal outcomes, such as preterm birth, preeclampsia,
maternal death, postpartum hemorrhage, and intrapartum fetal demise,
among others. Effect modification by gestational age of infection will
also be explored.
2. Quantify the magnitude of the association between ZIKV infection
in pregnancy and major birth defects, with specific focus on
microcephaly and congenital Zika syndrome. The prospective design of
the study will allow estimation of both absolute and relative risk for
microcephaly for women with ZIKV infection during pregnancy.
3. Identify risk factors for symptomatic ZIKV infection in
pregnancy among all women with laboratory-confirmed ZIKV in pregnancy.
A spectrum of risk factors will be considered, including maternal
demographics, ZIKV infection characteristics, and other potential risk
factors such as smoking and medication use.
4. Identify risk factors for ZIKV infection in infancy. A spectrum
of risk factors will be explored, including maternal infection factors
and birth and pregnancy factors.
5. Identify risk factors for symptomatic ZIKV infection in infancy
among infants with laboratory-confirmed ZIKV born to women enrolled in
the study. A spectrum of risk factors will be considered, including
maternal ZIKV infection in pregnancy factors, co-infections,
sociodemographic characteristics and birth factors.
[[Page 18465]]
6. Investigate associations between ZIKV infection in utero or in
infancy and hearing loss and other physical, neurologic, and
neurodevelopmental outcomes at 6 months of age.
7. Estimate survival of infants born to ZIKV infected mothers.
Secondary research questions we aim to address with the ZEN
Colombia study are:
1. Identify risk factors for ZIKV infection in pregnant women,
partners and infants. A spectrum of risk factors will be explored,
including mosquito bites and mosquito bite preventive measures, sexual
transmission, sociodemographic characteristics, and medical risk
factors. The results of this analysis will provide information on the
reduction in risk associated with adherence to recommended preventive
measures and risk factors for infection in pregnant women.
2. Identify characteristics associated with taking preventive
measures (mosquito bite prevention, sexual transmission) against
contracting Zika virus among pregnant women and their partners. The
results of this analysis will assist in targeting education or
intervention to individuals at greatest risk for Zika infection.
3. Describe symptoms associated with ZIKV and estimate the positive
predictive value of certain symptoms or constellations of symptoms in
pregnant women, men, and infants to allow for refinement of clinical
diagnosis of ZIKV infection in a setting in which testing and/or
results might not be readily available.
4. Assess the duration of viremia following ZIKV infection and
investigate risk factors (such as sociodemographics, comorbidities, and
co-infections) associated with prolonged viremia among pregnant women,
men, and infants with laboratory-confirmed ZIKV infection in blood.
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 at or within 72 hours of delivery. 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, 3, and 6 months), provide samples for laboratory
testing, and mothers will complete study-specific questionnaires about
infant ZIKV symptoms. Infants will also have cranial ultrasounds at
birth, their head circumference measured (birth, 72 hours, 1, 2, 3, and
6 months of age), and enhanced hearing/vision tests at 1 and 6 months
old. 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
total estimated annualized burden hours are 19,415, and there are no
costs to participants other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Respondents Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Pregnant women........................ Pregnant women 3,125 1 5/60
eligibility
questionnaire.
Pregnant women 2,500 1 35/60
enrollment
questionnaire.
Adult symptom 2,500 15 10/60
questionnaire.
Pregnant women follow-up 2,500 8 15/60
questionnaire.
Infant symptoms 2,250 14 10/60
questionnaire.
Male partners......................... Male partner eligibility 2,500 1 5/60
questionnaire.
Male enrollment 625 1 25/60
questionnaire.
Adult symptom 625 7 10/60
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. 2017-07879 Filed 4-18-17; 8:45 am]
BILLING CODE 4163-18-P