82 FR 18464 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 82, Issue 74 (April 19, 2017)
Centers for Disease Control and Prevention
Federal Register Volume 82, Issue 74 (April 19, 2017)
| Page Range | 18464-18465 | |
| FR Document | 2017-07879 |
[Federal Register Volume 82, Number 74 (Wednesday, April 19, 2017)] [Notices] [Pages 18464-18465] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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
![18464 Federal Register / Vol. 82, No. 74 / Wednesday, April 19, 2017 / Notices
Leroy A. Richardson, should be received within 30 days of Colombia’s Instituto Nacional de
Chief, Information Collection Review Office, this notice. Salud (INS) began surveillance for ZIKV
Office of Scientific Integrity, Office of the in 2015, reporting the first
Associate Director for Science, Office of the Proposed Project
autochthonous transmission in October
Director, Centers for Disease Control and ZEN Colombia Study: Zika in 2015 in the north of the country. As of
Prevention. Pregnant Women and Children in October 2016, Colombia has reported
[FR Doc. 2017–07881 Filed 4–18–17; 8:45 am] Colombia—New—Pregnancy and Birth over 105,000 suspected ZIKV cases,
BILLING CODE 4163–18–P Defects Task Force, National Center on with over 19,000 of them among
Birth Defects and Developmental pregnant women. With a causal link
Disabilities, Centers for Disease Control established between ZIKV infection in
DEPARTMENT OF HEALTH AND and Prevention (CDC). pregnancy and microcephaly, there is an
HUMAN SERVICES urgent need to understand: How ZIKV
Background and Brief Description
Centers for Disease Control and transmission can be prevented; the full
Zika virus (ZIKV) infection is a
Prevention spectrum of adverse maternal, fetal, and
mosquito-borne flavivirus transmitted
infant health outcomes associated with
by Aedes species mosquitoes, and also
ZIKV infection; and risk factors for
[30Day–17–17ABB] through sexual and mother-to-child
occurrence of these outcomes. To
transmission; laboratory-acquired
answer these questions, INS and CDC
Agency Forms Undergoing Paperwork infections have also been reported.
will follow 5,000 women enrolled in the
Reduction Act Review Evidence of human ZIKV infection was
first trimester of pregnancy, their male
observed sporadically in Africa and
The Centers for Disease Control and partners, and their infants, in various
Asia prior to 2007, when an outbreak of
Prevention (CDC) has submitted the ZIKV caused an estimated 5,000 cities in Colombia where ZIKV
following information collection request infections in the State of Yap, Federated transmission is currently ongoing.
to the Office of Management and Budget States of Micronesia. Since then, The primary research questions we
(OMB) for review and approval in evidence of ZIKV has been found in 65 aim to address with the ZEN Colombia
accordance with the Paperwork countries and territories, mostly in study are:
Reduction Act of 1995. The notice for Central and South America. Common 1. Evaluate associations between
the proposed information collection is symptoms of ZIKV in humans include ZIKV in pregnancy and adverse
published to obtain comments from the rash, fever, arthralgia, and nonpurulent pregnancy or maternal outcomes, such
public and affected agencies. conjunctivitis. The illness is usually as preterm birth, preeclampsia, maternal
Written comments and suggestions mild and self-limited, with symptoms death, postpartum hemorrhage, and
from the public and affected agencies lasting for several days to a week; intrapartum fetal demise, among others.
concerning the proposed collection of however, based on previous outbreaks, Effect modification by gestational age of
information are encouraged. Your some infections are asymptomatic. The infection will also be explored.
comments should address any of the prevalence of asymptomatic infection in 2. Quantify the magnitude of the
following: (a) Evaluate whether the the current Central and South American association between ZIKV infection in
proposed collection of information is epidemic is unknown. pregnancy and major birth defects, with
necessary for the proper performance of Although the clinical presentation of specific focus on microcephaly and
the functions of the agency, including ZIKV infection is typically mild, ZIKV congenital Zika syndrome. The
whether the information will have infection in pregnancy can cause prospective design of the study will
practical utility; (b) Evaluate the microcephaly and related brain allow estimation of both absolute and
accuracy of the agencies estimate of the abnormalities when fetuses are exposed relative risk for microcephaly for
burden of the proposed collection of in utero. Other adverse pregnancy women with ZIKV infection during
information, including the validity of outcomes related to ZIKV infection pregnancy.
the methodology and assumptions used; remain under study, and include 3. Identify risk factors for
(c) Enhance the quality, utility, and pregnancy loss, other major birth symptomatic ZIKV infection in
clarity of the information to be defects, arthrogryposis, eye pregnancy among all women with
collected; (d) Minimize the burden of abnormalities, and neurologic laboratory-confirmed ZIKV in
the collection of information on those abnormalities. pregnancy. A spectrum of risk factors
who are to respond, including through As the spectrum of adverse health will be considered, including maternal
the use of appropriate automated, outcomes potentially related to ZIKV demographics, ZIKV infection
electronic, mechanical, or other infection continues to grow, large gaps characteristics, and other potential risk
technological collection techniques or remain in our understanding of ZIKV factors such as smoking and medication
other forms of information technology, infection in pregnancy. These include use.
e.g., permitting electronic submission of the full spectrum of adverse health 4. Identify risk factors for ZIKV
responses; and (e) Assess information outcomes in pregnant women, fetuses, infection in infancy. A spectrum of risk
collection costs. and infants associated with ZIKV factors will be explored, including
To request additional information on infection; the relative contributions of maternal infection factors and birth and
the proposed project or to obtain a copy sexual transmission and mosquito-borne pregnancy factors.
of the information collection plan and transmission to occurrence of infections 5. Identify risk factors for
instruments, call (404) 639–7570 or in pregnancy; and variability in the risk symptomatic ZIKV infection in infancy
jstallworth on DSK7TPTVN1PROD with NOTICES
send an email to omb@cdc.gov. Direct of adverse fetal outcomes by gestational among infants with laboratory-
written comments and/or suggestions week of maternal infection or symptoms confirmed ZIKV born to women
regarding the items contained in this of infection. There is an urgency to fill enrolled in the study. A spectrum of risk
notice to the Attention: CDC Desk these large gaps in our understanding factors will be considered, including
Officer, Office of Management and given the rapidity of the epidemic’s maternal ZIKV infection in pregnancy
Budget, Washington, DC 20503 or by fax spread and the severe health outcomes factors, co-infections, sociodemographic
to (202) 395–5806. Written comments associated with ZIKV to date. characteristics and birth factors.
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![Federal Register / Vol. 82, No. 74 / Wednesday, April 19, 2017 / Notices 18465
6. Investigate associations between refinement of clinical diagnosis of ZIKV week until the partner has two negative
ZIKV infection in utero or in infancy infection in a setting in which testing consecutive tests for ZIKV or the
and hearing loss and other physical, and/or results might not be readily pregnancy ends. At all study visits, male
neurologic, and neurodevelopmental available. partners will complete visit-specific
outcomes at 6 months of age. 4. Assess the duration of viremia questionnaires and provide samples for
7. Estimate survival of infants born to following ZIKV infection and laboratory testing.
ZIKV infected mothers. investigate risk factors (such as
Secondary research questions we aim All newborns of mothers participating
sociodemographics, comorbidities, and in the study will be followed every
to address with the ZEN Colombia study co-infections) associated with prolonged
are: other week from birth to 6 months of
viremia among pregnant women, men, age. At all visits, infants will receive
1. Identify risk factors for ZIKV and infants with laboratory-confirmed
infection in pregnant women, partners national recommended clinical care (at
ZIKV infection in blood. birth and clinic visits at 1, 2, 3, and 6
and infants. A spectrum of risk factors
will be explored, including mosquito The project aims to enroll months), provide samples for laboratory
bites and mosquito bite preventive approximately 5,000 women, 1,250 male testing, and mothers will complete
measures, sexual transmission, partners, and 4,500 newborns. Pregnant study-specific questionnaires about
sociodemographic characteristics, and women will be recruited in the first infant ZIKV symptoms. Infants will also
medical risk factors. The results of this trimester of pregnancy for study have cranial ultrasounds at birth, their
analysis will provide information on the enrollment, followed by assessments head circumference measured (birth, 72
reduction in risk associated with during pregnancy (every other week hours, 1, 2, 3, and 6 months of age), and
adherence to recommended preventive until 32 weeks gestation and monthly enhanced hearing/vision tests at 1 and
measures and risk factors for infection thereafter), and at or within 72 hours of 6 months old. For mothers and their
in pregnant women. delivery. At all visits, participants will infants, relevant information collected
2. Identify characteristics associated complete visit-specific questionnaires. as part of clinical care will be abstracted
with taking preventive measures In addition to the questionnaires, at all from medical records. Study results will
(mosquito bite prevention, sexual pregnancy and delivery visits, be used to guide recommendations
transmission) against contracting Zika participants will receive Colombian made by both INS and CDC to prevent
virus among pregnant women and their national recommended clinical care and ZIKV infection; to improve counseling
partners. The results of this analysis provide samples for laboratory testing. of patients about risks to themselves,
will assist in targeting education or Male partners will be recruited their pregnancies, their partners, and
intervention to individuals at greatest around the time of the pregnant their infants; and to help agencies
risk for Zika infection. partners’ study enrollment, followed by prepare to provide services to affected
3. Describe symptoms associated with monthly visits until his pregnant children and families. Participation in
ZIKV and estimate the positive partner reaches the third trimester this study is voluntary. The total
predictive value of certain symptoms or (approximately 27 weeks gestation). If estimated annualized burden hours are
constellations of symptoms in pregnant the male partner contracts ZIKV during 19,415, and there are no costs to
women, men, and infants to allow for this time, visits will occur every other participants other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average
Number of responses burden per
Respondents Form name respondents per response
respondent (in hours)
Pregnant women ............................................. Pregnant women eligibility questionnaire ...... 3,125 1 5/60
Pregnant women enrollment questionnaire ... 2,500 1 35/60
Adult symptom questionnaire ......................... 2,500 15 10/60
Pregnant women follow-up questionnaire ...... 2,500 8 15/60
Infant symptoms questionnaire ...................... 2,250 14 10/60
Male partners .................................................. Male partner eligibility questionnaire ............. 2,500 1 5/60
Male enrollment questionnaire ....................... 625 1 25/60
Adult symptom questionnaire ......................... 625 7 10/60
Leroy A. Richardson, DEPARTMENT OF HEALTH AND as amended. The grant applications/
Chief, Information Collection Review Office, HUMAN SERVICES contract proposals and the discussions
Office of Scientific Integrity, Office of the could disclose confidential trade secrets
Associate Director for Science, Office of the National Institutes of Health or commercial property such as
Director, Centers for Disease Control and patentable material, and personal
Prevention. National Cancer Institute; Notice of information concerning individuals
[FR Doc. 2017–07879 Filed 4–18–17; 8:45 am] Closed Meetings associated with the grant applications/
BILLING CODE 4163–18–P Pursuant to section 10(d) of the contract proposals, the disclosure of
jstallworth on DSK7TPTVN1PROD with NOTICES
Federal Advisory Committee Act, as which would constitute a clearly
amended (5 U.S.C. App.), notice is unwarranted invasion of personal
hereby given of the following meetings. privacy.
The meetings will be closed to the Name of Committee: National Cancer
public in accordance with the Institute Special Emphasis Panel; HPV
provisions set forth in sections Review.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Date: May 10, 2017.
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Document Created: 2018-11-14 09:44:02
Document Modified: 2018-11-14 09:44:02
| 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 | 82 FR 18464 |
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