82 FR 226 pgs. 56028-56030 - Agency Forms Undergoing Paperwork Reduction Act Review
Type: NOTICEVolume: 82Number: 226Pages: 56028 - 56030
Pages: 56028, 56029, 56030Docket number: [30Day-18-1190]
FR document: [FR Doc. 2017-25495 Filed 11-24-17; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Disease Control and Prevention
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-18-1190]
Agency Forms Undergoing Paperwork Reduction Act Review
[top] In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia to the Office of Management and Budget (OMB) for review and approval. CDC previously published a "Proposed Data Collection Submitted for Public Comment and Recommendations" notice on August 30, 2017 to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(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, 725 17th Street NW., Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.
Proposed Project
ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia (OMB Control Number 0920-1190, expires 07/31/2019)-Revision-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. Health officials observed sporadic evidence of human ZIKV infection 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, health officials have found evidence of ZIKV 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 December 2016, Colombia has reported over 106,000-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 to prevent ZIKV transmission; 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 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, 4,500 newborns, and a subset of 900 infants/children. 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.
Researchers will recruit male partners 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.
Researchers will follow all newborns of mothers participating in the study every other week from birth to 6 months of age. At all visits, infants will receive national recommended clinical care (at birth and follow-up visits at 1, 2, 3, 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 and as part of clinical care, researchers will abstract relevant information from medical records.
[top] The revised information collection package includes the following changes.
CDC will use study results 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 and there are no costs to participants other than their time.
The total burden hours are 14,210.
| Type of respondents | Form name | Number of respondents | Number of responses per respondent | Average burden per response (in hours) |
|---|---|---|---|---|
| Pregnant Women | Pregnant Women Eligibility Questionnaire | 600 | 1 | 5/60 |
| Pregnant Women Enrollment Questionnaire | 500 | 1 | 35/60 | |
| Adult Symptoms Questionnaire | 500 | 15 | 10/60 | |
| Pregnant Women Follow-up Questionnaire | 500 | 8 | 15/60 | |
| Infant Symptoms Questionnaire | 2,250 | 14 | 10/60 | |
| Parent-Child Eligibility Questionnaire | 1,000 | 1 | 5/60 | |
| Parent-Child Enrollment Questionnaire | 900 | 1 | 20/60 | |
| Parent-Child Follow-up Questionnaire | 900 | 4 | 15/60 | |
| Ages and Stages Questionnaire: 2 and 6 Month Visits | 2,250 | 2 | 15/60 | |
| Ages and Stages Questionnaire: 12 and 24 Month Visits | 900 | 2 | 15/60 | |
| Bayley Scales of Infant and Toddler Development | 900 | 3 | 30/60 | |
| Strengths and Difficulties Questionnaire | 900 | 1 | 5/60 | |
| Peabody Developmental Motor Scales | 900 | 1 | 30/60 | |
| Parenting Stress Index IV | 900 | 5 | 10/60 | |
| Center for Epidemiologic Studies Depression Scale | 900 | 5 | 5/60 | |
| Test of Nonverbal Intelligence | 900 | 1 | 20/60 | |
| Male partners | Male Partner Eligibility Questionnaire | 150 | 1 | 5/60 |
| Male Enrollment Questionnaire | 125 | 1 | 25/60 | |
| Adult Symptoms Questionnaire | 125 | 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. 2017-25495 Filed 11-24-17; 8:45 am]
BILLING CODE 4163-18-P