ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia

OMB 0920-1190

Multiple projects have been jointly developed between INS and CDC, including enhanced surveillance of pregnant women with symptomatic Zika virus disease. CDC seeks to implement a prospective cohort study in which we will follow women enrolled in the first trimester of pregnancy, their male partners, and their children in several cities in Colombia in which ZIKV transmission is currently ongoing. This is a continuation study to collect data on the OMB-approved Emergency Clearance package 0920-1142, and the Standard ICR 0920-1190. This request for non-substantive change modifies some inclusion/exclusion criteria, a few questions, and permission for video recording.

The latest form for ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia expires 2021-02-28 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Parent-Child Follow-Up Questionnaire Form
Parent-Child Enrollment Questionnaire Form and Instruction
Parent-Child Eligibility Questionnaire Form
Test of Nonverbal Intelligence Form
Center for Epidemiologic Studies Depression Scale Form
Parenting Stress Index IV Form
Peabody Developmental Motor Scales Form
Strengths and Difficulties Questionnaire Form
Pregnant Women - Ages and Stages: 12 and 24 Month Questionnaire Form and Instruction
Pregnant Women - Ages and Stages 2 and 24 Month Questionnaire Form and Instruction
Male Partners - Adult Symptoms Questionnaire Form and Instruction
Male Partners - Male Enrollment Questionnaire Form and Instruction
Male Partners - Male Partner Eligibility Questionnaire Form and Instruction
Pregnant Women - Infant Symptoms Questionnaire Form
Pregnant Women - Pregnant Women Follow-Up Questionnaire Form and Instruction
Pregnant Women - Adult Symptoms Questionnaire Form and Instruction
Pregnant Women - Pregnant Women Enrollment Questionnaire Form and Instruction
Pregnant Women - Pregnant Women Eligibility Questionnaire Form and Instruction
0920-1190_Change_Request_Justification_23MAR2018.docx Justification for No Material/Nonsubstantive Change
Att D5_Parent_and_Child_Permission_Form_19JAN2018_clean.docx Supplementary Document
6921 Amendment #7 approval.docx Supplementary Document
60d FRN 2017-18405.pdf Supplementary Document
0920-1190_Change_Request_Justification_092717 JZ.docx Justification for No Material/Nonsubstantive Change
0920-1190_Change_Request_Justification_090617_submit.docx Justification for No Material/Nonsubstantive Change
0920-17ABB_Change_Request_Justification_06JUL17.docx Justification for No Material/Nonsubstantive Change
OMB_Part A_ZEN_full_15MAR2018_clean.docx Supporting Statement A
OMB_Part B_ZEN_full_15MAR2018_clean.docx Supporting Statement B
ATT_E3_6921 Vysnova relying on CDC.PDF Supplementary Document
ATT_E2_INS_ethics_approval_ZEN_English_12122016.docx Supplementary Document
Att_E1_6921_IRB_Amendment #3 approval.docx Supplementary Document
ATT_D3_Infant Permission Form 030117_CLEAN.docx Supplementary Document
ATT_D2_Male Participant Informed Consent 022217_CLEAN.docx Supplementary Document
ATT_D1_Pregnant Woman Informed Consent 03012017_CLEAN.docx Supplementary Document
Att_F2_FTE Nondisclosure.DOCX Supplementary Document
Att_F3_Agreement to abide by restrictions.docx Supplementary Document
Att_F1_Assurance of Confidentiality Zika Surveillance Final.doc Supplementary Document
Att_A_Section 301 of Public Health Service Act (42 U.S.C. 241).docx Supplementary Document
Parent-Child Follow-Up Questionnaire Form
Parent-Child Enrollment Questionnaire Form and Instruction
Parent-Child Eligibility Questionnaire Form
Test of Nonverbal Intelligence Form
Center for Epidemiologic Studies Depression Scale Form
Parenting Stress Index IV Form
Peabody Developmental Motor Scales Form
Strengths and Difficulties Questionnaire Form
Bayley Scales of Infant and Toddler Development Instruction
Pregnant Women - Ages and Stages: 12 and 24 Month Questionnaire Form and Instruction
Pregnant Women - Ages and Stages 2 and 24 Month Questionnaire Form and Instruction
Male Partners - Adult Symptoms Questionnaire Form and Instruction
Male Partners - Male Enrollment Questionnaire Form and Instruction
Male Partners - Male Partner Eligibility Questionnaire Form and Instruction
Pregnant Women - Infant Symptoms Questionnaire Form
Pregnant Women - Pregnant Women Follow-Up Questionnaire Form and Instruction
Pregnant Women - Adult Symptoms Questionnaire Form and Instruction
Pregnant Women - Pregnant Women Enrollment Questionnaire Form and Instruction
Pregnant Women - Pregnant Women Eligibility Questionnaire Form and Instruction

All Historical Document Collections

201803-0920-014 Approved without change	No material or nonsubstantive change to a currently approved collection	2018-03-27
201710-0920-013 Approved without change	Revision of a currently approved collection	2017-11-30
201710-0920-001 Approved without change	No material or nonsubstantive change to a currently approved collection	2017-10-05
201709-0920-001 Approved without change	No material or nonsubstantive change to a currently approved collection	2017-09-08
201707-0920-008 Approved without change	No material or nonsubstantive change to a currently approved collection	2017-07-19
201703-0920-014 Approved with change	New collection (Request for a new OMB Control Number)	2017-04-20

OMB Details

Pregnant Women - Pregnant Women Eligibility Questionnaire

Federal Enterprise Architecture: Health - Public Health Monitoring

Form NA	ZEN Columbia: Pregnant Women Eligibility - Spanish 08SEP2017	NA	Form and instruction
Form NA	ZEN Columbia: Pregnant Women Eligibility - English 08SEP2017	NA	Form and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.