OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 201710-0920-013 · OMB 0920-1190 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Parent-Child Follow-Up Questionnaire Form and Instruction New Available
Parent-Child Enrollment Questionnaire Form and Instruction New Available
Parent-Child Eligibility Questionnaire Form and Instruction New Available
Test of Nonverbal Intelligence Form New Available
Center for Epidemiologic Studies Depression Scale Form New Available
Parenting Stress Index IV Form New Available
Peabody Developmental Motor Scales Form New Available
Strengths and Difficulties Questionnaire Form New Available
Bayley Scales of Infant and Toddler Development Form New Available
Pregnant Women - Ages and Stages: 12 and 24 Month Questionnaire Form and Instruction New Available
Pregnant Women - Ages and Stages 6 Month Questionnaire Form and Instruction Removed Repair queued
Pregnant Women - Ages and Stages 2 and 24 Month Questionnaire Form and Instruction Modified Available
Male Partners - Adult Symptoms Questionnaire Form and Instruction Modified Available
Male Partners - Male Enrollment Questionnaire Form and Instruction Modified Available
Male Partners - Male Partner Eligibility Questionnaire Form and Instruction Modified Available
Pregnant Women - Infant Symptoms Questionnaire Form Unchanged Available
Pregnant Women - Pregnant Women Follow-Up Questionnaire Form and Instruction Modified Available
Pregnant Women - Adult Symptoms Questionnaire Form and Instruction Modified Repair queued
Pregnant Women - Pregnant Women Enrollment Questionnaire Form and Instruction Modified Repair queued
Pregnant Women - Pregnant Women Eligibility Questionnaire Form and Instruction Modified Available
6921 Amendment #7 approval.docx Supplementary Document Uploaded 2017-11-29 Repair queued
60d FRN 2017-18405.pdf Supplementary Document Uploaded 2017-11-29 Available
0920-1190_Change_Request_Justification_092717 JZ.docx Justification for No Material/Nonsubstantive Change Uploaded 2017-10-04 Available
0920-1190_Change_Request_Justification_090617_submit.docx Justification for No Material/Nonsubstantive Change Uploaded 2017-09-08 Available
0920-17ABB_Change_Request_Justification_06JUL17.docx Justification for No Material/Nonsubstantive Change Uploaded 2017-07-18 Repair queued
OMB_Part A_ZEN_full_14NOV2017.docx Supporting Statement A Uploaded 2017-11-29 Available
OMB_Part B_ZEN_full_14NOV2017.DOCX Supporting Statement B Uploaded 2017-11-29 Available
ATT_E3_6921 Vysnova relying on CDC.PDF Supplementary Document Uploaded 2017-03-29 Available
ATT_E2_INS_ethics_approval_ZEN_English_12122016.docx Supplementary Document Uploaded 2017-03-29 Available
Att_E1_6921_IRB_Amendment #3 approval.docx Supplementary Document Uploaded 2017-03-29 Available
ATT_D3_Infant Permission Form 030117_CLEAN.docx Supplementary Document Uploaded 2017-03-29 Available
ATT_D2_Male Participant Informed Consent 022217_CLEAN.docx Supplementary Document Uploaded 2017-03-29 Available
ATT_D1_Pregnant Woman Informed Consent 03012017_CLEAN.docx Supplementary Document Uploaded 2017-03-29 Available
Att_F2_FTE Nondisclosure.DOCX Supplementary Document Uploaded 2017-03-29 Repair queued
Att_F3_Agreement to abide by restrictions.docx Supplementary Document Uploaded 2017-03-29 Available
Att_F1_Assurance of Confidentiality Zika Surveillance Final.doc Supplementary Document Uploaded 2017-03-29 Available
Att_A_Section 301 of Public Health Service Act (42 U.S.C. 241).docx Supplementary Document Uploaded 2017-03-28 Available
IC Document Collections
IC IDCollectionTypeStatusForm
229193 Parent-Child Follow-Up Questionnaire Form and Instruction New
229192 Parent-Child Enrollment Questionnaire Form and Instruction New
229191 Parent-Child Eligibility Questionnaire Form and Instruction New
229189 Test of Nonverbal Intelligence Form New
229188 Center for Epidemiologic Studies Depression Scale Form New
229187 Parenting Stress Index IV Form New
229186 Peabody Developmental Motor Scales Form New
229184 Strengths and Difficulties Questionnaire Form New
229183 Bayley Scales of Infant and Toddler Development Form New
229181 Pregnant Women - Ages and Stages: 12 and 24 Month Questionnaire Form and Instruction New
226998 Pregnant Women - Ages and Stages 6 Month Questionnaire Form and Instruction Removed
226997 Pregnant Women - Ages and Stages 2 and 24 Month Questionnaire Form and Instruction Modified
226478 Male Partners - Adult Symptoms Questionnaire Form and Instruction Modified
226477 Male Partners - Male Enrollment Questionnaire Form and Instruction Modified
226476 Male Partners - Male Partner Eligibility Questionnaire Form and Instruction Modified
226475 Pregnant Women - Infant Symptoms Questionnaire Form Unchanged
226474 Pregnant Women - Pregnant Women Follow-Up Questionnaire Form and Instruction Modified
226473 Pregnant Women - Adult Symptoms Questionnaire Form and Instruction Modified
226472 Pregnant Women - Pregnant Women Enrollment Questionnaire Form and Instruction Modified
226464 Pregnant Women - Pregnant Women Eligibility Questionnaire Form and Instruction Modified
ICR Details
0920-1190 201710-0920-013
Historical Active 201710-0920-001
HHS/CDC 0920-1190
ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia
Revision of a currently approved collection   No
Regular
Approved without change 02/02/2018
Retrieve Notice of Action (NOA) 11/30/2017
  Inventory as of this Action Requested Previously Approved
02/28/2021 36 Months From Approved 07/31/2019
71,450 0 106,625
14,211 0 20,541
0 0 0
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, which covered collection of infants out to six months old. This Revision ICR will collect information on infants from 6 months out to two years after birth.
US Code: 42 USC 241 Name of Law: U.S. PHSA
  
None
Not associated with rulemaking
  82 FR 41265 08/30/2017
82 FR 56028 11/27/2017
No
19
IC Title Form No. Form Name
Pregnant Women - Pregnant Women Enrollment Questionnaire NA, NA ZEN Columbia - Pregnant Woman Enrollment Questionnaire - English 26MAY2017 ,   ZEN Columbia: Pregnant Women Enrollment Questionnaire - Spanish 08SEP2017
Pregnant Women - Adult Symptoms Questionnaire none, NA ZEN Columbia - Adult Symptoms Questionnaire - English ,   ZEN Colombia: Adult Symptoms - Spanish
Pregnant Women - Infant Symptoms Questionnaire NA, none ZEN Colombia: Infant Symptoms - English ,   ZEN Columbia: Infant Symptoms - Spanish 08SEP2017
Male Partners - Adult Symptoms Questionnaire NA, none ZEN Columbia - Adult Symptoms Questionnaire - English ,   ZEN Colombia: Adult Symptoms - Spanish
Pregnant Women - Pregnant Women Follow-Up Questionnaire NA, NA ZEN Columbia: Pregnant Women Follow-Up Questionnaire - English 08SEP2017 ,   ZEN Columbia: Pregnant Women Follow-Up Questionnaire - Spanish 08SEP2017
Male Partners - Male Partner Eligibility Questionnaire none, NA ZEN Columbia - Male Partner Eligibility - English 26MAY2017 ,   ZEN Colombia : Male Partner Eligibility - Spanish
Male Partners - Male Enrollment Questionnaire NA, NA ZEN Columbia - Male Partner Enrollment Questionnaire - English 26MAY2017 ,   ZEN Columbia: Male Partner Enrollment Questionnaire - Spanish 08SEP2017
Pregnant Women - Ages and Stages 2 and 24 Month Questionnaire NA, NA, NA, NA Ages and Stages Questionnaire - 2 month English ,   Ages and Stages Questionnaire - 2 month Spanish ,   Ages and Stages Questionnaire - 24 month English ,   Ages and Stages Questionnaire - 24 month Spanish
Pregnant Women - Ages and Stages 6 Month Questionnaire NA, NA, NA, NA Ages and Stages Questionnaire - 6 month English ,   Ages and Stages Questionnaire - 6 month Spanish ,   Ages and Stages Questionnaire - 4 month English ,   Ages and Stages Questionnaire - 4 month Spanish
Pregnant Women - Pregnant Women Eligibility Questionnaire NA, NA ZEN Columbia: Pregnant Women Eligibility - English 08SEP2017 ,   ZEN Columbia: Pregnant Women Eligibility - Spanish 08SEP2017
Pregnant Women - Ages and Stages: 12 and 24 Month Questionnaire NA, NA, NA, NA Ages and Stages Questionnaire - 12 month English ,   Ages and Stages Questionnaire - 12 month Spanish ,   Ages and Stages Questionnaire - 24 month English ,   Ages and Stages Questionnaire - 24 month Spanish
Parenting Stress Index IV NA Standardized Infant Assessments
Center for Epidemiologic Studies Depression Scale NA Center for Epidemiologic Studiesd Depression Scale
Parent-Child Eligibility Questionnaire NA, NA Parent-Child Follow-Up Eligibility Screening Form - English ,   Parent-Child Follow-Up Eligibility Screening Form - Spanish
Parent-Child Enrollment Questionnaire NA, NA Parent-Child Follow-Up Enrollment Form - English ,   Parent-Child Follow-Up Enrollment Form - Spanish
Parent-Child Follow-Up Questionnaire NA, NA Parent-Child Follow-Up Questionnaire - English ,   Parent-Child Follow-Up Questionnaire - Spanish
Strengths and Difficulties Questionnaire NA, NA Strengths and Difficulties Assessment - ENGLISH ,   Strengths and Difficulties Assessment - SPANISH
Test of Nonverbal Intelligence NA Standardized Infant Assessments
Bayley Scales of Infant and Toddler Development NA Standardized Infant Assessments
Peabody Developmental Motor Scales NA Standardized Infant Assessments
  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 71,450 106,625 0 -35,175 0 0
Annual Time Burden (Hours) 14,211 20,541 0 -6,330 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
Submission of this Revision for 0920-1190 ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia reflects 1) decrease in burden hours because of lowering number of remaining respondents to 500 pregnant women and 125 male partners during the pregnancy follow-up, as enrollment is progressing, and 2) increase in burden hours with the addition of data collection to follow 900 children from 6 months to 2 years of age
$4,105,479
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
Uncollected
Jeffrey Zirger 404 639-7118 [email protected]
  No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
11/30/2017