OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 201707-0920-008 · OMB 0920-1190 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Pregnant Women - Ages and Stages 6 Month Questionnaire Form and Instruction Unchanged Available
Pregnant Women - Ages and Stages 2 Month Questionnaire Form and Instruction Unchanged Repair queued
Male Partners - Adult Symptoms Questionnaire Form and Instruction Modified Repair queued
Male Partners - Male Enrollment Questionnaire Form and Instruction Unchanged Repair queued
Male Partners - Male Partner Eligibility Questionnaire Form and Instruction Modified Repair queued
Pregnant Women - Infant Symptoms Questionnaire Form Modified Available
Pregnant Women - Pregnant Women Follow-Up Questionnaire Form Modified Available
Pregnant Women - Adult Symptoms Questionnaire Form Modified Repair queued
Pregnant Women - Pregnant Women Enrollment Questionnaire Form Modified Available
Pregnant Women - Pregnant Women Eligibility Questionnaire Form and Instruction Modified Available
0920-17ABB_Change_Request_Justification_06JUL17.docx Justification for No Material/Nonsubstantive Change Uploaded 2017-07-18 Available
SSA Part A 09JUN2017.docx Supporting Statement A Uploaded 2017-06-12 Available
SSB Part B 09JUN2017.docx Supporting Statement B Uploaded 2017-06-12 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 Repair queued
ATT_D3_Infant Permission Form 030117_CLEAN.docx Supplementary Document Uploaded 2017-03-29 Repair queued
ATT_D2_Male Participant Informed Consent 022217_CLEAN.docx Supplementary Document Uploaded 2017-03-29 Repair queued
ATT_D1_Pregnant Woman Informed Consent 03012017_CLEAN.docx Supplementary Document Uploaded 2017-03-29 Repair queued
Att_F2_FTE Nondisclosure.DOCX Supplementary Document Uploaded 2017-03-29 Available
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
2016-27691 (002)_60Day FRN.pdf Supplementary Document Uploaded 2017-03-28 Available
Att_A_Section 301 of Public Health Service Act (42 U.S.C. 241).docx Supplementary Document Uploaded 2017-03-28 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
226998 Pregnant Women - Ages and Stages 6 Month Questionnaire Form and Instruction Unchanged
226997 Pregnant Women - Ages and Stages 2 Month Questionnaire Form and Instruction Unchanged
226478 Male Partners - Adult Symptoms Questionnaire Form and Instruction Modified
226477 Male Partners - Male Enrollment Questionnaire Form and Instruction Unchanged
226476 Male Partners - Male Partner Eligibility Questionnaire Form and Instruction Modified
226475 Pregnant Women - Infant Symptoms Questionnaire Form Modified
226474 Pregnant Women - Pregnant Women Follow-Up Questionnaire Form Modified
226473 Pregnant Women - Adult Symptoms Questionnaire Form Modified
226472 Pregnant Women - Pregnant Women Enrollment Questionnaire Form Modified
226464 Pregnant Women - Pregnant Women Eligibility Questionnaire Form and Instruction Modified
ICR Details
0920-1190 201707-0920-008
Historical Active 201703-0920-014
HHS/CDC 17AWY
ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 07/25/2017
Retrieve Notice of Action (NOA) 07/19/2017
  Inventory as of this Action Requested Previously Approved
07/31/2019 07/31/2019 07/31/2019
106,625 0 106,625
20,541 0 20,541
0 0 0
Minor changes in wording and translation are requested. The goal of the ZEN Colombia study is to better understand modifiable factors affecting the acquisition of Zika infection among pregnant women in Colombia, and the link between Zika infection during pregnancy and adverse outcomes. This is a continuation study to collect data on the OMB-approved Emergency Clearance package 0920-1142.
US Code: 42 USC 241 Name of Law: U.S. PHSA
  
None
Not associated with rulemaking
  81 FR 81144 11/17/2016
82 FR 26930 06/12/2017
Yes
10
IC Title Form No. Form Name
Pregnant Women - Ages and Stages 2 Month Questionnaire NA, NA Ages and Stages Questionnaire - 2 month English ,   Ages and Stages Questionnaire - 2 month Spanish
Pregnant Women - Pregnant Women Eligibility Questionnaire none, NA ZEN Colombia: Pregnant Woman Eligibility - Spanish 18Jul2017 ,   ZEN Colombia: Pregnant Woman Eligibility - English 26MAY2017
Pregnant Women - Pregnant Women Enrollment Questionnaire NA, none ZEN Colombia: Enrollment - Spanish ,   ZEN Columbia - Pregnant Woman Enrollment Questionnaire - English 26MAY2017
Pregnant Women - Adult Symptoms Questionnaire none, NA ZEN Colombia: Adult Symptoms - Spanish ,   ZEN Columbia - Adult Symptoms Questionnaire - English
Pregnant Women - Infant Symptoms Questionnaire none, none ZEN Colombia: Infant Symptoms - English ,   ZEN Colombia - Infant Symptoms - Spanish
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 none, NA ZEN Columbia: Follow-up Questionnaire - Spanish ,   ZEN Columbia - Pregnant Woman Follow-Up Questionnaire - English 26MAY2017
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
Pregnant Women - Ages and Stages 6 Month Questionnaire NA, NA Ages and Stages Questionnaire - 6 month English ,   Ages and Stages Questionnaire - 6 month Spanish
  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 106,625 106,625 0 0 0 0
Annual Time Burden (Hours) 20,541 20,541 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$4,105,479
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Shari Steinberg 404 639-4942 [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.
07/19/2017