OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 201610-0920-001 · OMB 0920-1142 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Adult Symptom Questionnaire Form New Available
Male Partner Enrollment Questionnaire Form New Repair queued
Male Partner Eligibility Questionnaire Form New Available
Infant Symptoms Questionnaire Form New Repair queued
Pregnant Women Follow-Up Questionnaire Form New Available
Adult Symptom Questionnaire Form New Available
Pregnant Women Enrollment Questionnaire Form New Available
Pregnant Women Eligibility Questionnaire Form New Available
60Day_FRN_ZEN.docx Supplementary Document Uploaded 2016-11-01 Available
ZEN Colombia - Signed OMB memo.pdf Supplementary Document Uploaded 2016-10-27 Available
Att_B9_Male Participant Informed Consent 09222016.docx Supplementary Document Uploaded 2016-10-26 Available
Att_B7_Pregnant Woman Informed Consent 09222016.docx Supplementary Document Uploaded 2016-10-26 Repair queued
OMB_Part B_ZEN_09262016.docx Supporting Statement B Uploaded 2016-10-26 Available
OMB_PartA_ZEN_10272016.docx Supporting Statement A Uploaded 2016-11-01 Available
Att_D_Assurance of Confidentiality Zika Surveillance Final.doc Supplementary Document Uploaded 2016-10-11 Repair queued
Att_C_6921 New Site Restricted Approval.docx Supplementary Document Uploaded 2016-10-11 Available
Att_A_Section 301 of Public Health Service Act (42 U.S.C. 241).docx Supplementary Document Uploaded 2016-10-11 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
223894 Adult Symptom Questionnaire Form New
223893 Male Partner Enrollment Questionnaire Form New
223892 Male Partner Eligibility Questionnaire Form New
223891 Infant Symptoms Questionnaire Form New
223890 Pregnant Women Follow-Up Questionnaire Form New
223889 Adult Symptom Questionnaire Form New
223888 Pregnant Women Enrollment Questionnaire Form New
223887 Pregnant Women Eligibility Questionnaire Form New
ICR Details
0920-1142 201610-0920-001
Historical Active
HHS/CDC 0920-16BGA
ZEN Colombia Study - Zika in Pregnant Women and Children in Colombia
New collection (Request for a new OMB Control Number)   No
Emergency 10/28/2016
Approved with change 11/01/2016
Retrieve Notice of Action (NOA) 10/27/2016
Approved consistent with the understanding that CDC will submit a complete submission package for a new ICR to OMB for standard review within 3 months.
  Inventory as of this Action Requested Previously Approved
05/31/2017 6 Months From Approved
170,500 0 0
25,668 0 0
0 0 0
The goal of the ZEN Colombia study is to better understand the adverse pregnancy, maternal and infant health outcomes associated with ZIKV infection during pregnancy and/or early infancy. In addition, the ZEN Colombia study will assess the modifiable factors affecting the acquisition of Zika infection among pregnant women in Colombia. The data from the ZEN Colombia study will provide critical information supporting the evidence-based strategies to prevent ZIKV infection in pregnancy; improved counseling of pregnant women and their partners about risks to themselves, their pregnancies, and their children; and effective preparedness for agencies providing services to affected children and families.
Accelerated OMB review is requested because this investigation is a part of an ongoing public health emergency response related to Zika virus in Colombia. Given the high numbers of pregnant women with ZIKV currently affected in Colombia and the need to enroll pregnant women in the first trimester, it is critical, then, that the enrollment into the ZEN Colombia study begins rapidly to ensure that a large number of pregnant women with Zika virus infection in the first trimester can be enrolled and followed up to assess outcomes.
US Code: 42 USC 241 Name of Law: Public Health Service Act
  
None
Not associated with rulemaking
No
  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 170,500 0 0 170,500 0 0
Annual Time Burden (Hours) 25,668 0 0 25,668 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
Submission is a New Emergency ICR related to the Zika Virus response.
$4,105,479
Yes Part B of Supporting Statement
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.
10/27/2016