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

ICR 201710-0920-001

OMB: 0920-1190

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form
Unchanged
Form and Instruction
Unchanged
Form and Instruction
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Form and Instruction
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Form and Instruction
Unchanged
Justification for No Material/Nonsubstantive Change
2017-10-04
Justification for No Material/Nonsubstantive Change
2017-09-08
Justification for No Material/Nonsubstantive Change
2017-07-18
Supporting Statement A
2017-10-04
Supporting Statement B
2017-06-12
Supplementary Document
2017-03-29
Supplementary Document
2017-03-29
Supplementary Document
2017-03-29
Supplementary Document
2017-03-29
Supplementary Document
2017-03-29
Supplementary Document
2017-03-29
Supplementary Document
2017-03-29
Supplementary Document
2017-03-29
Supplementary Document
2017-03-29
Supplementary Document
2017-03-28
Supplementary Document
2017-03-28
ICR Details
0920-1190 201710-0920-001
Historical Active 201709-0920-001
HHS/CDC 0920-1190-18AB
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 10/05/2017
Retrieve Notice of Action (NOA) 10/05/2017
  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

CDC is requesting a Non-Substantive Change to the OMB approved collection 0920-1190 ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia to add a 4 month Ages and Stages Questionnaire. This questionnaire would be in lieu of the 6 month Ages and Stages Questionnaire for infants born premature as they would not be able to meet the milestones indicated in the 6 month questionnaire. Therefore, there is no change to the estimated burden per response.

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 - Pregnant Women Eligibility Questionnaire NA, NA ZEN Columbia: Pregnant Women Eligibility - English 08SEP2017 ,   ZEN Columbia: Pregnant Women Eligibility - Spanish 08SEP2017
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 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 - Ages and Stages 2 Month Questionnaire NA, NA Ages and Stages Questionnaire - 2 month English ,   Ages and Stages Questionnaire - 2 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
    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.
10/05/2017


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