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

Forms and Documents

Document Name	Status
Parent-Child Follow-Up Questionnaire Form	Modified
Parent-Child Enrollment Questionnaire Form and Instruction	Modified
Parent-Child Eligibility Questionnaire Form	Modified
Test of Nonverbal Intelligence Form	Unchanged
Center for Epidemiologic Studies Depression Scale Form	Unchanged
Parenting Stress Index IV Form	Unchanged
Peabody Developmental Motor Scales Form	Unchanged
Strengths and Difficulties Questionnaire Form	Unchanged
Pregnant Women - Ages and Stages: 12 and 24 Month Questionnaire Form and Instruction	Unchanged
Pregnant Women - Ages and Stages 2 and 24 Month Questionnaire Form and Instruction	Unchanged
Male Partners - Adult Symptoms Questionnaire Form and Instruction	Unchanged
Male Partners - Male Enrollment Questionnaire Form and Instruction	Unchanged
Male Partners - Male Partner Eligibility Questionnaire Form and Instruction	Unchanged
Pregnant Women - Infant Symptoms Questionnaire Form	Unchanged
Pregnant Women - Pregnant Women Follow-Up Questionnaire Form and Instruction	Unchanged
Pregnant Women - Adult Symptoms Questionnaire Form and Instruction	Unchanged
Pregnant Women - Pregnant Women Enrollment Questionnaire Form and Instruction	Unchanged
Pregnant Women - Pregnant Women Eligibility Questionnaire Form and Instruction	Unchanged
0920-1190_Change_Request_Justification_23MAR2018.docx Justification for No Material/Nonsubstantive Change	2018-03-26
Att D5_Parent_and_Child_Permission_Form_19JAN2018_clean.docx Supplementary Document	2018-03-26
6921 Amendment #7 approval.docx Supplementary Document	2017-11-29
60d FRN 2017-18405.pdf Supplementary Document	2017-11-29
0920-1190_Change_Request_Justification_092717 JZ.docx Justification for No Material/Nonsubstantive Change	2017-10-04
0920-1190_Change_Request_Justification_090617_submit.docx Justification for No Material/Nonsubstantive Change	2017-09-08
0920-17ABB_Change_Request_Justification_06JUL17.docx Justification for No Material/Nonsubstantive Change	2017-07-18
OMB_Part A_ZEN_full_15MAR2018_clean.docx Supporting Statement A	2018-03-26
OMB_Part B_ZEN_full_15MAR2018_clean.docx Supporting Statement B	2018-03-26
ATT_E3_6921 Vysnova relying on CDC.PDF Supplementary Document	2017-03-29
ATT_E2_INS_ethics_approval_ZEN_English_12122016.docx Supplementary Document	2017-03-29
Att_E1_6921_IRB_Amendment #3 approval.docx Supplementary Document	2017-03-29
ATT_D3_Infant Permission Form 030117_CLEAN.docx Supplementary Document	2017-03-29
ATT_D2_Male Participant Informed Consent 022217_CLEAN.docx Supplementary Document	2017-03-29
ATT_D1_Pregnant Woman Informed Consent 03012017_CLEAN.docx Supplementary Document	2017-03-29
Att_F2_FTE Nondisclosure.DOCX Supplementary Document	2017-03-29
Att_F3_Agreement to abide by restrictions.docx Supplementary Document	2017-03-29
Att_F1_Assurance of Confidentiality Zika Surveillance Final.doc Supplementary Document	2017-03-29
Att_A_Section 301 of Public Health Service Act (42 U.S.C. 241).docx Supplementary Document	2017-03-28

IC Document Collections

IC ID	Document Title	Status
229193	Parent-Child Follow-Up Questionnaire Form	Modified
229192	Parent-Child Enrollment Questionnaire Form and Instruction	Modified
229191	Parent-Child Eligibility Questionnaire Form	Modified
229189	Test of Nonverbal Intelligence Form	Unchanged
229188	Center for Epidemiologic Studies Depression Scale Form	Unchanged
229187	Parenting Stress Index IV Form	Unchanged
229186	Peabody Developmental Motor Scales Form	Unchanged
229184	Strengths and Difficulties Questionnaire Form	Unchanged
229183	Bayley Scales of Infant and Toddler Development Instruction	Modified
229181	Pregnant Women - Ages and Stages: 12 and 24 Month Questionnaire Form and Instruction	Unchanged
226997	Pregnant Women - Ages and Stages 2 and 24 Month Questionnaire Form and Instruction	Unchanged
226478	Male Partners - Adult Symptoms Questionnaire Form and Instruction	Unchanged
226477	Male Partners - Male Enrollment Questionnaire Form and Instruction	Unchanged
226476	Male Partners - Male Partner Eligibility Questionnaire Form and Instruction	Unchanged
226475	Pregnant Women - Infant Symptoms Questionnaire Form	Unchanged
226474	Pregnant Women - Pregnant Women Follow-Up Questionnaire Form and Instruction	Unchanged
226473	Pregnant Women - Adult Symptoms Questionnaire Form and Instruction	Unchanged
226472	Pregnant Women - Pregnant Women Enrollment Questionnaire Form and Instruction	Unchanged
226464	Pregnant Women - Pregnant Women Eligibility Questionnaire Form and Instruction	Unchanged

ICR Details

OMB Control No: 0920-1190	ICR Reference No: 201803-0920-014
Status: Active	Previous ICR Reference No: 201710-0920-013
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1190-18PV
Title: ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/05/2018
	Date Received in OIRA: 03/27/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2021	02/28/2021	02/28/2021
Responses	73,250	0	71,450
Time Burden (Hours)	14,736	0	14,211
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: U.S. PHSA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 41265	08/30/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 56028	11/27/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 19

IC Title	Form No.	Form Name
Male Partners - Male Enrollment Questionnaire	NA, NA	ZEN Columbia: Male Partner Enrollment Questionnaire - Spanish 08SEP2017 ,   ZEN Columbia - Male Partner Enrollment Questionnaire - English 26MAY2017
Pregnant Women - Ages and Stages 2 and 24 Month Questionnaire	NA, NA, NA, NA	Ages and Stages Questionnaire - 24 month English ,   Ages and Stages Questionnaire - 24 month Spanish ,   Ages and Stages Questionnaire - 2 month English ,   Ages and Stages Questionnaire - 2 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	none, none	Parent Child Follow-up Eligibility Form ,   Parent Child Follow-up Eligibility Form - Spanish
Parent-Child Enrollment Questionnaire	none, none	Parent Child Enrollment Questionnaire ,   Parent Child Enrollment Questionnaire - Spanish
Parent-Child Follow-Up Questionnaire	none, none	Parent Child Followup Questionnaire ,   Parent Child Followup 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
Peabody Developmental Motor Scales	NA	Standardized Infant Assessments
Pregnant Women - Pregnant Women Enrollment Questionnaire	NA, NA	ZEN Columbia: Pregnant Women Enrollment Questionnaire - Spanish 08SEP2017 ,   ZEN Columbia - Pregnant Woman Enrollment Questionnaire - English 26MAY2017
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 Columbia: Infant Symptoms - Spanish 08SEP2017 ,   ZEN Colombia: Infant Symptoms - English
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

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ICR Summary of Burden

	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	73,250	71,450	0	1,800	0	0
Annual Time Burden (Hours)	14,736	14,211	0	525	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Minor changes are requested for the inclusion/exclusion criteria and some of the forms to clarify responses. Minor changes in burden resulted from these edits.

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Annual Cost to Federal Government: $4,105,479

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 03/27/2018

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