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

Forms and Documents

Document Name	Status
Parent-Child Follow-Up Questionnaire Form and Instruction	New
Parent-Child Enrollment Questionnaire Form and Instruction	New
Parent-Child Eligibility Questionnaire Form and Instruction	New
Test of Nonverbal Intelligence Form	New
Center for Epidemiologic Studies Depression Scale Form	New
Parenting Stress Index IV Form	New
Peabody Developmental Motor Scales Form	New
Strengths and Difficulties Questionnaire Form	New
Bayley Scales of Infant and Toddler Development Form	New
Pregnant Women - Ages and Stages: 12 and 24 Month Questionnaire Form and Instruction	New
Pregnant Women - Ages and Stages 6 Month Questionnaire Form and Instruction	Removed
Pregnant Women - Ages and Stages 2 and 24 Month Questionnaire Form and Instruction	Modified
Male Partners - Adult Symptoms Questionnaire Form and Instruction	Modified
Male Partners - Male Enrollment Questionnaire Form and Instruction	Modified
Male Partners - Male Partner Eligibility Questionnaire Form and Instruction	Modified
Pregnant Women - Infant Symptoms Questionnaire Form	Unchanged
Pregnant Women - Pregnant Women Follow-Up Questionnaire Form and Instruction	Modified
Pregnant Women - Adult Symptoms Questionnaire Form and Instruction	Modified
Pregnant Women - Pregnant Women Enrollment Questionnaire Form and Instruction	Modified
Pregnant Women - Pregnant Women Eligibility Questionnaire Form and Instruction	Modified
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_14NOV2017.docx Supporting Statement A	2017-11-29
OMB_Part B_ZEN_full_14NOV2017.DOCX Supporting Statement B	2017-11-29
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 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

OMB Control No: 0920-1190	ICR Reference No: 201710-0920-013
Status: Historical Active	Previous ICR Reference No: 201710-0920-001
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1190
Title: ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/02/2018
	Date Received in OIRA: 11/30/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2021	36 Months From Approved	07/31/2019
Responses	71,450	0	106,625
Time Burden (Hours)	14,211	0	20,541
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, 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.

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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
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

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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	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

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: 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

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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: 11/30/2017

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