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

Forms and Documents

Document Name	Status
Pregnant Women - Ages and Stages 6 Month Questionnaire Form and Instruction	New
Pregnant Women - Ages and Stages 2 Month Questionnaire Form and Instruction	New
Male Partners - Adult Symptoms Questionnaire Form and Instruction	New
Male Partners - Male Enrollment Questionnaire Form and Instruction	New
Male Partners - Male Partner Eligibility Questionnaire Form and Instruction	New
Pregnant Women - Infant Symptoms Questionnaire Form and Instruction	New
Pregnant Women - Pregnant Women Follow-Up Questionnaire Form and Instruction	New
Pregnant Women - Adult Symptoms Questionnaire Form and Instruction	New
Pregnant Women - Pregnant Women Enrollment Questionnaire Form and Instruction	New
Pregnant Women - Pregnant Women Eligibility Questionnaire Form and Instruction	New
SSA Part A 09JUN2017.docx Supporting Statement A	2017-06-12
SSB Part B 09JUN2017.docx Supporting Statement B	2017-06-12
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
2016-27691 (002)_60Day FRN.pdf Supplementary Document	2017-03-28
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
226998	Pregnant Women - Ages and Stages 6 Month Questionnaire Form and Instruction	New
226997	Pregnant Women - Ages and Stages 2 Month Questionnaire Form and Instruction	New
226478	Male Partners - Adult Symptoms Questionnaire Form and Instruction	New
226477	Male Partners - Male Enrollment Questionnaire Form and Instruction	New
226476	Male Partners - Male Partner Eligibility Questionnaire Form and Instruction	New
226475	Pregnant Women - Infant Symptoms Questionnaire Form and Instruction	New
226474	Pregnant Women - Pregnant Women Follow-Up Questionnaire Form and Instruction	New
226473	Pregnant Women - Adult Symptoms Questionnaire Form and Instruction	New
226472	Pregnant Women - Pregnant Women Enrollment Questionnaire Form and Instruction	New
226464	Pregnant Women - Pregnant Women Eligibility Questionnaire Form and Instruction	New

ICR Details

OMB Control No: 0920-1190	ICR Reference No: 201703-0920-014
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 17ABB
Title: ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 07/12/2017
	Date Received in OIRA: 04/20/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2019	24 Months From Approved
Responses	106,625	0	0
Time Burden (Hours)	20,541	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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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:
	81 FR 81144	11/17/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 26930	06/12/2017
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Pregnant Women - Pregnant Women Eligibility Questionnaire	NA, NA	ZEN Columbia: Pregnant Woman Eligibility - Spanish ,   ZEN Colombia: Pregnant Woman Eligibility - English 26MAY2017
Pregnant Women - Pregnant Women Enrollment Questionnaire	NA, NA	ZEN Columbia - Pregnant Woman Enrollment Questionnaire - Spanish ,   ZEN Columbia - Pregnant Woman Enrollment Questionnaire - English 26MAY2017
Pregnant Women - Adult Symptoms Questionnaire	NA, NA	ZEN Columbia - Adult Symptoms Questionnaire - Spanish ,   ZEN Columbia - Adult Symptoms Questionnaire - English
Pregnant Women - Infant Symptoms Questionnaire	NA, NA	ZEN Columbia - Infant Symptoms Questionnaire - Spanish
Male Partners - Adult Symptoms Questionnaire	NA, NA	ZEN Columbia - Adult Symptoms Questionnaire - Spanish ,   ZEN Columbia - Adult Symptoms Questionnaire - English
Pregnant Women - Pregnant Women Follow-Up Questionnaire	NA, NA	ZEN Columbia - Pregnant Woman Follow-Up Questionnaire - Spanish ,   ZEN Columbia - Pregnant Woman Follow-Up Questionnaire - English 26MAY2017
Male Partners - Male Partner Eligibility Questionnaire	NA, NA	ZEN Columbia - Male Partner Eligibility - Spanish ,   ZEN Columbia - Male Partner Eligibility - English 26MAY2017
Male Partners - Male Enrollment Questionnaire	NA, NA	ZEN Columbia - Male Partner Enrollment Questionnaire - Spanish ,   ZEN Columbia - Male Partner Enrollment Questionnaire - English 26MAY2017
Pregnant Women - Ages and Stages 6 Month Questionnaire	NA, NA	Ages and Stages Questionnaire - 6 month English ,   Ages and Stages Questionnaire - 6 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

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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	106,625	0	0	106,625	0	0
Annual Time Burden (Hours)	20,541	0	0	20,541	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: No

Burden Reduction Due to:

Short Statement: Submission of 0920-17ABB - ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia is a New ICR.

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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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 04/20/2017

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