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

Forms and Documents

Document Name	Status
Adult Symptom Questionnaire Form	New
Male Partner Enrollment Questionnaire Form	New
Male Partner Eligibility Questionnaire Form	New
Infant Symptoms Questionnaire Form	New
Pregnant Women Follow-Up Questionnaire Form	New
Adult Symptom Questionnaire Form	New
Pregnant Women Enrollment Questionnaire Form	New
Pregnant Women Eligibility Questionnaire Form	New
60Day_FRN_ZEN.docx Supplementary Document	2016-11-01
ZEN Colombia - Signed OMB memo.pdf Supplementary Document	2016-10-27
Att_B9_Male Participant Informed Consent 09222016.docx Supplementary Document	2016-10-26
Att_B7_Pregnant Woman Informed Consent 09222016.docx Supplementary Document	2016-10-26
OMB_Part B_ZEN_09262016.docx Supporting Statement B	2016-10-26
OMB_PartA_ZEN_10272016.docx Supporting Statement A	2016-11-01
Att_D_Assurance of Confidentiality Zika Surveillance Final.doc Supplementary Document	2016-10-11
Att_C_6921 New Site Restricted Approval.docx Supplementary Document	2016-10-11
Att_A_Section 301 of Public Health Service Act (42 U.S.C. 241).docx Supplementary Document	2016-10-11

IC Document Collections

IC ID	Document Title	Status
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

OMB Control No: 0920-1142	ICR Reference No: 201610-0920-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-16BGA
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: Emergency	Approval Requested By: 10/28/2016
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/01/2016
	Date Received in OIRA: 10/27/2016
Terms of Clearance: 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
Expiration Date	05/31/2017	6 Months From Approved
Responses	170,500	0	0
Time Burden (Hours)	25,668	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

Emergency Justfication: 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.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Pregnant Women Eligibility Questionnaire	NA	Pregnant Woman Eligibility Screening Form
Adult Symptom Questionnaire	NA	Adult Symptoms Questionnaire
Male Partner Eligibility Questionnaire	NA	Male Partner Eligibility Form
Adult Symptom Questionnaire	NA	Adult Symptoms Questionnaire
Male Partner Enrollment Questionnaire	NA	Male Enrollment Questionnaire
Pregnant Women Enrollment Questionnaire	NA	Pregnant Woman Enrollment Questionnaire
Pregnant Women Follow-Up Questionnaire	NA	Maternal Follow-Up Questionnaire
Infant Symptoms Questionnaire	NA	Infant Symptoms Questionnaire

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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	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

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 is a New Emergency ICR related to the Zika Virus response.

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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: 10/27/2016

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