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

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
Retrieve Notice of Action (NOA)	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

Agency Contact: Shari Steinberg 404 639-4942 [email protected]

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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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