US Zika Pregnancy Registry

OMB Control No: 0920-1143	ICR Reference No: 201607-0920-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 16AVB
Title: US Zika Pregnancy Registry
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: 11/04/2016
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/28/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2019	36 Months From Approved
Responses	77,000	0	0
Time Burden (Hours)	23,833	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The goal of this ICR is to monitor the frequency and types of adverse birth outcomes for women infected with Zika virus during pregnancy to strengthen the public health response to the Zika virus disease outbreak. The intended use of the resulting data is to better understand the clinical consequences of Zika virus infection in pregnancy and its impact on newborn infants.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: US 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
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 26231	05/02/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 46677	07/18/2016
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title Form No. Form Name Maternal Health History Form NA Maternal Health History Form Supplemental Maternal Prenatal Imaging and Diagnostics Form NA Supplemental Maternal Prenatal Imaging and Diagnostics Form Laboratory Results Form NA Laboratory Results Form Infant Health Follow-Up Form NA Infant Health Follow-Up Form Neonate Assessment at Delivery Form NA Neonate Assessment at Delivery Form

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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	77,000	0	0	77,000	0	0
Annual Time Burden (Hours)	23,833	0	0	23,833	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: 0920-16AVB is a New ICR submitted to continue collection of information approved previously in an Emergency Clearance.

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Annual Cost to Federal Government: $9,921,335

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

Agency Contact: Jeffrey Zirger 404 639-7118 [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: 07/28/2016

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