US Zika Pregnancy Registry

OMB Control No: 0920-1143	ICR Reference No: 201710-0920-014
Status: Historical Active	Previous ICR Reference No: 201703-0920-001
Agency/Subagency: HHS/CDC	Agency Tracking No: 18DL
Title: US Zika Pregnancy Registry
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: 11/02/2017
Retrieve Notice of Action (NOA)	Date Received in OIRA: 10/31/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2019	11/30/2019	11/30/2019
Responses	43,950	0	77,000
Time Burden (Hours)	13,596	0	23,833
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. This Non-Substantive Change is being made to continue information collection from exposed children through 2 years of age to monitor health outcomes and infant test results from child heath visits. There is a decrease in Burden to Respondents based on experience to date and to reflect estimates from October 2017 onward.

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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 - 2 year 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	43,950	77,000	0	-33,050	0	0
Annual Time Burden (Hours)	13,596	23,833	0	-10,237	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Submission of this Non-Substantive Change is being made to continue information collection from exposed children through 2 years of age. There is a decrease in Burden to Respondents based on experience to date and to reflect estimates from October 2017 onward.

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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

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: 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: 10/31/2017

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