US Zika Pregnancy Registry

Forms and Documents

Document Name	Status
Infant Health Follow-Up Form Form and Instruction	New
Neonate Assessment at Delivery Form Form and Instruction	New
Laboratory Results Form Form and Instruction	New
Supplemental Maternal Prenatal Imaging and Diagnostics Form Form and Instruction	New
Maternal Health History Form Form and Instruction	New
SSB - Zika Pregnancy Registry_03NOV2016.docx Supporting Statement B	2016-11-03
SSA - Zika Pregnancy Registry_03NOV2016.docx Supporting Statement A	2016-11-03
Att 11 USZPR ICR Nonresearch Determination.pdf Supplementary Document	2016-07-15
Att 10 USZPR ICR Assurance of Confidentialty.pdf Supplementary Document	2016-07-15
Att 9b USZPR ICR Developmental Milestones for Infant.docx Supplementary Document	2016-07-15
Att 7c USZPR_Health Dept Fact Sheet.pdf Supplementary Document	2016-07-15
Att 7b USZPR ICR_Pedatric Provider Fact Sheet.pdf Supplementary Document	2016-07-15
Att 7a USZPR ICR_Obstetric Provider Fact Sheet.pdf Supplementary Document	2016-07-15
Att 6 USZPR ICR _Provider Overview Letter.docx Supplementary Document	2016-07-15
Att. 2b -- Public Comment.pdf Supplementary Document	2016-07-15
Att. 2a -- 60-day FRN.pdf Supplementary Document	2016-07-15
Att 5b USZPR ICR_Fact sheet for parents.pdf Supplementary Document	2016-07-13
Att 5a USZPR ICR_Fact Sheet for Pregnant Women.pdf Supplementary Document	2016-07-13
Att 3 USZPR ICR_CSTE Interim Case Definition 2_26_16.pdf Supplementary Document	2016-07-13
Att 1 USZPR ICR_Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2016-07-13

IC Document Collections

IC ID	Document Title	Status
222498	Infant Health Follow-Up Form Form and Instruction	New
222497	Neonate Assessment at Delivery Form Form and Instruction	New
222496	Laboratory Results Form Form and Instruction	New
222495	Supplemental Maternal Prenatal Imaging and Diagnostics Form Form and Instruction	New
222494	Maternal Health History Form Form and Instruction	New

ICR Details

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
	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

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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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