US Zika Pregnancy Registry

Forms and Documents

Document Name	Status
Infant Health Follow-Up Form Form and Instruction	Modified
Neonate Assessment at Delivery Form Form and Instruction	Modified
Laboratory Results Form Form and Instruction	Modified
Supplemental Maternal Prenatal Imaging and Diagnostics Form Form and Instruction	Modified
Maternal Health History Form Form and Instruction	Modified
ATT_2_Updated_NRD_Email.pdf Supplementary Document	2017-10-25
0920-1143 Non-sub Change Request_10242017.docx Justification for No Material/Nonsubstantive Change	2017-10-25
Change Request_Provider Letters and Fact Sheets.docx Justification for No Material/Nonsubstantive Change	2017-03-01
Att 7c Fact Sheet for Health Departments.pdf Supplementary Document	2017-03-01
Att 7b Fact Sheet for Pediatric Provider.pdf Supplementary Document	2017-03-01
Att 7a Fact Sheet for Obstetic Provider.pdf Supplementary Document	2017-03-01
Att 6b Provider Overview Letter - Pedatric Provider.pdf Supplementary Document	2017-03-01
Att 6a Provider Overview Letter - Obstetric Provider.pdf Supplementary Document	2017-03-01
Att 5b Fact Sheet for Parents.pdf Supplementary Document	2017-03-01
Att 5a Fact Sheet for Pregnant Women.pdf Supplementary Document	2017-03-01
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. 2b -- Public Comment.pdf Supplementary Document	2016-07-15
Att. 2a -- 60-day FRN.pdf Supplementary Document	2016-07-15
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	Modified
222497	Neonate Assessment at Delivery Form Form and Instruction	Modified
222496	Laboratory Results Form Form and Instruction	Modified
222495	Supplemental Maternal Prenatal Imaging and Diagnostics Form Form and Instruction	Modified
222494	Maternal Health History Form Form and Instruction	Modified

ICR Details

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
	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

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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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