Zika Outcomes and Development of Infants and Children (ZODIAC) Investigation

Forms and Documents

Document Name	Status
Blood Draw Form and Instruction	New
Vision Exam Form and Instruction	New
Neurological Exam - Hammersmith Infant Neurologic Exam / Evaluation of Cerebral Palsy Form and Instruction	New
Physical Health Exam Form and Instruction	New
Growth Exam Form and Instruction	New
Parenting Stress Index - Short Form Form and Instruction	New
Patient Health Questionniare - 9 Form and Instruction	New
Ages and Stages Questionnaire - Social / Emotional Form and Instruction	New
Ages and Stages Questionniare - 3rd Edition Form and Instruction	New
Seizure Screen Form and Instruction	New
Parent Questionnaire Form and Instruction	New
Medical Record Abstraction Form Form and Instruction	New
Recruitment and Participation Log Form	New
SSB - ZODIAC Emergency ICR_submitted 7_14_17.docx Supporting Statement B	2017-07-17
SSA - ZODIAC Emergency ICR_submitted_7-14-17.docx Supporting Statement A	2017-07-17
Emergency Review Request Memo - ZODIAC Investigation_signed 7-14-17.pdf Supplementary Document	2017-07-17
Att. 12 - ZODIAC Non-Research Determination.docx Supplementary Document	2017-07-17
Att. 11 - Public Health Handsouts for Families with Babies with Microcephaly.docx Supplementary Document	2017-07-17
Att. 10 - List of ZODIAC Measures.docx Supplementary Document	2017-07-17
Att. 6 - Consent and Assent Forms.docx Supplementary Document	2017-07-17
Att. 5 - Public Health Handouts.docx Supplementary Document	2017-07-17
Att. 4 - Introductory Script.docx Supplementary Document	2017-07-17
Att. 1 - Authorizing Legislation.docx Supplementary Document	2017-07-17

IC Document Collections

IC ID	Document Title	Status
227556	Blood Draw Form and Instruction	New
227555	Vision Exam Form and Instruction	New
227554	Neurological Exam - Hammersmith Infant Neurologic Exam / Evaluation of Cerebral Palsy Form and Instruction	New
227553	Physical Health Exam Form and Instruction	New
227552	Growth Exam Form and Instruction	New
227551	Parenting Stress Index - Short Form Form and Instruction	New
227550	Patient Health Questionniare - 9 Form and Instruction	New
227549	Ages and Stages Questionnaire - Social / Emotional Form and Instruction	New
227548	Ages and Stages Questionniare - 3rd Edition Form and Instruction	New
227545	Seizure Screen Form and Instruction	New
227544	Parent Questionnaire Form and Instruction	New
227543	Medical Record Abstraction Form Form and Instruction	New
227542	Recruitment and Participation Log Form	New

ICR Details

OMB Control No: 0920-1194	ICR Reference No: 201707-0920-007
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-17AWX
Title: Zika Outcomes and Development of Infants and Children (ZODIAC) Investigation
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 07/31/2017
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/17/2017
	Date Received in OIRA: 07/17/2017
Terms of Clearance: Approved consistent with the understanding that if the collection extends beyond the 90 day emergency clearance period, CDC will submit to OMB an ICR for standard review and approval.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2017	6 Months From Approved
Responses	3,056	0	0
Time Burden (Hours)	628	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The overarching goal of the ZODIAC collection is to improve understanding of the long-term health and developmental consequences of congenital ZIKV infection, the impact on affected families, and their care needs. The intended use of the resulting data is to inform decisions by the CDC and the Ministry of Health of Brazil for the purposes of updating guidelines on care and prevention, control and health promotion, and to plan for the needs of affected children and families.

Emergency Justfication: Zika Virus infection studies have been completed in the U.S. and its territories. Children from these studies will soon be the age of children assessed in the ZODIAC investigation. Early intervention during sensitive periods is critical for mitigating disabilities in children. The longer this information collection is delayed, the greater the number of affected toddlers that will be too old to benefit from advances in understanding and care that follow from it. Comprehensive descriptions of the health and development of children affected by congenital ZIKV infection are needed to help verify preliminary conclusions from sparse data, and to more accurately describe the phenotype, which likely represents a broader spectrum than has been described to date. [15] In addition, knowledge about the frequency with which the various phenotype components co-occur in an infant, as well as whether any component(s) are consistently present, is lacking at this time.

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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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 13

IC Title	Form No.	Form Name
Vision Exam	NA	Vision Exam
Blood Draw	NA	Blood Collection
Recruitment and Participation Log	NA	Recruitment and Participation Log
Parenting Stress Index - Short Form	NA	Parenting Stress Index - Short Form
Ages and Stages Questionnaire - Social / Emotional	NA	Ages and Stages Questionnaire - SE
Medical Record Abstraction Form	NA	ZODIAC Medical Record Abstraction Form
Parent Questionnaire	NA	Caregiver Questionnaire
Ages and Stages Questionniare - 3rd Edition	NA	Ages and Stages Questionniare - 3
Seizure Screen	NA	Seizure Screen
Patient Health Questionniare - 9	NA	Patient Health Questionnaire - 9
Growth Exam	NA	Growth Exam
Physical Health Exam	NA	Physical Health Exam
Neurological Exam - Hammersmith Infant Neurologic Exam / Evaluation of Cerebral Palsy	NA	Hammersmith Infant Neurologic Exam (HINE)

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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	3,056	0	0	3,056	0	0
Annual Time Burden (Hours)	628	0	0	628	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: The submission of 0920-17AWX - ZODIAC is a New Emergency Clearance Request related to the Zika Virus outbreak.

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Annual Cost to Federal Government: $1,888,778

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: 07/17/2017

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