Zika Virus Enhanced Surveillance of Selected Populations

Forms and Documents

Document Name	Status
Zika Virus Disease Enhanced Surveillance – Hospitalization associated with Zika virus disease Form	New
Zika Virus Disease Enhanced Surveillance – Postnatally acquired Zika virus disease among children aged Form	New
Zika Virus Disease Enhanced Surveillance – Neurologic symptoms associated with Zika virus disease Form	New
Att. 8 - IRB.pdf Supplementary Document	2017-07-14
Att. 7 - ArboNet PIA.pdf Supplementary Document	2017-07-14
Att. 5 - Enhanced surveillance - Hospitalized.docx Supplementary Document	2017-07-14
Att. 6B - Script - Children.docx Supplementary Document	2017-07-14
Att. 6A - Script - Neurologic.docx Supplementary Document	2017-07-14
Emergency Review Request Memo - Enhanced ZIKV Surveillance 2.pdf Supplementary Document	2017-07-14
0920-17AHW 60d FRN published.pdf Supplementary Document	2017-07-14
Att. 1 - Section 301 of the Public Health Service Act - 42 USC 241.pdf Supplementary Document	2017-07-14
Supporting Statement B - Enhanced Zika Surveillance_04262017.docx Supporting Statement B	2017-07-14
Supporting Statement A - Enhanced Zika Surveillance_04262017.docx Supporting Statement A	2017-07-14

IC Document Collections

IC ID	Document Title	Status
227535	Zika Virus Disease Enhanced Surveillance – Hospitalization associated with Zika virus disease Form	New
227534	Zika Virus Disease Enhanced Surveillance – Postnatally acquired Zika virus disease among children aged Form	New
227533	Zika Virus Disease Enhanced Surveillance – Neurologic symptoms associated with Zika virus disease Form	New

ICR Details

OMB Control No: 0920-1192	ICR Reference No: 201706-0920-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-17AHW
Title: Zika Virus Enhanced Surveillance of Selected Populations
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: 07/17/2017
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/14/2017
	Date Received in OIRA: 07/14/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2017	6 Months From Approved
Responses	213	0	0
Time Burden (Hours)	372	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The objective of this proposal is to support state health departments better define the public health burden and clinical characteristics of severe manifestations of Zika virus disease. Improved clinician awareness of the spectrum of disease presentations will allow for more timely identification of disease cases and improved public health response which should mitigate the risk for local transmission. The specific goals and objectives are: 1. Describe the clinical manifestations and outcomes among: a. Patients hospitalized for Zika virus disease. b. Children <18 years of age with postnatally acquired Zika virus disease. c. Children of different age groups. d. Persons with neurologic symptoms associated with Zika virus disease. 2. Assess for unique clinical feature of Zika virus disease in children <18 years of age. 3. Compare demographics, underlying medical conditions, and acute symptoms among cases hospitalized and not hospitalized for Zika virus disease.

Emergency Justfication: CDC cannot reasonably comply with the normal OMB clearance procedures given the need for these data to evaluate and revise existing guidance documents and informational products prior to the summer months when we anticipate that Zika virus transmission in the Americas will substantially increase. Accelerated OMB review is requested to provide CDC with the ability to rapidly answer urgent remaining questions that will shape the course of this public health emergency response.

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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
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 24709	05/30/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Zika Virus Disease Enhanced Surveillance – Postnatally acquired Zika virus disease among children aged <18 years	NA	Zika Virus Disease Enhanced Surveillance – Postnatally acquired Zika virus disease among children aged <18 years
Zika Virus Disease Enhanced Surveillance – Neurologic symptoms associated with Zika virus disease	NA	Zika Virus Disease Enhanced Surveillance – Neurologic symptoms associated with Zika virus disease
Zika Virus Disease Enhanced Surveillance – Hospitalization associated with Zika virus disease	NA	Zika Virus Disease Enhanced Surveillance – Hospitalization associated with Zika virus disease

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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	213	0	0	213	0	0
Annual Time Burden (Hours)	372	0	0	372	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: Submission of 0920-17AHW - Zika Virus Enhanced Surveillance of Selected Populations is a New Emergency ICR related to the Zika response.

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Annual Cost to Federal Government: $8,130

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: 07/14/2017

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