Emergency Zika Package II: Persistence of zika virus in body fluids and case-control investigation of etiologic agents associated with Guillain-Barré Syndrome

Forms and Documents

Document Name	Status
Viral Shedding Eligibility Form Form and Instruction	New
GBS Questionnaire - Cases and Controls Form and Instruction	New
GBS Chart Abstraction Questionnaire Form and Instruction	New
Zika Virus Shedding Questionnaire - Asymptomatic Form and Instruction	New
Zika Virus Shedding Questionnaire - Symptomatic Form and Instruction	New
SSA - Emergency Zika Package II_18MAR2016.docx Supporting Statement A	2016-03-18
SSB - Emergency Zika Package II.docx Supporting Statement B	2016-03-18
Att. O -- IRB approval for shedding study.pdf Supplementary Document	2016-03-17
Att. N -- IRB Letter for case control investigation.pdf Supplementary Document	2016-03-17
Att P -- shedding study flow chart.docx Supplementary Document	2016-03-17
Att. M -- Shedding model coupon.docx Supplementary Document	2016-03-17
Att. L -- Shedding protocol for specimen collection.docx Supplementary Document	2016-03-17
Att. K -- Shedding counseling messages.docx Supplementary Document	2016-03-17
Att. I -- Shedding consent forms for asymptomatic contacts.docx Supplementary Document	2016-03-17
Att. H -- Shedding Consent Form.docx Supplementary Document	2016-03-17
Att. E -- Case-control consent form 2.docx Supplementary Document	2016-03-17
Att. D -- Case-control consent form.docx Supplementary Document	2016-03-17
Att. B -- 60-Day FRN for Zika Emergency II.docx Supplementary Document	2016-03-17
Att. A -- Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2016-03-17
Emergency request memo -- Zika II.pdf Supplementary Document	2016-03-17

IC Document Collections

IC ID	Document Title	Status
220684	Viral Shedding Eligibility Form Form and Instruction	New
220663	GBS Questionnaire - Cases and Controls Form and Instruction	New
220662	GBS Chart Abstraction Questionnaire Form and Instruction	New
220661	Zika Virus Shedding Questionnaire - Asymptomatic Form and Instruction	New
220660	Zika Virus Shedding Questionnaire - Symptomatic Form and Instruction	New

ICR Details

OMB Control No: 0920-1106	ICR Reference No: 201603-0920-008
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 16VC
Title: Emergency Zika Package II: Persistence of zika virus in body fluids and case-control investigation of etiologic agents associated with Guillain-Barré Syndrome
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: 03/21/2016
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/18/2016
	Date Received in OIRA: 03/18/2016
Terms of Clearance: Approved consistent with the understanding that associated collections extending beyond 6 months will be submitted to OMB as a non-emergency information collection request for formal review.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2016	6 Months From Approved
Responses	5,330	0	0
Time Burden (Hours)	769	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: As part of the CDC's response to the ongoing zika virus outbreak, two projects are being undertaken: a case-control investigation to determine demographic characteristics, environmental exposures, or infectious agents associated with GBS; and a cohort study to determine the prevalence/duration of Zika RNA in body fluids and the duration of Zika virus IgM antibodies in serum. The intended use of this information is to target and refine public health interventions to arrest ongoing spread of Zika.

Emergency Justfication: Zika virus (ZIKV) is a mosquito-borne flavivirus that has recently emerged in the Americas. Previously, outbreaks had occurred in Asia and islands in the south Pacific. In addition to mosquito-to-human transmission, ZIKV infections have been documented through sexual transmission, blood transfusion, laboratory exposure, intrauterine transmission resulting in congenital infection, and intrapartum transmission from a viremic mother to her newborn. The justification for use of the Emergency mechanism for the studies associated with this ICR are as follows: Project 1: The prevalence of ZIKV RNA in various body fluids among patients with acute ZIKV infection and the length of time that ZIKV RNA might persist in these body fluids is not well understood. Characterizing these parameters has implications both for potential human-to-human transmission and for diagnosis of ZIKV infection. Project 2: There is an urgent public health need to understand the potential association between GBS and ZIKV infection. Currently, increased numbers of GBS cases have been reported in ZIKV-affected contexts, but it is not known if this is due to ZIKV, another etiologic agent, or some combination/interaction thereof.

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Authorizing Statute(s): None

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: 5

IC Title	Form No.	Form Name
Zika Virus Shedding Questionnaire - Symptomatic	NA	Zika Shedding Study Questionnaire
Zika Virus Shedding Questionnaire - Asymptomatic	NA	Zika Shedding Study Questionnaire
GBS Chart Abstraction Questionnaire	NA	Chart Abstraction for the Investigation of GBS in relation to Arboviral Infections
GBS Questionnaire - Cases and Controls	NA	Case-Control Study Questionnaire for Investigation of GBS in relation to Arboviral Infections
Viral Shedding Eligibility Form	NA	Viral Shedding Eligibility 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	5,330	0	0	5,330	0	0
Annual Time Burden (Hours)	769	0	0	769	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 is a New Emergency ICR Request.

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Annual Cost to Federal Government: $135,552

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 03/18/2016

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