Zika Virus Associated Neurologic Illness Case Control Study in Puerto Rico

Forms and Documents

Document Name	Status
SEVERE NEUROLOGIC ILLNESS Questionnaire for Case/Control Form and Instruction	New
SEVERE NEUROLOGIC ILLNESS Chart Abstraction Questionnaire Form and Instruction	New
SSA Neuro PR emergency request_24OCT2016 FINAL.docx Supporting Statement A	2016-10-24
Severe Neuro in PR_Consent Form_16Oct.docx Supplementary Document	2016-10-24
Emergency Request Memo - CDC Zika Case-Control Study - Puerto Rico (003).pdf Supplementary Document	2016-10-19
SSB Neuro PR Emergency_10-4-16.docx Supporting Statement B	2016-10-19
Att. g -- IRB Letter for case control investigation.pdf Supplementary Document	2016-10-14
Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2016-10-14

IC Document Collections

IC ID	Document Title	Status
223951	SEVERE NEUROLOGIC ILLNESS Questionnaire for Case/Control Form and Instruction	New
223950	SEVERE NEUROLOGIC ILLNESS Chart Abstraction Questionnaire Form and Instruction	New

ICR Details

OMB Control No: 0920-1141	ICR Reference No: 201610-0920-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-
Title: Zika Virus Associated Neurologic Illness Case Control Study in Puerto Rico
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: 10/28/2016
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/25/2016
	Date Received in OIRA: 10/24/2016
Terms of Clearance: Within one week of approval, CDC will submit a 60day notice for continued implementation of this case control study

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2017	6 Months From Approved
Responses	180	0	0
Time Burden (Hours)	90	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Recent case reports, as well as notifications from physicians in Puerto Rico, have evidenced the association between Zika virus infection and a variety of neurologic illnesses. Most prominent among these is Guillain-Barre syndrome, which was first reported several months ago. However unexpected additional manifestations that have been reported in the past 3 months include cases of myelitis, encephalitis, papilledema, and other severe neurologic illnesses. The role with which Zika virus infection plays in each of these neurologic illnesses is unclear, specifically if the relationship is causative, non-specific, or coincidental. Should collection of data not commence immediately, potential harm to patients with severe neurologic illness may be expected as a result of unnecessary delays in identification of risk factors or interventions that may be associated with developing severe neurologic illness following either infection with Zika virus or other potential exposures. Data for the case-control investigation will be collected with a standardized questionnaire and, where applicable, chart abstraction form. Blood and urine specimens will be collected from all consenting participants and tested for evidence of ZIKV infection.

Emergency Justfication: Emergency Clearance is requested to continue to enroll patients in a Case-Control Investigation that will associate the risk of developing severe neurological illness (including Guillain-Barre Syndrome) following Zika Virus infection. These clinical findings are crucial to public health interventions.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: 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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
SEVERE NEUROLOGIC ILLNESS Questionnaire for Case/Control	NA	Case-Control Study Questionnaire for the Investigation of Severe Neurologic Illness in relation to Arboviral Infections
SEVERE NEUROLOGIC ILLNESS Chart Abstraction Questionnaire	NA	Chart Abstraction Questionnaire for the Investigation of Severe Neurologic Illness in relation to Arboviral Infections

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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	180	0	0	180	0	0
Annual Time Burden (Hours)	90	0	0	90	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: Package is a New Emergency submission aimed at collection of information related to the Zika Virus outbreak.

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Annual Cost to Federal Government: $26,030

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: 10/24/2016

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