OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Zika Virus Associated Neurologic Illness Case Control Study in Puerto Rico

ICR 201610-0920-005 · OMB 0920-1141 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
SEVERE NEUROLOGIC ILLNESS Questionnaire for Case/Control Form and Instruction New Available
SEVERE NEUROLOGIC ILLNESS Chart Abstraction Questionnaire Form and Instruction New Available
SSA Neuro PR emergency request_24OCT2016 FINAL.docx Supporting Statement A Uploaded 2016-10-24 Available
Severe Neuro in PR_Consent Form_16Oct.docx Supplementary Document Uploaded 2016-10-24 Available
Emergency Request Memo - CDC Zika Case-Control Study - Puerto Rico (003).pdf Supplementary Document Uploaded 2016-10-19 Available
SSB Neuro PR Emergency_10-4-16.docx Supporting Statement B Uploaded 2016-10-19 Available
Att. g -- IRB Letter for case control investigation.pdf Supplementary Document Uploaded 2016-10-14 Available
Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document Uploaded 2016-10-14 Available
IC Document Collections
IC IDCollectionTypeStatusForm
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
0920-1141 201610-0920-005
Historical Active
HHS/CDC 0920-
Zika Virus Associated Neurologic Illness Case Control Study in Puerto Rico
New collection (Request for a new OMB Control Number)   No
Emergency 10/28/2016
Approved without change 10/25/2016
Retrieve Notice of Action (NOA) 10/24/2016
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
01/31/2017 6 Months From Approved
180 0 0
90 0 0
0 0 0
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 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.
US Code: 42 USC 241 Name of Law: Public Health Service Act
  
None
Not associated with rulemaking
No
  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
Yes
Miscellaneous Actions
No
Package is a New Emergency submission aimed at collection of information related to the Zika Virus outbreak.
$26,030
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Jeffrey Zirger 404 639-7118 [email protected]
  No
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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
10/24/2016