Information Collection Request

CDC Emergency Operations Center Zika Related Clinical Inquiries and Surveillance

ICR 201602-0920-005 · OMB 0920-1101 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Survey of County-Level Surveillance Records of Aedes aegypti and Aedes albopictus Form and Instruction New Available
Infant Health Follow-Up Form - 2 Months of Age Form and Instruction New Repair queued
Assessment at Delivery Form Form and Instruction New Available
Clinical Inquiries Database Form and Instruction New Available
Maternal Health History Form Form and Instruction New Repair queued
Clinical Inquiries Database Form and Instruction New Available
Att. C -- Website Information - Zika Virus Disease and Pregnancy Registry.docx Supplementary Document Uploaded 2016-02-18 Available
Att N -- Pregnancy Register Information Sheet.docx Supplementary Document Uploaded 2016-02-18 Repair queued
Att. D -- Overview Letter.docx Supplementary Document Uploaded 2016-02-18 Available
Att. B -- 60-Day FRN - ZIKA.docx Supplementary Document Uploaded 2016-02-18 Repair queued
Supporting Statement B FINAL 18FEB2016.docx Supporting Statement B Uploaded 2016-02-18 Available
Supporting Statement A FINAL 17FEB2016.docx Supporting Statement A Uploaded 2016-02-18 Repair queued
Att. M -- IRB Approval Pregnancy Registry.pdf Supplementary Document Uploaded 2016-02-12 Available
Att. L -- IRB Approval Mosquito survey.pdf Supplementary Document Uploaded 2016-02-12 Available
Att. K -- IRB Approval Call Center.pdf Supplementary Document Uploaded 2016-02-12 Available
Att. A -- 42 USC 241.pdf Supplementary Document Uploaded 2016-02-12 Available
Signed memo 021616.pdf Supplementary Document Uploaded 2016-02-12 Available
IC Document Collections
IC IDCollectionTypeStatusForm
220152 Survey of County-Level Surveillance Records of Aedes aegypti and Aedes albopictus Form and Instruction New
220151 Infant Health Follow-Up Form - 2 Months of Age Form and Instruction New
220150 Assessment at Delivery Form Form and Instruction New
220149 Clinical Inquiries Database Form and Instruction New
220148 Specimen Collection Form Instruction New
220142 Maternal Health History Form Form and Instruction New
220140 Clinical Inquiries Database Form and Instruction New
ICR Details
0920-1101 201602-0920-005
Historical Active
HHS/CDC
CDC Emergency Operations Center Zika Related Clinical Inquiries and Surveillance
New collection (Request for a new OMB Control Number)   No
Emergency 02/18/2016
Approved with change 02/18/2016
Retrieve Notice of Action (NOA) 02/18/2016
Approved consistent with the understanding that the Agency will submit a new information collection request at the earliest possible date when it is determined that this emergency collection will extend beyond the 6 month clearance period.
  Inventory as of this Action Requested Previously Approved
08/31/2016 6 Months From Approved
2,520 0 0
705 0 0
0 0 0

Emergency Clearance required for CDC to collect information on Clinical Inquiries for 2016 Zika Virus outbreak. This ICR includes three projects necessitated by the zika response which all require emergency approval. These projects include: A call center in the EOC to respond to inquiries on clinical care of persons potentially of interest for zika virus infection; a register of pregnant women to monitor the frequency adverse birth outcomes for women infected with zika virus during pregnancy; and to carry out county-level surveillance of zika-transmitting mosquitos.
CDC cannot reasonably comply with the normal clearance procedures because CDC researchers need to begin surveillance activities related to the zika virus outbreak as quickly as possible. CDC needs to initiate these surveillance activities right away in order to increase the health security of the United States. Therefore, CDC requests a 180-day emergency clearance to operate a call center in the Emergency Operations Center to field clinical inquiries from physicians, health departments, and the general public; formulate a register for pregnant women to monitor the frequency and types of adverse birth outcomes for women infected with zika virus during pregnancy; and carry out a mosquito surveillance survey distributed to vector control professionals, entomologists, and public health biologists in order to gather information on the distribution of Aedes aegypti and Ae. Albopictus, the vectors that transmit zika virus.

US Code: 42 USC 241 Name of Law: PHSA
  
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 2,520 0 0 2,520 0 0
Annual Time Burden (Hours) 705 0 0 705 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
Submission is a New Emergency ICR for Zika Virus - Clinical Inquiries.

$127,840
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.
02/18/2016