OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

CDC Emergency Operations Center Zika Related Clinical Inquiries and Surveillance

ICR 201603-0920-014 · OMB 0920-1101 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Survey of County-Level Surveillance Records of Aedes aegypti and Aedes albopictus Form and Instruction Modified Available
Infant Health Follow-Up Form Form and Instruction Modified Available
Assessment at Delivery Form Form and Instruction Modified Available
Clinical Inquiries Database Form and Instruction Modified Available
Maternal Health History Form Form and Instruction Modified Available
Clinical Inquiries Database Form and Instruction Modified Repair queued
Att. D -- Overview Letter - Revised 31MAR2016_OMB.docx Supplementary Document Uploaded 2016-04-07 Repair queued
0920-1101 Non-sub Change Request_4_7_16 FINAL.docx Justification for No Material/Nonsubstantive Change Uploaded 2016-04-07 Repair queued
Att. S -- CSTE Case Definition.pdf Supplementary Document Uploaded 2016-04-07 Available
0920-1101 Non-sub Change Request_4_7_16.docx Justification for No Material/Nonsubstantive Change Uploaded 2016-04-07 Available
Att. R -- Fact sheet for Health Departments.docx Supplementary Document Uploaded 2016-04-07 Available
Att. Q -- Fact sheet for pediatric healthcare providers.docx Supplementary Document Uploaded 2016-04-07 Available
Att. P -- Fact sheet for obstetric healthcare providers.docx Supplementary Document Uploaded 2016-04-07 Available
Att. N -- Pregnancy Registry Information Sheet.docx Supplementary Document Uploaded 2016-04-07 Available
Att. M -- IRB determination.pdf Supplementary Document Uploaded 2016-04-07 Available
Att. C -- Website Information - Zika Virus Disease and Pregnancy Registry 31MAR2016.docx Supplementary Document Uploaded 2016-04-01 Repair queued
Att. M -- IRB determination.pdf Supplementary Document Uploaded 2016-04-07 Available
Att. R -- Definitions for case inclusion.docx Supplementary Document Uploaded 2016-03-31 Available
Att. Q -- CSTE Case Definition.pdf Supplementary Document Uploaded 2016-03-31 Available
Att. P -- Fact Sheet for Health Care Providers.pdf Supplementary Document Uploaded 2016-03-31 Available
Att. O -- Developmental Milestones for Infant.docx Supplementary Document Uploaded 2016-03-31 Available
Att. N -- Pregnancy Registry Information Sheet Revised 31MAR2016.pdf Supplementary Document Uploaded 2016-03-31 Available
Att. D -- Overview Letter - Revised 31MAR2016.docx Supplementary Document Uploaded 2016-03-31 Available
0920-1101 Non-sub Change Request.docx Justification for No Material/Nonsubstantive Change Uploaded 2016-03-31 Available
Att. B -- 60-Day FRN - ZIKA.docx Supplementary Document Uploaded 2016-02-18 Repair queued
Zika Emergency 1_SSB_non sub change CLEAN.docx Supporting Statement B Uploaded 2016-03-31 Repair queued
Zika Emergency 1 SSA non sub change CLEAN_4_7_16.docx Supporting Statement A Uploaded 2016-04-07 Available
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 Modified
220151 Infant Health Follow-Up Form Form and Instruction Modified
220150 Assessment at Delivery Form Form and Instruction Modified
220149 Clinical Inquiries Database Form and Instruction Modified
220148 Specimen Collection Form Instruction Modified
220142 Maternal Health History Form Form and Instruction Modified
220140 Clinical Inquiries Database Form and Instruction Modified
ICR Details
0920-1101 201603-0920-014
Historical Active 201602-0920-005
HHS/CDC
CDC Emergency Operations Center Zika Related Clinical Inquiries and Surveillance
No material or nonsubstantive change to a currently approved collection   No
Emergency 02/18/2016
Approved with change 04/07/2016
Retrieve Notice of Action (NOA) 04/01/2016
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 08/31/2016 08/31/2016
2,520 0 2,520
705 0 705
0 0 0
Non-substantive changes are being made because of the updated Council of State and Territorial Epidemiologists (CSTE) case definitions for confirmed and probable Zika virus disease and congenital Zika virus infection. Because of the updated CSTE case definitions, participation in the pregnancy registry is no longer voluntary. Estimates of annualized burden hours for this change request remain the same.
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 2,520 0 0 0 0
Annual Time Burden (Hours) 705 705 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$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.
04/01/2016