OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Zika Virus RNA Persistence in Pregnant Women and Congenitally Exposed Infants in Puerto Rico (ZIRP)

ICR 201706-0920-003 · OMB 0920-1189 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Infant Follow-Up Questionnaire Form and Instruction New Available
Infant Enrollment and Delivery Questionnaire Form and Instruction New Available
Pregnant Women Follow-Up Questionnaire Form and Instruction New Repair queued
Pregnant Women Symptom Questionnaire Form and Instruction New Available
Pregnant Women Enrollment Questionnaire Form and Instruction New Available
Pregnant Women Screening Form Form and Instruction New Available
OMB_Part B_ZIRP_full_v1_clean.docx Supporting Statement B Uploaded 2017-07-07 Available
OMB_Part A_ZIRP_full_v1_clean.docx Supporting Statement A Uploaded 2017-07-07 Available
Att E1- 7005 IRB Submission Approval.docx Supplementary Document Uploaded 2017-07-07 Available
Att D3 - Agreement to abide by data restrictions.docx Supplementary Document Uploaded 2017-07-07 Available
Att D2 - FTE Non-disclosure agreement.docx Supplementary Document Uploaded 2017-07-07 Repair queued
Att D1 - Assurance of Confidentiality.docx Supplementary Document Uploaded 2017-07-07 Repair queued
deb lubar signed memo.pdf Supplementary Document Uploaded 2017-07-07 Available
Att B - 60-day notice.pdf Supplementary Document Uploaded 2017-07-07 Available
Att A - Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document Uploaded 2017-07-07 Available
IC Document Collections
IC IDCollectionTypeStatusForm
227422 Infant Follow-Up Questionnaire Form and Instruction New
227421 Infant Enrollment and Delivery Questionnaire Form and Instruction New
227420 Pregnant Women Follow-Up Questionnaire Form and Instruction New
227419 Pregnant Women Symptom Questionnaire Form and Instruction New
227418 Pregnant Women Enrollment Questionnaire Form and Instruction New
227417 Pregnant Women Screening Form Form and Instruction New
ICR Details
0920-1189 201706-0920-003
Historical Active
HHS/CDC 0920-17NF
Zika Virus RNA Persistence in Pregnant Women and Congenitally Exposed Infants in Puerto Rico (ZIRP)
New collection (Request for a new OMB Control Number)   No
Emergency 07/10/2017
Approved without change 07/10/2017
Retrieve Notice of Action (NOA) 07/10/2017
As the information collection is scheduled to last for 15 months, CDC will submit a full Information Collection Request within 3 months after getting emergency approval
  Inventory as of this Action Requested Previously Approved
10/31/2017 6 Months From Approved
6,000 0 0
785 0 0
0 0 0
The Emergency ZIRP study aims to determine the prevalence and duration of ZIKV RNA persistence in pregnant women infected with ZIKV and their congenitally exposed infants. Information from the ZIRP Puerto Rico study will provide the data needed to establish ZIKV testing guidance for pregnant women and congenitally exposed infants, and will also provide information to assess the association between persistent ZIKV RNA in pregnant women or infants and adverse outcomes.
Currently, the Centers for Disease Control and Prevention (CDC) and the PRDH recommend that all pregnant women living in areas with active ZIKV transmission such as Puerto Rico, be tested for ZIKV. Limited data from human studies also suggest that pregnant women have persistent detection of ZIKV RNA in serum. Even less is known about persistent detection of ZIKV RNA in infants. One case study reported persistent ZIKV RNA detection in a male child born in Brazil at 40 weeks gestation with brain abnormalities. The increasing number of cases and stage of the outbreak in Puerto Rico provides an opportunity to collect actionable information on a shorter timeframe than is possible elsewhere. This study is expected to provide critical scientific information to help the United States prepare for the unprecedented challenges posed by Zika and possible clinical guidelines related to ZIKV RNA testing. Because information collection is scheduled to last for 15 months, CDC will submit a full Information Collection Request within 3 months after getting emergency approval.
US Code: 42 USC 241 Name of Law: U.S. PHSA
  
None
Not associated with rulemaking
  82 FR 18462 04/19/2017
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 6,000 0 0 6,000 0 0
Annual Time Burden (Hours) 785 0 0 785 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
Submission of 0920-17NF - Zika Virus RNA Persistence in Pregnant Women and Congenitally Exposed Infants in Puerto Rico (ZIRP) is a New Emergency Clearance Request.
$1,333,820
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.
07/10/2017