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 201710-0920-006 · OMB 0920-1217 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Parents of ZIKV-positive Infant - Infant Follow-Up Questionnaire Form and Instruction New Available
Parents of ZIKV-positive Infants - Infant Enrollment and Delivery Questionnaire Form and Instruction New Available
Zika-positive Pregnant Women - Pregnant Women Follow-Up Questionnaire Form and Instruction New Available
Zika-positive Pregnant Women - Pregnant Women Symptom Questionnaire Form and Instruction New Available
Zika-positive Pregnant Women - Pregnant Women Enrollment Questionnaire Form and Instruction New Repair queued
Zika-positive Pregnant Women - Pregnant Women Screening Form Form and Instruction New Available
Part B_ZIRP_CLEAN.docx Supporting Statement B Uploaded 2017-11-08 Available
Part A_ZIRP_CLEAN.docx Supporting Statement A Uploaded 2017-11-08 Available
List of Attachments.docx Supplementary Document Uploaded 2017-10-31 Available
Att E3-Amendment #1 approval.docx Supplementary Document Uploaded 2017-10-31 Available
Att E2- UPR IRB approval.pdf Supplementary Document Uploaded 2017-10-31 Available
Att E1- 7005 IRB Submission Approval.docx Supplementary Document Uploaded 2017-10-31 Available
Att D3 - Agreement to abide by restrictions.docx Supplementary Document Uploaded 2017-10-31 Available
Att D2 - FTE Nondisclosure.DOCX Supplementary Document Uploaded 2017-10-31 Available
Att D1 - Assurance of Confidentiality Zika Surveillance.doc Supplementary Document Uploaded 2017-10-31 Repair queued
60 Day FRN.pdf Supplementary Document Uploaded 2017-10-31 Available
Att A- Section 301_PHS_Act (42 U.S.C. 241).docx Supplementary Document Uploaded 2017-10-31 Available
IC Document Collections
IC IDCollectionTypeStatusForm
228861 Parents of ZIKV-positive Infant - Infant Follow-Up Questionnaire Form and Instruction New
228859 Parents of ZIKV-positive Infants - Infant Enrollment and Delivery Questionnaire Form and Instruction New
228856 Zika-positive Pregnant Women - Pregnant Women Follow-Up Questionnaire Form and Instruction New
228854 Zika-positive Pregnant Women - Pregnant Women Symptom Questionnaire Form and Instruction New
228852 Zika-positive Pregnant Women - Pregnant Women Enrollment Questionnaire Form and Instruction New
228847 Zika-positive Pregnant Women - Pregnant Women Screening Form Form and Instruction New
ICR Details
0920-1217 201710-0920-006
Historical Active
HHS/CDC 0920-17AZX
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
Regular
Approved without change 02/09/2018
Retrieve Notice of Action (NOA) 11/13/2017
  Inventory as of this Action Requested Previously Approved
02/29/2020 24 Months From Approved
6,000 0 0
785 0 0
0 0 0
This study is a part of an ongoing public health emergency response related to the Zika virus outbreak in Puerto Rico. Results of the ZIRP Puerto Rico study will provide critical data in establishing guidance for testing in pregnant women and congenitally exposed infants with exposure to ZIKV. It will also provide information on the association between persistent ZIKV RNA in pregnant women and adverse outcomes or infection in infants that can enable health care. This New ICR will continue the work initiated in Emergency Collection Request, OMB # 0920-1189.
US Code: 42 USC 241 Name of Law: U.S. PHSA
  
None
Not associated with rulemaking
  82 FR 18462 04/19/2017
82 FR 51839 11/08/2017
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
0920-17AZX - Zika Virus RNA Persistence in Pregnant Women and Congenitally Exposed Infants in Puerto Rico (ZIRP) is being submitted as a New ICR to continue collection of data originally approved as an Emergency Clearance Request.
$1,333,820
No
    Yes
    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.
11/13/2017