OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Zika Emergency Package III: Persistence of Zika virus in semen and urine of adult men with confirmed Zika virus infection

ICR 201604-0920-004 · OMB 0920-1109 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Follow-Up Survey Form and Instruction Unchanged Available
Introductory Survey Form and Instruction Unchanged Available
0920-1109 non-sub change request.docx Justification for No Material/Nonsubstantive Change Uploaded 2016-04-12 Available
Att. L -- Phone script from State health department.docx Supplementary Document Uploaded 2016-04-12 Available
Att. K -- Letter from state health department.docx Supplementary Document Uploaded 2016-04-12 Available
Att. J2 -- IRB Amendment.docx Supplementary Document Uploaded 2016-04-12 Available
SSA zika emergency III 28MAR2016.docx Supporting Statement A Uploaded 2016-03-28 Repair queued
Att. J -- IRB approval.docx Supplementary Document Uploaded 2016-03-28 Repair queued
Att. I -- Thank You and Test Results.docx Supplementary Document Uploaded 2016-03-28 Available
Att. H -- FAQs.docx Supplementary Document Uploaded 2016-03-28 Available
Att. G -- General Instructions.docx Supplementary Document Uploaded 2016-03-28 Available
Att. F -- Copy of Consent Form.docx Supplementary Document Uploaded 2016-03-28 Available
Att. E -- Instructions for Sample Collection.docx Supplementary Document Uploaded 2016-03-28 Available
Att. B -- 60-Day FRN.docx Supplementary Document Uploaded 2016-03-28 Available
Att. A -- Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document Uploaded 2016-03-28 Available
Emergency request memo to OMB.pdf Supplementary Document Uploaded 2016-03-28 Available
SSB zika emergency III 12APR2016.docx Supporting Statement B Uploaded 2016-04-12 Available
IC Document Collections
IC IDCollectionTypeStatusForm
220786 Follow-Up Survey Form and Instruction Unchanged
220785 Introductory Survey Form and Instruction Unchanged
ICR Details
0920-1109 201604-0920-004
Historical Active 201603-0920-011
HHS/CDC 16ABI
Zika Emergency Package III: Persistence of Zika virus in semen and urine of adult men with confirmed Zika virus infection
No material or nonsubstantive change to a currently approved collection   No
Emergency 03/30/2016
Approved without change 04/13/2016
Retrieve Notice of Action (NOA) 04/13/2016
Approved consistent with the understanding that associated collections extending beyond 6 months will be submitted to OMB as a non-emergency information collection request for formal review.
  Inventory as of this Action Requested Previously Approved
09/30/2016 09/30/2016 09/30/2016
3,250 0 3,250
58 0 58
0 0 0
Information on the frequency and duration of Zika virus shedding in semen and urine is needed urgently to inform public health recommendations for infected men and their partners. The purpose of this study is to enroll adult men with confirmed Zika virus infection and collect serial specimens of semen and urine. This study will fill gaps in the scientific knowledge base for Zika virus regarding the occurrence, persistence, and transmissibility of Zika virus in urine and semen.
Zika virus is an arthropod-borne flavivirus that has recently emerged in the Americas. Maternal infection has been linked to congenital microcephaly, fetal loss, and other adverse reproductive health outcomes. Although spread primarily by mosquitoes, recent reports have highlighted the potential for sexual transmission of Zika virus through the semen of infected men. The purpose of this study is to enroll adult men with confirmed Zika virus infection and collect serial specimens of semen and urine. This study will fill gaps in the scientific knowledge base for Zika virus regarding the occurrence, persistence and transmissibility of Zika virus in urine and semen. This is a prospective, descriptive cohort study that allows for determining the persistence of shedding Zika virus in semen and urine through serial specimen collection from individuals with confirmed Zika virus.The results of this study will be of great relevance to provide evidence-based information to circumvent Zika virus transmission. Results and analysis will be used to update and refine relevant counseling messages and recommendations as well as provide understanding for future Zika virus outbreaks..
US Code: 42 USC 241 Name of Law: Public Health Service Act
  
None
Not associated with rulemaking
No
2
IC Title Form No. Form Name
Follow-Up Survey NA Follow-Up Survey
Introductory Survey NA Verbal Script for Consent and Introductory Survey
  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 3,250 3,250 0 0 0 0
Annual Time Burden (Hours) 58 58 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Submission of 09290-16YE is a New Emergency ICR.
$36,397
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.
04/13/2016