OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Persistence of Zika virus in semen and urine of adult men in the United States with confirmed Zika virus infection

ICR 201606-0920-018 · OMB 0920-1139 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Follow-Up Survey Form and Instruction New Available
Introductory Survey Form and Instruction New Available
SSB Zika USA Shedding Study_09 26 2016 OMB_SHedits092816.docx Supporting Statement B Uploaded 2016-10-05 Available
SSA Zika USA Shedding Study_10042016 OMB.docx Supporting Statement A Uploaded 2016-10-05 Repair queued
Certificate_of_Translation_CDC_SPANISH_05 05 2016.pdf Supplementary Document Uploaded 2016-06-28 Available
Att. J -- IRB approval.docx Supplementary Document Uploaded 2016-06-28 Available
Att. L -- Phone script from state health department ESP.docx Supplementary Document Uploaded 2016-06-28 Available
Att. L -- Phone script from State health department.docx Supplementary Document Uploaded 2016-06-28 Available
Att. K -- Letter from state health department ESP.docx Supplementary Document Uploaded 2016-06-28 Available
Att. K -- Letter from state health department.docx Supplementary Document Uploaded 2016-06-28 Repair queued
Att. I -- Thank You and Test Results ESP.docx Supplementary Document Uploaded 2016-06-28 Available
Att. I -- Thank You and Test Results.docx Supplementary Document Uploaded 2016-06-28 Repair queued
Att. H -- FAQs ESP.docx Supplementary Document Uploaded 2016-06-28 Available
Att. H -- FAQs.docx Supplementary Document Uploaded 2016-06-28 Available
Att. G -- General Instructions ESP.docx Supplementary Document Uploaded 2016-06-28 Available
Att. G -- General Instructions.docx Supplementary Document Uploaded 2016-06-28 Available
Att. F -- Copy of Consent Form ESP.docx Supplementary Document Uploaded 2016-06-28 Repair queued
Att. F -- Copy of Consent Form.docx Supplementary Document Uploaded 2016-06-28 Repair queued
Att. E -- Instructions for sample collection ESP.docx Supplementary Document Uploaded 2016-06-28 Available
Att. E -- Instructions for Sample Collection.docx Supplementary Document Uploaded 2016-06-28 Available
Att. B2 -- Public Comment.pdf Supplementary Document Uploaded 2016-06-28 Available
Att. B1 -- 60-day FRN.pdf Supplementary Document Uploaded 2016-06-28 Available
Att. A -- Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document Uploaded 2016-06-28 Available
IC Document Collections
IC IDCollectionTypeStatusForm
222242 Follow-Up Survey Form and Instruction New
222241 Introductory Survey Form and Instruction New
ICR Details
0920-1139 201606-0920-018
Historical Active
HHS/CDC 0920-16ASR
Persistence of Zika virus in semen and urine of adult men in the United States with confirmed Zika virus infection
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 10/05/2016
Retrieve Notice of Action (NOA) 07/13/2016
  Inventory as of this Action Requested Previously Approved
10/31/2017 12 Months From Approved
3,250 0 0
133 0 0
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 is an extension of the Emergency Request that was previously approved by OMB, and will fill gaps in the scientific knowledge base for Zika virus regarding the occurrence, persistence, and transmissibility of Zika virus in urine and semen.
US Code: 42 USC 241 Name of Law: PHSA
  
None
Not associated with rulemaking
  81 FR 26231 05/02/2016
81 FR 44866 07/11/2016
Yes
  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 0 0 3,250 0 0
Annual Time Burden (Hours) 133 0 0 133 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
Submission of 0920-16ASR is a NEW ICR for continuation of a previously OMB-approved Emergency package.
$94,003
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.
07/13/2016