OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Zika virus persistence in body fluids of patients with Zika virus infection in Puerto Rico (ZIPER Study)

ICR 201606-0920-022 · OMB 0920-1140 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Contact Information Form Form New Available
Shedding Eligibility Form and Instruction New Available
Baseline and Follow-Up Questionnaire - Asymptomatic Form and Instruction New Available
Baseline and Follow-Up Questionnaire - Symptomatic Form and Instruction New Repair queued
Attachment M ZiPER Pregnancy Questionnaire.docx Supplementary Document Uploaded 2016-09-30 Available
SSB - Puerto Rico Shedding 9-28-2016clean.docx Supporting Statement B Uploaded 2016-09-30 Available
SSA - Puerto Rico Shedding_OMB2 09 28 2016 Clean.docx Supporting Statement A Uploaded 2016-09-30 Available
Att. L - IRB approval.pdf Supplementary Document Uploaded 2016-07-12 Available
Att. K - Counseling messages.docx Supplementary Document Uploaded 2016-07-12 Available
Att. J - Laboratory Form.docx Supplementary Document Uploaded 2016-07-12 Available
Att. I - Protocol for specimen collection ESP.docx Supplementary Document Uploaded 2016-07-12 Available
Att. I - Protocol for specimen collection.docx Supplementary Document Uploaded 2016-07-12 Available
Att. F - ZIPER Phone Recruitment Script ESP.docx Supplementary Document Uploaded 2016-07-12 Repair queued
Att. F - ZIPER Phone Recruitment Script.docx Supplementary Document Uploaded 2016-07-12 Available
Att. E - Consent forms ESP.docx Supplementary Document Uploaded 2016-07-12 Available
Att. E - Consent forms.docx Supplementary Document Uploaded 2016-07-12 Available
Att. C - Model coupon.docx Supplementary Document Uploaded 2016-07-12 Repair queued
Att. B1 -- Public Comment.pdf Supplementary Document Uploaded 2016-06-30 Available
Att. B - 60-Day FRN.pdf Supplementary Document Uploaded 2016-06-30 Available
Att. A - Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document Uploaded 2016-06-30 Available
IC Document Collections
IC IDCollectionTypeStatusForm
222428 Contact Information Form Form New
222266 Shedding Eligibility Form and Instruction New
222265 Baseline and Follow-Up Questionnaire - Asymptomatic Form and Instruction New
222264 Baseline and Follow-Up Questionnaire - Symptomatic Form and Instruction New
ICR Details
0920-1140 201606-0920-022
Historical Active
HHS/CDC 0920-16ARP
Zika virus persistence in body fluids of patients with Zika virus infection in Puerto Rico (ZIPER Study)
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
3,400 0 0
407 0 0
0 0 0
The ZIPER study will help inform the presence and duration of ZIKV shedding in several body fluids among RT-PCR-positive ZIKV cases from Puerto Rico. It will also provide information regarding the duration of detection of anti-ZIKV IgM antibodies and the time for development of IgG antibodies among the same population. In addition, this study will determine the prevalence of anti-ZIKV, IgM and IgG, and virus shedding in body fluids among household contacts of ZIKV cases. This ICR is submitted as a New collection to allow information collection activities to continue past Emergency Clearance deadline.
US Code: 42 USC 241 Name of Law: Public Health Service Act
  
None
Not associated with rulemaking
  81 FR 26231 05/02/2016
81 FR 44865 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 3,400 0 0 3,400 0 0
Annual Time Burden (Hours) 407 0 0 407 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
Submission of 0920-16ARP is a New ICR for continuation of Zika-related activities beyond Emergency Clearance.
$109,522
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