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 201707-0920-005 · OMB 0920-1140 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Contact Information Form Form and Instruction New Repair queued
Shedding Eligibility Form Form and Instruction New Available
Questionnaire for Men in Semen Study Form and Instruction New Available
Shedding Questionnaire - Asymptomatics Form and Instruction New Available
Shedding Questionnaire - Symptomatics Form and Instruction New Available
Shedding Questionnaire - Public Health Personnel Form and Instruction New Available
Contact Information Form Form Removed Available
Shedding Eligibility Form and Instruction Removed Repair queued
Baseline and Follow-Up Questionnaire - Asymptomatic Form and Instruction Removed Available
Baseline and Follow-Up Questionnaire - Symptomatic Form and Instruction Removed Available
Att. L - IRB approval.docx Supplementary Document Uploaded 2017-07-13 Available
Att. M - Informational Flyer.docx Supplementary Document Uploaded 2017-07-13 Available
Att. K - Counseling messages.docx Supplementary Document Uploaded 2017-07-13 Available
Att. J - Laboratory Form.docx Supplementary Document Uploaded 2017-07-13 Available
Att. I - Protocol for specimen collection ESP.docx Supplementary Document Uploaded 2017-07-13 Available
Att. I - Protocol for specimen collection.docx Supplementary Document Uploaded 2017-07-13 Available
Att. F - ZIPER Phone Recruitment Script ESP.docx Supplementary Document Uploaded 2017-07-13 Available
Att. F - ZIPER Phone Recruitment Script.docx Supplementary Document Uploaded 2017-07-13 Repair queued
Att. E - Consent forms ESP.docx Supplementary Document Uploaded 2017-07-13 Available
Att. E - Consent forms.docx Supplementary Document Uploaded 2017-07-13 Available
Att. C - Model coupon.docx Supplementary Document Uploaded 2017-07-13 Available
Att. B - 60-day FRN (0920-1140).pdf Supplementary Document Uploaded 2017-07-13 Available
Att. A - Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document Uploaded 2017-07-13 Available
SSB_0920-1140_2017_Revision.docx Supporting Statement B Uploaded 2017-07-13 Available
SSA_0920-1140_13JUL2017.docx Supporting Statement A Uploaded 2017-07-13 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
227482 Contact Information Form Form and Instruction New
227481 Shedding Eligibility Form Form and Instruction New
227480 Questionnaire for Men in Semen Study Form and Instruction New
227479 Shedding Questionnaire - Asymptomatics Form and Instruction New
227478 Shedding Questionnaire - Symptomatics Form and Instruction New
227477 Shedding Questionnaire - Public Health Personnel Form and Instruction New
222428 Contact Information Form Form Removed
222266 Shedding Eligibility Form and Instruction Removed
222265 Baseline and Follow-Up Questionnaire - Asymptomatic Form and Instruction Removed
222264 Baseline and Follow-Up Questionnaire - Symptomatic Form and Instruction Removed
ICR Details
0920-1140 201707-0920-005
Historical Active 201606-0920-022
HHS/CDC 0920-1140
Zika virus persistence in body fluids of patients with Zika virus infection in Puerto Rico (ZIPER Study)
Revision of a currently approved collection   No
Regular
Approved without change 08/15/2017
Retrieve Notice of Action (NOA) 07/14/2017
  Inventory as of this Action Requested Previously Approved
08/31/2018 36 Months From Approved 10/31/2017
1,302 0 3,400
241 0 407
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 Revision ICR is being submitted to allow information collection activities to continue with the addition of, 1) a follow-up household visit to determine how many household members of Zika virus-infected participants become infected during the 4 months following initial screening, and 2) a follow-up with men with Zika virus-positive semen specimens to better understand the effect of Zika virus infection on sperm.
US Code: 42 USC 241 Name of Law: Public Health Service Act
  
None
Not associated with rulemaking
  82 FR 16837 04/06/2017
82 FR 32554 07/14/2017
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 1,302 3,400 0 -2,098 0 0
Annual Time Burden (Hours) 241 407 0 -166 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
Submission of 0920-1140 is a Revision ICR to allow information collection activities to continue with the addition of, 1) a follow-up household visit to determine how many household members of Zika virus-infected participants become infected during the 4 months following initial screening, and 2) a follow-up with men with Zika virus-positive semen specimens to better understand the effect of Zika virus infection on sperm.
$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.
07/14/2017