Zika Virus Pilot Project

ICR 201806-0906-001

OMB: 0906-0036

Federal Form Document

Forms and Documents
IC Document Collections
IC ID
Document
Title
Status
231808 New
ICR Details
0906-0036 201806-0906-001
Historical Active
HHS/HRSA
Zika Virus Pilot Project
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 07/19/2018
Retrieve Notice of Action (NOA) 06/15/2018
The agency is required to display the OMB Control Number and inform respondents of its legal significance in accordance with 5 CFR 1320.5(b).
  Inventory as of this Action Requested Previously Approved
09/30/2018 36 Months From Approved
1,160 0 0
589 0 0
0 0 0

This is a request for OMB approval for a data collection form to be used as part of a pilot project regarding Zika virus (ZIKV) screening for deceased potential organ donors. Participating Organ Procurement Organizations (OPOs) will be asked to submit testing results for deceased potential donors who may have been exposed to ZIKV. Data for the ZIKV pilot project will be collected from those OPOs who agree to participate in the pilot project. This data collection will be analyzed to determine the potential effect of making available screening tests for ZIKV, when appropriate, to improve transplant safety, and to inform future OPTN policy regarding testing of solid organ donors for ZIKV.

US Code: 42 USC 274(b)(2)(I) Name of Law: PHSA Section 372(b)(2)(I)
   PL: Pub.L. 98 - 507 0 Name of Law: National Organ Transplant Act of 1984
  
None

Not associated with rulemaking

  83 FR 5794 02/09/2018
83 FR 27784 06/14/2018
No

1
IC Title Form No. Form Name
Zika Pilot Study Data Collection Form 1 Zika Data Elements Instrument.docx

  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 1,160 0 0 1,160 0 0
Annual Time Burden (Hours) 589 0 0 589 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new ICR so burden increases from zero (0) to 589 hours.

$385,092
No
    Yes
    Yes
No
No
No
Uncollected
Elyana Bowman 301 443-3983 [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.
06/15/2018


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