View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0906-0036
ICR Reference No:
201809-0906-001
Status:
Historical Active
Previous ICR Reference No:
201806-0906-001
Agency/Subagency:
HHS/HRSA
Agency Tracking No:
Title:
Zika Virus Pilot Project
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
09/27/2018
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/06/2018
Terms of Clearance:
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
Expiration Date
09/30/2021
36 Months From Approved
09/30/2018
Responses
1,160
0
1,160
Time Burden (Hours)
589
0
589
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
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
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
83 FR 5794
02/09/2018
30-day Notice:
Federal Register Citation:
Citation Date:
83 FR 27784
06/14/2018
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Zika Pilot Study Data Collection Form
1
Zika Data Elements Instrument.docx
ICR Summary of Burden
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
1,160
0
0
0
0
Annual Time Burden (Hours)
589
589
0
0
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$385,092
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
Yes
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Elyana Bowman 301 443-3983 enadjem@hrsa.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
09/06/2018
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