Zika Virus Pilot Project

Forms and Documents

Document Name	Status
Form 1 Zika Pilot Study Data Collection Form Form	New
FINAL ZIKA Supporting Statement 7-19-18 CLEAN.docx Supporting Statement A	2018-07-19

IC Document Collections

IC ID	Document Title	Status
231808	Zika Pilot Study Data Collection Form Form	New

ICR Details

OMB Control No: 0906-0036	ICR Reference No: 201806-0906-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/HRSA	Agency Tracking No:
Title: Zika Virus Pilot Project
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 07/19/2018
	Date Received in OIRA: 06/15/2018
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	09/30/2018	36 Months From Approved
Responses	1,160	0	0
Time Burden (Hours)	589	0	0
Cost Burden (Dollars)	0	0	0

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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.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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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

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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	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

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new ICR so burden increases from zero (0) to 589 hours.

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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

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Common Form ICR:  No

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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: 06/15/2018

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